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Senior Clinical Study Coordinator

Company: Kelly Services
Location: Rockville
Posted on: September 22, 2022

Job Description:

Kelly Services - has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a direct hire opportunity to work as a Senior Clinical Study Coordinator located in Rockville, MD. Shift: Monday-Friday, 8am-5pm 20% Travel requiredJob Description: A privately held, pre-IPO clinical-stage biotechnology company pioneering the study of LAMP-mediated nucleic acid-based immunotherapy using UNITE -. Powered by LAMP (Lysosomal Associated Membrane Protein), ITI's UNITE - platform is designed to utilize the body's natural biochemistry to develop vaccines that have the potential to generate broad immune responses. The UNITE - platform has a robust history of applications in various therapeutic areas, including infectious diseases, oncology, allergy, and autoimmune diseases. ITI is primarily focused on applying the UNITE - platform in oncology, where it could potentially have broad applications, including antigen-derived antibodies as biologics. The company has built a pipeline of four wholly owned oncology programs, the lead of which is in a Phase 2 clinical study for Glioblastoma Multiforme (GBM). The Incumbent will serve as a clinical representative for assigned projects. In association with his/her immediate supervisor, the Incumbent will manage the development and implementation process of the compan clinical operation services involving the Clinical Operations department or cross-functional teams focused on the delivery of new or existing projects. The Incumbent will proactively monitor projects from concept through completion. The Incumbent will organize and coordinate interdepartmental and outside vendor activities ensuring completion of the projects on schedule and within budget constraints to achieve success of the goals set forth at all stages in the clinical process. The incumbent will also ensure compliance with applicable company Standard Operating procedures and GCP guidelines, as well as Federal Regulations. Essential Functions Development of study timelines and budgets and obtain approvals from senior clinical leadership Manage the progress of clinical studies in accordance with agreed upon timelines and budgets Assure clinical study conduct is in compliance with SOPs, Good Clinical Practice Guidelines and federal regulations governing the conduct of clinical studies Identify issues affecting study conduct and work with department leads on satisfactory resolution Develops requests for proposal (RFP) and coordinates the selection of CROs and outside vendors Manages outside vendors and contractors Tracks key project metrics and action items Oversee the development, setup, and progress of all clinical study activities, including clinical management, Trial Master File maintenance, regulatory compliance, site selection, enrollment, site monitoring, drug supply, adverse events/serious adverse events, data management, biostatistics, and medical writing Oversee study activities by internal staff, vendors, and contractors Oversee and manage the development of study protocols and all associated study documents Track vendor and site payments Develop and/or coordinate the development of documents in support of clinical studies (protocol, CRFs, ICFs, manuals, SAP, IB, etc.) Work with internal departments and external vendors to establish appropriate study processes to ensure compliance with guidance documents and regulations. Reports progress of clinical projects to clinical management Participate in the development, review and approval of vendor agreements and budgets Supports site management and monitoring efforts as needed Monitoring of select sites to assure protocol & GCP compliance The Incumbent will assist in preparing clinical documents for regulatory submissions Mentor and train more junior level team members as needed Participate in cross functional team meetings, representing the department and providing clinical updates Assisting with financial planning and forecasting for assigned projects Assisting with vendor identification and selection, including but not limited to Request for Proposal (RFP) development, Proposal review, working with potential vendors to refine assumptions for their proposals, compiling quotes for comparison of tasks/costs Assisting with identification and/or development of needed SOPs, templates, systems Required Education and Experience RN or Bachelor's degree within a health/biomedical sciences field, or related field and equivalent experience. 6+ year's experience in working in clinical research and possessing 4+ years' experience monitoring and/or management of clinical studies in the pharmaceutical industry or at a CRO. Experience managing study set-up and execution in multiple therapeutic areas preferred. Previous small to mid-size biotech experience preferred. Knowledge of GCP, ICH guidelines and US FDA regulatory requirements for the conduct of clinical trials. Proficient in basic computer programs such as MS Office Suite and MS Project. Excellent written and verbal communication skills; ability to tactfully communicate sensitive information and demonstrated leadership capabilities Ability to work independently and in a cross-functional team environment. Must demonstrate excellent planning and organizational skills and an ability to generate creative solutions for complex problems. Understanding of clinical development, regulatory and QA, CMC, clinical trials operations and project management methodology. Understanding of basic protocol design and ability to implement/conduct phase I-IV clinical studies from start-up through closeout Previous experience as a CRA or in data management helpful Experience with budget and timeline management Experience in drafting and review of monitoring plans, risk plans and other internal documents needed for study start-up and management Experience in successfully participating in audits/inspections of assigned studies Ability to travel at least 20% of the time if needed. Ability to effectively manage internal and external teams In depth understanding of the drug development process and how each step is connected Prior experience in assisting in the development and deployment of clinical study supplies. This would include working with packaging and labeling vendors, collaborating on label text, etc. Prior experience in assisting in the development and deployment of electronic case report forms. The incumbent would have a high-level understanding of how data management develops and deploys and eCRF system and what steps are necessary Prior experience in working with and/or managing biostatisticians, data management personnel, medical writers to obtain needed data outputs, clinical study reports (CSRs), datasets and programsAPPLY NOW FOR IMMEDIATE CONSIDERATION!! #P1

Keywords: Kelly Services, Rockville , Senior Clinical Study Coordinator, Healthcare , Rockville, Maryland

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