Highland Performance Solutions is proud to be leading a retained search for Flourish Research for a Site Director to lead the Richmond, VA de novo site. This is a fully onsite role.
Who We Are
Advancing the health and wellness of society through clinical trials, Flourish Research is one of the largest integrated clinical research site companies in the US, with best-in-class sites who have a strong brand and track-record of recruiting and retaining a highly diversified patient populations in the therapeutic areas of cardiology, metabolic disorders/renal, CNS, pulmonology, and vaccines. Flourish's fully integrated site network strategy with centralized infrastructure and investment in technology allows for superior patient access, engagement, and diversification as well as consistent, high quality data delivery. Flourish has differentiated its sites through an investment in Quality Management Systems, a focus on patient diversity, and deep clinical expertise backed by SMEs in its Centers of Excellence focus areas.
The Role & Opportunity
The Site Director in Richmond, VA, will be responsible for the execution and oversight of the clinic's operational functions, including P&L management. This role is pivotal in establishing and growing a start-up de novo site, executing Flourish Research's mission of providing high-quality clinical trials to our expanding client base through a fiscally responsible and collaborative approach. As part of the local leadership team, you will report directly to the Regional Director of Operations.
Key Responsibilities
Financial & Operational:
- Commitment to the Flourish Approach and implementation/oversight of corresponding clinical and operational initiatives.
- Responsible for site level operational and financial metrics including budget targets, reports, and actions for continuous improvement activities.
- Must become knowledgeable about the history, operations, positioning and other facets of the site and Flourish Research that has led to its current market position.
- Regularly analyzes operational volume and labor staffing models to determine optimal staffing requirements.
- Leads, develops, mentors, and engages a team of clinic and administrative staff to execute against the clinical/operational strategy.
- Responsible for driving performance and coaching/development objectives.
- Own the P&L for their individual site, responsible for executing against margin/EBITDA targets and other performance related metrics.
- Implement plans & processes to maintain productivity and profitability.
- Effectively uses financial levers to manage a P&L and operational budget, inclusive of fixed and variable costs and requesting capital expenditures.
- Understand a clinical trial agreement budget and how it applies to their operations to maximize revenue opportunities.
- Responsible for reviewing, understanding and driving key performance indicators.
Team Management:
- Recruit, train, assess, develop and retain clinical and administrative staff to ensure successful team and business performance.
- Use routines and best practices to assess performance, provide recognition and performance coaching when gaps are identified.
- Identify site level management development and training needs and ensure training is obtained.
- Serve as the change, culture and engagement champion, driving People and Culture initiatives for the site in partnership with site level and regional management.
- Work with the training team to develop training programs for their clinical and administrative staff.
- Direct specialty recruiting strategy to fulfill needs for short, mid and long-term site level success and market development.
- Collaborate with other Flourish site directors to problem-solve and leverage best practices across the region.
Site Management:
- Given this is a start-up, the site director will serve as the primary Clinical Research Coordinator (CRC) until a team is hired. The Site Director will continue to act as a working manager, providing backup support for CRCs as needed, including consenting patients, taking vitals, performing ECGs, and other trial-related duties. The ability to perform phlebotomy, or learn to perform phlebotomy, is required.
- Train and supervise staff on all CRC duties, including consenting patients, taking vitals, ECGs, and ensuring these tasks are carried out accurately and efficiently.
- Work closely with the Quality and Risk teams and department managers to implement Standard Operating Procedures (SOPs) and policies to ensure compliance with Good Clinical Practices, federal regulations/ICH guidelines, HIPAA laws and sponsor protocols.
- Attend pre-study qualification visits. Participate in ongoing and close-out monitoring visits with sponsor/(CRO) representatives.
- Ensure the safety of study participants through appropriate training of staff and adherence to regulatory guidelines.
- Ensure continuous high-level involvement by principal investigators as required by FDA regulations/ICH guidelines and SOPs by maintaining frequent communications with and coordinating the training of physician investigators and their staff.
- Ensure data integrity by working closely with Quality Control (QC) for the timely submission of quality data to our sponsors.
- Holds the Flourish shared services functions accountable to deliver against agreed upon service level targets; including but not limited to Human Resources, Feasibility, Business Development, Budgets and Contracts, Quality, Training, Information Technology, Realtime and Finance.
- Establish and manage effective patient acquisition programs to ensure successful enrollment of clinical trials at their site; including, management of referring physician practices.
Minimum Qualifications
- Bachelor's degree required. Science, nursing, or healthcare management preferred. Degrees in a relevant field (business, management, etc.) are acceptable.
- Minimum of 5 years' experience in site management in an operational leadership role, including managing industry sponsored clinical trial sites.
- Given this is a start-up, the site director will work on a small team (including the PI, CRC, Recruitment Specialist and Sub-I) and will serve as back-up for Clinical Research Coordinators (CRC). They will act as a working manager, performing consenting, conducting vital signs, ECGs, phlebotomy and laboratory processing as needed.
- 1-3 years of experience in starting up and expanding a new site and leading growth across all aspects of clinical trials including patient recruitment.
- Demonstrated strong leadership and team-building abilities.
- Excellent multi-tasking and problem-solving skills.
- Entrepreneurial spirit with an ability to work independently.
- Strong planning and execution skills to operationalize and implement strategic imperatives.
- Willingness to travel as needed, depending on business needs and client requirements.
- Occasional night and weekend work schedules may be required.
Professional Skills
- Ability to forecast and execute business planning, both from an operational and financial aspect.
- Ability to effectively multitask and prioritize competing demands in a fast-paced, dynamic environment.
- Capability to work independently, adept at on-the-spot problem-solving in a business context.
- Proficiency in forecasting and executing business planning, encompassing both operational and financial aspects.
- Demonstrated aptitude in tactical and strategic planning for site management, coupled with strong leadership qualities.
- Willingness to travel as required by the role, with the extent varying based on business needs and client requirements.
- Excellent collaboration skills to foster effective teamwork and partnerships.
- Exceptional oral and written communication skills for clear and concise interaction.
- Proficient in Office365 products and other relevant computer applications.
- Experience in reviewing and implementing Standard Operating Procedures (SOPs).
- Strong problem-solving skills with a focus on risk assessment and impact analysis.
- Proven track record in process improvement initiatives.
- Proficient in negotiation and conflict management techniques.
Why Join Flourish Research?
- Be part of a mission-driven organization dedicated to advancing clinical research.
- Opportunity to lead and grow a start-up site with significant impact.
- Collaborative and supportive work environment.
- Competitive compensation and benefits package.
Compensation and Benefits Package
- $100K - $130K salary with 20% bonus potential
- Annual Performance-Based Merit Salary program
- Paid Time Off
- 8 Paid holidays, Including 2 Floating Holidays
- 401K plan: 4% Match
- Employee Review and Performance Program
- Tuition Reimbursement Policy
- Employee Referral Bonus
- Supplemental Parental Leave
Requirements for Application
- Apply via LinkedIn or send a resume and salary requirements to: [email protected]
- No faxes or phone calls will be accepted
- Flourish is an equal opportunity employer