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About the Role
The Site Director provides leadership, development, and task direction for a team of clinical research professionals. This role is responsible for the feasibility, start-up, and end-to-end execution of clinical trials, including budget and timeline management. Ensures compliance with regulations, Good Clinical Practice (GCP), and company guidelines, while fostering a culture of continuous improvement.
Responsibilities
- Direct site 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 contact for sponsors, CROs, and vendors
- Represent the site at internal and external meetings
- Partner with site marketing team to develop a pipeline of referral sources
- 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 site to support corporate strategic goals
- Collaborate with 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 for research-related activities
- Identify risks and proactively create and implement mitigation strategies
- Facilitate the daily operations of clinical research programs
- Recognize, exemplify, and adhere to Pinnacle’s values
- Oversee the site's clinical operations team
- Manage staffing levels and lead hiring, termination, and performance management
- Conduct performance reviews in accordance with company policies
- Pursues 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 Preventive Action Plans (CAPA) as required
Requirements
- Minimum of a bachelor’s degree in science or related field
- Minimum of five years’ experience in a clinical research setting required, including coordinating complex research projects
- Minimum of two years of management experience in a research/clinic setting
- Proficiency in Microsoft Office 365 applications
- Experience with clinical trial protocols and their governing regulations
- Demonstrated experience in leading people and managing resources
- Demonstrated expertise in project management and budget negotiation
- Valid driver's license, a safe driving record, and an automobile that is appropriately insured
- Impeccable integrity and personal and professional values
- 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
- Energetic self-starter and highly organized with a strong attention to detail
- Demonstrated organizational skills, project-management skills, and outstanding time management
- Strong people skills include the ability to interact with individuals from diverse backgrounds
- Ability to oversee confidential matters and sensitive information with discretion and good judgment
- Ability to build relationships with scientific, medical, executive, administrative, and other personnel at all levels of the organization
- Work is performed in an office/laboratory and/or a clinical environment
- Exposure to biological fluids and/or bloodborne pathogens
- Personal protective equipment required
- 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
Skills
- Clinical research
- GCP
- Microsoft Office 365
- Project management
- Budget negotiation
- Leadership
- Communication
- Problem-solving
- Critical thinking
Location
- Office/laboratory and/or a clinical environment
Work Type
- Full-time
Experience Level
- Minimum of five years’ experience in a clinical research setting
- Minimum of two years of management experience in a research/clinic setting
Education Level
- Bachelor’s degree in science or related field
- Graduate degree preferred (MS, MPH, MHA)
- Research professional certification from ACRP or SOCRA is preferred
Benefits
- 401k
- Medical, dental, vision, long term disability, short term disability, FSA, and life insurance
- 3 weeks of paid time off
- 14 paid company holidays
- Scrub voucher (specific positions apply)
About the Company
- Summit Clinical Research Solutions is an equal opportunity employer.
Equal Opportunity
- All applicants will be considered for employment without regard to race, color, religion, disability, gender, national origin, age, genetic information, military or veteran status, sexual orientation, gender identity, marital status or any other protected Federal, State/Province or Local status unrelated to the performance of the work involved.