Director, Clinical Research (On-Site)

The Director of Clinical Research oversees all aspects of the research processes conducted at the clinic and actively seeks new research opportunities and monitors and assesses the financial feasibility of studies. Also ensures ongoing compliance with federal, state and local laws as they pertain to clinical research.

Job Relationships

• Reports to the VP & Chief Medical Office

Principal Responsibilities

• 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.

Education/Experience

• 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.

Licenses/Certificates

• Research certification (CCRP, CCRC, CCRA) preferred.

Knowledge, Skills and Abilities

• 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.

Working Environment

• 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.

PHI/Privacy Level

• HIPAA1