Base Salary: Confidential Bonus: Benefits: Other Compensation: A superb base salary and bonus structure are available; compensation is commensurate with experience and will be discussed with qualified candidates only.
Skills and Experience
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Qualifications / Skills Required
1) BA/BS (Chemistry, Biology or other science preferred)
2) 2 - 5 years of experience in clinical study monitoring/coordination, interpretation of FDA or international regulations and/or in biotechnology or a related industry
3) Knowledge of ICH-GCP
4) Willingness to travel (up to 30%)
Job Description
Print Job Description
Partial Job Description 1) Co-ordinate and monitor domestic and international studies undertaken by the company in support of research, marketing/sales and regulatory objectives, with limited oversight/supervision 2) Verify the reported trial data are accurate, complete and verifiable from source documents and the study is conducted in compliance with the approved protocol, Good Clinical Practices (GCP), SOPs, and applicable regulatory requirements 3) Participate in the study development and start-up process which may include, review and/or development of study protocols, designing and/or reviewing Case Report Forms (CRFs), preparing informed consent forms, developing study documents 4) Recruit and qualify clinical trial sites, including review of regulatory documents as required 5) Conduct site initiation, interim monitoring and closeout monitoring visits in compliance with all applicable regulations and company procedures 6) Prepare site visit reports 7) Maintain and track revisions to all documentation for accuracy, including informed consent forms and CRFs 8) Establish and maintain professional relationships (in person, by phone and/or email) with clinical investigators and site personnel as necessary to support clinical studies 9) Monitor status of communications with clinical study sites 10) Maintain and manage clinical study activities in database systems, consistent with company timelines and objectives 11) Organize, construct and audit in-house Trial Master Files 12) Ensure site and in-house Trial Master Files are complete, organized, and contain the required documents 13) Analyze and evaluate clinical data presented in literature or generated as part of sponsored studies 14) Continue to develop regulatory knowledge of worldwide IVD requirements 15) Prepare documents for regulatory communications, including submissions (pre-IDE, 510(k), PMA, CLIA Waiver, registration dossiers) 16) Support all clinical affairs activities as needed
