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Job Title: Clinical Research CoordinatorJob Description

The Clinical Research Coordinator acts as a liaison between principal investigators, sub-investigators, clinical research nurses, and regulatory specialists, ensuring compliance with all regulatory issues and protocol changes. This role involves collaboration with the principal investigator and clinical team to review study feasibility and potential competition with other protocols. The coordinator plays a crucial role in budget finalization and oversees subject enrollment, ensuring informed consent is properly obtained and documented.

Responsibilities

+ Collaborate with the principal investigator to review study feasibility and evaluate competition.

+ Review study budgets with principal investigator and finalize with the budget coordinator.

+ Evaluate proposed study protocols for sample collection, data management, and subject risks.

+ Oversee subject enrollment and ensure informed consent is documented.

+ Coordinate research activities including scheduling laboratory tests and medical exams.

+ Draft study-specific orders, billing templates, and study calendars with the study team.

+ Schedule subjects for appointments, procedures, or inpatient stays as required.

+ Monitor study activities for compliance with protocols and regulatory policies.

+ Register protocol patients with statistical centers and track enrollment status.

+ Act as the principal investigator's representative in communications with sponsors and IRB.

+ Maintain accurate records on clinical trial protocols in the clinical trial management system.

+ Coordinate with clinical research finance for appropriate billing of trial-related activities.

+ Prepare for and assist in sponsor monitor site visits, resolving issues found.

+ Maintain contact with sponsors for site visits and data inquiries.

+ Ensure compliance with record maintenance including case report and regulatory forms.

+ Oversee specimen requisition, collection, labeling, storage, or shipment.

+ Prepare for quality assurance audits by study sponsors or federal agencies.

+ Develop study-related documentation such as protocol worksheets and adverse event reports.

+ Identify and resolve protocol problems, including revisions.

+ Organize space for study equipment and supplies.

+ Participate in developing study protocols and data collection procedures.

+ Contact outside healthcare providers and communicate with subjects for follow-up information.

+ Review scientific literature and participate in continuing education and conferences.

+ Collaborate with investigators on presentations or reports of study results.

+ Attend research meetings and conferences as required.

+ Participate in staff meetings and in-service education.

+ Other duties and projects as assigned.

Essential Skills

+ Bachelor’s degree in science or healthcare field.

+ Minimum of 2 years experience in a Senior Clinical Data Coordinator or Senior Regulatory Specialist role, or at least 4 years related experience in clinical research.

Work Environment

The Clinical Research Coordinator is responsible for coordinating and overseeing clinical operations of all assigned clinical trials. This role involves assessing, planning, implementing, and ensuring compliant study conduct according to all relevant local, federal, and state regulatory and institutional policies and standard operating procedures. The coordinator works under the general supervision of the principal investigator responsible for the clinical trials to which they are assigned.

Job Type & Location

This is a Permanent position based out of Hackensack, New Jersey.

Pay and Benefits

The pay range for this position is $80000.00 - $80000.00/yr.

HMH perm benefits are offered

Workplace Type

This is a fully onsite position in Hackensack,NJ.

Application Deadline

This position is anticipated to close on Oct 30, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.