Clinical Trial Specialist
Job
Actalent
Remote
$75,920 Salary, Full-Time
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Job Description
Job Title:
Clinical Trial Specialist Job Description As a Clinical Trial Specialist, you will coordinate the initiation and activation of all new clinical trial protocols. This involves verifying approvals from the Scientific Review Board (SRB), Institutional Review Board (IRB), and Human Research Oversight Committee (HROC), as well as finalizing data collection plans and finance/contract approvals prior to study activation. Responsibilities Coordinate the preparation of study tools, such as study binders, medication diaries, eligibility checklists, and flow sheets. Develop study tools using software like Excel® and Word® in collaboration with the Research Nurse Clinician (RNC) and physicians. Review patient charts and medical history to confirm protocol eligibility and obtain necessary source documents. Ensure IRB-approved informed consent forms are obtained, signed, and properly filed in medical records. Register consented research patients with study sponsors and input data into clinical trials databases. Maintain research records for all patients enrolled in clinical trials, including consent forms, eligibility documentation, and Case Report Forms (CRF). Assist with grading adverse events and complete Serious/Unexpected Adverse Event (SAE) forms as required. Provide regular reports to tumor study group members and Principal Investigators. Serve as a liaison with study sponsors, schedule monitoring visits and conference calls, and address sponsor queries. Ensure study conduct aligns with treatment plans and Good Clinical Practice (GCP) guidelines. Essential Skills 2-3 years of experience as a Clinical Research Coordinator. Proficiency in clinical research, especially in oncology. Experience with informed consent processes and patient recruitment. Comfortable communicating with patients. Solid knowledge of software programs such as Excel®, Word®, and Access®. Additional Skills & Qualifications Bachelor's degree required. Detail-oriented with excellent organizational, communication, and interpersonal skills. Ability to maximize resources and demonstrate resourcefulness. Self-accountability to high professional standards. Willingness to accept personal and professional responsibility. Work Environment Join a dynamic team with 40 full-time employees specializing in various disease-specific groups such as breast, lung, phase 1, and gastrointestinal studies. Our operation includes research associates, quality assurance, informatics, education, and finance departments. We currently have 100 full-time employees and enroll approximately 5,000 subjects per year across Newark and seven other sites in the state. With 300 active trials and 1,000 active subjects, we aim for a long-term goal of 2,500 subjects. Our trials encompass all phases for both adult and pediatric subjects. Job Type & Location This is a Contract to Hire position based out of New Brunswick, 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 New Brunswick,NJ.
San Francisco Fair Chance Ordinance:
Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.Massachusetts Lie Detector:
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.Similar jobs in New Brunswick, NJ
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