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			Title: Principal Clinical Research Associate, Clinical Affairs Department: Reports To: FLSA Status: Click here to Apply for this position. Make sure to attach your resume and include the job title in the subject line. Job Summary Experience managing and monitoring phase 2-4 clinical studies in the pharmaceutical/biotech industry. Demonstrated knowledge of FDA requirements including Good Clinical Practices (GCP) and ICH guidelines, and HIPPA are essential. Proactively monitors evolving regulatory environment of clinical research and incorporates new regulations and guidelines into everyday practice. Experience and a desire to work in a fast-paced entrepreneurial environment of a growing company are essential.Essential Duties and Responsibilities The Principal CRA, Clinical Affairs will independently coordinate/execute clinical research activities for multiple or complex single studies. Responsible for day-to-day field operations, including oversight of CROs, contract CRAs and vendors with guidance from senior management. Manage assigned studies through all phases of study process, including budgets and timelines. Plan, forecast and manage study logistics and develop study operation documents and data collection forms. Identify, qualify, train and manage study sites, as well as conduct and document the study per protocol, GCP/ICH guidelines and SOPS. Must be willing to travel up to 50% as needed. Average range of travel will be 25-35%. Ensure data quality and study related documents (e.g. CRF guidelines, study manuals, data management edit checks, etc.) adhere to protocol, government regulations and other relevant regulations and GCP/ICH guidelines Responsible for identifying study site issues through documented site reports and other sources of information, and bringing to the attention of senior management for discussion and implementation of a corrective action plan Responsible for the evaluation and selection of new study investigators under the direction of the senior management Maintain project tracking system updated with current study status; provide accurate progress reports on assigned studies Participate in cross-functional departmental meetings and interface with personnel directly or indirectly involved in the management of the clinical studies Other Skills Bachelor's or Master’ Degree in Life Sciences or related discipline with 5-8 years of CRA experience in the biotechnical and/or pharmaceutical industry. Extremely detail oriented and able to organize and manage CROs, consultants and multiple KOL sites participating in a clinical study Ability to interpret and evaluate clinical data and literature, basic understanding of statistics and protocol development for new products Ability to identify study-related, CRO- related or site-related issues, determine the causes and possible solutions to the problem Demonstrated experience in managing multiple projects simultaneously with aggressive timelines Experience and demonstrated ability to work at a high level of productivity with minimum of infrastructure Inter-personal flexibility - ability to adapt to other personalities in a respectful manner that is conducive to goal achievement, good judgment, professionalism and independence interfacing with CROs, study coordinators and investigators Proficiency in MSWord, EXCEL & PowerPoint essential Excellent written and verbal skills