Senior Director Clinical Trials And Research

Purpose:
The Director, Clinical Trials & Research, for CCARE Physicians, PC, is responsible and accountable for the daily operations and management of staff, of the research program. Responsible for contributing to the creation and execution of the clinical trial development strategy, study contract review, study budget review, negotiation, and in consultation with the finance department, the overall financial activities of the department. Assures compliance with all regulatory requirements and standards of good practice (GCP) related to the conduct of clinical research.
Responsibilities/Essential Functions (other duties as assigned):

• • • Proactively work with current and new sponsors, to secure new research opportunities.
    • Advanced leadership skills and the ability to effectively collaborate with external partners, regulators, and diverse internal stakeholders and collaborators are essential prerequisites.
    • Assist the Principal Investigators in recruiting studies and assessing their feasibility for the clinic practice site(s).
    • Supervises staff, including Research Nurses, Clinical Research Coordinators, Regulatory Coordinators, Research Manager, and other support staff; coordinates quality and customer service activities.
• Managing people with a wide range of educational backgrounds and skills. Demonstrates management and conflict resolution skills to effectively lead and motivate others. Strong decision-making skills and ability to use independent judgement to quickly set priorities, solve problems and resolve conflict.
  • • Assure that new employees are oriented, ensuring documentation of competencies through the use of the appropriate forms.
    • Assure all research staff are properly trained on the CTMS (WCG Velos eResearch eXpress).
    • Create and maintain an effective staffing plan.
    • Identify staff education needs and provides developmental opportunities.
    • Ensure research staff, subIs, and PIs complete and maintain appropriate certifications specific to clinical trial participation (GCP, Conflict of Interest, FDA Focused, and others as required).
    • Ensure documentation of competency of staff through feedback and annual evaluations with input from appropriate team members.
    • Coach staff to enhance performance and provide corrective action as needed.
    • Partners with Human Resources (HR) to ensure compliance with HR policies and procedures.
    • Complete and/or validate payroll via ADP on a weekly basis. Assure accurate completion of timecards.
    • Orchestrate change to improve organizational outcomes.
    • Foster an open work environment that is conducive to teamwork and encourages communication to and from staff.
    • Facilitate regular staff meetings and employs other means of effective communication.
    • Demonstrate the ability to apply a varied leadership style based upon the individuality of team members.
    • Support collaboration with other departments to share pertinent information.
    • Assure compliance with all regulatory requirements related to human subject’s research, including but not limited to the regulations and guidelines of the Food, Drug and Cosmetic Act; and accepted standards of Good Clinical Practice (GCP).
    • Ensure that the physical environment of the department promotes quality patient outcomes, patient and staff safety.
    • Create and maintain a culture of kindness and service excellence in the department.
    • Promote clinical excellence through applied clinical knowledge, leadership, team recommendations and Research utilization.
    • Ensure timely reporting and follow up of all patient incidents.
    • Assure that policies and standard operation procedures (SOPs) are complete, accurate, and up to date and reflect current operations, utilizing PowerDMS for SOP management.
    • Review, negotiate, and approve all study budgets with the assistance of the finance department.
    • Monitor all study funds and revenues assuring that sponsor invoicing and sponsor payments or collections are done in a timely manner.
    • Assure charges related to research have been adjusted appropriately from the patient accounts and that outside vendors (EVDI, Sonora Quest, Chandler Cardiology, etc.) are paid appropriately for research services provided.
    • Review, negotiate, and approve all sponsor contracts. Consult with Principal Investigators and the Practice Administrator, as appropriate.
    • May provide coverage to staff and function in the role of Research Nurse or Clinical Research Coordinator, as applicable
• Works to ensure enrollment goals of the Clinical Trials program (per site) are being met
• Monitors subject visits
• Supports the team and investigators in overall conduct of the trials
• Follows the established monitoring SOPs both corporate and clinical, as well as protocol for specific monitoring plan
• Works with QA/QC program prior to sponsor visit
• Oversees employees' work before monitoring
• Reviews budgets, including clinical research and physicians' costs
• Works with the corporate office to evaluate recruitment plans and study start up
• Must be able to type and work on a computer.
• Ability to work in a constant state of alertness and safe manner.
• Performs other duties as requested by supervisor, administrator, or physicians.

Experience, Qualifications/Education:

• 3+ years of relevant experience as a clinical research associate or clinical research coordinator (clinical research experience overall)
• RN with a current California RN License required
• Bachelor’s degree or other formal professional/technical preparation in relevant discipline. Master’s degree strongly preferred.
• Minimum of 4 years’ Management experience in a research setting.
• Minimum of 5 years’ experience in clinical research, finance related to research, compliance in the field of research. Oncology nursing and Research experience preferred.
• Nursing degree/experience highly desirable.
• Current GCP Certification required, or completed within 30 days of hire
• Current CPR certification required
• Knowledge of computer/telephony support, preferably in a health care environment
• Strong customer service background, preferably in health care environment
• Excellent verbal communication skills
• Competence with computer processing functions and other standard office equipment
• Ability to manage and prioritize multiple tasks
• Ability to calmly and professionally resolve customer issues with diplomacy and tact
• Ability to work independently with minimal supervision
• Strong organizational skills

Working Conditions:

• This position functions primarily indoors in a medical / business environment. Employee may be subject to blood borne pathogens, radiation, biowaste and other medically-related factors, with exposure to moderate noise levels.
• Visual acuity to read and compute screen and paper documents; close and distance vision, peripheral vision depth perception, ability to adjust focus; hearing acuity to converse with staff and customers;ability to walk, stoop, bend, kneel, and lift and move 25 pounds on a regular basis; ability to sit for hours at a time. Employee will be exposed to moderate noise levels, interruptions, and occasionally asked to work evening and weekends as needed.