Clinical Research Director directs and oversees the clinical research function for a healthcare organization. Develops research studies and creates standards and guidelines for clinical research services and programs. Being a Clinical Research Director ensures adherence to standard operating procedures, good clinical practice and FDA regulations. Requires an advanced degree. Additionally, Clinical Research Director typically reports to top management. The Clinical Research Director manages a departmental sub-function within a broader departmental function. Creates functional strategies and specific objectives for the sub-function and develops budgets/policies/procedures to support the functional infrastructure. Deep knowledge of the managed sub-function and solid knowledge of the overall departmental function. To be a Clinical Research Director typically requires 5+ years of managerial experience. (Copyright 2024 Salary.com)
Description
THE ROLE
The Director of Clinical Research works closely with the CMO and VP Service Lines to identify and plan research programs to provide leadership in the design, organization, development and implementation of Research. This position ensures that services and programs are developed collaboratively and timely; are provided effectively, supported, monitored and financially successful. This position works closely with the PH&S system, research staff, PI's, ancillary services and local leadership to assure the goals of the department are met. A primary responsibility is to maintain positive relationships and to develop trust to assure we have access to high quality clinical studies that meet our investigators needs. The candidate should exhibit behaviors that ensure collaboration within the PH&S organization which enhance professional performance and reflect the Core Values and the Mission.
ESSENTIAL FUNCTIONS
Assesses, plans, implements and evaluates the research programs, services and projects:
Works with physicians and other staff members in carrying out program objectives (including supporting investigator-initiated studies).
Oversees all aspects of clinical research operations.
Facilitates all critical study start-up processes including confidentiality disclosure, budget, and clinical trial agreement.
Coordinates and manages all study information: included but not limited to data collection, incident reporting, and regulatory activities.
Maintain regulatory compliance requirements and training requirements for investigators and other research staff.
Work in conjunction with the Foundation in support of fundraising and subsequent management of research gifts/awards.
Works in concert with the medical director of academic affairs to support and comply with any undergraduate and graduate medical education requirements for scholarly and research work (ex. Accreditation Council for Graduate Medical Education requirements for PRMCE training programs.
Promotes quality within department:
Develops, implements, monitors and evaluates department specific performance and service standards.
Ensures implementation of high quality care based on department and hospital standards.
Takes initiative to implement quality improvement efforts.
Assures all regulatory standards and other operation standards are adhered to and documented.
Quality records/reports are prepared and submitted in a timely manner.
Risk management reports are followed up promptly and reported to Risk management for trending.
Develops and interprets departmental policies and procedures.
Develops and revises policies and procedures as they relate to research.
Department Financial performance:
Accurately prepares annual budgets in accordance with goals and objectives.
Consistently operates department budgets/cost centers within approved budget.
Consistently monitors productivity standards in response to volume changes.
Consistently demonstrates focus on cost management and cost reduction.
Analyzes costs, productivity, trends and patient levels for outpatient cancer programs.
Establishes and monitors effective systems of communication:
Demonstrates professional demeanor and ability to communicate effectively to individual and groups.
Remains calm and constructive when dealing with difficult issues, persons and circumstances.
Demonstrates strong communication with medical staff regarding services to the physicians.
Holds regular department staff meetings and maintains open communication with department caregivers.
Solicits information from managers, supervisors and staff in problem-solving process improvement. Resolves inter and/or intra department complaints promptly and effectively.
Utilizes effective leadership and Human Resource skills:
Actively and willingly participates in assigned committees, task forces and other work groups.
Attends at least 80% of all management meetings/retreats and/or other management functions.
Participates in 95% of management skills development via internet programs or management education sessions requested by their assistant administrator.
Department evaluations are maintained at 95% level. Assesses and evaluates employee performance, recognizing exemplary performance, and identifies opportunities for performance improvement.
Human Resource and/or union contracts are administered appropriately.
Proactively and in consultation with Human Resource, manages department staff, monitors absentee rates and takes corrective action.
Actively monitors turnover and seeks retention strategies.
Supervises all staff fairly and consistently.
Develops staff through coaching, cross training, internal/external education opportunities to improve or enhance job skills.
Delegates to appropriate patient care team members.
Strategically Plans for Department:
Works with the CMO and with the medical director of research (or division chief as delegated by the CMO) to set and implement strategic plans, goals and objectives for the research department, including but not limited to research programs and culture. Identifies need for and develops research policies, activities, and training programs with stakeholders ensuring consistency with the mission, goals and objectives.
Conducts regular review of progress towards goals and demonstrates satisfactory progress toward identified goals.
Maintains active knowledge of trends within specialty and external markets and communicates these to administration to enhance overall planning effectiveness.
Daily Operational Management:
Obtain desirable clinical trials by reaching out to sponsors and principal investigators.
Primary administrator in preparation and submission of grants / contract applications for federal, industry, philanthropic funding. Negotiates terms and conditions of grants and contracts while monitoring compliance. Ensures timely submittal of progress and final reports for all grants providing administration oversight for grant activities including budgetary.
Oversee the study evaluation and startup process.
Maintain positive relationships with ancillary services, leadership, sponsors, and investigators to optimize opportunities for collaborations.
Ensure that studies are thoroughly reviewed and approved.
Work with the Medical Directors to promote and grow research throughout the organization.
Develop a hospital communication plan in order to raise the awareness of research at PRMCE / PRCP.
Assure research equipment is in good working order, purchase new equipment as needed.
Review and prepare departmental policies and procedures on an annual or more frequent basis.
Lead department performance improvement activities / meetings to ensure the development and implementation of processes which support quality patient care and effective work performance.
Work with medical staff newsletter and marketing to raise research awareness.
Establish quality initiatives.
Establish relationships in the community to foster research growth.
Human Resource Management:
Work with Human Resources to recruit, interview, select, hire, and employ an appropriate number of employees.
Coach, mentor, and develop staff, including new employee onboarding and providing career development opportunities.
Empower employees to take responsibility for their career and goals. Delegate responsibility and expect accountability including regular feedback.
Foster a spirit of teamwork and unity among research members that allows for disagreement over ideas, conflict and expeditious conflict resolution with the appreciation of diversity as well as cohesiveness, sportiveness, and working efficiently and effectively together.
Lead employees using a performance management and development process that provides an overall context and framework to encourage employee contribution and includes goal setting, feedback, and performance development planning.
Lead employees to meet the organizations expectations for productivity, quality and goal accomplishment.
Provide effective performance feedback through employee recognition, rewards, and disciplinary action, with assistance of Human Resources when needed.
Maintain employee work schedules including assignments, job rotation, training, paid time off, absenteeism, and overtime.
Maintain transparent communication. Appropriately communicate organization information through department meetings, one-on-ones, email, IM and regular interpersonal communication.
Demonstrates the Mission and Values:
Fosters a caring environment for customers and caregivers.
QUALIFICATIONS
Bachelor's Degree in Science and/or business
Master's Degree in Science and/or business (preferred)
10 or more years of Clinical Trials Research Administration / Coordination experience
5 years of progressive management experience in leading teams, process group facilitation, project management, and financial management
Experience in strategic planning
Experience managing the administrative components of large scale research
Experience in grant and contract proposal development and administration
Experience with Lean Concepts and Change Management Practices and Techniques
Oversees the day to day operations of the clinical research program
Long-term strategic vision and ability to present ideas effectively in a variety of settings
Communicate effectively with staff, physicians, system leadership and patients
Demonstrates ability to work as an effective leader with consistent record of successful teamwork
Proactively identify and resolve issues
Identify and lead quality projects
Organizational and prioritization skills including team building and problem solving techniques
Outstanding interpersonal relationship building and employee coaching and development skills
Management experience in a team oriented workplace
Demonstrated ability to lead and develop a department and department staff members.
Communicate in concise, clear, and inspiring during staff meetings in both formal and informal settings
Diplomatic with a positive attitude and customer service orientation
Recruitment and Retention practices
Knowledge and experience in business, management and supervision
Evidence of the ability to practice a high level of confidentiality
Ability to identify areas for improvement and develop educational programs to meet the needs of the department
Ability to establish and maintain priorities for responding to requests and follow established policies
Knowledge of the functions, operations, and mission of the Clinical Research Department
Knowledge of EMR / Research system operations
Ability to analyze, develop and implement procedures to maximize reimbursement
Knowledge of physician and professional fee billing practices and principles, and third party payment procedures
General accounting practices including accounts payable and accounts receivables
Demonstrated knowledge of basic economics, budgeting, and accounting practices
General knowledge of various employment laws, practices and employee relations
Advanced working knowledge of regulatory requirements (federal, state, and local) for administration of research
Knowledge of Clinical Trial Management Systems
Ability to multi-task and meet deadline in a fast paced environment
Above average written and spoken communication skills
Excellent computer skills in a Microsoft Windows platform. Including but not limited to Outlook, Word, Excel, PowerPoint and Access.
About Providence
At Providence, our strength lies in Our Promise of “Know me, care for me, ease my way.” Working at our family of organizations means that regardless of your role, we’ll walk alongside you in your career, supporting you so you can support others. We provide best-in-class benefits and we foster an inclusive workplace where diversity is valued, and everyone is essential, heard and respected. Together, our 120,000 caregivers (all employees) serve in over 50 hospitals, over 1,000 clinics and a full range of health and social services across Alaska, California, Montana, New Mexico, Oregon, Texas and Washington. As a comprehensive health care organization, we are serving more people, advancing best practices and continuing our more than 100-year tradition of serving the poor and vulnerable.
The amounts listed are the base pay range; additional compensation may be available for this role, such as shift differentials, standby/on-call, overtime, premiums, extra shift incentives, or bonus opportunities.
Check out our benefits page for more information about our Benefits and Rewards.
Requsition ID: 211577
Company: Providence Jobs
Job Category: Research
Job Function: Clinical Support
Job Schedule: Full time
Job Shift: Day
Career Track: Leadership
Department: 3002 ADMINISTRATION WA PRMCE
Address: WA Everett 1321 Colby Ave
Pay Range: $63.28 - $103.89
The amounts listed are the base pay range; additional compensation may be available for this role, such as shift differentials, standby/on-call, overtime, premiums, extra shift incentives, or bonus opportunities.
Check out our benefits page for more information about our Benefits and Rewards.
Providence is proud to be an Equal Opportunity Employer. Providence does not discriminate on the basis of race, color, gender, disability, veteran, military status, religion, age, creed, national origin, sexual identity or expression, sexual orientation, marital status, genetic information, or any other basis prohibited by local, state, or federal law.
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