Job Title: Clinical Trials Management Associate
Company: Integrated Resources INC
Location: Foster City, CA, USA
Employment Type: Contractor
Compensation: $39 to $53.25 per hour (Estimated Pay)
Position Summary:
Integrated Resources, Inc. is seeking a Clinical Trials Management Associate to join their team in Foster City, CA. This contract-based role will involve managing clinical trial activities, ensuring site compliance with protocols and regulatory requirements, and assisting with various aspects of study timelines, vendor coordination, and data review. The successful candidate will have a solid understanding of clinical trial management, FDA regulations, ICH Guidelines, and GCPs, and will play a key role in ensuring the success of clinical trials.
Key Responsibilities:
Conduct site evaluations, initiations, closeout visits, and routine monitoring visits with limited supervision.
Ensure site compliance with study protocols, regulatory requirements, and data quality.
Assist in setting and updating study timelines.
Assist in CRO or vendor selection and coordinate with CROs or vendors.
Draft and review protocols, informed consents, case report forms, and monitoring plans.
Review routine data and assist in the preparation of safety, interim, and final study reports.
Resolve data discrepancies.
Participate in meetings and conference calls with CROs, vendors, and multi-functional teams.
Contribute to abstract presentations, oral presentations, and manuscript development.
Train Clinical Research Associates and Clinical Project Assistants.
Participate in departmental or interdepartmental strategic initiatives.
Travel is required.
Qualifications and Skills:
Education: Bachelor's degree or equivalent in a relevant field.
Experience: Proven experience in clinical trials management, including site evaluations, vendor coordination, and data review.
Skills:
Strong verbal, written, interpersonal, and presentation skills.
Proficient in Word, PowerPoint, and Excel.
Familiarity with FDA and/or EMEA Regulations, ICH Guidelines, and GCPs.
Ability to prioritize tasks and plan proactively.
Strong problem-solving skills with the ability to anticipate obstacles and develop solutions.
Ability to develop tools and processes to increase project efficiency.
Additional Information:
Travel: Required as part of the role.
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