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Clinical Trials Management Associate

2+ years
Not Disclosed
10 March 3, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Clinical Trials Management Associate

Company: Integrated Resources INC
Location: Foster City, CA
Job Type: Contract

Job Description:

The Clinical Trials Management Associate will support clinical research activities, ensuring compliance with protocols, regulatory requirements, and quality standards. This role involves site evaluations, CRO/vendor coordination, data review, and regulatory documentation.

Key Responsibilities:

1. Clinical Research & Compliance

  • Conduct site evaluations, initiations, monitoring, and closeout visits.
  • Ensure site compliance with protocols, regulatory standards, and data quality.
  • Assist in setting and updating study timelines.

2. Vendor & CRO Coordination

  • Support CRO and vendor selection.
  • Coordinate CROs and vendors under supervisor guidance.
  • Draft and review protocols, informed consents, case report forms, and monitoring plans.

3. Data Management & Reporting

  • Assist in data review and preparation of safety, interim, and final study reports.
  • Resolve data discrepancies.
  • Participate in meetings and conference calls with CROs, vendors, and teams.

4. Training & Cross-Functional Collaboration

  • Assist in training Clinical Research Associates and Clinical Project Assistants.
  • Work with teams across departments to address study issues.
  • Contribute to departmental strategic initiatives.

Qualifications:

  • Proficiency in clinical research processes with prior experience as a Clinical Research Associate.
  • Strong knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs.
  • Excellent verbal, written, and presentation skills.
  • Ability to manage multiple tasks, plan proactively, and anticipate obstacles.
  • Proficiency in Word, PowerPoint, and Excel.

Additional Information:

  • Travel required.
  • Referral bonus available for recommending qualified candidates.