Clinical Research Associate - Remote or In-Person

Job Description
About this Position

The clinical research associate will help drive the clinical trial process for several sample collections including submitting protocols, ordering supplies, performing site initiation visits with our physicians, and monitoring the quality of the samples and paperwork we receive. The person who would adapt to this role with the greatest success would be an excellent problem solver, able to work well under pressure, negotiate with doctors, clients, and the IRB, as well able to juggle competing priorities at once.

The associate would be working closely with the Project Manager.

About RDI

Research & Development Institute (RDI) is growing to be one of the pre-eminent Contract Research Organization and Research Lab dedicated to the In Vitro Diagnostic Industry. Since its founding in 2008, RDI has contributed to bringing 110+ new assays to the market either through sample collection trials or validation and verification testing trials.

RDI's customers include the largest In Vitro Diagnostic manufacturers and boasts a national network of physicians & labs.

ROLE RESPONSIBILITIES

• Help prepare clinical protocol, case report forms, informed consents, and other required documents for clinical studies.
• Identifies and qualifies clinical investigators and clinical sites.
• Proposes and negotiates budgets for clinical studies.
• Initiates payments to sites.
• Obtains and reviews all required essential documents necessary for study initiation.
• Initiates clinical studies and provides for investigator and staff training.
• Monitors clinical studies, ensuring site compliance with the clinical protocol and ICH/GCP guidelines, assures subject rights, safety, and welfare are protected, ensures data integrity through completeness, accuracy, and legibility.
• Conducts pre-study, initiation, interim, and close-out monitoring site visits and completes site visit reports.
• Maintains accurate and timely sponsor/site correspondence and communication.
• Prepares and presents project progress reports to keep management and team informed.
• Responds to audits and data queries representing a project or team.
• Prepares standard the clinical sections of regulatory submissions and international registration packages.
• Prepares and reviews product labeling and promotional materials.
• Coordinates preparation of responses to IRB's questions regarding the clinical study.
• Prepares publications, abstracts, or presentations for professional meetings with minimal assistance.

QUALIFICATIONS:

Prior experience as a CRA or CRC with audit experience preferred
Experience in a Clinical Laboratory is an nice to have

Job Posted by ApplicantPro