Clinical Research Coordinator I - TMCH Cancer Center

SUMMARY:

The Clinical Research Coordinator I - Oncology (CRC I) is an entry-level research professional responsible for supporting Phase II-IV oncology clinical trials. This role involves implementing clinical research protocols, managing data, and ensuring compliance with regulatory and institutional guidelines. The CRC I works under supervision and is expected to develop foundational knowledge in clinical research operations.

ESSENTIAL FUNCTIONS:

Clinical Trial Support

• Screen potential patients for protocol eligibility.
• Coordinate patient care in compliance with protocol requirements.
• Assist patients in completing study activities, ensuring a positive and supportive experience.
• Provide direct support for specimen collection and processing, perform ECGs, vital signs and quality of life assessments (paper or tablet)
• Facilitate and coordinate daily clinical activities; the position plays a critical role in the conduct of studies.

Data and Documentation

• Collect, document, and enter clinical trial data accurately and in a timely manner.
• Maintain detailed records of research activities for audit readiness.
• Ensure proper collection, processing, and handling of specimens.

Regulatory and Compliance

• Ensure compliance with regulatory, ethical, and institutional guidelines throughout all phases of the research study.
• Maintain strict patient confidentiality in accordance with HIPAA and applicable laws.
• Participate in monitoring and auditing activities.
• Provide a safe environment for patients, families, and staff by adhering to OSHA and CDC standards.

Training and Collaboration

• Participate in required training and education programs.
• Collaborate effectively with patients, clinical staff, and research team members.
• Attend all SIVs and train appropriately for each study.

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: None required. One (1) yearof relevant experience preferred.

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:

• Familiarity with FDA, IRB, OHRP, and GCP regulations.
• Ability to extract data from medical records.
• Knowledge of clinical trial procedures and data processing systems.
• Basic understanding of oncology clinical trial protocols.
• Familiarity with medical terminology.
• Basic knowledge of clinical research principles and industry standards.
• Proficiency in Microsoft Office and electronic health record (EHR) systems.
• Strong organizational skills and attention to detail.
• Effective written and verbal communication skills.
• Ability to work collaboratively in a team environment.
• Requires problem solving, decision-making, critical thinking, analytical, and deduction skills.