Oncology Clinical Trials Coordinator
1 week ago
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 effectively communicating protocol details to staff.
Key Responsibilities
Develops, executes, monitors, and reports on the status of clinical research projects, ensuring timely delivery:
- In partnership with the physician, evaluates patient eligibility through interviews and medical record assessments, facilitating the consent process.
- Reviews protocols and establishes systems for patient screening and scheduling for study visits.
- Accountable for successful patient recruitment for assigned protocols.
- Generates study notes and other necessary documentation for protocols.
- Ensures accurate and prompt entry of study notes into the institution's electronic medical record, retrieving relevant information as needed. This role requires the ability to gather pertinent data and discern what information is essential to report. Responsible for 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, collaborating with multidisciplinary team members (research nurses, laboratory staff, and clinic personnel) as necessary.
- 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.
- Aids in training staff for institutional and sponsored studies.
- Contributes relevant information for quality assurance on Non-Investigator Initiated Trials to ensure data integrity.
- Acts as a mentor to other research team members.
- Serves as a resource for research personnel regarding protocols and compliance information.
- Communicates with the Principal Investigator, protocol lead research nurse, and others regarding deadlines, research meetings, and other relevant information.
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 required 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.
- Demonstrates proactive and effective oral and written communication skills when interacting with institutions, patients, and agencies (e.g., pharmaceutical companies, sponsoring organizations) through various communication channels. Assimilates relevant information to compose written correspondence.
- Must be capable of independently initiating weekly assignments without supervision.
- Must possess the ability to understand and respond to telephone conversations with physicians and other healthcare team members, both within and outside the institution. Excellent 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:
Three years of experience in research study or direct patient care, which may include nursing, data collection, or related fields. 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.
The University of Texas MD Anderson Cancer Center is committed to providing equal employment opportunities 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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