Clinical Research Associate

5+ years

$100K/yr - $135K/yr

Remote

12 May 17, 2024

Job Description

Job Type: Full Time Education: B.S. Skills: Causality Assessment, Communication Skills, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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

Employer: [Company Name]

Location: United States

Employment Type: Full-time

Salary Range: $100,000/yr - $135,000/yr (Exact compensation may vary based on skills, experience, and location)

General Position Overview

The Clinical Research Associate (CRA) / Senior CRA is responsible for assisting with clinical trial management, site management, data review and cleaning, and occasionally leading the planning and development of the study set-up and execution. The role ensures compliance with protocols, ICH/GCP, regulatory requirements, and SOPs/Work Instructions.

Key Accountabilities/Core Job Responsibilities

Study Planning and Conduct:

Act as primary contact for vendors, investigational sites, and cross-functional teams, escalating to the study lead as necessary.
Support and occasionally lead the development/review of clinical study plans, presentations, and project/study-related documents including contracts/site payments.
Assist in the development and design of CRFs, participating in the EDC and IXRS specification process and UAT.
Oversee and mentor junior team members.
Perform in-house review of clinical data listings for completeness and accuracy, escalating issues as needed.
Manage clinical monitoring activities and overall site management, ensuring compliance with GCP and applicable regulations, and tracking site performance metrics.
Distribute study newsletters and track/report recruitment updates.
Assist in the development, approval, and distribution of study-related documents including CRFs, study protocols, study manuals, and other study tools.
Participate in clinical study team meetings.
Collaborate with internal cross-functional teams (e.g., Clinical Science, Biometrics, Regulatory Affairs) to ensure effective delivery of assigned project milestones.

Site Monitoring Activities:

Ensure compliance with CFR, GCP, and internal SOPs and guidelines.
Communicate project progress, challenges, and opportunities regularly to Clinical Leadership.
Monitor clinical and laboratory data for accuracy and regulatory compliance, ensuring resolution of data queries.
Monitor safety issues and site evaluations, resolving with Clinical Team Leader.
Monitor SAE reporting and request follow-up information according to SOP.
Review protocol violations with the investigator and take corrective actions.
Reconcile drug accountability records and regulatory documents at sites.
Provide timely monitoring reports in accordance with SOPs.
Assist Data Management in resolving data queries.
Ensure availability of study supplies at sites and participate in other tasks as needed.
Perform pre-study site qualification visits to evaluate site adequacy.
Conduct ongoing monitoring visits to verify subject rights, data accuracy, and compliance.
Perform close-out visits and other trial completion activities.
Ensure site compliance with study protocols, safety, and investigational product accountability.
Assist in query writing and resolution.
Provide on-site training for investigators and site personnel.
Collaborate with cross-functional teams on safety data evaluation, compliance, and data management.
Communicate with clinical study team and sites to ensure adherence to timelines.
Organize study files, inventory, and materials.
Ensure clinical sites have adequate supplies to conduct the study.
Attend and/or perform site initiation visits.
Assist with mass communications, newsletters, and study coordinator training as needed.

General:

Complete required corporate training on standards, policies, and work instructions.
Perform other work-related duties as assigned.

Qualifications:

B.S. degree required.
5+ years of CRA experience monitoring clinical trials in biotech, pharmaceutical, or CRO environment (8+ years for Sr. CRA).
Experience with trial conduct from start-up through close-out.
Working knowledge of ICH GCP and FDA regulations.
Ability to work effectively with minimal supervision.
Ability to multi-task and manage deliverables across all assigned trials.
Strong written and verbal communication skills.
Ability to travel frequently.
Self-motivated and able to work in a small team environment.

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Clinical Research Associate

Job Description

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

General Position Overview

Key Accountabilities/Core Job Responsibilities

Study Planning and Conduct:

Site Monitoring Activities:

General:

Qualifications:

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