Clinical Research Associate - Part Time

Saint Peters Healthcare System•New Brunswick, NJ

37d•$24 - $39

About The Position

The Clinical Research Associate - Part Time will serve as the organizational appointee for assigned MFM research projects, maintaining the relationship and oversight of study procedures. This role involves the initiation and implementation of observational or clinical research projects, including maintaining investigator and research staff CVs, licensure, and training records. It also includes drafting and updating the Informed Consent Form, and completing Institutional Review Board (IRB) modifications with supporting documentation. The associate will maintain oversight of designated research project study activities, including subject recruitment, consenting and enrollment/randomization, performing study procedures, data entry, specimen processing, and maintaining regulatory files. They will also serve as a liaison between various stakeholders, maintain the Clinical Trial Management System (CTMS), ensure patient confidentiality, and attend research meetings. Compliance with all SPUH policies and procedures is required.

Requirements

Bachelor's Degree in science or healthcare field preferred.
Two years of experience in healthcare and/or research.
Ability to work independently as well as in a team environment.
Proficient in Microsoft Office Suite.

Nice To Haves

Certified Clinical Research Professional (CCRP) or other similar research accreditation preferred.
Previous Phlebotomy experience or certification preferred.

Responsibilities

Serve as the organizational appointee for assigned MFM research projects, maintaining the relationship and oversight of study procedures.
Initiation / implementation of the observational or clinical research projects assigned including: Maintenance of Investigator and Research Staff CVs, Licensure and Training Records, Drafting and updating the Informed Consent Form with CIRB Boilerplate, Completion of Institutional Review Board (IRB) modifications with supporting documentation.
Maintain oversight of designated research project study activities including performing the following functions: Subject recruitment, Consenting and Enrollment/Randomization, Perform study procedures/assessments in accordance with clinical trial guidelines, Complete Data Entry into Case Report Forms and Query Resolution, Process/Ship Specimens per trial requirements, Maintain Regulatory files including delegation logs, FDA form 1572, training logs and other trial documents in compliance with federal and local regulations, Process IRB amendments, annual renewals, closures, etc, Attend regular meetings with members of the project at partnering institutions and sponsors to report on study progress.
Maintain financial records including Accounts Receivable Report, Check remittance with back-up details and assist with the annual A-133 audit.
Serve as a liaison between investigators, research staff, hospital staff, the IRB and sponsors.
Maintain and utilize research's Clinical Trial Management System (CTMS).
Maintain strict patient confidentiality including restricted access to clinical trial files.
Attend and participate in research meetings and report on study progress.
Perform other tasks as assigned by leadership.
Comply with all SPUH policies, procedures, objectives, quality assurance, safety, environmental and infection controls.