Clinical Affairs Coordinator needed in St. Louis

A pharma company in the Midwest is in need of a Clinical Affairs Coordinator.  The qualified candidate will support and assist the Clinical Study Manager in the coordination of clinical research programs designed to support the effort to obtain New Drug Applications and Abbreviated New Drug Applications for various therapeutic entities.   The candidate will serve on one or more clinical research project teams to provide coordination and administrative support and will be responsible for efficient performance of assigned clinical research project tasks to ensure that project/program milestones and objectives are met.      ESSENTIAL JOB FUNCTIONS: · Set-up, manage and maintain necessary and appropriate clinical research study files in accordance with SOP’s and FDA, ICH and GCP guidelines or regulations. May participate in development of protocols, CRFs, ICFs, and other clinical trial documents as appropriate.· Track and report progress of assigned project(s) in conjunction with Clinical Study Manager and other internal or external clinical project team members.  Assist clinical project team in identifying, documenting and evaluating project risks throughout the project life cycle and implementing corrective action as appropriate· Assist Clinical Study Manager in overseeing and managing day-to-day activities and tasks performed by the internal project team or external vendor(s) or combination thereof to ensure assigned project(s) meet(s) quality, budget and timeline specifications.· Assist Clinical Study Manager in identifying, qualifying, contracting and managing external vendors as appropriate to perform/conduct project related tasks or functions. · Assist Clinical Study Manager in tracking budget of assigned project(s) by maintaining accurate and timely records of costs incurred and payments made to investigational sites and other vendors as appropriate.· Assume primary responsibility for maintenance of Clinical Affairs SOP binder.  Work with Clinical Affairs management and personnel to identify and develop appropriate and necessary Clinical Affairs SOPs.· Provide administrative and clerical support on assigned project(s) as appropriate. · Assist Clinical Study Manager with coordination and preparation of project status reports to insure management is kept informed of project progress and status.· Attend regular project team meetings for assigned projects and prepare and circulate meeting minutes.·  Assist in establishing a highly motivated and enthusiastic project team, ensuring open communications and high quality teamwork.· Assist in and/or perform project quality control and quality assurance activities as required.  · Perform assigned duties in accordance with SOPs.· Other duties as assigned KNOWLEDGE/SKILLS/ABILITIES · Knowledge of FDA/GCP/ICH requirements for clinical trial conduct· Ability to exercise independent judgment and creativity in developing methods, techniques and evaluation criteria for obtaining results.· Self motivated with the ability to be effective with minimum supervision.· Demonstrated success in collaboration with others.· Demonstrated ability to use independent thought, judgment and creativity to formulate and implement effective solutions to complex problems.· Must possess superior organizational skills.· Excellent computer knowledge and skills for implementing programs and networking within and outside the company.  Experience with MS Word, MS Excel and MS PowerPoint required.  Experience with MS Project preferred.· Excellent communication skills (both written and oral) and ability to interact with many departments.· Must be flexible with the ability to rapidly and effectively respond to changing priorities.· Ability to travel as needed (estimated 5% to 15% travel to conduct QC/QA functions) EDUCATION/EXPERIENCE· High School diploma required.  · College degree preferred, preferably in a scientific discipline. · At least two (2) years of general business/administrative experience is required.  · Clinical research experience in a pharmaceutical/biotechnology company, CRO or clinical trials research environment is highly preferred.  Reference Code:3020982 Email:Apply by Email