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Job Title: Clinical Research Coordinator

Job Description

The Clinical Research Coordinator acts as a liaison among principal investigators, sub-investigators, clinical research nurses, and regulatory specialists, ensuring smooth communication and compliance with all regulatory issues and protocol changes. This role involves collaboration with the principal investigator and clinical team to review studies for feasibility, assess potential protocol competition, and finalize budget drafts. The coordinator is responsible for overseeing subject enrollment, ensuring informed consent, scheduling necessary medical exams, and maintaining compliance with protocols and regulations.

Responsibilities

+ Coordinate research activities, including scheduling laboratory tests, radiology testing, and other medical exams.

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

+ Schedule subjects for appointments, procedures, or inpatient stays as per study protocols.

+ Monitor study activities for compliance with protocols and regulations.

+ Register protocol patients with appropriate statistical centers.

+ Track enrollment status and document dropout information.

+ Represent the principal investigator in communications with sponsors, IRB, and medical personnel.

+ Maintain accurate records on each protocol and patient in the clinical trial management system.

+ Work with clinical research finance to ensure appropriate billing of clinical trial activities.

+ Schedule, prepare, and assist with sponsor monitor site visits.

+ Maintain contact with sponsors to coordinate site visits and resolve data issues.

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

+ Prepare for and participate in quality assurance audits.

+ Prepare study-related documentation, including protocol worksheets and adverse event reports.

+ Identify and resolve protocol problems.

+ Organize space for study equipment and supplies.

+ Develop study protocols, including guidelines for administration or data collection procedures.

+ Communicate with outside health care providers and subjects for follow-up information.

+ Review scientific literature and participate in continuing education activities.

+ Collaborate with investigators to prepare presentations or reports on clinical study results.

+ Attend research meetings and conferences as required.

+ Participate in staff meetings and in-service education.

Essential Skills

+ BA/BS degree in science or healthcare field.

+ At least 4 years of related experience in the field of clinical research.

Additional Skills & Qualifications

+ Knowledge of oncology and clinical research.

+ Experience in preparing protocol worksheets and procedural manuals.

+ Strong organizational and communication skills.

Work Environment

The Clinical Research Coordinator works under the general supervision of the principal investigator, coordinating and overseeing clinical operations of assigned trials. The role involves assessing, planning, implementing, and ensuring compliant study conduct according to all relevant regulations and institutional policies. The work environment is dynamic, requiring collaboration with various teams and participation in conferences and continuing education activities.

Pay and Benefits

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

HMH Perm Benefits available immediately

Workplace Type

This is a fully onsite position in Hackensack,NJ.

Application Deadline

This position is anticipated to close on May 31, 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.