Assistant Clinical Research Coordinator
New York, NY
Title: Assistant Clinical Research Coordinator
Location: New York, NY
Occupational Category: Healthcare Finance and Operations
Description: Our client, a multispecialty group practice in New York City, is seeking to hire an Assistant Clinical Research Coordinator.
- Develop trial protocols to present to committee.
- Identify, evaluate, and establish trials sites, and closing sites down on completion of trial.
- Train site staff on therapeutic areas, protocol requirements, proper source documentation, and case report form completion.
- Collaborate with ethics committee regarding rights, safety and well-being of trial subjects.
- Order, track, and manage IP and trial materials.
- Oversee and document IP dispensing, inventory, and reconciliation.
- Protect subject? confidentiality, updating their information, and verifying IP has been dispensed and administered according to protocol.
- Coordinate project meetings.
- Administering patient rating and psychiatric rating scales.
- Computerized data entry (EDC, IWRS, Microsoft Word, Excel).
- CRF completion and lab collection and processing.
- Implement action plans for sites not meeting expectations.
- Collaborate with regulatory authorities.
- Ensure compliance with SOPs and local regulations, as well as ICH and GCP guidelines.
- Comply with office policy and procedure & follows directives.
- GCP certification
- Knowledge of how to perform Informed Consent, required.
- Knowledge of how to collect AEs and report SAEs, required.
- Phlebotomy experience preferred.
- Experience preforming EKGs preferred.