Site Director

Bioclinica, Inc Orlando , FL 32801

Posted 2 weeks ago

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.

Primary Responsibilities

  • 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)

Secondary Responsibilities

Maintains Quality Service and Departmental Standards by

  • Reading, understanding and adhering to organizational Standard Operating Procedures ("SOP")
  • Assisting in establishing and enforcing departmental standards

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

  • Attending and participating in applicable company-sponsored training

Qualifications:

Education:

Bachelor's degree required.

Advanced degree preferred.

Clinical research certifications such as CCRC and/or CCRP preferred.

RN license preferred.

Experience:
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

Goal oriented

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

Working conditions:

Travel: 0-10%

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.

EEO Statement

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.


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Site Director

Bioclinica, Inc