Clinical Research Associate

3-6 years

$100K/yr

Trenton

10 Aug. 16, 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, 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 Research Associate (CRA)

Contract Duration: 12 months

Location: Remote (Princeton, NJ) – Requires up to 50% travel

Responsibilities:

Ensure adherence to protocol and regulatory policies during clinical trials by training investigators and study coordinators, and by following up on corrective actions.
Maintain the integrity of the study by identifying and resolving discrepancies, obtaining missing data, and managing complex trial components, including core lab activities.
Contribute to the development and writing of clinical protocols, case report forms, and other study-related documents, addressing issues through collaboration with relevant personnel.
Stay current on regulations for applicable geographies and study types (e.g., IDE, non-significant risk, feasibility, exempt) and act as a resource on clinical trial regulations.
Provide training for contract research organizations (CROs) that offer additional monitoring support.

Qualifications:

Bachelor’s degree in a related field.
Experience in multi-site data monitoring, covering all visit types, with a strong understanding of U.S. regulations.
Proven ability to create and review clinical documents such as training materials for site initiation visits (SIVs), protocols, case report forms (CRFs), informed consent forms (ICFs), and brochures.
Participation in data management activities, including user acceptance testing (UAT) and study reviews.
Minimum of one year of clinical research experience on the sponsor side.
3-6 years of experience in a clinical environment, preferably with medical device and/or in vitro diagnostic (IVD) experience.

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Clinical Research Associate

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