Sutter Job Openings – Coordinator, Clinical Research

Job Description:

Sutter Pacific Medical Foundation is a not for profit corporation that exists to provide medical services, research and education. The foundation provides the infrastructure for the delivery of physician services, and contracts with a separate corporation comprised of physicians and other care providers to deliver the clinical services. This multi-specialty foundation will provide a platform from which new physicians can be recruited to continue to provide physician services in a nonprofit, community setting. The Foundation’s vision is to create a medical group that will deliver high quality, market competitive medical services.

Under the broad supervision of the Administrative Director of Clinical Research, and in collaboration with an assigned principal investigator. This position carries out the regulatory and protocol requirements of clinical trials.

Job Responsibilities:

Maintains thorough familiarity of individual protocol procedures/requirements for which the position if primarily responsible.

• Functions as an advocate for patients and their families providing support as a liaison between the patient, Principal Investigator, Medical Center, and study sponsors as the need arises.
• Maintains patient confidentiality according to standard of medical practice, the Guidelines for Good Clinical Practice, HIPAA and IRB regulations.
• Completes case report forms as required by individual sponsor protocols and coordinates sponsor monitoring visits with timely resolution of sponsor queries. Provides source documentation and patient records as required.
• Conducts patient interviews regarding compliance with medication schedule, elicits and documents information regarding adverse events and concurrent medications in accordance with protocol requirements.
• Participates in the informed consent process by providing information and assistance to patients and their families.
• Communicates on a regular basis with the principal investigator or sub- investigators regarding the status of patients in the trial.
• Acts as primary liaison with the trial sponsor or contract research organization.
• Functions as a member of a research team communicating with other team members for the efficient management of clinical trial patients.
• Maintains knowledge of current regulatory requirements of clinical trials and tenants of “Good Clinical Practice”. Carries out clinical trial responsibilities in compliance with Institutional Standard Operating Procedures.
• Participates as a member of a research team, acting as a medical resource for Non-medical research team members.
• Assures accurate dispensing of study medication in compliance with individual sponsor protocols.
• Assures accurate and timely data collection as transcribed onto sponsor case report forms as required by individual study protocols/sponsors.
• Maintains complete source documentation on each study subject as required by study sponsor.
• Prepares and maintains clinical trial regulatory documents. Submits SAEs, IND safety reports and progress reports on time to assure continuing project approval as required by the IRB guidelines and applicable regulatory agencies.

Job Requirements:

• BA or BS or equivalent experience required.
• 2+ year of prior clinical trial coordinator preferred or equivalent experience required.
• Skills & Knowledge
• Knowledge of the design and conduct of clinical trials with the appropriate skills required to perform functions of the position.

Job Details:

Company: Sutter Health

Vacancy Type:  Full Time

Job Location: Santa Rosa, CA, US

Application Deadline: N/A

Apply Here

jobstrivia.xyz