Clinical Research Coordin

NJ Eye LLC is a private equity backed, independent, integrated eye care organization with its corporate headquarters in Union, New Jersey. The company has over 250 eye care professionals and business support roles across a growing network of over 17 eye care clinic locations, spanning New Jersey, with plans to affiliate with other eye care practices in New Jersey, New York, Connecticut, Pennsylvania, Delaware, Maryland, and nationwide.

Role and Responsibilities:

• Leads recruitment efforts and screens potential patients for eligibility for studies
• Ability to achieve enrollment targets on assigned studies
• Obtains informed consent from patients and conducts study visits for clinical trials
• Creates Case Report Forms
• Completes assessments on study subjects as per protocol
• Documents study assessments
• Enters study data into EDC systems
• Collects, processes, stores and ships lab specimens; documents lab procedures, lab results and follows up with patients and medical staff as necessary
• Coordinates, monitors visits with CRAs for each trial to ensure accurate documentation; makes corrections to data as necessary
• Assists during sponsor and FDA audits
• Responsible for submissions and reports to the IRB; maintains documentation of IRB communications and decisions
• Documents adverse events and notifies PI, sponsor and IRB
• Assumes test article accountability
• Possesses a sound and in-depth understanding of each protocol that has been assigned as a primary responsibility
• Maintains compliance with Good Clinical Practice; Clinical Safety Data Management, 21 CFR, and has IATA certification
• Travels to investigator meetings
• Participates in weekly meetings with the research team, provides study metrics
• Responds to requests in a timely manner, gives/receives correct information, encourages dialogue and follow-through, secures accurate signatures, maintains files in an organized and up-to-date manner
• Other tasks as required

Qualifications:

 Education: Bachelor’s degree preferably in Science or related field. Equivalent relevant experience and/or training in lieu of education is acceptable.

Experience: 2+ years’ relevant experience (e.g. research, clinical, interaction with study population, program coordination)

Knowledge/Skills/Experience:

• Excellent Excel, Word, PowerPoint and reporting skills
• Excellent interpersonal skills to deal effectively with patients, physicians, clinicians and administrators
• Excellent organizational skills and self-management skills to independently manage work flow
• Ability to prioritize
• Meticulous attention to detail
• Knowledge of medical terminology
• Knowledge of good clinical practice, FDA, OHRP, HIPAA policies
• Ability to use EMR data as a subject recruitment tool
• Experience using Microsoft Office Suite, and clinical research systems (CTMS, Regulatory)
• Certification through either ACRP or SoCRA highly preferred

At PRISM Vision Group, we believe great work deserves great rewards. Here’s what you can expect when you join our team:

Salary Range: $49,000.00 to $70,000 USD

• Competitive Compensation – Base salary, performance bonuses, and regular reviews.
• Health & Wellness – Comprehensive medical, dental, and vision insurance; and wellness program.
• Retirement Planning – 401(k) with company match.
• Generous Time Off – Paid vacation, sick leave, and company holidays.
• Learning & Development –career growth programs.
• Other Perks – Commuter benefits, Voluntary Accident and Critical Illness plans, FSA/HSA and Dependent Care FSA. employee discounts, and more.

NJ Eye LLC is an Equal Opportunity / Affirmative Action employer. Candidates are selected solely on the basis of legally permissible job-related criteria without regard to race, color, religion, sex, national origin, disability, marital status, or sexual orientation, in accordance with federal and state law.