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Coordinates the activities associated with the evaluation, initiation, and management of clinical trials. Manages clinical studies, including CRO oversight. Coordinates the training of staff involved in trial management.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Develop plans to manage clinical trials, determine operational risks and develop and mitigation plans to address risks proactively
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:
None
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education:
BS/BA in biological sciences or related field, or BSN, MS, MSN, PharmD or MPH
Experience/The Ideal Candidate will have:
Typically requires a minimum of 6 years of related experience in life sciences, including 4 years in experience in clinical research
Knowledge/Skills:
Experience with development of prospective site-selection criteria
Protocol development experience
Familiar with advanced concepts of clinical research
Ability to deal with time demands, incomplete information or unexpected events
Experience in interactions with outside vendors, e.g., CROs and contract labs
Experience with administration of site budgets and grants with supervision
Experience with reviewing adequacy of site-proposed ICs for compliance with relevant regulations
Demonstrated ability to write and present clearly using on scientific and clinical issues terminology
Advanced computer skills
Good organizational and planning skills
Strong interpersonal skills and communication skills (both written and oral)
Ability to work effectively in a team/matrix environment
Ability to understand technical, scientific and medical information
Familiar with basic concepts of clinical research
Ability to problem-solve
WORKING CONDITIONS:
G&A and Development/Alameda:
Environment: primarily working indoors, performing clerical work
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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.
