Clinical Operations Assistant

The role of the Clinical Operations Assistant Coordinator is critical in ensuring the day to day conduct of multiple clinical studies.  This  position is multifunctional, a significant component being activities relating to outsourcing of clinical activities while the remainder relate to the tasks necessary to ensure GCP adherence, timely execution of studies, and maintaining timely responses for our vendor partners.  This is a

Specific responsibilities include, but are not limited, to:Act as first line of contact with external vendors in securing executed CDAs; In collaboration with the study team, discuss the activities to be outsourced and develop an Excel bid grid and textual background of the study, indicating services expected from each vendor; Arrange for on-site feasibility presentations by vendor staff.  The meetings must be coordinated such that integral clinical personnel are available.  Coordinate in advance with the vendors so that a targeted agenda is developed to ensure team concerns / topics of greatest interest are well-covered during the on-site session;  Track receipt of proposals from each vendor and as materials are received and develop a comparison sheet to facilitate clinical team review; As vendor contracts are submitted, work with Legal on review of the master service agreements ;arrange teleconferences or direct communication between legal counsel within Neurogen and at individual vendors;For multicenter clinical trials, work with the CRO project manager to have individual site clinical study agreements reviewed;Organize and manage the Trial Master File and site specific files for each study in adherence with Neurogen SOPs; Liaise with Regulatory to ensure credentials for each participating investigator are submitted to the agency in a timely manner;Assist with development and maintenance of standard slide decks for use during Investigators? Meetings;Assist in the preparation of documents and slide presentations As appropriate, arrange capabilities presentations for vendors; provide vendor personnel with guidance as to specific areas of interest in advance;Develop Request for Information (RFI) materials and submit to a broad range of possible vendors ;Process contracts and set up p.o.?s; Track receipt and payment of invoices;Research  suitable vendors to ensure that the the most appropriate are selected for each project in terms of corporate culture, size, economy and quality;Maintain a database of prospective vendors and file of any relevant capabilities documentation; Maintain a database of prospective sites and file of documentation of any relevant experience and areas of therapeutic interest;Develop and maintain a library of journal articles relevant to the clinical area; These will include all references for all study protocols;  Maintain the Trial Master File for each study in adherence with Neurogen SOPs;Provide Regulatory with any updates for site documents which need to be provided to FDA ;Develop and maintain a database of all clinical trials including at a minimum the details of the study, vendors involved, enrollment status (eg. a manual Clinical Trials Management System).Work closely with safety group in receiving, accounting for and correctly disposing of unused study medication;  Organize a retrospective review of outsourcing on a study by study basis to identify areas for future improvement.

Qualifications include:BA/BS degree or equivalent work experience;Prior experience in a pharmaceutical or biopharmaceutical organization;Ability to prepare RFPs and track contracts for programs an efficient and effective manner within a constantly changing environment; Exceptional interpersonal, negotiation, and project management skills Attention to detail, excellent organizational abilities and superb time management and an ability to effectively prioritize;Good computer, mathematical computation, analytical and problem solving skills;A keen interest in learning about clinical drug development;  Familiarity with the drug development process, clinical trial terminology and knowledge of Good Clinical Practices (GCPs) are a plus.