Clinical Trials Coordinator for Genitourinary Oncology

2 weeks ago

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

The Clinical Research Coordinator plays a vital role in supporting the research team and principal investigator in overseeing clinical trials, ensuring adherence to study protocols, maintaining quality standards, 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, and aids in the consent process.
  • Reviews study protocols and establishes systems for patient screening and scheduling for study visits.
  • Ensures effective patient recruitment for assigned research protocols.
  • Prepares on-study documentation and other necessary materials for research protocols.
  • Responsible for precise and prompt documentation of study notes in the institution's electronic medical records, gathering relevant information for reporting. This includes scheduling laboratory tests and tracking follow-up appointments as per protocol requirements.
  • Monitors and records any deviations, violations, adverse events, and other study-related activities.
  • Familiarity with protocol management databases and tools such as CRF, CORe, Prometheus, GURU, Microsoft Office, Excel, and others as required.
  • Collaborates with the principal investigator and Research Nurse Manager on ongoing study tasks, working alongside multidisciplinary team members (research nurses, laboratory staff, and clinic personnel) 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 inquiries from sponsors and regulatory bodies.
  • Supports training initiatives for staff involved in clinical trials.
  • Contributes relevant information for quality assurance on Non-Investigator Initiated Trials to ensure data integrity.
Offers guidance and support for research staff peers, including educational and training components:

  • Acts as a mentor to other research team members.
  • Serves as a resource for research personnel regarding protocols and compliance.
  • Communicates effectively with the principal investigator, protocol lead research nurse, and others about deadlines, research meetings, and other relevant information.
Assists with

Administrative Research Functions:

  • Engages in the submission process for Continuing Reviews in collaboration with the trial manager and principal investigator for Investigational New Drug (IND) reports and other necessary documentation.
  • Participates in protocol initiation meetings and close-out visits.
  • Contributes to the development of policies, procedures, and workflows to enhance project efficiency and effectiveness.
Communicates in a manner that promotes a positive and productive environment:

  • Demonstrates strong oral and written communication skills when interacting with institutions, patients, and agencies (including NCI, pharmaceutical companies, and sponsoring organizations) through various communication channels. Synthesizes relevant information to create written correspondence.
  • Must be capable of independently initiating weekly tasks without supervision.
  • Must effectively understand and respond to telephone communications with physicians and other healthcare team members, both within and outside the institution. Exceptional verbal and written communication skills are essential.
  • Advocates for the clinical research process in accordance with institutional, divisional, and departmental standard operating procedures, adhering to Good Clinical Practice guidelines.
  • Performs other duties as assigned.

EDUCATION:

Required:
Bachelor's degree.

Preferred:
Master's degree.

EXPERIENCE:

Required:

A minimum of three years of experience in research studies or direct patient care, which may include nursing, data collection, or related fields. Additional years of equivalent experience may substitute for the required educational degree on a one-to-one basis. For candidates with a preferred degree, one year of relevant experience is required.

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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