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Clinical Trial Specialist

Company: Actalent
Location: New Brunswick
Posted on: November 18, 2022

Job Description:

Description: Coordinates the initiation and activation of all new clinical trial protocols. This includes, but is not limited to, verifying Scientific Review Board (SRB), Institutional Review Board (IRB), Human Research Oversight Committee (HROC), data collection plans and finance/contract approvals prior to study activation. Coordinates the preparation of study tools including but not limited to study binders, medication diaries, eligibility checklists and flow sheets (as required). Using Oncore/Excel /Word, develops study tools, including but not limited to eligibility checklists, medication diaries, calendars, and flow sheets (as required). In collaboration with the Research Nurse Clinician (RNC) and/or physician, reviews patients charts and medical history to confirm protocol eligibility and obtains source documents (i.e. medical record documentation) as needed. Under the direction of the RNC and/or physician, ensures that IRB approved informed consent form has been obtained, signed, placed in the medical record, and that a copy was provided to the patient. Registers consented research patients with study sponsor (e.g. industry, NCI Cooperative group, etc.) and inputs into Oncore clinical trials database maintained. Maintains research record (e.g. patient consent, eligibility, Case Report Forms (CRF), registration confirmation, corresponding source documents, etc.) for all patients enrolled in Cancer Institute of New Jersey clinical trials. This includes, but is not limited to, Network centers, community physicians offices and hospitals. In collaboration with the RNC and physician, assists with grading adverse events using the most recent version of National Cancer Institute (NCI) common toxicity criteria or protocol specific grading scales. Completes Serious/Unexpected Adverse Event (SAE) form for all internal and multicenter serious/unexpected adverse events as required by study sponsors, federal requirements and institutional guidelines. Ensures research record (e.g. patient consent, eligibility, CRFs, registration confirmation, corresponding source documents, etc.) is maintained for all patients enrolled. This includes, but is not limited to, community physicians offices and hospitals. Using Oncore, provides regular reports to the tumor study group members and Principal Investigator on all studies to which he/she is assigned. Understands and anticipates needs of study sponsors. Serves as study liaison with study sponsors, schedules monitoring visits and conference calls. Provides accurate, timely, intelligent responses to sponsors queries. In collaboration with the RNC, assures that personnel, including investigators, are conducting the study according to the treatment plan and GCP guidelines. Additional Skills & Qualifications: Bachelors Degree requires. two to three years of relevant clinical research experience. Solid knowledge of computer software programs such as Excel, Word, and/or Access. The ideal candidate will be detail orientated, have excellent organizational, communication and interpersonal skills, hold self-accountable to high standards of professional excellence, be able to maximize resources and be resourceful, seeks and accepts personal and professional responsibility on a continued basis. Experience Level: Entry Level About Actalent:Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. Were supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Actalent, New Brunswick , Clinical Trial Specialist, Healthcare , New Brunswick, New Jersey

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