Suncoast Skin Solutions
Clinical Trials Director - Jacksonville
A Clinical Research Director manages and provides strategic leadership for clinical trials, overseeing all phases from design and planning to execution, data analysis, and regulatory compliance. The role involves leading cross-functional teams, managing budgets, ensuring adherence to ethical standards and FDA guidelines, and communicating results to stakeholders.
Key Responsibilities
- • Develops long-range plans, goals, and policies for clinical research programs.
- • Manages the entire lifecycle of clinical trials (Phase I-IV), including design, obtaining, monitoring, data collection, and analysis.
- • Recruits, trains, and manages diverse teams, fostering a positive environment.
- • Oversees budgets, allocates resources, and manages fiscal aspects of research.
- • Ensures adherence to FDA, ICH-GCP, and internal SOPs, handling regulatory filings and audits.
- • Reports progress, risks, and results to senior management, sponsors, and other stakeholders.
- • Establishes relationships with clinical sites, KOLs, and manages external vendors like CROs.
- • Implements data collection protocols, manages data quality, and oversees database lock procedures.
- • Minimal oversight and some travel to our Tampa region as needed.
Required
- • Advanced degree (PhD, MD, MPH, PharmD) often required, with strong scientific understanding.
- • Extensive experience (8+ years) in clinical trial management, often with multi-phase trial oversight.
- • Strong leadership, team-building, and communication skills.
- • Deep understanding of GCP, ICH guidelines, and relevant regulations.
- • Excellent problem-solving, organizational, and adaptability.
A Clinical Research Director (CRD) manages and provides strategic leadership for clinical trials, overseeing everything from design and planning to execution, data analysis, and regulatory compliance, ensuring studies meet ethical standards and FDA guidelines while leading cross-functional teams of scientists and coordinators, managing budgets, and communicating results to stakeholders. Key duties include developing trial strategies, managing site operations, ensuring adherence to Good Clinical Practices (GCP), overseeing budgets and resources, and contributing to regulatory submissions.
Clinical and Administrative
Clinical and Administrative
- Strategic Oversight: Develops long-range plans, goals, and policies for clinical research programs.
- Trial Management: Manages the entire lifecycle of clinical trials (Phase I-IV), including design, obtaining, monitoring, data collection, and analysis.
- Team Leadership: Recruits, trains, and manages diverse teams, fostering a positive environment.
- Budget & Resources: Oversees budgets, allocates resources, and manages fiscal aspects of research.
- Regulatory Compliance: Ensures adherence to FDA, ICH-GCP, and internal SOPs, handling regulatory filings and audits.
- Stakeholder Communication: Reports progress, risks, and results to senior management, sponsors, and other stakeholders.
- Site & Vendor Management: Establishes relationships with clinical sites, KOLs, and manages external vendors like CROs.
- Data Integrity: Implements data collection protocols, manages data quality, and oversees database lock procedures.
- Minimal oversight and some travel to our Tampa region as needed.
- Demonstrates initiative and responsibility
- Able to perform repetitive tasks without loss of focus
- Adheres to ethical principles
- Time Management
- Adapts to change
- Attends all team meetings and mandatory in-service training/education
- Recognizes and respects cultural diversity
- Adapts communication to individual’s ability to understand
- Uses professional, pleasant telephone etiquette
- Uses medical terminology appropriately
- Treats all patients and co-workers with compassion, empathy, and mutual respect
- Projects a professional manner and image
- Consistent attendance and punctuality
- Adherence to time clock procedures
- Maintains confidentiality and documents accurately
- Uses appropriate guidelines for releasing patient information
- Practices within the scope of education, training, and personal capabilities
- Conducts self in accordance with Suncoast’s Employee Handbook.
- Maintains awareness of federal and state health care legislation and regulations; OSHA, HIPAA, and CLIA
- Efficiency
- Attention to details
- Organized
- Punctual
- Takes initiative, proactive
- Team Player
- Honesty/Integrity
- Flexible
- Calm under pressure
- “A Doer”, persistence
- Problem solver, Strategic thinking, Creativity
- Analytical skills
- Clear and concise communication/Listening skills
- Quick Learner, Intelligence
- Follow through on commitments
- Enthusiastic, Friendly, Positive attitude
- Openness to advice and constructive criticism
- Strong work ethic
- Prolonged sitting/standing/walking
- Use of headsets
- Occasional travel
- Multitasking position
- Repetitive head, neck, hands wrists and arm motion/rotation
- Extensive reading, writing, typing required. Typing speed 45wpm +
- Lifting to 25lbs
- Frequent use of office administrative, computer, and phone equipment
- Education: Advanced degree (PhD, MD, MPH, PharmD) often required, with strong scientific understanding.
- Experience: Extensive experience (8+ years) in clinical trial management, often with multi-phase trial oversight.
- Leadership: Strong leadership, team-building, and communication skills.
- Knowledge: Deep understanding of GCP, ICH guidelines, and relevant regulations.
- Skills: Excellent problem-solving, organizational, and adaptability.
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