Clinical Research Associate

Clinical Research Associate - Part Time

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.
• 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.

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

We offer competitive base rates that are determined by many factors, including job-related work experience, internal equity, and industry-specific market data. In addition to base salary, some positions may be eligible for clinical certification pay and shift differentials. The salary range listed for exempt positions reflects full-time compensation and will be prorated based on employment status. Saint Peter's offers a robust benefits program to eligible employees that will support you and your family in working toward achieving and maintaining secure, healthy lives now and into the future. Benefits include medical, dental, and vision insurance; savings accounts, voluntary benefits, wellness programs and discounts, paid life insurance, generous 401(k) match, adoption assistance, back-up daycare, free onsite parking, and recognition rewards. You can take your career to the next level by participating in either a fully paid tuition program or our generous tuition assistance program. Learn more about our benefits by visiting our site at Saint Peter's.