Clinical Research Program Coordinator - Gynecologic Oncology and Reproductive Medicine

MD Anderson Cancer Center - Houston, TX (30+ days ago)4.1


The University of Texas MD Anderson Cancer Center in Houston is one of the world's most respected centers focused on cancer patient care, research, education and prevention. It was named the nation's No. 1 hospital for cancer care in U.S. News & World Report’s 2017 rankings. It is one of only 49 comprehensive cancer centers designated by the National Cancer Institute.

ESSENTIAL JOB FUNCTIONS
Protocol Development and Processing

Responsible for revising, developing and/or composing key and supporting documents for investigator-initiated clinical trial protocols and associated projects, including the Ovarian Cancer Moon Shot Program. Prepares assigned protocols and amendments for successful submission to internal and external systems. Interfaces with internal departments and external programs, committees, boards, etc. Utilizes technical writing skills to compose and abstract medical and scientific information for preparation of written correspondence, reports, and other documents under the direction of the Principal Investigators, managers, and supervisors. Interacts with protocol sponsors (industry, government, and cooperative groups). Knowledgeable regarding pharmaceutical protocol submission process, formatting requirements, deadlines, and regulatory issues. Responsible for ensuring that all regulatory and institutional requirements are met before study activation.

Research Program Support
Provides administrative support for program activities and projects for the department’s Clinical Research Program and Ovarian Cancer Moon Shot Program. Attends departmental research program meetings to assist in providing oversight and/or support for all designated site-specific research programs and committees. Works closely with Project Manager, Innovative Therapies to prepare data, reports, and other information for departmental or program meetings. Develops and implements laboratory manuals to guide the collection, processing, and distribution of research samples from clinical trials. Coordinates the logistics for clinical research samples. Responsible for procuring equipment, supplies, and other resources necessary for the collection, processing, and/or distribution of clinical research samples.

Regulatory Management
Composes the correspondence accompanying protocol submissions and ensures that the submissions are prepared properly. Maintains regulatory files for all assigned studies. Interacts and provides appropriate correspondence to industry trial monitors, IND office monitors and institutional auditors. Addresses continuing review and/or CRC/PBHSRC/IRB contingencies or forwards to the study manager or Principal Investigator for completion. Forwards copies of IRB approval memos to outside agencies (NCI, CROs, or pharmaceutical firms) as needed.

SALARY RANGE
Minimum: $50,800 – Midpoint: $63,500 – Maximum: $76,200

EDUCATION
Required: Bachelor’s degree in Nursing, Public Health, Healthcare Administration or related scientific field.

Preferred: Master’s degree in Nursing, Public Health, Healthcare Administration or related scientific field.

EXPERIENCE

Required: With Bachelor’s degree, six years of experience in area of research study obtained from nursing, data gathering or other related experience. With preferred degree, three years of experience in area of research study obtained from nursing, data gathering or other related experience.

Preferred: Master’s degree in Nursing, Public Health, Healthcare Administration or related scientific field.