Director, Clinical Research - (US-TX-San Antonio - 78299)

Minimum Education: None
Job Type: Full Time
Email this job to yourself or to a friend | Job Match Test | Resume Guide

Responsibilities: Job SummaryThe Director of Clinical Research is responsible for all clinical research operations at WellMed. It is the responsibility of the Director to plan and steer all activities required to attain corporate and departmental goals.Essential Job Functions1.Develop short and long term departmental goals in accordance with corporate goals for growth and expansion.2.Develop short and long term strategic plans to assure the maintenance and growth of the research department.3.Develop annual budget plan to assure adequate resources for ongoing operations and departmental growthPrepare and submit annual budget for Board ApprovalReview and analyze monthly expenditures and Budget Analysis report from accounting and institute changes to meet requirements as necessaryPrepare justification reports as needed for unavoidable overruns as needed4.Develop, track and maintain partner relationships with physicians, sponsors and CROs5.Conduct contract and budget negotiations with sponsors and CROs pertaining new studies6.Assure that processes are in place to procure and initiate new research studies to further departmental goals7.Assure that processes are in place to maintain FDA, ICH/GCP, OSHA, FAA compliance in the conduct of all trials and procedures.Maintain adequate Standard Operating Procedures and assure training of all staffAssure that all training is documented and available to review by regulatory agenciesAssure that all certifications are maintained and documented8.Assure that processes are in place to maintain the integrity and high quality of data for all trials conducted.Review quality assurance records on a regular basisMeet frequently with quality assurance, marketing and recruitment specialists to determine effectiveness of current policies and revise as needed per recommendations9.Assure that processes are in place to provide for and maintain the safety of trial participants within regulatory boundaries10.Coordinate operations/programs incorporating other departments and/or companies within the corporation11.Cooperate with the Medical Director in the development of programs in the advancement of departmental/corporate goal12.Staff Management responsibilities:Conduct yearly evaluations and approve merit increases as necessary.Submit payroll in a timely mannerInvestigate all compliance/ethical issues relating to the conduct of research; report findings appropriately and develop a plan of action as needed in a timely manner.Conduct all required staff counseling sessions as neededMaintain adequate staffing to fulfill contracted responsibilities.13.Performs all other related duties as needed.Requirements: Bachelor’s degree in a healthcare related field. (8 additional years of comparable work experience beyond the required years of experience may be substituted in lieu of Bachelor degree)§Greater than 10 years progressive experience in the conduct of Clinical Research Trials at the site level§Knowledge of alllevels of responsibilities required in the conduction a clinical research trial§Advanced knowledge of FDA regulations and ICH/GCP guidelines with the ability to appropriately apply that knowledge in the development of departmental standards§Must be able to delegate responsibility appropriately and fairly§Must have a general understanding and working knowledge of medical office operational requirements§Must have a general understanding and working knowledge of the principals of financial tracking and reporting§Must have a general understanding of contract negotiations and ability to analyze budgetary requirements§Must have advanced Computer Skills;esp. Outlook, WORD, Excel and PowerPoint§Must have advanced verbal and written communication skills§Must be able to travel overnight for research related meetings and conferences.

For more information of this job and to Apply Online, please visit us at http://www.employmentcrossing.com/lcjsjobdetail.php?akey=33772e92e1de4a9ead7366ca48ac1039

For more information please visit us at http://www.employmentcrossing.com