Clinical Trial Site Manager

Job Title: Clinical Trial Site Manager

Location: San Francisco, CA

Job Type: Full Time

Job Details:

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