Clinical Nurse

Please note that this is a 1 year contract position.Hybrid scheduleTop 3 skills: Strong clinical experience, varied experience in different research roles, some experience with writing/reviewing regulatory submission documents Client is looking for a candidate with nursing/physician's assistant background. Candidates need to have good clinical experience and clinical research experience. The ideal candidate would be a nurse with strong clinical research experienceEducation and Experience:A minimum of a Bachelor's degree is required. An advanced degree (e.g., MS, RN, RD, PhD or PharmD) is preferred. A minimum of at least 6 years of clinical research and development experience within the Required Technical Knowledge and Skills:Experience in cardiovascular, metabolic and/or retinal product development and cross company alliances is preferredSignificant experience with managing/ supervising clinical trials, clinical research programs is requiredStrong interpersonal and communication skills are essentialPOSITION SUMMARY:The Coordinator is a responsible member of a clinical team dedicated to the development and execution of clinical strategies and the clinical and operational implementation of a complex compound program. The Coordinator provides active scientific contribution to a cross-functional clinical team developing a molecular entity. The Coordinator provides input to the clinical development plan, works on the development of the clinical trial protocol, clinical trial materials, and takes responsibility for coordinating completion of clinical study reports and supports preparation of relevant documents for regulatory filings. This role involves extensive team matrix interactions with colleagues from a number of different disciplines. The Coordinator may be asked to contribute to the evaluation of scientific opportunities in the therapeutic area.ESSENTIAL FUNCTIONS:Supports preparation of clinical development plans, trial protocols, and supports the operations group with trial set up and monitoring and assists with completion of clinical study reportsAssists Physicians in evaluation of adverse events (pre and post-marketing) for relationship to treatment and supports the interpretation and reporting of resultsAssists Regulatory Affairs in determining requirements for any corrective actions or health authority reportingInterprets, reports and prepares oral and written results of product research, in concert with senior clinical personnel, in preparation for health authority submissionsResponsible for data review in conjunction with other clinical team membersOTHER RESPONSIBILITIES / DETAILED DUTIES:Assists Regulatory Affairs in the development of drug regulatory strategiesParticipate on and may lead cross-functional teams for evaluation of new product ideas, implement franchise business strategies, etc.Reviews medical literature and related new technologiesMay be asked to lead the execution of contractsMay be asked to assess medical publications emerging from the team and its affiliatesMay be responsible, with appropriate colleagues, for review of Company advertising and promotionApplicants must provide their phone number. Reference job number A1309.