The Regional Clinical Research Associate completes project activities associated with monitoring functions of Phase I-IV clinical research studies. Perform investigator site management activities in adherence to all applicable regulatory guidelines and standard operating procedures (SOPs).
Responsibilities include (but are not limited to) :
- Adhere with corporate internal polices and requirements, including submission of timesheets and expense reports in a timely manner.
- Conduct study feasibility and site selection activities, if the Site Manager has been adequately trained (3 site selection visits with Clinical Research Manager, Clinical Team Lead, Sr. Site Manager or Site Manager II, and 6 months of experience).
- Assist with investigator meeting activities including organization, preparation and attendance
- Conduct site management activities after appropriate training including but not limited to site selection visits, site initiation visits, site training, site routine monitoring visits, and site close out visits.
- Ensure the integrity of clinical data and adherence to applicable regulatory, protocol, and company guidelines.
- Establish and maintain good rapport with study sites.
- Write study visit reports and follow up letters within the timeline established by applicable SOPs and guidelines.
- Coordinate timely shipment of clinical supplies and study drug to sites.
- Ensure proper storage, dispensation and accountability of clinical supplies and study drug.
- Maintain adequate site tracking records.
- Follow-up of drug safety issues and safety reports in timely manner, if applicable.
- Communicate site study issues, concerns, and progress to Clinical Research Manager, Project Manager and Clinical Team Lead
- Assist with the implementation of corrective actions when appropriate.
- Assist in data clarification process (incl. query process).
- Perform telephone monitoring activities in order to obtain study status information.
- Prepare /review all patient tracking records.
- Input and maintain study information concerning status of financial reimbursement to sites, as applicable.
- Conduct and assist with administrative activities as a member of the project team.
- Participate in routine study progress meetings, face to face or via teleconference.
- Bachelor's Degree required
- Minimum 3-4 years of monitoring experience
- Minimum 2 years of oncology experience
ReSearch Pharmaceutical Services (RPS) is a clinical research organization, and a little bit more. The Warburg Pincus-owned company manages...