Clinical Research Associate - Part Time

About the role

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. They will initiate and implement observational or clinical research projects, manage study activities, and ensure compliance with regulatory standards.

Responsibilities

• Serve as the organizational appointee for assigned MFM research projects, maintaining the relationship and oversight of study procedures.
• Initiate and implement 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, 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 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.

Pay

Salary Range: 24.33 - 38.93 USD

Benefits

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.

At Saint Peter's, we offer a robust benefits program to eligible employees that supports 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.