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Clinical Trials Management Associate Ii

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 II

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

Job Description:

The Clinical Trials Management Associate II will be responsible for monitoring clinical trials and ensuring compliance with regulatory requirements. This role involves working with CROs, vendors, and cross-functional teams to support clinical research activities.

Key Responsibilities:

1. Clinical Trial Monitoring & Compliance

  • Conduct site evaluations, initiations, monitoring, and closeout visits.
  • Ensure site compliance with protocols, regulatory requirements, and data quality standards.
  • Assist in setting and updating study timelines.
  • Support CRO/vendor selection and coordination.

2. Study Documentation & Reporting

  • Draft and coordinate review of protocols, informed consents, case report forms, and monitoring plans.
  • Assist in reviewing data discrepancies and preparing safety, interim, and final study reports.
  • Participate in abstract presentations, oral presentations, and manuscript development.

3. Stakeholder Coordination & Training

  • Participate in meetings with CROs, vendors, and multi-functional teams.
  • Interface with other functional areas to address routine study issues.
  • Assist in training Clinical Research Associates (CRAs) and Clinical Project Assistants.

4. Strategic Initiatives & Process Improvement

  • Contribute to departmental or interdepartmental strategic initiatives.
  • Develop tools and processes to improve project efficiency.
  • Anticipate obstacles and proactively develop solutions to meet project goals.

Qualifications:

  • Excellent verbal, written, and interpersonal communication skills.
  • Proficiency in Microsoft Word, PowerPoint, and Excel.
  • Knowledge of FDA/EMEA Regulations, ICH Guidelines, and GCPs governing clinical trials.
  • Ability to prioritize multiple tasks and meet deadlines.
  • Strong problem-solving and strategic thinking skills.
  • Willingness to travel as required.

Additional Information:

  • Referral Bonus Available – Candidates can refer friends/colleagues for this position.