Sr. Clinical Studies Coordinator

Houston, Texas
September 19 2021
Health Sciences
Organization Type

Coordination/support to clinical trials and research protocols

1. Coordination and oversight of activities related to initiation and conduct of clinical trials.
• Maintain current financial folder for each assigned study.
• Ensure that research charge tickets are used appropriately and contribute information, as requested, to departmental financial staff for reconciliation of sponsored study accounts.
• Timely notification of patient on study to patient access coordinator and PBS.
• Screen patients for protocol eligibility through personal interviews and/or medical record review in inpatient and outpatient settings.
• Coordinate, evaluate, and follow the patient's participation in clinical settings. Provide collaborative oversight for the multidisciplinary team as necessary to document patient care, achieve objectives of clinical trials, and maintain patient safety.
• Instruct co-workers in allied fields in procedures for recording patient information.
• Participate in maintaining data necessary for audits, supervise audits, and oversee coordination of FDA audits.
• Understand and adhere to policies and procedures related to conduct of clinical trials.
• Provide leadership for the overall effective operation of designated protocols, which includes development, design, and resolution of operations and budget issues in collaboration with the principal investigator or study sponsor.
• Provide leadership for a multidisciplinary team to effectively meet protocol goals.

2. Coordination of regulatory correspondence on clinical research studies.
• Communicate verbally and in writing, as needed or as requested by the principal investigator of the study, with internal reviewers or external agencies (pharmaceutical companies and /or government sponsors).
• Complete forms and comply with institutional, state, and federal agencies; prepare reports for the surveillance committee and the sponsoring agencies as specified in the reporting requirements.
• Understand and adhere to policies and procedures related to conduct of clinical trials.

3. Direct support to clinical trial research protocols.
• Review protocol documents including abstracts, text and informed consent for relevant information.
• Register patients on research protocols by verifying eligibility/exclusion criteria and entering patients in PDMS per protocol. Communicate necessary registration information to sponsoring drug company as directed by PI, and with the assistance of the research nurse.
• Schedule patient tests; keep patients informed about test results and studies.
• Assist in obtaining consent for studies.
• Act as liaison with patients, physicians and research staff in providing administrative and patient care services for the coordination of research studies. If required for multi-center trials, maintain contact with other institutions in studies and coordinates all data pertaining to such studies.
• Complete case report forms in a timely and accurate fashion.
• Assist in the screening for adverse events.
• Follow patients while on study for safety monitoring. Adhere to institutional policies concerning safety and infection control.
• Provide support for labor-intensive protocols as needed.
• Monitor protocol compliance by assisting in coordination of protocol-specific lab, radiographic, and clinical evaluation of patients.
• Collect or facilitate the collection of specimens as outlined in assigned protocols upon request:
• Understand and adhere to policies and procedures related to conduct of clinical trials.

4. Oversee, coordinate, and participate in the collection and evaluation of data for principal investigators.
• Monitor the retrieval of protocol-related data as documented in the medical record and ensure accurate entry into a computerized database or on a handwritten case report form.
• Generate PDMS data reports, protocol summary reports, and user-generated data reports as requested.
• Compile protocol and other data for manuscript submissions.
• Provide assistance upon request for the preparation of technical reports, abstracts, posters and manuscripts for submission to corporate and federal sponsors, conferences, and scientific journals.
• Understand and adhere to policies and procedures related to conduct of clinical trials.
• Additional projects, as assigned.

Training and mentoring • Train and mentor new study coordinators and data coordinators to perform the functions delineated in their position descriptions.
• Assist with supervisory functions such as counseling employee in regard to institutional policies and procedures.
• Provide input for performance evaluations.
• Provide training and guidance with regard to policies and procedures that are related to conduct of clinical trials.
• Monitor accuracy compliance by study coordinators and data coordinators by performing QA audits.
• Plan, design, and conduct complex professional and ancillary staff education and disseminate information by means of training sessions/presentations and/or written communications.
• Conduct department training sessions to insure protocol compliance and dissemination of new information and policies.

Other Other duties as assigned.

Bachelor's degree. Five years experience in area of research study or direct patient care obtained from nursing, data gathering or related field. May substitute required education degree with additional years of equivalent experience on a one to one basis. With preferred degree, three years of required experience. 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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