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Senior Clinical Research Associate

San Francisco, CA

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Senior Clinical Research Associate
San Francisco, CA | Clinical Operations | Clinical Operations

Job Description
Job Responsibilities
Support the Study Lead responsible for the study(ies) with various
aspects of a trial execution to ensure that studies are completed on
time, within budget, and in compliance with SOPs, FDA regulations and
ICH/GCP guidelines.
Assist with key study parameters (e.g. start-up activities,
enrollment, site management, data collection, data reviews, site
feasibility, database lock, etc.) and proactively identify solutions
within the clinical team when issues arise.
Develop and review informed consent forms, study manuals, and other
study operations materials.
Assist in the process of evaluating, selecting, and managing
clinical study sites.
Assist in the evaluation of CROs, other vendors, and systems. With
supervision, negotiate contracts/budgets with CROs and other vendors
as applicable.
Assist/lead the oversight and management of CROs/vendors.
Participate in assessing study metrics/progress and providing
updates to the Study lead.
Develop/review action plans to address issues with investigational
sites and/or CROs/vendors.
Assist/create study specific tools and manuals to ensure timeliness,
standardization and control of data quality.
Serve as a primary contact for assigned sites/countries.
Review and provide input on regulatory documents and Clinical Trial
Application documents as assigned.
Review and negotiate clinical site study contracts and budgets.
Assist, coordinate, and present at Investigator Meetings and CRA
Training meetings as needed.
Perform Sponsor Oversight Visits as required.
Support internal and external audits/Inspections of clinical trial
sites and vendors and assist with resolution of audit/Inspection
Coordinate/participate in clinical team
meetings/teleconference/WebEx and prepares agendas, meeting minutes,
and track action items.
Create/revise/review departmental SOPs, as requested.
Participate in department process improvement initiatives.
Perform other work-related duties as assigned.
Skills & Requirements
Knowledge of FDA regulatory requirements and ICH/GCP guidelines.
Demonstrated proficiency in supporting the operational activities of
a clinical trial, from start-up to close-out. Experience with working
on global trials a plus.
Strong organizational skills, ability to prioritize and multi-task.
Excellent verbal and written communication skills.
Demonstrated problem-solving and negotiation abilities.
Ability to work as part of a team/active team participant.
Computer proficiency (Outlook, MS Word, Excel, and Powerpoint).
Education and Experience
Bachelor s degree in a scientific discipline or health-related
Minimum of 4 years clinical research experience and at least 2
years experience as a CRA in a biopharmaceutical company or CRO.
Previous experience with Global oncology clinical trials is strongly
Previous site monitoring experience performing site Qualification,
Initiation, Interim and Close-Out Visits a plus.
Working Conditions
* Willingness to travel as necessary, consistent with project needs.

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