Clinical Research Coordinator III - TMCH Cancer Center

SUMMARY :

The Clinical Research Coordinator III - Oncology (CRC III) is a senior-level research professional who independently leads and manages complex oncology clinical trials (Phase I FIH through Phase IV) or multiple moderate-complexity studies. This role requires advanced knowledge of clinical research regulations, oncology protocols, and institutional policies. The CRC III provides strategic input on protocol development, regulatory strategy, financial and operational execution, and serves as a subject matter expert, mentor to junior staff, and a key liaison between investigators, sponsors, and regulatory bodies.

ESSENTIAL FUNCTIONS :

Clinical Trial Management

• Independently manage all aspects of assigned clinical trials, including industry-sponsored and investigator-initiated studies.
• Lead coordination of high-complexity oncology trials.
• Conduct feasibility assessments, protocol development, and study start-up activities.
• Coordinate site visits (pre-study, initiation, monitoring, and close-out).
• Ensure adherence to study protocols, regulatory requirements, and institutional policies.
• Monitor participant safety, report adverse events, and ensure timely follow-up.
• Review and report protocol deviations; develop corrective action plans.
• Conduct drug accountability reviews and documentation.
• Oversee regulatory submissions and ensure audit readiness.
• Represent the site in sponsor meetings, audits, and regulatory inspections.

Participant Coordination and Direct Patient Care

• Oversee recruitment, screening, enrollment, and retention strategies.
• Conduct informed consent discussions and ensure proper documentation.
• Coordinate patient care in compliance with protocol requirements.
• Provide direct patient care including vital signs, ECGs, specimen collection, and quality-of-life assessments.
• Assist patients in completing study activities, ensuring a positive and supportive experience.
• Work alongside physicians and APPs to capture response evaluations per protocol.

Data and Documentation

• Collect, enter, and manage clinical data and source documentation.
• Lead data query resolution and quality assurance processes.
• Maintain accurate, detailed records of research activities for audit readiness.
• Ensure proper collection, processing, and handling of specimens.

Regulatory and Compliance

• Prepare and submit IRB applications, amendments, and continuing reviews.
• Ensure compliance with regulatory, ethical, and institutional guidelines.
• Maintain regulatory binders, source documentation, and case report forms.
• Provide a safe environment through compliance with OSHA, CDC, and HIPAA standards.

Leadership and Collaboration

• Train, mentor, and supervise junior coordinators and research assistants.
• Collaborate with investigators, sponsors, monitors, and internal departments.
• Develop and implement SOPs, training plans, and process improvement initiatives.
• Participate in required training and education programs.

Operational and Strategic Support

• Assist in budget development, contract negotiation, and resource planning.
• Contribute to grant writing, protocol design, and publication efforts.
• Analyze data trends and contribute to strategic decision-making.
• Develop contingency plans and respond to unforeseen circumstances.

Adhere to TMCH organizational and department-specific safety, confidentiality, values, policies, and standards.

Perform related duties as assigned.

MINIMUM QUALIFICATIONS

EDUCATION: Bachelor's degree in a relevant field or equivalent experience.

EXPEREINCE: Five (5) years of relevant experience required.

LICENSURE OR CERTIFICATION : Current Basic Life Support (BLS) required. Certification as a Clinical Research Coordinator (CCRC), Clinical Research Professional (CCRP), Medical Assistant, or a Phlebotomy certification, preferred.

KNOWLEDGE, SKILLS, AND ABILITIES :

• Advanced knowledge of clinical trial regulations and oncology care.
• Strong leadership, analytical, decision-making, and project management skills.
• Proficiency in electronic data capture systems and Microsoft Office.
• Excellent communication and interpersonal abilities.
• Ability to work independently and collaboratively in a team environment.
• Demonstrated compassion, cultural sensitivity, and emotional support for patients and families.
• Ability to adapt to diverse populations and maintain professionalism under stress.