Senior Clinical Research Coordinator

Prism Vision Group•Toms River, NJ

16h•Onsite

About The Position

This exempt role is located with NJ Retina, Tom's River, NJ location, which is part of Prism Vision Group. The Senior Clinical Research Manager oversees operations of clinical research studies at the study sites, manages the responsibilities and conducts clinical trials in compliance with GCP, Regulatory Authorities’ regulations/guidelines, and applicable SOPs and protocols at a large multi-site, specialty/sub-specialty medical group for a region.

Requirements

Bachelor’s degree in health sciences, Public Health, Clinical Research, Science in Nursing and/or relevant field.
5+ years of clinical trial/study management experience and knowledge.
Managing study sponsors, CROs and vendor management experience highly preferred.
Experience with study start-up, timeline planning and management of clinical trials including vendor oversight
In depth knowledge of ICH/GCP, regulatory guidelines/directives, and drug development and clinical research processes
Experience with data collection processes, data review and comfort with using technology including analytics
Excellent organizational and time-management skills
Ability to identify critical issues and escalation to leadership when appropriate. Demonstrated judgment, organizational, planning, and control skills
Solid computer skills – requirement of MS applications - MS Project, Word, Excel, PowerPoint
Study Tools including electronic system skills – CTMS / EDC/eTMF, etc. preferred

Nice To Haves

Experience with clinical trials related to the diseases of the retina, macula and vitreous a plus.

Responsibilities

Lead point person for performance of the startup process of clinical research trials involving the study of investigational products/devices to treat diseases of the retina, macula and vitreous at the research sites.
Under the guidance of head of corporate clinical research, collaborates with Principal Investigator, patients, Clinical Research Coordinators, clinical staff, pharmaceutical sponsors, Contract Research Organizations (CROs), Academic Research Organizations (AROs), and other clinical service providers
Responsible for monitoring the quality of study documents and adherence to established processes and plans
Assists the Clinical Research Manager with developing subject recruitment/retention strategy and related initiatives
Facilitates Serious Adverse Event (SAE) reporting process, manages sponsors and IRB interaction
Ensures compliance with protocols, Good Clinical Trials Practices as well as perform all aspects of the study
Local travel to clinical offices required
Participates in clinical trials conduct, including recruiting and enrolling patients, performing study visits, collecting patient data, entering patient data into EDC, assisting during monitoring visits and resolving queries.
Assumes investigational product/device accountability
Responsible for inventory of research supplies and coordinating with the purchasing personnel to maintain adequate quantities
Responsible for special projects and other assignments as required