Clinical Research Associate

0-3 years

Not Disclosed

Denver

10 July 18, 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 Description

Position: Senior Clinical Research Associate (SCRA) / Clinical Research Associate (CRA)
Type: Permanent, Home-Based
Location: Washington, Oregon, Colorado, Wyoming, Montana, Utah, Arizona, Idaho, Nevada, New Mexico

Role Overview:

Join one of the fastest-growing CROs as a (Senior) Clinical Research Associate. This role involves monitoring clinical trials, ensuring compliance with clinical protocols, federal regulations, FDA guidelines, and protecting the rights and safety of human subjects.

Responsibilities:

Clinical Trial Monitoring:

Monitor clinical trials and ensure investigators conduct research per clinical protocol requirements.
Ensure data quality on initial review meets acceptable clinical standards.
Protect the rights and safety of human subjects involved in clinical studies.

Investigator Recruitment and Site Management:

Participate in the investigator recruitment process.
Perform initial qualification visits of potential investigators.
Evaluate the site's capability to manage and conduct clinical studies, both clinically and technically.

Study Start-Up and Regulatory Coordination:

Work with the Study Start-up Group to prepare sites for study initiation.
Obtain regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials.
Coordinate with the Study Start-up Group and site staff to obtain IRB/EC approval of study-specific documents.

Study Initiation and Training:

Perform study initiation activities, including protocol review, regulatory issues, study procedures, and training on eCRF completion.
Train site staff on the EDC system and verify site computer systems.

Compliance and Monitoring:

Conduct periodic site file audits to ensure compliance with GCPs and the company's standard operating procedures.
Ensure adherence to Good Clinical Practices and investigator integrity through on-site monitoring visits.
Validate source documentation as required by the sponsor.
Prepare monitoring reports and letters using approved company/sponsor forms and reports.

Clinical Trial Materials Management:

Document accountability, stability, and storage conditions of clinical trial materials.
Perform investigational product inventory.
Ensure the return of unused materials to designated locations or verify destruction as required.

Data Quality and Integrity:

Review the quality and integrity of clinical data through in-house review of electronic CRF data and on-site source verification.
Resolve data queries with sites.
Review protocols, eCRFs, study manuals, and other related documents as requested by the Clinical Trial Manager.

Communication and Coordination:

Serve as the primary contact between the company and investigators.
Coordinate all correspondence and ensure timely transmission of clinical data.
Assist with final data review and query resolution through database lock.
Perform study close-out visits.
Assist with and attend Investigator Meetings for assigned studies.
Mentor new clinical study monitors.
Request site audits for reasons of validity.

Qualifications and Skills:

Education:

BS/BA in one of the life sciences.

Experience:

Proven experience in monitoring and/or coordinating clinical trials preferred.
Experience in a clinical setting is a plus.

Skills:

Strong knowledge of clinical research processes and medical terminology.
Excellent written and verbal communication skills.
Strong organizational and interpersonal skills.
Ability to reason independently and recommend specific solutions in clinical settings.
Ability to mentor entry-level CRAs.
Understanding of electronic data capture, including basic data processing functions.
Knowledge of current GCP/ICH guidelines applicable to clinical research.

Other Requirements:

Ability to qualify for a major credit card.
Valid driver’s license and ability to rent an automobile.
Willingness and ability to travel domestically and internationally (approximately 50%-75%).
Language: English (required).
Work authorization: United States (required).
Computer literacy and knowledge of electronic data capture preferred.

Equal Opportunity Employer:

We are an equal opportunity employer and value diversity in the workplace.

This structured format provides a clear, organized presentation of the job description, responsibilities, qualifications, and other key information.

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Clinical Research Associate

Job Description

Job Description

Role Overview:

Responsibilities:

Qualifications and Skills:

Equal Opportunity Employer:

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