Bioclinica, Inc Orlando , FL 32801
The Site Director provides overall leadership and management congruent with the philosophy and mission of the company and guided by Good Clinical Practices (GCP), International Committee on Harmonization (ICH) guidelines, and company SOPs/policies to ensure efficient productivity, high quality, exemplary service, and cost-effective management of resources. Responsible for profitable management of the clinical research business, consistent with company principles, strategies, and goals/objectives. Accountable for the overall coordination, organization, and efficient implementation of clinical trials. Performs diverse managerial and marketing responsibilities requiring considerable analysis, judgment, and detailed understanding of clinical research processes. Works closely with the Principal Investigator to evaluate clinical trials and ensure that all study-related procedures are completed properly from a clinical and a regulatory perspective.
Develop and direct implementation of strategic business and operational plans, projects, and systems as determined with the Administrative Team
Determine and achieve clinic goals, including both monthly and trial-specific performance, as determined with the VP of RN-US
Maintain financial profitability through proper revenue generation and expense management, as determined with the VP of RN-US
In conjunction with site PIs, establish and maintain exemplary sponsor relations for successful ongoing trial recruitment
Establish and maintain exemplary community relations with physicians, healthcare organizations, and patient advocacy groups
Oversee clinic functions to achieve acceptable standards determined and to ensure compliance with Regulatory, State and FDA standards
Interact with other Site Directors to provide consultative support to achieve company-wide success
Attend scheduled trainings and meetings
Establish, foster, and maintain effective working relationships with consulting PIs
Establish, foster, and maintain a positive, motivated, and productive staff
Select, train, and confer with managers to ensure effective coordination of all activities for maximal productivity
Develop and update business plan
Identify and pursue market expansion opportunities
Oversee the financial performance of the line of business
Assist Senior Management in identifying new business opportunities in the sector
Review staffing models and schedules
Interview, hire, train, review, and manage staff
Indirectly manage other clinical and administrative staff and contractors (e.g., laboratory, pharmacy, recruitment, etc.)
Coordinate the provision of needed support services (e.g., accounting, facilities management, etc.)
Manage the processes of appointment scheduling, informed consent, subject visits, source document, Case Report Form and other document preparation and disposition
Collaborate on the sales and marketing plan for clinical research services
Help generate leads (via networking, research, etc.) and follow up with potential sponsors
Evaluate study protocols (e.g., with respect to enrollment/retention potential, office capacity and capabilities, profit potential, and other determinants of success), with input from the Principal Investigator
Coordinate site visits and other communications with sponsoring organizations prior to study implementation, and works through Clinical Research Coordinators to provide ongoing coordination of sponsor communications thereafter
Collaborate on business arrangements, budgets, and contracts with potential sponsors
Determine along with the Principal Investigator, which studies to pursue
Meet with the recruitment department to review identified media to be used for patient recruitment (e.g., newspapers, radio, telemarketing, etc.), and the implementation and results of the selected communications strategies (e.g., generating mailing lists, writing advertising copy, etc.)
Ensure that studies are implemented in compliance with Good Clinical Practice (GCP) guidelines as promulgated by the Food and Drug Administration (FDA) and the International Conference on Harmonization (ICH)
Maintains Quality Service and Departmental Standards by
Contributes to team effort by
Working with internal staff to resolve issues
Exploring new opportunities to add value to organization and departmental processes
Helping others to achieve results
Performing other duties as assigned
Maintains Technical and Industry Knowledge by
Bachelor's degree required.
Advanced degree preferred.
Clinical research certifications such as CCRC and/or CCRP preferred.
RN license preferred.
5+ years of progressive clinical research experience required.
Proven success in a management position required.
Additional skill set:
Strong motivational skills and abilities promoting a team based approach
Strong organizational and leadership skills
Ability to maintain professional and positive attitude
Knowledgeable of clinical research requirements and processes
Thorough understanding of regulatory requirements, GCP, and ICH guidelines
Excellent interpersonal, customer service, quality, and communication skills (written and oral)
Strong management, leadership, judgment, and organizational skills
Ability to manage multiple tasks/projects simultaneously
In depth knowledge of applicable regulations, SOPs, and policies/procedures
Ability to resolve problems quickly and effectively.
Takes initiative, team player, and can adapt well to a changing environment
Strong medical background and familiar with medical terminologies
Familiar with MS Office and Clinical Conductor
Lifting: 0-10 lbs
Other: Computer work for long periods of time
This position description should not be deemed all inclusive. Additional requirements and expectations may be assigned. At all times, employees are expected to adhere to company policies and company SOPs.
Bioclinica is an equal opportunity employer. Bioclinica evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.