Genitourinary Oncology Clinical Research Coordinator

2 weeks ago

Houston, Texas, United States MD Anderson Cancer Center Full time

The Clinical Research Coordinator plays a pivotal role in collaborating with the research team and principal investigator to oversee research protocols, ensuring adherence to guidelines, maintaining quality assurance, and facilitating communication among staff regarding protocol details.


Key Responsibilities
Develops, executes, monitors, and reports on the status of clinical research projects, ensuring timely completion:

  • In collaboration with the physician, evaluates patient eligibility through interviews and medical record assessments, assisting in the consent process.
  • Reviews protocols and establishes systems for patient screening and scheduling for study visits.
  • Ensures accurate and effective patient recruitment for assigned protocols.
  • Creates on-study documentation and other necessary materials for protocols.
  • Responsible for precise and prompt documentation of study notes in the electronic medical record, gathering relevant information for reporting. This includes scheduling laboratory tests and tracking follow-up visits as per protocol.
  • Monitors and documents deviations, violations, adverse events, and other study-related activities.
  • Familiarity with protocol databases and tools such as CRF, CORe, Prometheus, GURU, Microsoft Office, Excel, and others as required.
  • Consults with the Principal Investigator and Research Nurse Manager regarding ongoing study tasks and collaborates with multidisciplinary team members as needed.
Aids in the analysis and quality assurance of clinical research data:

  • Assists in coordinating routine monitoring and audits with industry sponsors or clinical research organizations.
  • Provides timely and appropriate responses to sponsor inquiries and regulatory queries.
  • Supports training initiatives for staff involved in sponsored studies.
  • Contributes relevant information for quality assurance on Non-Investigator Initiated Trials to ensure data integrity.
Offers support and guidance to research staff peers, emphasizing education and training:

  • Acts as a mentor to other research team members.
  • Serves as a resource for research personnel regarding protocols and compliance.
  • Communicates with the Principal Investigator, protocol lead research nurse, and others about upcoming deadlines and research meetings.
Engages in

Administrative Research Activities:

  • Participates in the submission process for Continuing Reviews in consultation with the trial manager and Principal Investigator for Investigational New Drug (IND) reports and other required documentation.
  • Engages in protocol initiation meetings and close-out visits.
  • Contributes to the development of policies, procedures, and workflows to enhance project efficiency and effectiveness.
Communicates effectively to foster a positive and productive environment:

  • Demonstrates proactive and effective communication skills, both oral and written, when interacting with institutions, patients, and agencies.
  • Must be capable of independently initiating weekly tasks without supervision.
  • Must understand and respond to conversations with physicians and other healthcare team members, demonstrating excellent verbal and written communication skills.
  • Advocates for the clinical research process in alignment with institutional, divisional, and departmental SOPs, adhering to Good Clinical Practice standards.
  • Performs other duties as assigned.

EDUCATION:

Required:
Bachelor's degree.

Preferred:
Master's degree.

EXPERIENCE:

Required:

Three years of experience in research studies or direct patient care, gained through nursing, data collection, or related experience. Additional years of equivalent experience may substitute for the required education on a one-to-one basis. With a preferred degree, one year of required experience is necessary.

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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