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<![CDATA[TestAmerica is recognized as the leading environmental testing firm in the United States. Operations include a nationwide network of 40 environmental testing laboratories and 27 service centers. TestAmerica provides innovative technical expertise and comprehensive analytical testing services. We recruit candidates with science degrees and college students interested in the sciences. Employees enjoy our comprehensive training programs and dedication to continuous development. We have an immediate need for a ENTRY LEVEL Organic Extractions Analyst in Nashville, Tennessee. The Analyst I performs environmental analyses and/or preps of samples using standard analytical techniques in compliance with TestAmerica’s Quality Assurance programs and SOP’s. Shift: <li>Full time position</li> <li>4- 10hr/day shift which will include Saturday shift</li> <li>Must be able to work OT when sample volume requires it</li> Essential Duties and Responsibilities * Responsible for meeting TestAmerica H&S guidelines as appropriate to job function * Performs routine lab tasks that provide experience and familiarization with methods, practices, and programs. These include: * Preparation of samples using standard techniques * Performing chemical analysis using standard techniques * Calculating data * Recording and reporting data and any unusual test occurrences to the supervisor * Performing routine maintenance of instruments * Conforming to lab QA/QC practices * Responsible for general housekeeping in his/her work area * Ability to become trained and competent on complex instrumentation including any but not limited to gas chromatography, gas chromatography/mass spectrometry, atomic absorption, ICP, and instrument specific data systems. TestAmerica offers competitive pay and a comprehensive benefits package, including medical, dental, 401(k), life and disability plans as well as generous vacation benefits and an Employee Assistance Program. **Recent graduates encouraged to apply - this is an entry level position** Requirements Education: <li>BS in Chemistry or 8 years laboratory experience may substitute for degree. Experience: <li>Laboratory experience helpful. Previous production-oriented work helpful (awareness and ability to meet deadlines) Knowledge <li>Analytical and/or General Science </li> <li>Scientific methods and method compliance</li> <li>Strong Mathematics background </li> <li>Knowledge of Standard Operating Procedures</li> <li>Knowledge of laboratory procedures</li> <li>Laboratory safety rules and chemical hazards</li> ]]>

<![CDATA[TestAmerica is recognized as the leading environmental testing firm in the United States. Operations include a nationwide network of 40 environmental testing laboratories and 27 service centers. TestAmerica provides innovative technical expertise and comprehensive analytical testing services. We recruit candidates with science degrees and college students interested in the sciences. Employees enjoy our comprehensive training programs and dedication to continuous development. We have an immediate need for a ENTRY LEVEL Metals Analyst in Nashville, Tennessee. The Analyst I performs environmental analyses and/or preps of samples using standard analytical techniques in compliance with TestAmerica’s Quality Assurance programs and SOP’s. Shift: <li>Full time position</li> <li>Mon-Friday shift with occassional Saturday schedule</li> <li>Must be able to work OT when sample volume requires it</li> Essential Duties and Responsibilities * Responsible for meeting TestAmerica H&S guidelines as appropriate to job function * Performs routine lab tasks that provide experience and familiarization with methods, practices, and programs. These include: * Preparation of samples using standard techniques * Performing chemical analysis using standard techniques * Calculating data * Recording and reporting data and any unusual test occurrences to the supervisor * Performing routine maintenance of instruments * Conforming to lab QA/QC practices * Responsible for general housekeeping in his/her work area * Ability to become trained and competent on complex instrumentation including any but not limited to gas chromatography, gas chromatography/mass spectrometry, atomic absorption, ICP, and instrument specific data systems. TestAmerica offers competitive pay and a comprehensive benefits package, including medical, dental, 401(k), life and disability plans as well as generous vacation benefits and an Employee Assistance Program. **Recent graduates encouraged to apply - this is an entry level position** Requirements Education: <li>BS in Chemistry or 8 years laboratory experience may substitute for degree. Experience: <li>Laboratory experience helpful. Previous production-oriented work helpful (awareness and ability to meet deadlines) Knowledge <li>Analytical and/or General Science </li> <li>Scientific methods and method compliance</li> <li>Strong Mathematics background </li> <li>Knowledge of Standard Operating Procedures</li> <li>Knowledge of laboratory procedures</li> <li>Laboratory safety rules and chemical hazards</li> ]]>

<![CDATA[Virginia-based firm has a requirement for a full-time Environmental Biologist in the Nashville area. Job discription includes the following: Able to assist in preparation and review of environmental documents such as Integrated Natural Resources Management Plans (INRMP), National Environmental Policy Act (NEPA), environmental surveys, project proposals, progress reports and management plans. Shall be able to perform EPAS inspections for compliance, scientific sampling, biological and environmental monitoring for different facilities and have the skills and ability to manage the data obtained and provide comprehensive briefings, assessments and recommendations on such projects. Qualifications include: Bachelor's degree in biology or environmental science and requires a minimum of two years experience in a biological or environmental field. Good organizational, oral and written communication skills are required. Please email resumes to cwhitehurst@bwm.hrcoxmail.com or fax to (757)588-4700.]]>

<![CDATA[BioExpress is a nationwide distribution company which specializes in providing high quality laboratory instruments, reagents and supplies to the life science research market. We have an immediate opening in a growing and established territory. Responsibilities will include calling on Private Biotechnology/Pharmaceutical Companies and Academic Accounts within Tennessee, Alabama, and Mississippi with a strong emphasis on Vanderbilt University, the University of Tennessee, St. Jude Children's Research Hospital, and the University of Alabama. This opportunity involves a high level of customer interaction, a solid understanding of the customer's scientific supply needs, and the ability to present tailored solutions. Candidates should have a BS Degree in the Life Sciences (Microbiology, Biochemistry, Molecular Biology, etc…) or sufficient research experience. Candidates with proven, successful sales experience will also be strongly considered. Candidates must also be highly motivated, able to demonstrate the ability to produce with minimal supervision, and possess strong communication skills. Only candidates selected for interviews will be contacted.]]>

<![CDATA[Since 1967 EMPIRICAL LABORATORIES has consistently provided exceptional analytical services for a complete range of environmental test requirements, including the analysis of conventional and non-conventional pollutants in groundwaters, surface waters, industrial wastewaters, soils, sediment, tissue, vegetation, air, solid wastes, and drinking water. EMPIRICAL LABORATORIES has an immediate FULL-TIME opening for a Laboratory Scientist to join our team of professionals. We offer an attractive benefit package which includes competitive salaries, comprehensive medical and dental, flexible spending accounts, vacation/holiday paid time off and 401K. (DFWP/EOE/MFDV) ESSENTIAL FUNCTIONS: Performs sample processing, analysis, reporting, and review as assigned and in accordance with required regulatory criteria. Assists in training, problem solving, and provides backup for all personnel within the laboratory operation as directed. Works effectively within the section team to meet the overall goals of the section, which would also be in line with the overall Company’s goals. MINIMUM REQUIREMENTS: - A minimum of a bachelor degree in the sciences. - A MINIMUM OF ONE TO TWO YEARS EXPERIENCE IN VOLATILE ORGANIC COMPOUND ANALYSIS IN THE ENVIRONMENTAL INDUSTRY. - Good organizational skills. - Good written and verbal communications skills. - Ability to follow directions and work independently. TOOLS AND EQUIPMENT USED: Computer and peripherals, laboratory information management system software, any range of standard and computerized instruments and equipment utilized within the assigned laboratory area, and a variety of chemical reagents.]]>

<![CDATA[OUR Lab is hiring for a Lab Assistant. *****Hours are full time Monday through Friday***** **** 8am – 4:30pm **** ***Salary Range: $12.50 - $15 / Hour*** **All qualified applicants, please forward resume to resume@ourlab.net.** Responsibilities: Accessioning in Specimens Grossing Histology specimens Quality control Filing Slides Other duties as assigned Requirements (Education, Skills, Experience, License, etc): AS or BS Degree in a Biological Sciences, Chemistry or Physics Histology Experience preferred, but not required “OUR Lab is a drug free workplace; all applicants will be screened prior to employment and may be subject to random drug screens.” ]]>

<![CDATA[OUR Lab is hiring for a Lab Assistant-Accessioner. *****Hours are part time Monday through Friday***** **** 7am – 11am **** ***Salary Range: $10 - $12 / Hour*** **All qualified applicants, please forward resumes to resume@ourlab.net.** Responsibilities: Accessioning histology specimens, entering demographics Filing histology slides Other duties as Assigned Requirements (Education, Skills, Experience, License, etc): High School diploma or GED required Some computer skills are necessary Excellent eye for detail Ability to learn quickly Excellent organizational skills “OUR Lab is a drug free workplace; all applicants will be screened prior to employment and may be subject to random drug screens.” ]]>

<![CDATA[------------------------------------------------------------------------------------------------------------------------------------------ OLSA Resources ® is a National Award Winning Staffing and Engineering Agency that places people on temporary and long-term Jobs assignments with a variety of clients in the sectors of Administration Business, Financial, Engineering, IT, Manufacturing, Medical and Warehousing. ------------------------------------------------------------------------------------------------------------------------------------------ SUBMITTALS: Candidates applying without their Resumes will not be Reviewed. Must send a Resume ------------------------------------------------------------------------------------------------------------------------------------------ POSITIONS: 1 ------------------------------------------------------------------------------------------------------------------------------------------ PAY RANGE: $10.00 ------------------------------------------------------------------------------------------------------------------------------------------ JOB DETAILS: Grade 2 - Prepares laboratory specimens for designated departments/locations prior to laboratory analysis and testing. Unpacks specimens from branches or ports and routes specimens by type to various staging areas. Prepares all specimens received for testing in designated laboratory departments or locations such as staging of specimens, centrifuge, separate serum, and blood smears. Aliquots sample for departments. Prepares excess specimen samples for storage and resolves and document problem specimens. Administrative: Answer telephones, maintain logs/records, organizational skills, proficiency with numbers, research information, time management, train employees, use computerized databases, written and verbal communications. Machine: Personal computer. Physical Demands: Speech clarity, utilization of fingers and hands, standing-remaining on one’s feet in an upright position, sitting-remaining in the normal seated position, handling-seizing, holding, grasping. Moderate physical effort (up to 30 pounds); must comply with applicable safety procedures. Additional job duty (as assigned): (Hazardous Chemical Waste Management) Proper identification of known hazardous material in the work place. The knowledge of personal protection measures. The avoidance of accidents. The knowledge of hazardous waste characteristics, hazardous waste volume generation limits, accumulation limits, spill control measures, record keeping, proper handling and container management, labeling, container and storage inspection. Working Conditions: Possible exposure to infection from disease-bearing specimens; regularly exposed to the risk of blood-borne diseases; must comply with applicable safety procedures. Vision Requirements: Far acuity-ability to see clearly at 20 feet or more; near acuity-ability to see clearly at 20 inches or less; depth perception-ability to judge distance and space relationships; color vision-ability to distinguish and identify different colors. License/Certification/Education: Normally a High School Diploma or equivalent w/1-2 years of experience ------------------------------------------------------------------------------------------------------------------------------------------ SHIFT: Day ASSIGNMENT LENGTH: 4 months ------------------------------------------------------------------------------------------------------------------------------------------ DRUG SCREEN and BACKGROUND may be required before submittal start of work. ------------------------------------------------------------------------------------------------------------------------------------------ APPLY ONLINE: <a href="http://www.olsaresources.com/JobDetails.aspx?rid=RQ00011918" rel="nofollow">http://www.olsaresources.com/JobDetails.aspx?rid=RQ00011918</a> ------------------------------------------------------------------------------------------------------------------------------------------ Thank You OLSA Resources ® HR Department WEBSITE: www.olsaresources.com Technical Professional Staffing | Engineering Design Services | Information Technology | Human Factor WBENC Star Award | TOP 100 Women Business | TOP 100 Diversity Business |TOP 100 Private Business ------------------------------------------------------------------------------------------------------------------------------------------ ]]>

<![CDATA[Since 1967 EMPIRICAL LABORATORIES has consistently provided exceptional analytical services for a complete range of environmental test requirements, including the analysis of conventional and non-conventional pollutants in groundwaters, surface waters, industrial wastewaters, soils, sediment, tissue, vegetation, air, solid wastes, and drinking water. EMPIRICAL LABORATORIES has an immediate FULL-TIME opening for a Laboratory Technician to join our team of professionals. We offer an attractive benefit package which includes competitive salaries, comprehensive medical and dental, flexible spending accounts, vacation/holiday paid time off and 401K. (DFWP/EOE/MFDV) DUTIES: -Assists and provides backup for all personnel within the laboratory operations as necessary. -Follows directions to perform assigned responsibilities within the section, in a timely and accurate manner. -Responsibilities may include glassware cleaning, sample and standard preparation, sample and standard disposal, instrument loading and sample receiving and processing. -Work within the specified department to meet the overall goals in the department in compliance with good laboratory practices and also in line with overall company goals. -Follows laboratory practices for safety and waste management. -Adheres to all company policies and procedures at all times. -Maintains cleanliness of work area. EDUCATION: -A minimum of a high school diploma KNOWLEDGE AND EXPERIENCE: -Entry level -Good organizational skills -Good written and verbal communications skills -Ability to follow directions and work independently -Working knowledge of standard office commercial computer software preferred]]>

<![CDATA[Clinical Research Associate (CRA) CRAs are responsible for monitoring and compliance activities related to the company's clinical trials. Other duties and responsibilities include collaboration with regulatory affairs, clinical manufacturing, and R&D. Specific responsibilities include: • Responsible for the administration and organization of clinical research activities at the investigational site level; including training and monitoring of investigators / clinical site staff, supporting regulatory submissions for EU, US, and Canada, writing reports, and ensuring regulatory compliance of clinical trials with regulations and quality systems; • Ensure that the highest quality and ethical standards of the Company's clinical research activities are maintained; • Monitoring and/ or auditing of investigative sites, CROs, ans study files; • Manage follow-up activities associated with clinical unexpected and serious adverse event reporting; • Management of investigator contracts and payment process; Our ideal candidate will possess: • Bachelors Degree in Nursing or Life Sciences • At least 2 years clinical trial experience related to trial monitoring; prefer experience in orthopedic medical devices or combination products in trauma and/or bone biology • Professional certification preferred (CCRP, CCRA, etc.); strong proficiency with Excel, Word and Power Point; excellent organizational and interpersonal skills • Ability and willingness to travel up to 50%-60% of time depending upon project needs ]]>

<![CDATA[ Responsibilities • Design and direct the company’s global clinical study strategy to obtain timely regulatory approval of products and acceptance by clinicians • Lead the design of credible clinical studies, integrating inputs from clinical study professionals, clinicians, statisticians, regulatory agencies, and management • Manage contracted Clinical Research and Core Lab staff and other consultants to prepare materials, engage clinicians, conduct studies, compile data, and produce reports on schedule and within budgets • Develop relationships with participating clinicians and clinical research staff to assure effective management and communications • Lead the preparation of the clinical portion of regulatory submissions • Represent the company’s clinical perspective in regulatory agency interactions • Inform senior management of clinical study status and issues • Participate in publication of clinical results Experience & Education • 10+ years working in clinical study programs in the medical products industry, including at least 4 years managing design and successful completion of clinical studies • Demonstrated effectiveness in managing and motivating Clinical Research Organizations • Significant role in directing participating clinicians • Knowledge of international clinical regulatory requirements • Strong planning, communication, and management skills • Preparation of clinical publications • BS/MS in life sciences with training in clinical research • Frequent international travel RESPONSIBILITIES OF POSITION • Develop the clinical strategies for assigned therapeutic area(s) in collaboration with business partners. • Effectively execute on the clinical strategies and studies to achieve defined business goals and objectives.* • Direct the analysis, planning and implementation of the Clinical Studies and ensure that project timelines and budgets are met.* • Lead and mentor the group, ensuring that the team is staffed with highly motivated and skilled professionals who contribute to the overall AMS mission.* • Lead the recommendation and selection process of all pre and post clinical research studies within the therapy area(s)* • Build strategic partnerships to achieve departmental and organizational objectives. Interact with internal and external leaders, regulatory agencies, customers, vendors and/or suppliers.* • Communicate at all levels in the organization to ensure that therapeutic area(s) strategic plans are clearly understood and the vision, values, and philosophy of the company are maintained.* • Define, assist and prioritize with clinical investigators appropriate clinical research papers, abstracts, and presentations within the therapy area(s) • Coordinate resources with other groups within the clinical department to ensure resource allocations that maximize global revenue forecasting and meet business objectives within budget.* • Monitor and ensure compliance with company policies and procedures (e.g. compliance with FDA, ISO, EEO regulations, etc.). • Work with other members of the clinical affairs management team to develop and/or identify new work processes that will have broad applicability throughout the company; contributes ideas for improving work processes and achieving organizational goals; investigates and solves problems that impact work processes and personnel in multiple units or departments. • Must be able to travel at least 20% of schedule, both domestic and international. • Develop plans to enhance enrollment, promote collaborations with KOLs, and ensure compliant clinical sites EXPERIENCE • > 5 years experience in managing drug, medical device, or epidemiological multi-center IDE or IND studies, or equivalent. Must have primary responsibility in designing, executing a full study; preferably a regulated study successfully • 1 to 2 years experience managing a team of clinical professionals is preferred • Demonstrated ability and/or experience in physician/patient contact. • Experience working on and leading cross-functional teams required, multi-disciplinary experience including marketing is preferred. • Track record of working independently, performing accurate assessment and planning, providing leadership, utilizing effective problem solving and creative thinking techniques, consistently meeting deadlines and achieving deliverables, and demonstrated professionalism and follow through. • Must be seen by their peers as a leader and have demonstrated ability to achieve results through leading teams of professionals. SKILLS • In-depth knowledge of IDE/IND, PMA/NDA, 510(k) or equivalent and GCP procedures. Working knowledge of GCI procedures and international processes. • In-depth knowledge of clinical study processes and statistical concepts and principles. • Technical and medical aptitude required in achieving an expert level of knowledge of the therapeutic area(s) disease states and the device/technology utilized in treatment and diagnosis of associated conditions. • Demonstrated ability to drive cross-functional efforts and manage clinical project teams and oversight a project portfolio with consistent achievement of deliverables. In-depth knowledge of study design and development of study processes to support the design. • Ability to establish immediate credibility at all levels, inside and outside the organization • Demonstrated effective written, verbal and interpersonal communication skills • Creative problem solving skills coupled with good judgment ]]>

<![CDATA[Since 1967 EMPIRICAL LABORATORIES has consistently provided exceptional analytical services for a complete range of environmental test requirements, including the analysis of conventional and non-conventional pollutants in groundwaters, surface waters, industrial wastewaters, soils, sediment, tissue, vegetation, air, solid wastes, and drinking water. EMPIRICAL LABORATORIES has an immediate FULL-TIME opening for a Sample Receiving Specialist to join our team of professionals. We offer an attractive benefit package which includes competitive salaries, comprehensive medical and dental, flexible spending accounts, vacation/holiday paid time off and 401K. (DFWP/EOE/MFDV) DUTIES: -Receipt and distribution of environmental samples -Provide supporting functions and act as back-up to Department Supervisor -Receives/prepares bottle order requests from clients -Assists with sample disposal -Cleans and prepares coolers for stock -Adheres to established procedures of field sampling -Provide prompt, professional and courteous service to clients -Follows laboratory practices for safety and waste management EDUCATION: -A minimum of a high school graduate KNOWLEDGE AND EXPERIENCE: -Entry level -Must have a valid Tennessee Driver’s License; have and maintain a good driving record -Working knowledge of standard office commercial computer software and data systems preferred -Must have good written and verbal communication skills -Ability to follow instructions closely and work independently PHYSICAL REQUIREMENTS: -Ability to lift heavy equipment and supply materials (approx. 60 lbs.) -Ability to work in all types of weather and travel within the State day to day ]]>

<![CDATA[Wanted, experienced photovoltaic / hydronic system project managers or installers - willing to teach others how to install and service photovoltaic arrays and hydronic hot water and radiant heating systems. CAD experience and experience with flow charts and project schedules is desired. MS Office Word and Excel required - knowledge of NEC required. ]]>

<![CDATA[ Position Title: Senior Clinical Research Associate Manager: Associate Director Clinical Operations/ CD Manager Position Purpose: Performance and/or supervision of monitoring activities pertaining to clinical trials. Ensure compliance with SOPs, GCP and regulatory requirements. Educational /Experience requirements: B.S., MS degree or experience in a life science/biological related field preferred. At least 2 years of experience in monitoring of clinical trials. Working knowledge of GCP and ICH Guidelines, FDA/EU guidelines, and local requirements. Fluent in English. Essential Position Function: Ability to perform monitoring activities and manage work in an environment of rapidly changing priorities. Strong organizational and time management skills with good attention to detail. Ability to work within an international team environment. Ability to problem solve and work independently. Excellent interpersonal communication skills (verbal and written). Ability to travel at least 50% of time. Proficient in MS office suite. Primary Responsibilities: • Cooperate with responsible CTMs and/or Clinical Operations Manager and/or CD Managers, if applicable, on all aspects of the clinical trials. • Identify investigators, perform feasibility and assess sites with regard to protocol requirements and local aspects. • Conduct site visits (eg selection, initiation, periodic, close-out) in phase 1 through 4 trials and prepare Monitoring Reports, if applicable. • Manage assigned investigational trial sites, if applicable and identify areas requiring follow-up and improvement at each site and recommend corrective actions. • Serve as main contact and support for sites on all monitoring issues and site-specific issues • Responsible for source data verification and clarification of discrepancies with investigator, ensure resolution of data queries, if applicable. • Ensure adequate reporting/tracking of subject status, protocol deviations and adverse events, if applicable. • Review Protocol and Amendments and manage/support preparation of CRFs, diaries and other clinical trial documents. • Collect, review and maintain regulatory documents. • Provide translation or organize translation of trial related documentation (for IEC/IRB and regulatory submissions and Trial Master File) for assigned countries in accordance with GCP, regulatory requirements. • Assist with and/or prepare all necessary documentation for IEC/IRB and regulatory submissions, eg local or site specific versions of Informed Consent, as applicable. • Assist with filing and archiving of trial related documents as required by local laws, as applicable. • Provide regular updates on monitoring activities and/or issues of respective trials and participate in Clinical Trial Team meetings. • Support Clinical Operations Manager in e.g. training/mentoring of internal and vendor personnel on trial specific monitoring issues and procedures, preparation, review and update of monitoring tools, tracking of monitoring activities. • Manage assigned CRAs and vendor activities and performance evaluation. • Conduct assessment visits with assigned CRAs as necessary to ensure quality of monitoring activities and initiate corrective actions where appropriate. • Such other responsibilities and projects that the Company/Trial Team may assign, eg, cooperation on SOP preparation/review. ]]>

<![CDATA[• Cooperate with team members on all aspects of clinical trials. • Participate in clinical Trial Team meetings and/or other trial-related meetings as appropriate • Prepare, distribute and file agenda, minutes and meeting materials as required • Draft and/or assist with the preparation of trial-related documents, tools and templates, including newsletters. • Create and maintain designated trial tracking systems in accordance with trial requirements • Assemble and/or review regulatory packages • Set-up, maintain and manage TMF in collaboration with the ACPM/CPM and TMF personnel • Review and file documents in the Trial Master File (TMF) • Facilitate communication and flow of information: • Between Trial Team and CSMs and/or Vendors, as applicable; • Investigator Site personnel; • Review and process investigator grants/payments and vendor payments, as needed to ensure budgetary contractual agreements are met • Assist CPMs in the reconciliation of vendor invoices • Assist CPMs with maintenance of study budget(s) • Distribute Safety Alerts to Investigators as needed • Support ACPMs/CPMs with administrative duties (e.g. create of presentations, travel and expenses, calendar management) • Coordinate scheduling for delivery of goods and/or services, including printed materials. • Occasional travel including overnight stays may be required. • Such other responsibilities and projects, according to competence, that the Company/Trial Team may assign ]]>

<![CDATA[ Associate Clinical Project Manager (ACPM) Accountable for planning, coordination and supervision of all monitoring and site-related operational activities of one or more clinical studies from protocol summary through study report, including trial master file archiving and other operational post-report activities. Provides operational support to the CPM to deliver the project within planned timelines and according to required standards of quality and compliance. MAJOR ACCOUNTABILITIES Lead, train, track, and coordinate activities of the monitoring team to execute studies (predominantly phases IIIb/IV) in the required countries to deliver timely and high quality study data. • Oversee all study related site management and monitoring activities including review and follow up of monitoring visit reports and study-related accompanied site visits. • Review and approval site regulatory package. • Proactively manage compliance and quality issues. • Assist in site contract issues and follow up where needed • In collaboration with CPM/Study Team, ensure that the study is audit/inspection ready at all times and any resulting findings from audits/inspections are addressed appropriately and in a timely manner. • Generate study documents (eg Patient Information Sheets, Informed Consent Forms, CRFs, Monitoring Manual, and associated tools) and coordinate translations • Review and give input into Protocols, Amendments, Clinical Trial Reports, and other trial related documents. • Manage, review and ensure quality of content of Trial Master File including archiving. • Support CPM in management of trials including but not limited to • vendor selection and management • training • logistics • selection of sites • maintenance of tracking systems • follow up of missing SAE data • Coordinate IEC/IRB submissions. Prepare or review responses to questions from regulatory authorities, and IECs/IRBs. • May perform duties described in the CPM job description (see Appendix) with oversight as necessary, according to competence level • Ensure quality and adherence to the relevant SOPs, GCP, regulatory guidelines and working practices. • Travel including overnight stays, possibly global, required. • Perform other tasks as deemed necessary by the Company • Perform Co-monitoring activities with the CRA/CSMs and generate follow up reports Education B.S. (or its equivalent) in a life science/biological or health related field required. A higher-level relevant qualification is preferred. Experience • At least three years’ relevant experience in clinical development preferably including team leadership and monitoring experience • Experience or capability to manage in-house and/or outsourced regional monitoring in global Phase IIIb/IV multicenter clinical studies from study start-up to archiving of the trial master file Specific skills • Team leadership and motivation of individuals on international teams • Operational task management • Delivery of presentations and training to both large and small audiences • Excellent verbal and written communication in English • Proficiency in the Microsoft office suite • Good interpersonal skills • Excellent time management and organizational skills • - Scientific and technical knowledge: - GCP and regulatory environment - Basic medical and research knowledge - Basic principles of data management and statistics Problem solving • Proactive approach, drive and follow through • Managing multiple concurrent responsibilities in an environment of changing priorities without close supervision. • Ability to handle detailed technical matters and team dynamics. • Reconciliation of conflicting priorities. ]]>