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Clinical Research Site Director

2 months ago

Orlando, United States Elixia Full time

Who are we?

Elixia is a trusted clinical site organization, providing industry-leading patient recruitment and clinical trials management and analysis for Cardiology/Nephrology, Behavioral Health, and Infectious Disease – not just for a single trial, but across your entire therapeutic pipeline.


Schedule:

  • Full time
  • Monday to Friday
  • Weekends as needed


Summary: The Site Director performs clinical research activities as a Clinical Research Coordinator while also serving as Manager of clinical research staff at the Site. The Site Director shall provide the services outlined in this job description, which services may be updated from time to time by the Company.


Strategic and Operational Management:

  • Develops and executes the site’s strategic plan in alignment with the Company’s goals and objectives;
  • Evaluates overall performance of the Site and recommends and implements processes and plans for improvement;
  • Monitors the Site RealTime calendar to ensure coverage of the Site’s services and coordination of staff PTO;
  • Promptly reports to Company Management concerns or limitations in the performance of a clinical research study;


Staff Development and Management:

  • Fosters a culture of excellence, teamwork, and innovation among site staff;
  • Recruits, trains, and mentors site staff, including Clinical Research Coordinators, Research Assistants, Administrative Assistants, Registered Nurrses, support personnel, etc;
  • Supervises performance of other Clinical Research Coordinators, Research Assistants, and support staff at the Site, conducts periodic performance reviews, and Counseling Records where necessary;
  • Fosters a culture of continuous learning and professional development;
  • Assists Human Resources with site terminations.


Quality Assurance and Compliance:

  • Maintains up-to-date knowledge of all relevant regulatory guidelines and requirements;
  • Ensures the site’s compliance with FDA, ICH, and local regulatory agency regulations;
  • Implements and maintains quality assurance processes to uphold data integrity and patient safety.
  • Records adverse events and side effect data and confers with Investigators regarding the reporting of events to oversight agencies;
  • Prepares for or participates in quality assurance audits conducted by study sponsors, federal agencies, or designated review groups;
  • Conducts regular internal audits and address findings promptly;


Clinical Research Coordination: In addition to assuming management responsibilities as a Site Director, this individual performs the duties of a Clinical Research Coordinator, including:

  • Protects the rights, safety, and welfare of human subjects, follows Good Clinical Practice, and works cooperatively with others;
  • Monitors study activities to ensure compliance with study protocols and with applicable federal, state, and local regulatory and Site policies;
  • Oversees the planning, initiation, and execution of clinical trials at the site;
  • Maintains required records of study activity including case report forms, drug dispensation records, and regulatory forms;
  • Tracks enrollment status of subjects and documents dropout information, such as dropout causes and subject contact efforts and communicates this information as directed;
  • Manages and optimizes patient recruitment and retention efforts;
  • Assesses eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and other health care professionals;
  • Oversees subject enrollment to ensure that informed consent is properly obtained and documented;
  • Ensures that patients receive the highest standard of care throughout their participation in clinical trials;
  • Addresses any patient concerns or issues promptly and professionally;
  • Instructs research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, and documentation procedures;


Communication and Liaison:

  • Acts as a primary liaison between the site, sponsors, CROs and regulatory agencies;
  • Maintains open and effective communication channels with all stakeholders;
  • Communicates with laboratories or Investigators regarding laboratory findings;
  • Collaborates with Investigators and Company Management to prepare presentations or reports of clinical study procedures, results, and conclusions;


Documentation and Reporting:

  • Creates source documents as assigned, such as regarding protocols, memos, and patient participation;
  • Prepares study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports;
  • Documents findings and events in the CTMS platform and in other binders and platforms as directed;
  • Reviews proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks;


Additional Responsibilities:

  • Orders drugs or devices necessary for study completion;
  • Reviews scientific literature, participates in continuing education activities, and/or attends conferences and seminars to maintain knowledge of clinical research;
  • Occasional travel to Company sites, Investigator meetings, and/or Company meetings;
  • Performs other duties as assigned, including duties routinely performed by the Company’s Research Assistants.


Qualifications

  • Proficiency in FDA regulations governing clinical trials
  • Experience with statistical software for data analysis
  • Strong supervisory skills to lead research staff effectively
  • Ability to collect and manage research data accurately
  • Familiarity with documentation review processes in clinical research
  • Capability to perform phlebotomy procedures
  • Knowledge of medical terminology relevant to clinical trials management
  • Previous experience in a clinical research settings
  • Good Clinical Practice (GCP) Certification
  • IATA Certification


Equal Opportunity: The Company is an equal opportunity employer and does not discriminate based on race, religion, color, national origin, age, sex, gender, sexual orientation, disability, or any other characteristic protected by law. You must be able to perform the essential functions of the position satisfactorily. Reasonable accommodation may be made to enable employees with disabilities to perform the essential functions of this job, absent undue hardship.


Job Type: Full-time


Benefits:

  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Employee assistance program
  • Flexible spending account
  • Health insurance
  • Health savings account
  • Life insurance
  • Paid time off
  • Parental leave
  • Retirement plan
  • Vision insurance


Schedule:

  • 8 hour shift
  • Day shift
  • Monday to Friday
  • Weekends as needed


Experience:

  • Management: 2 years (Required)
  • Site Director: 2 years (Required)


License/Certification:

  • Good Clinical Practice Certificate (Required)
  • IATA Certification (Required)