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Clinical Trials Management Associate

0-2 years
Not Disclosed
10 April 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

Employer: Integrated Resources, Inc. (IRI)
Location: Foster City, CA
Job Type: Contract


About Integrated Resources, Inc. (IRI)

Integrated Resources, Inc. (IRI) is a strategic workforce solutions provider with decades of industry expertise. Founded in 1996, IRI has built a strong reputation by attracting and retaining top professionals across multiple sectors, including IT, Life Sciences, Allied Healthcare, and CRO services.


Job Description

The Clinical Trials Management Associate will play a key role in clinical trial execution, site management, vendor coordination, and regulatory compliance. This role requires limited supervision and involves monitoring clinical sites, assisting with study documentation, and supporting cross-functional teams.


Key Responsibilities

Clinical Site Management

  • Conduct site evaluations, initiations, routine monitoring visits, and closeouts.

  • Ensure compliance with protocols, regulatory requirements, and data quality standards.

  • Assist in setting and updating study timelines.

Vendor & CRO Coordination

  • Support CRO/vendor selection and coordination.

  • Work with vendors to ensure seamless trial execution.

Study Documentation & Regulatory Compliance

  • Draft and coordinate protocol reviews, informed consent forms, case report forms, and monitoring plans.

  • Assist in data review, preparation of safety/interim/final study reports, and resolution of data discrepancies.

  • Maintain knowledge of FDA, EMEA, ICH guidelines, and Good Clinical Practices (GCPs).

Cross-functional Collaboration & Training

  • Participate in meetings and conference calls with CROs, vendors, and multi-functional teams.

  • Support Clinical Research Associate (CRA) and Clinical Project Assistant (CPA) training.

  • Contribute to departmental or interdepartmental strategic initiatives.

Process Improvement & Problem-Solving

  • Develop tools and processes to improve trial efficiency.

  • Identify potential obstacles and proactively implement solutions.

  • Understand functional and organizational perspectives to meet project goals.


Qualifications

Required Skills & Experience

  • Proficiency in all areas relevant to a Clinical Research Associate (CRA).

  • Excellent verbal, written, interpersonal, and presentation skills.

  • Strong working knowledge of FDA and EMEA Regulations, ICH Guidelines, and GCPs.

  • Experience with clinical trial software, including Word, PowerPoint, and Excel.

  • Ability to prioritize tasks, plan proactively, and follow structured procedures.

Preferred Qualifications

  • Experience in abstract presentations, oral presentations, and manuscript development.

  • Strong background in clinical trial operations and regulatory compliance.


Additional Information

  • Travel is required for this role.

  • Referral bonus available for successful candidate recommendations.

  • Integrated Resources, Inc. is JCAHO Certified and recognized as one of INC 5000’s fastest-growing private companies.


Why Join Integrated Resources, Inc.?

  • Work with an industry-leading workforce solutions provider.

  • Gain valuable experience in clinical trial management.

  • Collaborate with leading pharmaceutical and biotech organizations.

  • Access growth and training opportunities in a dynamic work environment.


Apply Now

Interested candidates should apply today to take the next step in their clinical trials management career.