Senior Clinical Research Associate: Ivd

Kelly Science, Engineering, Technology & Telecom

5-8 years

$50/hr - $60/hr

Remote, USA

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.

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Senior Clinical Research Associate: Ivd

Job Description

Job Title:

Location:

About the Company:

Responsibilities:

Requirements:

Preferred Qualifications:

Compensation:

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