CLIN RSCH SUPV 1

Responsibilities

• Develop project plans, interview key sponsors, and deliver tangible project results.
• Develop and update Standard Operating Procedures (SOPs).
• Design and perform ad hoc performance analysis of the projects and the project staff.
• Perform business process reviews, operational reviews, and design and implement workflows and controls.
• Develop project-related presentation materials for studies.
• Maintain an inventory of the status of all clinical trials on a quarterly basis to assess overall targets and outcomes.
• Ensure study documents are retained and stored onsite and offsite according to FDA guidelines when studies have closed.
• Provide ongoing staff training, ensure continued compliance, coordinate amendment updates, maintain study files, ensure audit readiness, recruit patients, and track enrollment.
• Lead staff to ensure proper close-out of studies, discuss subjects' options, and ensure documentation and storage of study files meet legal requirements.
• Ensure optimal systems are in place to comply with regulatory requirements for the safe conduct of clinical research.
• Ensure all IRB documents are up to date.
• Oversee preparation of new IRB applications, arrange renewals of existing protocols, respond to IRB requests for revisions, and coordinate protocol changes with study sponsors.
• Ensure timely reporting of protocol violations to study sponsors and adverse events to the IRB.
• Respond to requests and reviews of studies from sponsors, study monitors, the FDA, and other entities, including complex audits of study performance.
• Manage infrastructure before and during study execution, including database management, space allocation, equipment procurement, and specimen/sample storage and transportation.
• Work with leadership to ensure proper execution of studies.
• Manage activities for cohorts in various areas of studies and disciplines, and for clinical trials in various disciplines.
• Collaborate with other universities, clinical entities, and industry using collected data to understand disease progression and predictors.
• Contribute to or lead scientific presentations and publications based on study data collected.
• Contribute to the development of new grant proposals.
• Protect the University from non-compliance and potential litigation by ensuring contract compliance, meeting local and federal laws, and ensuring compliance with hiring and supervision laws.
• Implement safeguards and proper compliance with federal and local regulations to ensure audit prevention and success.
• Act as a regulatory authority and advisor by training and educating employees and advising leadership and Principal Investigators (PIs).
• Manage audits.
• Institute and maintain a Quality Improvement Process.

  Qualifications

  • Demonstrated ability to develop recruitment strategies in complex environments and differing patient pools, independently identifying recruitment leads, implementing new strategies, and continually adjusting strategies to meet current recruitment goals.
  • In-depth knowledge of clinical trials, protocols, FDA regulations, and complex visit structures.
  • Project management skills to oversee the administrative operations of the clinical trials program; knowledge of strategies for recruiting human subjects.
  • Exceptional analytical skills to evaluate the importance and urgency of problems; excellent demonstrated interpersonal, verbal, and written communication skills.
  • Demonstrated project management skills with the ability to effectively manage multiple priorities, prioritize projects, and meet the demands of a fast-paced and dynamic work environment.
  • Adaptable to quickly changing priorities.
  • Demonstrated experience managing people with a wide range of educational backgrounds and skills.
  • Demonstrated management and conflict resolution skills to effectively lead and motivate others.
  • Demonstrated experience in training others in the field of research.
  • Strong communication skills, including verbal and written communication, active listening, critical thinking, persuasiveness, advising and counseling skills.
  • Clear and concise communicator with the ability to influence and negotiate.
  • Excellent interpersonal skills, including problem-solving, teamwork development, leadership, and mentorship.
  • Ability to effectively motivate others, work collaboratively to achieve common goals, and cultivate relationships with multiple stakeholders at various levels of administration.
  • Demonstrated ability to analyze complex and non-routine issues requiring innovative solutions.
  • Demonstrated ability to operate effectively in a changing organizational and technological environment.
  • Demonstrated ability to assess and respond to audit risk; ability to develop project plans and schedules and motivate teams to meet deadlines.
  • Demonstrated ability to interpret and apply policies and regulations.
  • Significant project and clinical trial management experience or progressively responsible experience in a related position, including regulatory and compliance responsibilities.
  • Fluency in spreadsheet software; ability to develop complex spreadsheets independently; demonstrated skills in audit preparation, execution, and follow-up.