Responsibilities
Clinical Research Coordinator I (CRC I) is a fundamental member of the research team. Working under the PI, he/she is responsible for coordinating the conduct of clinical trials in accordance with all applicable regulations and guidelines. Depending on experience, the CRC I will operate under close supervision and guidance while in training. Some responsibilities of the CRC I, depending on need include:
- Facilitate and coordinate the daily cancer clinical trial activities
- Coordinate the conduct of clinical trials per Good Clinical Practice and CFR guidelines
- Work cooperatively with on-site research staff of Investigators, Nurses, Medical Assistants.
- Accurate and timely trial data collection and reporting
- Submit regulatory documents to IRB and Sponsor
- Attend investigator meeting(s)
- Obtain physician signatures
- Recruit subjects/patients
- Screen, track and schedule trial pts
- Teach subjects/patients about protocol expectations for trial visits
- Perform study/protocol procedures in a detailed, accurate manner
- Maintain study files on site
- Report all adverse events and SAEs
- Collect laboratory specimens, processing and shipping lab work
- Maintain communication and correspondence (by telephone, email, fax, etc.) with subjects, sponsor, monitor and other site study personnel.
- Complete case report forms (CRF) and electronic data capture (EDC) for PI review and approval
- Coordinate site study monitor and sponsor visits
- Maintain study-specific supplies
- Prepare for study closure and archiving
- Knowledge of medical terminology (Oncology and Urology preferred).
- Knowledge of good clinical practice, FDA, OHRP, HIPAA policies.
- Proficiency with the Microsoft Office Suite, Google Docs, SharePoint.
- Meticulous attention to details
Job Qualifications
- At least 1 year of experience in a clinical research setting, often transitioning from an assistant role
- Prior experience in an oncology or urology setting preferred
- Performs primary duties with greater independence and has progressed to performing more advanced skill sets as directed.
- Some EMR (electronic medical records) experience required
- Some Electronic Data Capture (Rave, Oracle, Inform, etc.) experience preferred
Knowledge, Skills & Abilities
- Excellent organization and communications skills required.
- Strong interpersonal skills – ability to effectively interact with all levels of staff and external contacts.
- Must be detail oriented and have the ability to follow-through.
- Ability to effectively manage time and prioritize workload.
- Must practice discretion and adhere to site confidentiality guidelines at all times.
- Must have computer skills including the use of Microsoft Office.
