Location: Rochester,NY, USA
Job Title: Clinical Research Coordinator
Location: Rochester, NY
Type/Duration: Contract, 6 month renewable
Start Date: ASAP
Job Summary:
The Study Coordinator works closely with the Principal Investigator managing study conduct from study selection through study closeout. The Study Coordinator is responsible for the quality and integrity of their assigned clinical studies in accordance with Good Clinical Practice (GCP) and applicable regulations.
Duties/Responsibilities: Manage all aspects of a study ensuring adherence to the protocol, GCP, and applicable regulations, including participating in the informed consent process, coordinating, and performing all study visit procedures per protocol, managing Investigational Product and study related supplies and equipment, assisting with monitoring visits, attending Investigator Meetings, and assisting with query resolution, as required.
Provide the highest level of care and excellent customer service for study participants.
Collaborate with lab staff to plan for and manage laboratory samples throughout the length of the study, including review of the laboratory manual.
Ensure study drug is dispensed, accounted for and returned to the Sponsor per protocol.
Ensure Serious Adverse Events (SAEs) are reported to Principal Investigator, Sponsor, and IRB (through Regulatory) within 24 hours of site being notified of event, including collecting all required information for initial and follow-up reporting.
Ensure visit logs and CTMS visit status are accurate and complete.
Facilitate ongoing Quality Assurance (QA) review of studies, in collaboration with the QA department, including assisting with risk assessments, root cause analysis, and development of corrective and preventative actions as applicable.
Required Skills/Abilities: Excellent verbal and written communication skills.
Excellent interpersonal and customer service skills.
Excellent organizational skills and attention to detail.
Excellent time management skills with a proven ability to meet deadlines.
Strong analytical and problem-solving skills.
Ability to prioritize tasks and to delegate them when appropriate.
Ability to function well in a high-paced environment.
Education and Experience: 4-year degree in related field or NYS LPN License required or related experience as a clinical trial coordinator.
At least two years experience in clinical research setting preferred.
CCRC preferred.
Physical Requirements: Must be able to lift up to 15 pounds.
Benefits:
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.