Senior Clinical Research Coordinator

4 weeks ago

Houston, United States Katalyst Healthcares & Life Sciences Full time
Responsibilities:
  • Coordinate, evaluate, and follow patient progress while on studies maintaining knowledge of adverse events, protocol-related labs and research tests, and protocol responses. Collaborate with the multidisciplinary team as necessary to achieve the objectives of the trial.
  • Collaborate with physicians, advanced practice providers, research nurses, and data managers to assure appropriate documentation of patient care and obtain the necessary information required by the protocol.
  • Screen patients for protocol eligibility through personal interviews and/or medical record review in inpatient and outpatient settings.
  • Perform protocol-specific duties under the direct supervision of protocol PI, research nurses' manager/supervisor as needed or appropriate.
  • Obtain informed consent for non-treatment studies and assist in obtaining informed consent for treatment studies by discussing the study requirements and answering any study-specific questions for the patient and family.
  • Screen study patients for and report adverse events as required per the trial sponsor.
  • Ensure that patients are scheduled for research-required tests and appointments by reviewing electronic health records and coordinating with schedules as needed.
  • Complete the clinical content template for new submission of protocols or protocol amendments. That includes changes to the treatment plan including required tests.
  • Creates and maintains delegation of authority log, as needed.
  • Creates and maintains study-specific training logs, as needed.
  • Ensures that data and regulatory documents are complete for audits and monitoring per standard operating procedures visits.
  • Prepare continuing reviews and annual reports.
  • Conducts quality assurance data reviews to evaluate protocol compliance and data accuracy as assigned.
  • Provide guidance and instruction to research support staff as needed to promote protocol compliance in accordance with federal and institutional standards.
  • Communicates with clinical staff to ensure protocol patient safety and protocol compliance.
  • Prepares data and participates in data review meetings as required by the department.
  • Enters data and maintains management reports on the databases for various research purposes.
  • Assist in developing an onboarding training manual to standardize the onboarding process for new research staff.
  • Develops a training plan for incoming clinical studies coordinators and research data coordinators.
  • Provides updates to research staff regarding updates to or new institutional policies as appropriate.
  • In collaboration with supervisor/ manager, implement a mentoring plan for incoming staff, as directed.
  • Provides supervisory back-up as directed by supervisor/ manager.
  • Provides performance evaluation feedback for staff members as requested.
  • Requires flexibility in work schedule due to operational requirements, Attend meetings/work responsibilities outside of the set schedule.
Requirements:
  • Bachelor's degree in health sciences.
  • Preferred Education: Master's Level Degree or Ph.D. in Health Sciences.
  • Certification: None
  • Preferred Certification:
  • Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP)
  • 5 years of experience in the area of research study or direct patient care obtained from nursing, data gathering, or related field.
  • May substitute the required education degree with additional years of equivalent experience on a one-to-one basis.
  • With the preferred degree, three years of the required experience.

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