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Job #02590

About our client Our client is a clinical research company founded in 1977 with two sites, one in Port Chester, NY and one in Rockland, Maine. The company is seeking an individual capable of being Site Manager for its Rockland, Maine facility. Position Location Clinical Site Manager Rockland, ME Salary Reports to Highly competitive package, commensurate with experience Management Responsibilities 1) Oversee all aspects of clinical study execution, including scheduling, staffing, set-up, protocol and report 2) Write/review and comply with the regulatory requirements 3) Act as a liaison with sponsors and CRO representatives 4) Procure regular full-time, part-time and temporary staff 5) Schedule studies/timeline management 6) Schedule doctors and other medical professionals 7) Ensure that the sponsor deadlines are met (data, reports, responses, etc.) 8) Organize spaces, study-flow and timing 9) Make site visits (situational) 10) Perform training tasks like training new employees, orientation, payroll administration and maintenance of training records 11) Communicate performance standards and expectations 12) Coordinate services with New York office – ADP subject checks, employee payroll changes, employee insurance and 401(k) changes 13) Maintain the subject database locally as well as with the vendors 14) Develop and recruiting guides 15) Query the subject database as a part of recruiting strategy (query strategy, timing and initiation) 16) Develop study schedule(s) 17) Prioritize calling multiple queries for one study and/or multiple studies 18) Monitor recruiting success via targets and strategy adjustments (if required) 19) Handle advertising placement like cost control, timing, etc. 20) Determine the database requirements and source of new database (if needed) 21) Ensure completion of site questionnaires 22) Develop and execute investigator and sub-investigator agreements 23) Study the budget projections and also the feasibility assessments 24) Act as a host for site visits 25) Ensure compliance with protocol, ethical standards and GCPs 26) Handle document deviation and justification for quality assurance and other regulatory documents 27) Track and coordinate – protocol drafts, consents, CRFs (pre and post-study), stats report, report drafts, study files, etc. 28) Advise and train New York site staff 29) Update procedures and ensure adherence to them 30) Maintain disposal records 31) Comply with OSHA/EPA/IATA Site plan – update and disseminate (as required) 32) Train – determine staff requirements, procurement of training, maintenance of training records 33) Handle bio-hazard disposal – updates to procedures (as required), adherence to them, maintenance of disposal records and appropriate shipping procedures for bio-hazardous and dangerous goods 34) Determine needs – capital and consumable, ongoing office, studies 35) Procure, find and order or make purchasing trip(s) 36) Maintain lab coats, dry ice supply, etc. 37) Handle equipment maintenance such as repairs, troubleshooting, calibration documentation, etc. 38) Oversee office maintenance (carpets, paint, lights, organization cleanliness, etc.) Requirements 1) Degree in Life Sciences 2) Experience as a Site Manager, Study Coordinator, Quality Assurance Manager or Clinical Research 3) 2+ years of industry experience 4) Knowledge of GCP-ICH 5) Computer skills (MS Windows, Word, Excel, Access and Internet) 6) Ability to successfully manage and motivate staff while maintaining a cooperative and pleasant working environment 7) Willingness to travel – up to 10%