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Senior Clinical Research Associate: Ivd

5-8 years
$50/hr - $60/hr
10 May 22, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title:

Senior Clinical Research Associate (Sr. CRA)

Location:

Remote (US)

About the Company:

Kelly® Science & Clinical is collaborating with a biotech company in California, dedicated to advancing scientific discoveries and pioneering diagnostic solutions.

Responsibilities:

  • Execute all activities related to clinical trials, including clinical site selection, contract negotiation, study initiation visits, interim monitoring visits, and study close out visits.
  • Perform data monitoring activities, including on-site and remote audits of study data for accuracy, integrity, and completeness.
  • Identify and address issues at sites related to GCP or protocol compliance that may impact data integrity or the timely completion of the study.
  • Prepare study documents such as training materials, case report forms, and protocol-specific informed consent forms for review by project lead.
  • Maintain a high level of familiarity with GCP and assigned protocols.

Requirements:

  • Bachelor’s degree in a scientific discipline (Clinical Sciences, Health/Life Sciences, Biology, Biochemistry, Human Physiology, or similar).
  • 5 to 8 years of experience in monitoring In Vitro Diagnostic (IVD) products or medical devices.
  • Proficiency in all aspects of clinical trials, including clinical site selection, study visits, preparation of study contracts and budgets, and drafting study-specific documents.
  • Up-to-date knowledge of clinical trial regulatory requirements and guidelines (e.g., GCP, ICH, FDA).
  • Excellent oral and written communication skills, with the ability to build strong relationships with investigators and site staff.
  • Willingness to travel 25 – 50%, including solo international travel 4-6 times per year to destinations such as Continental US, Sub-Saharan Africa, South Asia, Southeast Asia, South America, and Central America.

Preferred Qualifications:

  • Experience with in vitro diagnostic (IVD) products, particularly in molecular diagnostics or immunodiagnostics, focusing on oncology and/or infectious disease.
  • Familiarity with laboratory automation and biological databases.
  • CCRA certification.

Compensation:

  • Base Salary Range: $50/hr - $60/hr
  • Compensation may vary based on skills, experience, and location.