This Remote position located in the South East USA will be working with Provident Research Inc. in a dedicated Functional Source (embed) relationship. Our client is a major manufacturer of Medical Devices and this role is responsible for managing clinical activities at multiple study sites, as well as fostering strong, productive relationships with colleagues within the Organization. Interviews are being scheduled now to fill immediate openings.
Cardiology Medical Device experience Mandatory.
Responsible for managing clinical study activities for multiple sites in single or several Clinical Projects.
Oversees performance of appointed study sites conducting company initiated clinical studies.
Responsible for the site visits, monitoring, communication and deliverables for the assigned study sites.
Serves as a member of the clinical study team and is the liaison between Clinical Operations and Study Site personnel for the specific clinical projects.
This opening is immediate due to expansion.
This position affords you an opportunity to experience many different aspects of the clinical development industry. Our client is proud to offer a career pathway that looks to internal candidates for promotion.
For the right individuals, this position offers a competitive salary along with:
- Medical, Dental, and Vision
- Life Insurance
- 401(k) Plan
- Paid Vacation and Holidays
A Bachelor Degree is required.
Experience Previous Regional monitoring required
Requires understanding and application of regulations and standards applied in clinical research areas
Relevant industry certifications preferred (i.e. CCRA, RAC, CDE)
Demonstrated competencies in the following areas are required:
- Strong Written and Verbal Communications
- Strong organizational skills
- Ability to travel Regionally up to 65%
- Attention to details
Key Job Activities:
- Build relationships with investigators and site staff
- Monitor patient safety on-site (review for missing SAEs, AEs, ConMed) and address protocol violations
- Take responsibility for specific tasks on projects, or acts as the main CRA contact on individual projects
- Perform on site visits in accordance with the monitoring plan
- Conduct on-site study-specific training (if applicable)
- Perform site facilities inspection
- Monitor and maintain ICH-GCP compliance