Clinical Research Associate

0-2 years

Not Disclosed

Remote, USA

10 Nov. 14, 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

Job Title: Senior Clinical Research Associate (SCRA) / Clinical Research Associate (CRA)

Location: Home-based (Washington/Oregon/Colorado/Wyoming/Montana/Utah/Arizona/Idaho/Nevada/New Mexico)

Job Overview: An exciting opportunity has become available for a Senior Clinical Research Associate or Clinical Research Associate to join one of the fastest-growing CROs. This permanent, home-based position offers the chance to work in a dynamic and evolving environment. The role involves monitoring clinical trials and ensuring that investigators conduct research in line with clinical protocol requirements and regulatory standards.

Key Responsibilities:

Ensure clinical trials comply with applicable federal regulations and FDA guidelines.
Maintain data quality through initial reviews to meet clinical standards.
Protect the rights and safety of human subjects involved in clinical studies.
Participate in the investigator recruitment process and conduct initial qualification visits to evaluate site capability.
Coordinate activities with the site in preparation for study initiation.
Obtain regulatory approvals and assist with study-specific documentation.
Perform study initiation, monitoring, and close-out activities.
Train site staff on EDC systems and verify site computer systems.
Conduct periodic site audits for compliance with GCPs and company SOPs.
Prepare monitoring reports and maintain accountability for clinical trial materials.
Review and resolve data queries in collaboration with study sites.
Serve as the primary contact between the company and investigator, ensuring timely data transmission.
Assist with data review, query resolution, and database lock processes.
Attend Investigator Meetings and serve as a mentor to new clinical study monitors.

Qualifications, Skills, and Experience:

Strong knowledge of the clinical research process and medical terminology.
Proven experience in clinical trial monitoring or coordination (experience in a clinical setting is a plus).
Excellent written and verbal communication skills to interact with study personnel.
Strong organizational, interpersonal, and mentoring skills.
Ability to work independently and recommend solutions in clinical settings.
Familiarity with electronic data capture (EDC) systems.
Knowledge of current GCP/ICH guidelines for clinical research.
Valid driver’s license and ability to travel domestically and internationally (50%-75%).
BS/BA in a life science field with field monitoring experience.
Proficiency in computer literacy and EDC systems preferred.

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Clinical Research Associate

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