Job Details
Clinical Trials Site Manager, you will be an
essential member of our clinical team. You will lead the study team and be responsible for the execution
of complex clinical trials from study design through study close out. You will be responsible for business
and financial management of our research site as well as oversight of day-to-day operations.
Education: B.A./B.S. degree (or equivalent combination of education and experience) in Health Sciences
or related field
What you will do:
Perform daily oversight and business management of all trials from start to study closure
Manage and build a team of clinical research coordinators
Oversee and lead patient recruitment to fill studies in a timely manner, expand recruitment
sources
Conduct procedures such as vital signs, blood draw according to study protocol
Package, label, process, and ship specimen, filing and tracking of study visits, surveys
documents, including monitoring reports and study source documents
Serve as primary contact for sponsors regarding new studies, submission, IRB, IMVs, PSV and
renewals
Perform oversight of clinical activities, NDA, FQ, site qualifications, and site initiation
management
Manage trial feasibility process and oversee site capability assessments in collaboration with the
sponsor team
Ensure trials follow in accordance with ICH/GCP standards and SFRI's SOPs
Participate in review of clinical data to ensure readiness for QA and IRB regulatory audits
Assist regulatory staff with maintaining accurate information in all regulatory documents and study
binders
Review clinical monitoring reports to ensure identification of site issues and implement corrective
actions
Lead research staff to meet deadlines, and support quality and profitability
Track budgets and report expenses to contribute to budget forecasting
Oversee the drafting of site materials including training, manuals, and support documentation
Evaluate and provide revisions on protocols and clinical and regulatory documents
Lead weekly staff meetings related to BF, staffing, expenses. A/R, payable, study protocols clinic
updates, and research activities
Conducts interviews, hiring, and reviews for study team
Ensure proper use and maintenance of all study equipment, inspections and calibrations
Responsible for overall administration of all site-related activities
Required Skills:
2+ years experience in coordinating clinical trials
2+ years experience in a clinical operations or leadership role
Current GCP and familiarity with FDA/ICH regulations
Relevant experience across more than one phase of development, and across the entire lifecycle
of a study
Excellent organization and attention to detail
Quick and eager learner
Ability to work independently
Strong critical thinking
Professional demeanor
Excellent oral and written communication
Preferred Skills:
2+ years of experience in related fields (MA, CNA, LPN)
Licensed Phlebotomist/Vaccination administration
Experience in the Biopharmaceutical industry, Dermatology, Esthetics, Dietary Supplements or
Ophthalmology, or Internal Med, Infection, Ob Gyn, Neurology, Cardiology or GI studies
Experience working with young patient groups and diverse communities
Job Types: Full-time, Contract
Schedule:
8 hour shift
Monday to Friday
Ability to commute/relocate:
San Francisco, CA 94127: Reliably commute or planning to relocate before starting work