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) / Clinical Research Associate (CRA)
Location: Home-Based (Washington, Oregon, Colorado, Wyoming, Montana, Utah, Arizona, Idaho, Nevada, New Mexico)
Travel Requirement: 50%-75% domestic and international

Company Overview:

Join one of the fastest-growing Contract Research Organizations (CROs) as we expand our team! We are looking for a motivated Senior Clinical Research Associate (SCRA) or Clinical Research Associate (CRA) to play a key role in the monitoring and management of clinical trials. This permanent, home-based position can be located in multiple states across the U.S., and offers an exciting opportunity to work with a dynamic and rapidly expanding company.

Position Overview:

As a Clinical Research Associate (CRA) or Senior Clinical Research Associate (SCRA), you will be responsible for ensuring that clinical trials are conducted according to the protocol, federal regulations, and FDA guidelines. You will be instrumental in protecting the rights and safety of human subjects and maintaining the quality and integrity of trial data.

Key Responsibilities:

Clinical Trial Monitoring:
Ensure that clinical research is conducted in compliance with the clinical protocol, federal regulations, and FDA guidelines. Protect the safety and rights of study participants.
Investigator Recruitment & Site Management:
Participate in the investigator recruitment process, including performing initial qualification visits and evaluating site capabilities to manage and conduct clinical trials.
Study Start-up & Initiation:
Work with the Study Start-up Group to coordinate activities at the site, obtain necessary regulatory documentation (IRB/EC approvals), and initiate studies by training site staff on protocol, study procedures, and eCRF completion.
On-Site Monitoring:
Conduct periodic monitoring visits, including site file audits, and ensure adherence to Good Clinical Practices (GCPs). Validate source documentation as required and prepare monitoring reports.
Clinical Data Management:
Review and verify the quality and integrity of clinical data through in-house electronic CRF (eCRF) data review and on-site source verification. Work with sites to resolve data queries.
Investigational Product Management:
Document accountability, stability, and storage conditions of clinical trial materials, conduct inventory checks, and verify the return or destruction of unused materials as required.
Study Close-Out:
Perform study close-out visits and assist with final data review and query resolution through database lock.
Collaboration & Mentorship:
Serve as the primary point of contact between the company and the investigator, coordinating all correspondence and ensuring the timely transmission of clinical data. Mentor junior CRAs as needed.
Travel & Site Audits:
Travel domestically and internationally as required (up to 50%-75%) to perform monitoring visits and assist with site audits as necessary.

Qualifications:

Education:
BS/BA in a life science or related field.
Experience:
Proven experience in clinical trial monitoring and/or coordination, with a clinical setting background considered a plus. Experience with electronic data capture and basic data processing functions is preferred.
Skills:
- Strong understanding of the clinical research process, medical terminology, and GCP/ICH guidelines.
- Exceptional written and verbal communication skills, capable of expressing complex ideas to study personnel.
- Strong organizational and interpersonal skills with the ability to work independently.
- Ability to mentor and guide junior CRAs.
- Proficient in electronic data capture systems.
Travel Requirements:
Ability and willingness to travel domestically and internationally, approximately 50%-75% of the time.
Other:
Valid driver’s license, the ability to rent an automobile, and eligibility to qualify for a major credit card.

Additional Information:

We are an equal opportunity employer and value diversity in our workforce. We are committed to fostering an inclusive and respectful environment for all employees.

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Clinical Research Associate

Job Description

Company Overview:

Position Overview:

Key Responsibilities:

Qualifications:

Additional Information:

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