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Job Title: Clinical Trial Specialist

Job Description

As a Clinical Trial Specialist, you will coordinate the initiation and activation of new clinical trial protocols. This role involves verifying necessary approvals from various boards and committees, preparing study tools, and ensuring that all patient documentation is accurate and complete. You will work closely with Research Nurse Clinicians and physicians to confirm protocol eligibility and maintain comprehensive research records.

Responsibilities

+ Coordinate the initiation and activation of all new clinical trial protocols, ensuring all necessary approvals are obtained before study activation.

+ Prepare study tools such as study binders, medication diaries, eligibility checklists, and flow sheets.

+ Develop study tools using software like Excel® and Word®, and review patients' charts to confirm protocol eligibility.

+ Ensure informed consent forms are obtained, signed, and properly filed in the medical records.

+ Register consented research patients with the study sponsor and input data into the clinical trials database.

+ Maintain research records, including patient consent, eligibility, Case Report Forms (CRFs), registration confirmation, and corresponding source documents.

+ Assist with grading adverse events using National Cancer Institute criteria or protocol-specific grading scales.

+ Complete Serious/Unexpected Adverse Event (SAE) forms as required by study sponsors, federal requirements, and institutional guidelines.

+ Provide regular reports to tumor study group members and the Principal Investigator on assigned studies.

+ Serve as a study liaison with study sponsors, scheduling monitoring visits and conference calls, and responding to sponsors’ queries.

Essential Skills

+ Clinical Research Coordination

+ Experience in Oncology

+ Informed Consent Processes

+ Patient Recruitment and Enrollment

+ Experience with Source Documents

+ 2-3 years of clinical research coordinator experience

Additional Skills & Qualifications

+ Bachelor’s Degree

+ Solid knowledge of computer software programs such as Excel®, Word®, and Access®

+ Detail-oriented with excellent organizational, communication, and interpersonal skills

+ Ability to maximize resources and seek personal and professional responsibility

Job Type & Location

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

Pay and Benefits

The pay range for this position is $35.00 - $38.00/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 hybrid position in Newark,NJ.

Application Deadline

This position is anticipated to close on Dec 3, 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.