Senior Clinical Research Coordinator

This exempt role is located with NJ Retina, Tom's River, NJ location, which is part of Prism Vision Group.

Compensation Range:

$63,044.14

• $130,937.

83/Annual (Dependent on Experience) 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.

K EY 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

QUALIFICATIONS

Education:

Bachelor's degree in health sciences, Public Health, Clinical Research, Science in Nursing and/or relevant field.

Experience:

5+ years of clinical trial/study management experience and knowledge. Managing study sponsors, CROs and vendor management experience highly preferred. Experience with clinical trials related to the diseases of the retina, macula and vitreous a plus.

Knowledge/Experience/Essential Skills:

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

Qualifications:

QUALIFICATIONS

Education:

Bachelor s degree in health sciences, Public Health, Clinical Research, Science in Nursing and/or relevant field.

Experience:

5+ years of clinical trial/study management experience and knowledge. Managing study sponsors, CROs and vendor management experience highly preferred. Experience with clinical trials related to the diseases of the retina, macula and vitreous a plus.

Knowledge/Experience/Essential Skills:

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