Regional Director

Pinnacle Clinical Research• US,

4d•$155,000 - $175,000•Hybrid

About The Position

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.

Requirements

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
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
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
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

Nice To Haves

Research professional certification from ACRP or SOCRA preferred

Responsibilities

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
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.
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