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Senior Clinical Research Associate

3-5 years
Preferred by Comapny
10 Nov. 25, 2024
Job Description
Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

This role is focused on managing the clinical trial process from site identification through study closeout, with a significant emphasis on establishing strong relationships with site staff, investigators, and other stakeholders. The key responsibilities include managing all aspects of site initiation, such as contract negotiation, feasibility assessments, regulatory submissions, and site-specific document management.

Key duties include:

  • Being the main point of contact for assigned sites, ensuring smooth communication and resolution of issues.
  • Managing the completion of essential regulatory documents, negotiating informed consent forms, and submitting to relevant IRB/IEC and MoH/RA bodies.
  • Overseeing site activation, patient recruitment, and retention strategies, while maintaining adherence to study protocols.
  • Conducting site visits, both in-person and remotely, to ensure compliance and address issues.
  • Managing site-specific data quality, addressing recruitment plans, and ensuring documentation accuracy.
  • Participating in audits and regulatory inspections, keeping sites audit-ready.

Skills needed for this role include strong problem-solving abilities, initiative-taking, excellent communication, organizational skills, proficiency in clinical trial management systems, and experience in managing cross-functional teams. A background in biological sciences, pharmacy, or a related health discipline is preferred.

The role offers flexibility and requires occasional travel based on study needs. Experience in site management or clinical research is essential, with the ability to independently manage projects and mentor team members.