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Job Title: Clinical Research AssociateDepartment: Hematology/Oncology Research Location: Lipson Cancer Institute RGH Hours Per Week: 40Schedule: Monday- Friday, Days 8am to 430pm 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.

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 Nurse

+ 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.

REQUIRED 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

PREFERRED QUALIFICATIONS:

+ Certification as a Clinical Research Associate by the Association of Clinical Research Professionals (ACRP)

EDUCATION:

BS (Required)

LICENSES / CERTIFICATIONS:

PHYSICAL REQUIREMENTS:

M - Medium Work - Exerting 20 to 50 pounds of force occasionally, and/or 10 to 25 pounds of force frequently, and/or greater than negligible up to 10 pounds of force constantly to move objects; Requires frequent walking, standing or squatting.

For disease specific care programs refer to the program specific requirements of the department for further specifications on experience and educational expectations, including continuing education requirements.

Any physical requirements reported by a prospective employee and/or employee’s physician or delegate will be considered for accommodations.

PAY RANGE:

$20.75 - $27.75

CITY:

Rochester

POSTAL CODE:

14621

The listed base pay range is a good faith representation of current potential base pay for a successful full time applicant. It may be modified in the future and eligible for additional pay components. Pay is determined by factors including experience, relevant qualifications, specialty, internal equity, location, and contracts.

Rochester Regional Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity or expression, national origin, age, disability, predisposing genetic characteristics, marital or familial status, military or veteran status, citizenship or immigration status, or any other characteristic protected by federal, state, or local law.