Site Director

Flourish Research•Charlotte, NC

2d•Onsite

About The Position

Flourish Research is seeking a motivated and talented Site Director to support its Charlotte site. Flourish Research is a progressive clinical trial organization with capabilities in various research areas. The company is committed to a diverse and inclusive work environment, offering excellent benefits, a supportive culture, and growth opportunities. The Site Director will be responsible for overseeing the financial and operational aspects of the site, managing a team of operations managers, and ensuring compliance with regulations and protocols. This role involves driving performance, managing the site's P&L, and fostering a positive team environment. The position also requires close collaboration with quality and risk teams, participation in monitoring visits, and ensuring participant safety and data integrity.

Requirements

Bachelor’s degree in science, nursing, or healthcare management
Minimum of five years' experience in clinical research.
Minimum five years of experience in an operational leadership role with experience managing site level leaders.
Minimum eight years of experience in a clinical research role.
Exceptional knowledge of clinical research methods.
Strong management and leadership skills.
Demonstrated ability to collaborate and align with operations.
Excellent oral and written communication skills.
Excellent computer skills to include Office365 products.
Experience in writing and reviewing Standard Operating Procedures.
Strong problem solving, risk assessment and impact analysis abilities.
Demonstrated experience in process improvement.
Strong negotiation and conflict management skills.
Flexible and able to multi-task and prioritize competing demands.
Ability to think independently and influence when appropriate.

Responsibilities

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.
Regularly analyzes operational volume and labor staffing models to determine optimal staffing requirements.
Leads, develops, mentors, and engages a team of operations managers to execute against the clinical/operational strategy.
Responsible for driving performance and coaching/development objectives.
Own the P&L for the 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.
Recruit, train, assess, develop and retain clinical 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.
Identifies site level management development and training needs and ensures training is obtained.
Serve as the change, culture and engagement champion, driving People and Culture initiatives for the site in partnership with site level management.
Work with the training team to develop a pipeline of effective leadership at the facility level.
Direct specialty recruiting strategy to fulfill needs for short, mid and long-term site level success and market development.
Represent Flourish Research in a professional and courteous manner (verbal, written and in appearance) when interacting with all staff, clients, and vendors.
Work closely with the Quality and Risk teams, team leads/site managers and department managers to establish and maintain SOPs and policies and procedures to ensure compliance with Good Clinical Practices, federal regulations/ICH guidelines, HIPAA laws and sponsor protocols.
Assist in planning, establishing and maintaining structured in-service trainings and/or staff meetings to ensure that all employees are informed, trained and compliant with SOPs and policies and procedures, federal regulations/ICH guidelines and HIPAA laws.
Participate in pre-study, ongoing and close-out monitoring visits with sponsor/(CRO) representatives.
Ensure the safety of study participants through appropriate training of staff and by working closely with Scientific and Medical Affairs.
Ensure continuous high-level involvement by principal investigators as required by FDA regulations/ICH guidelines and SOPs by maintaining frequent communications with and 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.
Additional duties as assigned by management.