Associate Director of Clinical Operations

At K2 Medical Research, a privately-owned clinical research facility in the greater Orlando and Central Florida area, we specialize in conducting multiphasic clinical trials that promote the development of innovative and effective medical treatments while maintaining the safety and privacy of our participants. We are committed to fighting the diseases that plague our loved ones and ourselves. By harnessing the power of advanced clinical research and connecting our patients with the treatments of tomorrow, we can improve the health of our local communities, and by extent, the population of our world.

K2 is seeking an experienced Associate Director of Clinical Operations for our South Downtown Orlando clinic.

The Associate Director of Clinical Operations assists the Director of Operations with day-to-day clinical operations and provides leadership and support to the clinical staff to ensure high quality, high volume, and efficient productivity. They maintain effective and positive working relationships with patients, sponsors, physicians, and employees. Assists in the coordination, organization, and efficient implementation of clinical trials. Performs diverse managerial responsibilities requiring considerable analysis, judgment, and detailed understanding of clinical research processes. Works closely with the Lead Project Managers and Principal Investigators to evaluate clinical trials and ensure that all study-related procedures are completed properly from a clinical and a regulatory perspective.

Primary Responsibilities

• Provide leadership and guidance to the Project Management (PM) teams, fostering a positive and collaborative work environment.
• Oversee interviewing, hiring, training, and management of PMs and
• Manages the collaboration of PM teams and other clinical and administrative staff and contractors (e.g., RAs, Marketing/Recruitment/Outreach, Laboratory, Pharmacy, Investigators, EDC, Raters, Training, Regulatory, and Compliance, etc.).
• Assists in coordinating the provision of needed support services (e.g., accounting, human resources, facilities management, etc.).
• Manages the processes of appointment scheduling, informed consent, subject visits, source document, etc.
• Oversee PM team and front office activities, ensuring compliance with clinical research protocols, ethical standards, and relevant regulations.
• Monitor and evaluate PM team and front office performance, implementing quality improvement initiatives as needed.
• Ensure the provision of compassionate, safe, and evidence-based care to subjects participating in research studies.
• Prepare and manage PM services, ensuring optimal resource allocation.
• Maintain accurate documentation, records, and reports related to PM services.
• Ensure compliance with regulatory requirements, accreditation standards, and research ethics guidelines.
• Attend meetings and relay pertinent information to PM team members timely.
• Attend periodic training sessions and meetings pertinent to position.
• Contribute to the effective implementation of company programs and services.
• Maintain excellent communication and effective working relationships with subjects, sponsors, clinical and admin team members.
• Coordinate site visits and other communications with sponsoring organizations prior to study implementation and work through PM teams to provide ongoing coordination of sponsor communications thereafter.
• Travel as needed
  
  

Knowledge, Skills, Abilities

• B.A. or B.S. required, advanced degree preferred; minimum of 2 years progressive experience in managing clinical trials.
• At least 2-3 years prior experience in clinical research preferred.
• Understanding of Clinical Research Requirements: Familiar with clinical research study processes and requirements. Understands regulatory requirements, as well as Good Clinical Practices (GCP) and International Conference on Harmonization (ICH) guidelines.
• Thoroughness and Accuracy: Able to collect, organize, interpret, and record detailed information as required by study sponsors and regulatory and review agencies.
• Communication: Able to communicate with providers, co-workers, sponsors, and others in a collaborative and courteous manner. Knowledgeable in medical terminology so as to communicate with physician office and laboratory staff. Skilled in persuading potential sponsors to place research with the site.
• Management: Able to manage a staff of clinical professionals and create a productive, satisfying work environment.
• Independence: Demonstrates the initiative to act independently, initiating activity as required and making appropriate decisions within the constraints of study protocols, regulatory requirements, this job description, and company policy.
• Adaptability: Able to initiate or modify behavior to achieve desired outcomes in spite of environmental factors, priorities, or problems that might not be well defined or that are subject to change.
• Computer Skills: Able to use standard office software, as well as proprietary applications unique to the clinical research industry and individual sponsoring organizations.
  
  

At K2, we value our employees and their professional and personal needs, and support these through our benefit offerings:

• Medical, Dental, Vision, Flexible Spending Accounts, Employer paid Long-Term disability and Life Insurance, Short Term Disability, Accident and Critical Illness Insurance, Voluntary Life and Long-Term Care Insurance, Legal Shield, Employee Assistance Program, and various discount programs.
• 401(K) Plans- Traditional and Roth plans are available; 4% employer match that is immediately vested
• PTO of 16 days per year, 17 days after the first year of FT employment
• 9 paid Holidays
• K2 observes a four-day work week, Monday through Thursday, for full time employees. Fridays are non-working days unless required by business needs.