Job Description
Job Title: Clinical Research Associate Location: Charlotte, NC 28277 Duration: 06 months contract with the possibility of extension Job Description: We are seeking an experienced and motivated Clinical Research Associate (CRA) to join our dynamic team. The successful candidate will play a crucial role in the preparation, execution, and monitoring of clinical trials, ensuring adherence to Good Clinical Practices (GCP) and regulatory requirements. This is a 6-month contract position with the potential for extension, requiring up to 80% independent travel.
Responsibilities: 1. Site Preparation and Initiation (30%) - Coordinate activities with the site in preparation for the study initiation.
- Obtain regulatory documentation for successful trial implementation.
- Review protocol, regulatory issues, and study procedures with site personnel.
- Provide training on electronic Case Report Forms (eCRF) and monitoring activities.
2. On-site Monitoring (50%) - Conduct Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-out Visits.
- Assure adherence to GCP, investigator integrity, and compliance with study procedures.
- Perform validation of source documentation and prepare monitoring reports.
- Act as the primary contact between the company and site investigators.
3. Risk-Based Monitoring and Data Accuracy (15%) - Implement Risk-Based Monitoring practices for Phase II – IV trials.
- Apply root cause analysis, critical thinking, and problem-solving skills during monitoring.
- Ensure data accuracy through Source Data Review, Source Data Verification, and Case Report Form review.
- Assess investigational product through physical inventory and records review.
4. Reporting and Communication (5%) - Provide trial status tracking and progress reports to Research Director and Study Team Lead.
- Update study systems per agreed conventions (e.g., Clinical Trial Management System, CTMS).
- Contribute to investigator meetings and maintain regular contact with sites between visits.
- Complete administrative tasks such as expense reports and timesheets.
Qualifications: Education: - Bachelor's degree or equivalent
- CRA Certification
Work Experience: - Minimum 5 years of experience as a Clinical Research Associate
- Thorough knowledge of ICH GCP principles and Regulatory requirements
Skills & Experience: - Effective clinical monitoring skills
- Understanding of medical/therapeutic areas and terminology
- Strong critical thinking and problem-solving skills
- Proficient in Risk Based Monitoring concepts
- Excellent oral and written communication skills
- Ability to work independently and in a team
- Good computer skills, including Microsoft Office proficiency
Preferred Qualifications: - Master’s Degree in a healthcare-related area
- 5-10 years of CRA or clinical trial regulatory management experience
- Additional certifications in clinical research (ACRP, SOCRA, etc.)
Job Tags
Contract work, Work experience placement, Interim role,