Job Title: Clinical Trial Specialist

Job Description

As a Clinical Trial Specialist, you will coordinate the initiation and activation of new clinical trial protocols, ensuring compliance with necessary approvals and data collection plans. You will prepare study tools, develop study materials using software tools, review patient charts to confirm protocol eligibility, and manage informed consent forms. Additionally, you will register research patients, maintain research records, assist in grading adverse events, and provide regular reports to study groups and investigators. You will also serve as a liaison with study sponsors and ensure adherence to treatment plans and guidelines.

Responsibilities

• Coordinate the initiation and activation of new clinical trial protocols, ensuring necessary approvals and data collection plans are in place.
• Prepare study tools including study binders, medication diaries, eligibility checklists, and flow sheets.
• Develop study tools using software such as Excel®, Word®, and Access®.
• Review patient charts and medical history to confirm protocol eligibility and obtain source documents.
• Ensure informed consent forms are obtained, signed, and properly filed.
• Register consented research patients with study sponsors and input data into clinical trials database.
• Maintain research records for all enrolled patients, including consent forms, eligibility, Case Report Forms (CRFs), and source documents.
• Assist with grading adverse events and complete Serious/Unexpected Adverse Event (SAE) forms.
• Provide regular reports to tumor study group members and Principal Investigator.
• Serve as a liaison with study sponsors, schedule monitoring visits and conference calls, and respond to sponsors' queries.
• Ensure study personnel conduct the study according to treatment plans and Good Clinical Practice (GCP) guidelines.

Essential Skills

• Experience as a Clinical Research Coordinator
• Proficiency in clinical research, particularly in oncology
• Ability to recruit and enroll patients
• Experience handling informed consent and source documents
• 2-3 years of clinical research coordinator experience
• Excellent communication skills and comfortability communicating with patients
• Knowledge of computer software programs such as Excel®, Word®, and Access®

Additional Skills & Qualifications

• Bachelor’s Degree required
• 1-3 years of relevant clinical research experience
• Detail-oriented with excellent organizational, communication, and interpersonal skills
• Ability to hold oneself accountable to high standards of professional excellence
• Resourceful and able to maximize resources
• Seeks and accepts personal and professional responsibility on a continued basis

Work Environment

The work environment includes a clinical operations team of 40 FTEs across disease-specific groups such as breast, lung, phase 1, and GI. Additional teams include RA, QA, Informatics, Education, and Finance, with a total of 100 FTEs. The organization enrolls approximately 5,000 subjects per year across Newark and seven other sites in the state. There are 300 active trials with a goal of 2,500 active subjects, covering all phases for both adult and pediatric patients.

Pay and Benefits

The pay range for this position is $35.00 - $37.00/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 Livingston,NJ.

Application Deadline

This position is anticipated to close on Apr 14, 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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $35 - $37