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Clinical Research Associate

Gforce Life Sciences
GForce Life Sciences
3-6 years
Not Disclosed
10 Aug. 6, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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

Job Opportunity: Clinical Research Associate (CRA)

Duration: 12-month Contract
Location: Remote (Princeton, NJ) - Requires 50% Travel

Responsibilities:

  • Ensure compliance with clinical study protocols and regulatory guidelines through training and guidance of investigators and study coordinators, and follow-up on corrective actions.
  • Verify the validity of studies by resolving discrepancies, obtaining missing data, and tracking core lab activities and complex trial components.
  • Contribute to the development and writing of clinical protocols, case report forms (CRFs), and other study aids for investigational products by addressing issues and collaborating with relevant personnel.
  • Maintain expertise in regulations for various study types (IDE, non-significant risk, feasibility, exempt, etc.) and serve as a resource for clinical trial regulations.
  • Provide training for contract research organizations (CROs) involved in additional monitoring support.

Qualifications:

  • Bachelor’s degree in a related field.
  • Experience in multi-site data monitoring, covering all visit types, and a strong understanding of US regulations.
  • Proficiency in creating and reviewing clinical documents such as training materials for site initiation visits (SIVs), protocols, CRFs, informed consent forms (ICFs), and brochures.
  • Experience in data management activities, including user acceptance testing (UAT) and study reviews.
  • Minimum of one year of clinical research experience from the sponsor side.
  • 3-6 years of experience in a clinical environment with Medical Device and/or In Vitro Diagnostic (IVD) experience.

Additional Information:

  • This role involves remote work with the requirement of 50% travel to study sites.