Hackensack, NJ, 07602, USA
1 day ago
Clinical Research Regulatory Coordinator
Job Title: Clinical Research Coordinator Job Description We are seeking a dedicated and detail-oriented Clinical Research Coordinator to oversee the initiation and activation of new clinical trial protocols. The successful candidate will ensure compliance with all regulatory requirements and coordinate the preparation of necessary study tools and documentation. Responsibilities + Verify Scientific Review Board (SRB), Institutional Review Board (IRB), Human Research Oversight Committee (HROC), data collection plans, and finance/contract approvals prior to study activation. + Coordinate the preparation of study tools, including study binders, medication diaries, eligibility checklists, and flow sheets. + Develop study tools using computer software such as Excel®, Word®, and Access®. + Review patients’ charts and medical history to confirm protocol eligibility and obtain source documents in collaboration with the Research Nurse Clinician (RNC) and/or physician. + Ensure that IRB approved informed consent forms are obtained, signed, and properly documented. + Register consented research patients with study sponsors and input data into the clinical trials database. + Maintain research records for all patients enrolled in clinical trials, including patient consent, eligibility, Case Report Forms (CRF), and corresponding source documents. + 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 Principal Investigators on all assigned studies. + Serve as study liaison with study sponsors, schedule monitoring visits and conference calls, and respond to sponsors’ queries accurately and timely. + Ensure that personnel, including investigators, conduct the study according to the treatment plan and Good Clinical Practice (GCP) guidelines. Essential Skills + 1-3 years of clinical research coordinator experience. + Bachelor’s Degree. + Solid knowledge of computer software programs such as Excel®, Word®, and Access®. + Experience and comfortability communicating with patients. Additional Skills & Qualifications + 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 available resources. + Capable of seeking and accepting personal and professional responsibility on a continual basis. 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.
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