Director, Clinical Research (On-Site)
- Reports to the VP & Chief Medical Office
- Responsible for the day-to-day business operations of the department; Develop, evaluate, and revise policies and procedures for the department in order to guide department staff, research investigators, physicians, other providers, senior team, and other SC employees as appropriate
- Direct and coordinate research activities between sponsoring company, IRB's, research investigators, local hospitals, and Springfield Clinic.
- Remain current with laws and regulations affecting clinical research.
- Supervise department staff with assistance from Clinical Research Manager; Interview, hire, discipline, oversee training and provide coverage (as needed) for all personnel within the department to ensure effective utilization of staff, time, and resources; Handle time off requests and conduct performance evaluations for direct reports.
- Serve as a budget and contract liaison between business partners regarding department endeavors.
- Develop agenda and minutes for assigned SC committee meetings and report to committee chairman as necessary; conduct regularly scheduled departmental staff meetings.
- Collaborate with Accounting Department regarding status of research accounts, employee project hours, and reallocation of administrative expenses; Maintain and update (as needed) the Research Financials Allocation Policy; assist Clinical Research Manager with tracking of enrollment goals for each study along with the tracking of monthly financial projections.
- Collaborate with Patient Accounting and process research patient invoices monthly; Ensure research revenue is received (and invoiced as needed) and research expenses are paid in a timely manner.
- Collaborate with the Legal Department to ensure all activities meet safety, security & compliance guidelines per all applicable federal, state, local laws, regulations, policies & procedures.
- Collaborate with Legal Department to keep current with global health authority laws and regulations; identifies gaps and implements process improvements resulting from new/revised regulations or guidance.
- Oversee Regulatory Specialist and ensure regulatory tasks are completed in a timely manner; Provide cursory review of all research Informed Consent Forms prior to IRB submission.
- Comply with the Springfield Clinic incident reporting policy and procedures.
- Adhere to all OSHA and Springfield Clinic training & accomplishments as required per policy.
- Provide excellent customer service and adhere to Springfield Clinic's Code of Conduct and Ethics Standards.
- Perform other job duties as assigned.
- Minimum BS degree required.
- Strong understanding of Phase 1-4 clinical trials in drug/device development.
- Five (5+) or more years of direct clinical research experience as an Investigator, Clinical Research Study Coordinator, Clinical Research Associate or equivalent experience working in the clinical research field.
- Research certification (CCRP, CCRC, CCRA) preferred.
- Must provide own transportation to travel to all clinic locations.
- Excellent interpersonal, leadership, and organizational skills; a strong attention to detail with effective oral and written communication.
- Strong analytical and accounting skills with a strong knowledge of computer software including Windows, Word, Excel, Outlook, and PowerPoint.
- Must have the ability to lead and direct clinical research staff; work effectively with physicians, other providers, allied staff, and the senior team.
- Must possess manual dexterity to handle equipment with the ability to lift/push/pull up to 50 lbs.
- Must have the ability to control emotions and maintain composure under stress, using tact and good judgment.
- Must be able to stand and walk for long periods and capable of stooping, bending, and lifting.
- A strong working knowledge of GCP/ICH, FDA regulations, and HIPAA, as well as local and state laws and regulations regarding clinical research.
- Office based with travel to other Springfield Clinic locations (including satellite offices) and other business related travel, as required to conduct day to day business aspects of the department.
- HIPAA1
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