Clinical Research Associate - Part Time

Saint Peter’s Healthcare System; New Brunswick (NJ); On-site; USD 33,517 - 53,629; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) match

Tuition assistance program

Free onsite parking

Adoption assistance

Job summary

Saint Peter’s Healthcare System is seeking a MFM Clinical Study Grant role to oversee assigned MFM research projects, maintain regulatory compliance, and coordinate with sponsors.

You will manage study procedures, recruitment, data entry, and regulatory documentation while ensuring patient confidentiality and collaboration with investigators and staff.

Qualifications

• 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 similar accreditation preferred.
• Previous Phlebotomy experience or certification preferred.

Responsibilities

• Serve as organizational appointee for assigned MFM research projects and oversee study procedures.
• Initiate observational or clinical research projects and maintain investigator/training records.
• Oversee recruitment, consenting, enrollment, randomization, and data collection.
• Maintain regulatory files and CTMS; manage IRB amendments and renewals.
• Coordinate with investigators, staff, hospital personnel, IRB, and sponsors.
• Attend meetings and report on study progress; ensure compliance with regulations.

Skills

Independent work

Team collaboration

MS Office Suite

Phlebotomy experience

Education

Bachelor's degree in science or healthcare

Tools

Microsoft Office

Job description

MFM Clinical Study Grant

• 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.

Salary Range: 24.33 - 38.93 USD.

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.