Clinical Research Associate 1

Job TitleResponsible for providing Clinical Research support for all clinical trials.LocationNew Brunswick, New Jersey, United States, 08901Job DescriptionUnder the direction of supervisor or designee, this position will serve as support for the clinical study team. Essential duties and responsibilities include participating and assisting in design and preparation of protocols and case report forms, generating clinical SOPs, policies, charters, and plans according to US and international guidelines, participating in the evaluation of potential clinical sites according to established criteria of acceptability, responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions, initiating studies performing initiation site visits, arranging for shipment of clinical supplies, case report forms, and other necessary materials, conducting ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions, preparing site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites, conducting study termination visits, obtaining final reports from investigators, and participating in the preparation of final reports for regulatory submission, assisting with the maintenance of clinical archive and electronic files, and other tasks as assigned.RequirementsTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. BA, BS, RN, BSN or equivalent Basic knowledge and adherence to GCPs 1-2 years of clinical research experience or equivalent experience or training Strong attention to detail Ability to multi-task Unquestionable integrity and highest ethical standards Excellent written and verbal communication skills Self-motivated, assertive, and driven.