Asheville, NC 3 Key Clinical Research Positions Available Apply online: http://www.mission-health.org/careers Interim Research Director- Contract Position Research Institute Mission Hospital, Asheville, NC The Research Institute at Mission Hospital is currently seeking a Contracted Interim Director of Research to fill an integral role. The Director provides operational oversight, strategic planning, program development and supervision of all clinical research activities. The Director is responsible for the administrative review of all research occurring in the Health System to facilitate the conduct of high quality clinical trials and investigator-initiated research in compliance with applicable regulations. The Research Institute provides a centralized infrastructure to promote quality research, encourage collaborations, and ensure fiscal and regulatory compliance to benefit Mission’s patients. The Director leads a team of clinical and non-clinical staff to support a range of clinical research studies in all therapeutic areas with the exception of oncology. The Director provides oversight of various functions, including pre-award and post-award management, Medicare Coverage Analysis, contract and budget negotiation, and regulatory compliance. The Director acts as the liaison with research industries, federal government, and Universities to support and enhance the research portfolio. The position requires a Bachelors degree. The preferred education is a Masters or terminal degree (MD, PhD, DrPH, ScD). The position requires significant experience with a minimum of seven years in direct Clinical Trial leadership, along with demonstrated successful management of clinical and non-clinical staff in the conduct of FDA-regulated and Federal-funded research. Preference is given for candidates with a certification in Healthcare Research Compliance (CHRC) Duration Sixty (60) days contingent upon meeting performance expectations as defined in the contract. A possible option of continuation may be granted at the discretion of Mission Health. This position is not currently posted. If interested email current CV with cover letter describing experience, qualifications, and compensation requirements to xxxxxx@msj.org or xxxxxx@msj.org Manager - Research Contracts & Admin Job Summary: Provides the leadership in establishing best practice for clinical research contracting, budgeting and billing. Provides administrative leadership and support for clinical research, ensuring compliance with all regulatory agencies and institutional guidelines. Critically evaluates all clinical research agreements, ensuring compliance with institutional policies and practices, regulatory agencies and guidance documents. Serves as the primary liaison and conducts contract and budget negotiations with external sponsors. Tracks and monitors the review and negotiation process, providing regular status reports to researchers. Continually monitors contracting entities' performance and negotiates new or renewal contracts and/or amendments. Works closely with legal counsel, financial analysts, business managers, materials management, clinicians and others in the contracting and negotiating process. Ensures appropriate administrative review of all proposed research activities. Required Education: Bachelor's degree with 5+ years of experience in research contracting and negotiation and research administration. Training in Human Subjects Protection. Preferred Education: Masters Degree or Doctorate in health-care related field or J.D. Required License: Certified Research Contracting Professional (CRCP) or Healthcare Research Compliance (CHRC) or obtained within one year of hire date. Required Experience: 5+ years in clinical research site; solid understanding of clinical research contracting and budgeting; coverage analysis development and demonstrated ability to deal with difficult and challenging situations in a professional, courteous manner at all times, make independent decisions, handle multiple priorities, and build collaborative working relationships; requires a high level of interpersonal skills, including political sensitivity and problem solving. Salary Range: Min 78900.00 Mid 118300.00 Max 157800.00. Apply online http://www.mission-health.org/careers Cardiology Research Manager Job Summary: This position is responsible for planning and coordinating clinical trials, and supervising research staff of the Asheville Cardiology Associates (ACA) Clinical Research Department Required Education: BS in health related field. Preferred Education: BSN or MSN Required License: RN and BCLS, ACLS. CCRC required within 2 years of hire. Preferred License: Certified Clinical Research Coordinator (CCRC) through the Association of Clinical Research Professionals (ACRP) Required Experience: Three years medical research related experience, preferable in Cardiology Detailed knowledge of FDA, GCP and ICH regulations and guidelines pertaining to research Use of medical and statistical knowledge to read and interpret research protocols Preferred Experience: Previous management experience; experience in computer database development and management ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.healthresearch.org (click on the "LISTSERV" link in the upper right corner) A link directly to helpful tips: http://tinyurl.com/resadm-l-help ======================================================================
