Clinical Research Coordinator II

Position Title: Clinical Research Coordinator 2 Employment Type: Full-Time, Exempt

Hours: 8 :0 0am-5:00pm (Monday-Friday) Practice: NJ Retina PRISM Vision Group Partner Practice Location: Edison, New Jersey

Travel: Not Required Compensation: $49,000.00 to $70,000/ yr based on experience and qualifications

The Clinical Research Coordinator reports to the Manager of Clinical Research and will aid in the coordination and conduct of research under the supervision of a designated physician. The Clinical Research Coordinator will perform a variety of duties involved in the collection, compilation, documentation and analysis of clinical research data. The Clinical Research Coordinator has knowledge of the research studies, rationale, subjects and procedures associated with the studies

KEY RESPONSIBILITIES

Leads recruitment efforts and screens potential patients for eligibility for 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

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/Experience/Essential Skills:

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 policie s

KEY RESPONSIBILITIES

Leads recruitment efforts and screens potential patients for eligibility for 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

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/Experience/Essential Skills:

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 policie s