Clinical Data Coordinator

Job Title: Data Coordinator

Job Description

The Clinical Data Coordinator plays a crucial role in maintaining essential study documents for clinical research studies. This position involves entering data onto Case Report Forms, ensuring study compliance, and collaborating with a dedicated research team.

Responsibilities

• Prepare reports and assist with statistical analysis.
• Maintain regulatory binders in accordance with FDA guidelines.
• Assist research nurses with audit preparations.
• Ensure timely submission of research data, laboratory specimens, and query correspondences.
• Obtain and maintain Dangerous Goods Shipping Certification.
• Collaborate daily with Principal Investigators, Research Nurse Coordinators, Sponsors, and Contract Research Organizations.
• Obtain patient consent for minimal risk studies.
• Organize and prepare for all study-related sponsor visits including Pre-Site Initiation Visits, Site Initiation Visits, Routine Monitor Visits, and Close-Out Visits.
• Verify that all patients have provided informed consent before entering study-specific data.
• Compare schedule of events to Case Report Form (CRF) to capture study-specific data points accurately.
• Record accurate data by completing paper or electronic CRFs.
• Resolve data queries accurately and within study-specific timeframes.
• Maintain adequate inventory of research supplies and ensure their currency.
• Centrifuge human specimens as per study-specific laboratory manual guidelines.
• Process and ship human specimens and biologic agents per protocol guidelines and Federal Regulations.
• Obtain and file research-related documents such as Curricula Vitae, Medical Licenses, Lab Certifications, and Financial Disclosures.
• Ensure regulatory binders are maintained with essential study documents.
• Maintain timely patient follow-up by accurately reviewing the study-specific follow-up schedule.
• Report, track, and file off-site Serious Adverse Events (SAEs) to the governing Institutional Review Board (IRB).
• Utilize the SAE reporting log to track off-site SAEs per protocol.
• Prepare reports, including enrollment logs, to assist with institutional statistical analysis.
• Lift, push, and pull materials as required, and spend extended periods working at a computer workstation.
• Identify and address the needs of the patient population served.

Essential Skills

• Minimum of 2 years of clinical research experience.
• Bachelor’s degree in Science (preferably in Chemistry, Biology, or Nursing) or 3 years of extensive research experience.
• Experience entering data into Case Report Forms.
• Experience maintaining regulatory binders.
• Ensuring timely submissions of research data.

Additional Skills & Qualifications

• Oncology experience is preferred.
• Experience working with blood processing is advantageous.

Work Environment

The role involves a standard workday of 9:00 AM to 5:30 PM, with an initial training period from 8:00 AM to 4:30 PM for the first 90 days.

Job Type & Location

This is a Contract to Hire position based out of Hackensack, NJ.

Pay and Benefits

The pay range for this position is $21.00 - $25.00/hr.

Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Hackensack,NJ.

Application Deadline

This position is anticipated to close on Nov 20, 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 actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $21 - $25