What are the responsibilities and job description for the Oncology Clinical Research Coordinator III position at Helios CR, Inc?
Job Title: Clinical Research Coordinator III- Oncology
FSLA Classification: Non-Exempt
Reports to: CRC Manager
Job Summary/ Objective:
The Clinical Research Coordinator III is responsible for supporting the management and oversight of clinical trials. This role involves working closely with a team to ensure the smooth execution of research studies under the guidance of the Investigator and CRC Manager.
Essential Functions:
Overseeing Clinical Trials:
- Ensure smooth conduct of study visits and clinical trials.
- Monitor study participants’ health throughout the trial.
- Schedule study visits within protocol-required timelines
- Coordinate lab work, imaging, and other required procedures
- Document all aspects of the study visit and subject status.
Data Collection and Analysis:
- Collect and enter data obtained from study visits into source documents, study logs, and EMR, as well as EDC where data management personnel are not assigned.
- Assist data management team with resolution of queries
Participant Interaction:
- Educate study participants about study objectives and visit procedures.
- Communicate with study participants regarding any adverse events or side effects and the management of them.
- Administer applicable questionnaires.
- Monitor participants' adherence to protocol guidelines.
Collaboration and Compliance:
- Liaise with laboratories
- Liaise with Imaging vendors
- Liaise with pharmacy staff and infusion nurses
- Liaise with regulatory and quality assurance departments on protocol adherence and documents.
- Monitor study compliance with protocols and ethical standards.
- Ensure adherence to regulatory requirements.
Record Keeping:
- Maintain research records, including source documents, study logs, case report forms, and EMR
- Direct specimen collection, labeling, packaging, transport, shipping, and storage.
Logistics and Supplies:
- Ensure all necessary equipment and supplies are in stock and functional.
Education/Experience/Skills:
Education: Bachelor's degree preferred in a health-related field
Experience: 3 years of experience in Clinical Research
Skills:
Regulatory
- Filing and accessing documents, Study Submission Assistant, Conduct Close-out Visits
- Report protocol deviations and SAEs to the IRB (where not performed by the Research Navigator)
Finance
- Stipend payments
- Manage site budgets
- Insurance Coordination
Subject Interaction
- Recruit, interview, screen, enroll, and randomize subjects
- Obtain Informed Consent
- Collect medical history
- Conduct study visits
- Triage patients' questions
Administrative
- Source documentation
- EDC completion
- Query resolution
- AE/SAE documentation and reporting
- Address protocol violations and deviations
- Order/ maintain supplies
Clinical Skills
- Phlebotomy preferred
- Vital Signs
- EKG
- Order and organize lab reports
- IP Administration
- Manage Medical Records
Others
- Support training and answer questions of other staff members
- Support monitoring visits
- Leads sponsor communication
- Manage subject visits during managers’ absence
- Liaise with Investigators in manager’s absence
Working Conditions/ Physical Demands:
Standard operating hours are Monday through Friday, 8:00 a.m. to 5:00 p.m. May be required to complete job-related tasks outside of that time frame more than a standard 40-hour work week. Requires prolonged walking, standing, bending, stooping, and stretching. Requires hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires a normal range of hearing and eyesight to record, prepare, and communicate appropriate reports.
Travel required: as needed (travel to IMs may be required)
Disclaimer
This job description may not be inclusive of all assigned duties, responsibilities, or aspects of the job described, and may be amended at any time at the sole discretion of the Employer.