Job Description
Summary:
The Regional Director provides leadership, development, and task direction for a team of clinical research professionals spanning multiple sites. Responsible for feasibility, start-up, and execution of clinical trials in the assigned region. Responsible for budget and timeline management, resourcing, and execution of clinical trials end to end. Ensures compliance with regulations, Good Clinical Practice (GCP), Pinnacle SOPs, and corporate guidelines. Collaborates cross-functionally across the organization. Coordinates, tracks and reports study status. Mentors team members. Contributes to a culture of continuous improvement and performance measurement. Sets the example for others by modeling Pinnacle values. Must be organized, collaborative, goal- and solutions-oriented, flexible, and have superior critical thinking skills.
Duties and Responsibilities:
Clinical Research:
• Direct multiple sites’ operations activities and continually improve workflow
• Direct operational execution according to agreed timelines and budgets
• Comply with policies, SOPs, and governing regulations
• Identify and resolve issues using advanced clinical trial and GCP knowledge
• Maintain quality control standards and evaluate their effectiveness
• Ensure staff fulfill training and regulatory requirements for their role
• Review protocols and attend trainings to guide trial execution and protocol adherence
• Serve as the primary site or region contact for sponsors, CROs, and vendors
Administration:
• Represent the sites and region at internal and external meetings
• Partner with regional marketing team to develop a pipeline of referral sources with corresponding outreach and relationship cultivation
• Oversee completion of Study Feasibilities and RFI responses
• Assist with budget negotiations for new studies
• Develop and maintain partnerships with key external parties
• Align the sites in the region to support corporate strategic goals
• Collaborate with the corporate departments
• Collaborate with study sponsors on site-level marketing initiatives
• Identify vendors and participate in the vendor selection process
• Serve as a liaison to other sites and regions for research related activities.
• Identify risks and proactively create and implement mitigation strategies
• Facilitate daily operations of clinical research programs
• Recognize, exemplify and adhere to Pinnacle’s values and competitive differentiators of People & Culture, Science, and Quality.
Supervision:
• Oversee the site and regional clinical operations team
• Manage staffing levels and cross-site support within the region.
• Lead hiring, termination, and performance management for direct reports
• Conduct performance reviews in accordance with company policies
• Pursue ongoing continuing education for leadership and skill development
• Oversee training to ensure clinical staff competency
• Approve PTO while ensuring staffing levels meet daily business demands
• Identify facility, supply and equipment needs to maintain site capabilities
• Implement Corrective Action Preventative Action Plans (CAPA) as required
Duties, responsibilities, and activities may change, or new ones assigned at any time.
Education Experience:
• Minimum of a bachelor’s degree in science or related field; graduate degree preferred (MS, MPH, MHA)
• Minimum of five years’ experience in a clinical research setting required, including coordinating complex research projects
• Research professional certification from ACRP or SOCRA preferred
• Minimum of four years of management experience in a research/clinic setting
• Experience with clinical research protocols and their governing regulations
• Demonstrated experience in leading people and managing resources
• Demonstrated expertise in project management and budget negotiation
Knowledge, Skills and Other Abilities:
• Proficiency in Microsoft Office 365 applications
• Impeccable integrity and personal and professional values
• Ability to build relationships with scientific, medical, executive, administrative, and other personnel at all levels of the organization
Competencies:
• Must be able to work independently and collaborate with others
• Strong analytical, problem-solving, and decision-making skills
• Proactive at identifying and solving issues
• Superior written and oral communication skills, including the ability to synthesize complex material and present information accurately and appropriately
• Energetic self-starter and highly organized with a strong attention to detail
• Demonstrated organizational skills, project-management skills, and outstanding time management, including keen attention to detail
• Strong people skills include the ability to interact with individuals from diverse backgrounds and to oversee confidential matters and sensitive information with discretion and good judgment
Work Environment and Physical demands:
The work environment and physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Work is performed in an office/laboratory and/or a clinical environment.
• Exposure to biological fluids and/or bloodborne pathogens.
• Personal protective equipment required such as protective eyewear, garments, and gloves.
• Occasional travel may be required domestically and/or internationally
• Ability to work in an upright and/or stationary position for 6-10 hours per day.
• Frequent mobility required.
• Occasionally squatting, kneeling, or bending
• Light to moderate lifting and carrying or moving objects including medical equipment with a maximum lift of 20-50 lbs.
• Valid driver's license, a safe driving record, and an automobile that is appropriately insured