Coordinator, Clinical Studies

Houston, Texas
August 27 2019
Organization Type
Mission Statement

The mission of The University of Texas M. D. Anderson Cancer Center is to eliminate cancer in Texas, the nation and the world through outstanding programs that integrate patient care, research and prevention, and through education for undergraduate and graduate students, trainees, professionals, employees and the public.


The primary purpose of the Coordinator, Clinical Studies position is to provide administrative and patient care services for the coordination of clinical trials. The Coordinator, Clinical Studies will assist in the preparation of information, reports, and logs for clinical research protocols.

Key Functions

· Assumes responsibility for the effective operation of research protocols in collaboration with the Principal Investigator (PI) and study sponsor:

· Applies clinical and research knowledge in effective management of research protocols.

· Reviews patient eligibility of potential subject cases with research nurses and physicians. Independently performs all protocol related tasks including patient screening, consenting study subjects, collecting specimens, monitoring, and evaluating patient responses.

· Accurate and successful patient recruitment, scheduling and retention

· Reads protocol and helps develop systems for screening and scheduling patients. Develops on-study notes and other documents as needed for protocols.

· Collaborates with the multidisciplinary team as necessary

· Provides documentation in the patient's medical record or recruitment log per protocol and institutional requirements

· Creates protocol specific documentation reference tools

· Responsible for day to day regulatory management (DOA, SAE, deviations, violations, continuing review, etc.)

Participates in protocol-specific tasks as needed:

· Assesses patients for protocol eligibility through personal interviews and medical record review in the outpatient and inpatient settings

· Assesses patients in the inpatient/outpatient clinical setting for follow up appointments per protocol requirements

· Responsible for acting as a back-up to other research data coordinators in the procurement of biological sample including tissue and blood and delivery of all samples to laboratory for processing.

· Ensures strict adherence to safety guidelines and use appropriate sterile techniques for obtaining samples.

· Participates in organization/coordination of information expected to be monitored/audited

· Provides protocol summary reports as requested

Data Management:

· Responsible for review and screening of medical records and clinical data.

· Responsible for completion of data forms, treatment records, surgery and pathology information.

· Maintains a quality assurance system for consent documents and other protocol related activities.

· Develops system for recruiting patients, obtaining patient data, and ensuring the transfer of information to contracting agencies confidentially.

· Visually reviews data for correctness and edits as necessary with RN oversight.

Institutional Compliance:

· Collaborates as well as works independently conducting minimal risk studies according to institutional policies, as well as FDA and ICH GCP guidelines.

· Applies research knowledge for effective management of research protocols.

· Directly communicates and ensures approval from PI prior to implementation of new or existing protocols.

· Demonstrates knowledge of the current NCI CTCAE criteria and institutional reporting requirements. Assess and records all adverse events and serious adverse events. Submits external safety reports to OPR/IRB within the required timelines.

Maintains a level of professional expertise and credibility through educational programs:

· Keep current concerning research, oncology and data management issues through reading, attending meetings and in-services

· Attends departmental research meetings and conferences

· Provides accurate information as requested to the multidisciplinary team

· Completes all mandatory institutional training requirements

Other Functions

· Conduct personal interviews with patients in clinic or in-patient rooms or by talking on the phone. Ability to contact local physicians by phone or letter when necessary for protocol follow up.

· Responsible for acting as a back up to other research data coordinators and assists research nurses with case report form completion and data query resolution

· Other duties as assigned

Education Required: Bachelor's degree.

Experience Required: Three years experience in area of research study or direct patient care obtained from nursing, data gathering or other related experience. May substitute required education degree with additional years of equivalent experience on a one to one basis. With preferred degree, one year of required experience.

Experience Preferred: Clinical Research experience and working with protocols

It is the policy of The University of Texas MD Anderson Cancer Center to provide equal employment opportunity without regard to race, color, religion, age, national origin, sex, gender, sexual orientation, gender identity/expression, disability, protected veteran status, genetic information, or any other basis protected by institutional policy or by federal, state or local laws unless such distinction is required by law.

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