Clinical Research Coordinator Full-time

Clinical Research Coordinator

The Department of Oncology at Dell Medical School is seeking a Clinical Research Coordinator to join their Oncology Clinical Trial team. The ideal candidate will have strong organizational and multitasking skills, proficiency in data entry, and excellent communication abilities, which are essential for this role. Join us in making a difference in the lives of cancer patients through innovative clinical research and compassionate care.

The Clinical Research Coordinator (CRC) is responsible for coordinating and managing clinical research projects under the direction of the Principal Investigator (PI). This role involves overseeing the daily operations of clinical trials, ensuring compliance with regulatory requirements, and maintaining accurate documentation. The CRC works closely with research participants, clinical staff, and external sponsors to facilitate the smooth execution of studies.

ESSENTIAL JOB FUNCTIONS:

• Study Coordination
• Manages the day-to-day activities of clinical trials.
• Ensures compliance with study protocols and regulatory requirements.
• Coordinates participant recruitment, screening, and enrollment.
• Maintains accurate and timely documentation of study activities.
• Data Management
• Collects, enters, and verifies clinical trial data.
• Ensures data integrity and accuracy.
• Prepares data reports for review by the PI and sponsors.
• Manages electronic data capture systems.
• Regulatory Compliance
• Prepares and submits regulatory documents to IRBs and other regulatory bodies.
• Ensure ethical approval for studies is maintained, from initial approval through amendments, annual renewals, and terminations.
• Ensures adherence to Good Clinical Practice (GCP) guidelines.
• Maintains regulatory binders and essential documents.
• Coordinates audits and inspections.
• Participant Interaction
• Informs and consents study participants.
• Schedules and conduct study visits.
• Monitors participant safety and well-being.
• Provides education and support to participants.
• Collaboration and Communication
• Communicates study progress and issues to the PI and research team.
• Liaises with sponsors, monitors, and other external stakeholders.
• Participates in team meetings and training sessions.
• Facilitates effective teamwork and collaboration.
• Other duties as identified by department
• Assists with grant writing and funding applications.
• Participates in the development of study protocols and procedures.
• Attend professional development workshops and conferences.
• Provides mentorship and training to junior research staff.
• Adheres to internal controls and reporting structure.
• Performs related duties as required.

KNOWLEDGE/SKILLS/ABILITIES

• Ensures accuracy in data collection and documentation.
• Identifies and corrects errors promptly.
• Maintains meticulous records.
• Clearly conveys information to participants and team members.
• Facilitates effective collaboration.
• Provides clear and concise reports.
• Manages multiple tasks and priorities efficiently.
• Maintains organized study files and documentation.
• Ensures timely completion of study activities.
• Identifies and resolves issues that arise during studies.
• Develops solutions to improve study processes.
• Thinks critically and analytically.
• Utilizes electronic data capture systems effectively.
• Understands medical terminology and clinical research methods.
• Adapts to new technologies and software.

EDUCATION & EXPERIENCE

Minimum Qualifications:

• Bachelor's degree in a health-related field.
• Minimum of 3 years of experience in clinical research coordination/human-subject research experience (screening/consent, visit coordination, data entry, IRB submissions).
• Relevant education and experience may be substituted as appropriate.

Preferred Qualifications:

• Master's degree in clinical research, Public Health, or a related field.
• Minimum of 5 years of experience in clinical research coordination.
• Certification as a Clinical Research Coordinator (CCRC) or equivalent.

LICENSES, REGISTRATIONS OR CERTIFICATIONS

• Required:
• Certification as a Clinical Research Coordinator (CCRC) or equivalent.
• Preferred:
• Additional certifications in clinical research or related fields.

WORKING ENVIRONMENT/EQUIPMENT

• May work around standard office conditions
• May work around biohazards
• Repetitive use of a keyboard at a workstation
• Field work as necessary

Required Materials

• Resume/CV
• 3 work references with their contact information; at least one reference should be from a supervisor
• Letter of interest