Clinical Research Associate

0-2 years

Not Disclosed

Remote, USA

10 Nov. 6, 2024

Job Description

Job Type: Full Time Remote 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) – Home-Based (Multiple Locations)

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

About the Role:

An exciting opportunity has arisen for a Senior Clinical Research Associate (SCRA) to join one of the fastest-growing CROs. This is a home-based position with flexibility to be based in Washington, Oregon, Colorado, Wyoming, Montana, Utah, Arizona, Idaho, Nevada, or New Mexico. As an SCRA, you will play a key role in the successful monitoring and oversight of clinical trials, ensuring compliance with regulatory requirements and safeguarding the rights and safety of trial participants.

Responsibilities:

Monitor Clinical Trials: Ensure that clinical trials are conducted in accordance with federal regulations, FDA guidelines, and the study protocol.
Site Qualification & Recruitment: Participate in the investigator recruitment process, conduct initial qualification visits, and evaluate sites' ability to manage clinical studies.
Study Start-up: Collaborate with the Study Start-up Group to prepare sites for study initiation, including obtaining regulatory approvals and training site staff on study protocols and eCRF completion.
Site Training: Provide training to site staff on the EDC system and ensure proper setup of site computer systems.
On-Site Monitoring: Perform site visits to ensure compliance with GCPs and SOPs. Conduct source document verification and ensure data quality.
Investigational Product Management: Manage clinical trial materials, ensuring proper storage, accountability, and return or destruction of materials.
Data Review & Query Resolution: Review electronic CRFs and work with sites to resolve data queries.
Study Close-Out: Assist with study close-out activities and review final data before database lock.
Investigator Liaison: Serve as the primary point of contact between the company and study sites, facilitating communication and timely data transmission.
Mentorship: Provide guidance and mentorship to new clinical study monitors as needed.
Auditing: Request and perform site audits to validate study data as required.

Qualifications & Skills:

Experience: Proven experience in monitoring and/or coordinating clinical trials. Clinical setting experience is a plus.
Education: BS/BA in life sciences or a related field.
Knowledge: Familiarity with the clinical research process, medical terminology, and GCP/ICH guidelines.
Skills: Strong organizational, communication, and interpersonal skills. Ability to think critically and recommend solutions in clinical settings.
Data Capture: Understanding of electronic data capture (EDC) systems and data processing functions.
Travel: Willingness to travel 50-75% domestically and internationally.
Licenses & Certifications: Valid driver’s license and eligibility for a major credit card.
Work Authorization: Must be authorized to work in the United States.

Why Join Us?

Be part of one of the fastest-growing CROs in the industry.
Flexible home-based position with travel opportunities.
Work in a dynamic, collaborative environment where you can make a real impact on the success of clinical trials.
Competitive salary and benefits package.

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Clinical Research Associate

Job Description

About the Role:

Responsibilities:

Qualifications & Skills:

Why Join Us?

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