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Under the supervision of a senior member of the assigned clinical trials, the Clinical Research Specialist will coordinate day-to-day operational execution of clinical trials.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Perform CRO oversight activities such as Trip Report Review, TMF review and co-monitoring visits, per Study Plans. Provide written documentation of all activities including issues and findings in Spreadsheets or databases
Co-monitor clinical study sites up to 25% of travel; write and review reports for PSSVs, SIVs, IMVs, and COVs as required
Assist in the management of external vendors (e.g. clinical labs, study assessment labs)
Responsible for study start- up activities and tracking study metrics (e.g. ICF review, Investigator/site performance, recruitment, regulatory documents, and CRO TMF catalog); track study metrics such as site start-up, Investigator/site performance, recruitment, regulatory documents, CRO TMF catalog
Maintain internal document management system (e.g. Livelink) and TMF ensuring important documents and communication filed timely and appropriately
Assist with protocol- and study-specific training with vendor(s), site personnel and clinical sites
Review template informed consents and monitoring visit reports for completeness and accuracy and adherence to the protocol
Coordinate clinical drug / supply reconciliation with oversight of site and CRA reconciliation
May conduct data listing review of CRF data for safety, thoroughness, and data preparation for final study reports
Review and/or create study document (e.g. newsletters, worksheets, study trackers)
Assist in the coordination of study team management meetings, prepare agenda, draft and finalize minutes and track action items to completion
Working knowledge of clinical trial databases (e.g. EDC, CTMS, eTMF) and interactive response technologies (e.g., IWRS, IXRS), including report generation
Maintain a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, local regulatory requirements, SOPs, and study specific procedures
SUPERVISORY RESPONSIBILITIES:
Provides mentorship and guidance to junior level staff
EDUCATION/EXPERIENCE/SKILLS:
Education:
BS/BA degree in related discipline
Experience:
Four years of life sciences or medically related field experience including 3 years in managing clinical trials or equivalent combination of experience and education/training.
Experience in monitoring oncology studies preferred
Knowledge/Skills/Abilities:
Good communication skills both oral and written are a must. Applies strong analytical and business communication skills.
Familiarity with medical terminology and/or GCP guidelines strongly preferred.
Applies technical standards, principles, theories, concepts and techniques.
Excellent organizational skills are required.
Demonstrated success in problem solving.
Good computer skills are required. Working knowledge of MS Word, Excel, and PowerPoint is required, and applications as needed for job.
Detail oriented.
Ability to work in a team environment.
Self-motivation, eagerness to grow professionally and commitment to self-development.
Occasional travel may be required
JOB COMPLEXITY:
Works on assigned problems of moderate scope with analysis of situation or data required.
Exercises judgment within defined procedures and practices to determine appropriate action.
Builds productive internal and external working relationships.
Uses professional concepts and company’s policies and procedures to solve a variety of routine problems.
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DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
