Clinical Research Associate in ROCHESTER, New York at Rochester Regional Health

Position Summary:

The CRA assists physician investigators in preparing studies for approval, obtains and submits clinical information as required by the study, maintains regulatory files and documents, and works to increase accrual to studies.

Key Responsibilities:

• Registers, compiles, and submits data; monitors research study compliance; maintains a system for effective research data flow.

• Maintains regulatory documentation for numerous study protocols including but not limited to submitting new protocols, amendments, annual reviews, safety letters / updates, to CIC (Clinical Investigation Committee)

• Opens and maintains clinical studies for subject accrual

• New studies identified:

• Prepares and submits abstract/summary letter to CIC and investigators

• Revises consent form to meet RGHS standards

• Prepares, submits and files appropriate regulatory documents

• Updates consent form and protocol documents

• Receipt of Addenda and Re-approvals

• Informs investigators and Research Nurses

• Submits addenda to the CIC

• Reviews and revises consent form as necessary.

• Assists in enrolling patients in clinical studies

• Obtains clinical information necessary to enroll the patient in the study

• Calls the study center to enroll the patient

• Communicates the study assignment to physician

• Assists investigator in preparing treatment and testing calendar and monitors for timely completion of study requirements.

• Interacts with cancer center pharmacist in requisitioning and storing study medications

• Facilitates recruitment of study subjects

• Helps chief investigator publicize study among colleagues.

• Evaluates patient eligibility for clinical trial participation: Reviews charts of new and returning patients to screen for eligibility. Flags the charts of eligible patients for MD review.

• Collaborates with CRAs at other sites to improve accrual and follow-up of patients.

• Answers investigator and study subject questions about the clinical trial parameters.

• Monitoring and Auditing:

• Prepares materials for monitor visits and audits

• Assists the investigators in finding/correcting any missing information

• Obtains and submits to study sponsor x-rays, operative reports, laboratory, pathology or other specialized reports as needed for protocol purposes.

• Obtains data from outside physicians when needed for data collection and submission.

• Utilizes study sponsor web-sites to locate and download forms, protocols, consents and other data posted on the various sites of the co-operative studies.

• Participates with investigator in occasional out-of-town meetings (2-3 weekends per year).

• Enhances professional growth and development by participating in educational programs, reading current literature and participating in in-service meetings and workshops. If not certified, is encouraged to work toward certification as a Clinical Research Associate.

Minimum Qualifications:

• Bachelor’s degree in Biology, Clinical Research, Health Informatics, or related field strongly preferred. Equivalent combination of education and prior work experience in Clinical Research or a Healthcare setting will be considered in lieu of Bachelor’s degree.

• 3 years of clinical research experience preferred; experience in a medical setting required

• Strong analytical, computer, and communication skills

Required Licensure/Certification Skills:

• Preferred but not required: Certification as a Clinical Research Associate by the Association of Clinical Research Professionals (ACRP)

Rochester General Health System is an Equal Opportunity / Affirmative Action Employer. Minority/Female/Disability/Veteran