Clinical Research Coordinator II
3 weeks ago
At Bauer's Intelligent Transportation, we are seeking a highly skilled Clinical Research Coordinator II to join our team. This role is responsible for conducting clinical trials in accordance with federal and hospital regulations.
Key Responsibilities:
- Facilitate and coordinate daily cancer clinical trial activities
- Coordinate clinical trials per Good Clinical Practice and CFR guidelines
- Work directly with on-site research staff, including Investigators, Nurses, and Medical Assistants
- Accurately and timely collect and report trial data
- Submit regulatory documents to IRB and Sponsor
- Attend investigator meetings
- Obtain physician and staff signatures
- Recruit subjects/patients
- Screen, track, and schedule trial patients
- Coordinate the Informed Consent Process
- Teach subjects/patients about protocol expectations
- Perform study/protocol procedures in a detailed and accurate manner
- Maintain study files completely and accurately
- Report all adverse events and SAEs within required timelines
- Collect laboratory specimens, process, and ship lab work
- Maintain communication and correspondence with subjects, sponsor, monitor, and other site study personnel
- Complete case report forms (CRF) and electronic data capture (EDC) for PI review and approval
- Respond to all data queries and sponsor requests in a timely manner
- Coordinate site study monitor and sponsor visits
- Maintain study-specific supplies
- Prepare for study closure and archiving
- Maintain appropriate training required to carry out protocol-driven activities
Qualifications:
- 3-5 years of equivalent experience in medical clinic or research coordination
- CCRP, ACRP certification preferred but not required
- Prior experience with Urology and Oncology clinical trials preferred
- Performs primary duties with greater independence and has progressed to performing more advanced skill sets as directed
- Some EMR experience required
- Some Electronic Data Capture (Rave, Oracle, Inform, etc.) experience required
Knowledge, Skills & Abilities:
- Excellent organization and communications skills
- Strong interpersonal skills 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 always adhere to site confidentiality guidelines
- 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
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