In-house Clinical Research Associate

Devon Consulting, Clinical group Email: Apply by Email Reference Code: D8531 In-house Clinical Research Associate Our client, a global leader in the pharmaceutical/biotech arena located in Rahway, is looking to hire an Associate Medical Program Coordinator  (Clinical Research Associate).  This is an excellent opportunity to showcase your skills in a top-notch pharmaceutical environment, and you will receive a competitive salary, comprehensive benefits and career enhancement opportunities.Position SummaryThe incumbent is partially responsible for the scientific and operational support for clinical trials conducted as part of an investigational drug or clinical biomarker development program. May serve as a liaison between Clinical Pharmacology/Experimental Medicine and other functional areas for program wide issues. The Associate Medical Program Coordinator ensures that assigned studies meet objectives for the program(s). The Associate Medical Program Coordinator is the primary contact for all regulatory and operational issues in support of clinical research studies and should demonstrate clinical trial management skills and independent professional judgment. With minimal guidance and supervision, co-author clinical sections of protocols, clinical investigator brochures, clinical study reports, and regulatory agency update reports, as well as contribute to publications and abstracts. Work closely with contributing authors such as statistician, Clinical Monitors, Global Clinical Supplies Operations, preclinical groups, etc. Assist in literature reviews and prepare meeting presentations. Assist Sr. Medical Program Coordinator and/or Clinical Monitor staff in scientific leadership/investigator initiatives including preparation of publications, meeting presentations etc., including those requiring in-depth understanding of individual studies and the integration of clinical study data. Under supervision, author, review and approve global consent form(s), conduct informed consent and template language negotiations with sites and Institutional Review Boards (IRBs) in accordance with approved guidelines. Liaise with informed consent group as needed for relevant guidance for consent negotiations. Review and monitor required regulatory documentation for study initiation, maintenance, and close-out. Liaise with the Medical Program Financial Specialist (MPFS) regarding budgetary matters for clinical trials, including approving payment to sites and vendors based on quality/cycle time metrics.Manage program and study clinical supplies, including shipment to study sites. Participate in the discussion of protocol design with site and coordinate/conduct the appropriate protocol specific training necessary to conduct a study. Develop plans for study monitoring and data review for clinical trials. Conduct clinical study monitoring activities in accordance with company and Good Clinical Practices/International Conference on Harmonisation (GCP/ICH) guidelines; author site monitoring visit reports and follow-up on required actions. Act as the primary site contact for operational and protocol issues in support of clinical research studies. Communicate with sites on issues related to protocol conduct, and regulatory documents/requirements. Escalate critical protocol-specific medical issues to the Clinical Monitor as appropriate. Participate in functional area meetings, which may include Experimental Medicine Operations Team (EMOT), Regulatory Clinical Trial Submission Team (RCTST), Early Development Team (EDT), Product Development Team (PDT), cross functional teams, process improvement initiatives, etc. Promote communication of best practices and participate in drafting or review of departmental SOPs. Assist in the development and oversee administration of endpoint collection procedures (including quality control measures) to enable use of tools in subsequent clinical trials. Manage and report serious adverse events to ensure compliance with MRL reporting requirements and resolve outstanding issues. Create and/or edit case narratives. Interact directly with study site(s), subsidiary personnel, and Worldwide Product Safety.QualificationsRequired: Bachelor's or Master's Degree in Science field. Minimum of (2) years clinical research experience. Desired: Pharma/industry early phase clinical trials experience strongly preferred. Qualifications for this position require 2-4 years of relevant career experience in clinical research or drug development with a demonstrated record of accomplishments; ideal candidate will have previous experience with protocol development and managing resolution of protocol issues. Excellent oral (including presentation) and written communication, project management, and computer/database management skills a must. Experience in clinical trial design, authoring clinical development documents and clinical study results, monitoring clinical studies, and understanding of clinical research process from program planning to submission preferred.Consistently cited as a great place to work, we discover, develop, manufacture and market a wide range of vaccines and medicines to address unmet medical needs. Each of our employees is joined by an extraordinary sense of purpose – bringing company’s finest achievements to people around the world.We offer an excellent salary and an industry-ranked benefits program, including tuition reimbursement, work-life balance initiatives and developmental programs at all levels. company’s retirement package includes a pension plan and one of the best 401(k) plans in the nation. 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