Senior Clinical Research Associate / Cra Ii

2+ years

Not Disclosed

Remote, USA

10 July 30, 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, 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

Position Summary:

The Senior Clinical Research Associate I (Sr. CRA I) at Syneos Health will work in a dynamic clinical environment, focusing on site qualification, initiation, monitoring, and close-out activities for clinical trials. The Sr. CRA I ensures compliance with regulatory, ICH-GCP, and company SOPs while maintaining patient safety and data integrity. This role requires collaboration with site personnel, project teams, and sponsors to achieve project goals.

Job Responsibilities:

Site Management:
- Perform site visits (qualification, initiation, monitoring, and close-out) to ensure compliance with protocols and regulations.
- Evaluate site performance, provide recommendations, and communicate/escalate serious issues.
- Verify informed consent processes, protect patient confidentiality, and ensure data accuracy.
Data Management:
- Conduct Source Document Reviews and verify clinical data in case report forms (CRF).
- Resolve queries and ensure electronic data capture compliance.
- Manage investigational product (IP) inventory and ensure proper labeling, storage, and administration.
Documentation and Compliance:
- Review and reconcile the Investigator Site File (ISF) with the Trial Master File (TMF).
- Document activities through confirmation letters, reports, and communication logs.
- Support subject/patient recruitment, retention, and awareness strategies.
Project Coordination:
- Manage site-level activities to ensure project objectives and timelines are met.
- Act as primary liaison with project site personnel, ensuring training and compliance.
- Participate in Investigator Meetings and sponsor meetings.
Mentorship and Training:
- Provide training or mentorship to junior CRA staff.
- Assist in audit preparation and follow-up actions.
Additional Responsibilities:
- Support site identification, chart abstraction, and data collection for Real World Late Phase (RWLP) studies.
- Collaborate with sponsors, medical science liaisons, and local country staff.
- Identify operational efficiencies and process improvements.
- Develop country-level informed consent forms and ensure regulatory compliance.

Qualifications:

Education and Experience:
- Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience.
- Knowledge of Good Clinical Practice (GCP) and ICH Guidelines.
Skills:
- Proficiency in computer skills and adaptability to new technologies.
- Excellent communication, presentation, and interpersonal skills.
- Ability to manage travel requirements up to 75%.

Why Syneos Health:

At Syneos Health, we value our employees and provide opportunities for career development, training, and recognition. We foster an inclusive culture where diverse perspectives are embraced. Our commitment to employee well-being includes a comprehensive benefits package, flexible PTO, and competitive salary.

Additional Information:

Syneos Health offers a range of benefits, including health insurance, 401k, stock purchase plans, and more. The salary range for this position is $63,090 to $145,000, varying based on qualifications and experience. Syneos Health encourages employees to be fully vaccinated against COVID-19 and complies with local regulations regarding vaccination.

Join Our Talent Network:

If your experience aligns with this role, or if you're interested in other opportunities at Syneos Health, we encourage you to apply or join our Talent Network to stay connected. We value diverse experiences and welcome candidates who bring transferable skills to our team.

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Senior Clinical Research Associate / Cra Ii

Job Description

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