****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.
Primary Responsibilities:
• This position must be able to work independently on multiple research projects with minimal written policies or procedures. This position requires daily interaction with pharmaceutical sponsors, physicians, other health care personnel (e.g., nurses, patient care coordinators, insurance companies), and patients. Up to 10 projects will be in progress simultaneously, with the expectation of additional projects in the future.
• With minimal guidance, implement research project procedures that meet research objectives and ensure compliance with all aspects of the Institution, the Food and Drug Administration (FDA), and the National Institutes of Health (NIH) regulations pertaining to clinical research in human subjects (e.g., investigator financial disclosure requirements of the FDA)
• Develop, document and maintain procedures for patient registration and protocol implementation to ensure that research execution meets Good Clinical Practice guidelines.
• Work with clinical research staff to design, create and revise research instruments (e.g., case report forms) as necessary to ensure quality data that satisfies research objectives.
• Prompt completion of electronic data capture systems and electronic case report forms. Timely resolution of queries and questions from industry sponsors, contract research organizations and Institutional Review Board.
• Work with Regulatory Coordinator to ensure that reports to the Institutional Review Board and study sponsors are timely, accurate and satisfy applicable regulation. With minimal guidance, develop and implement corrective action plans to ensure protocol adherence and data integrity.
• Work collaboratively with research team to ensure that projects are executed successfully and completed within required time frames to meet research objectives.
• Prepare interim reports for principal investigators, industry sponsors and Institutional Review Boards to ensure that each project is moving toward timely completion.
• Gather metrics on current EDC/QC processes including but not limited to:
• Current delegation of workload and percentage of work done of data entry team, including, but not limited to:
• Number of study subject binders/visits entered into various data systems
• Number of queries resolved within a week’s period per data manager.
• Investigation and root cause analysis of current data process issues and the development of tracking/metrics-gathering systems to ensure company prescribed protocols are being met.
• Facilitation of study startups in obtaining and distributing of information specific to data processes and procedures, including but not limited to:
• Attendance at Study Initiation Visits to garner and distribute pertinent information on specific studies to all personnel associated with study. This information is including but not limited to:
• Which data system will be used for the capture of study data.
• The obtaining of early study access and/or screenshots for system readiness.
• Specific information needing to be entered for Screen Fails.
• Requests for EDC eCRF guidelines to ensure system readiness.
• Access Requests for Data Entry Team via various lines of communication to ensure full access at study start up.
• Initiation and maintenance of new logs deemed appropriate by management to facilitate communication and book accountability.
• Facilitation of meetings between EDC/QC and Source/Coordinators regarding specific issues with study protocol adherence.
• Compilation of weekly report including all metrics gathered within week, providing a snapshot of the progress on current process improvement initiatives.
• Providing query reports to assist in query resolution
• Answering queries
• Maintaining organized and accessible documentation of violations to current Compass Research protocol/GCP.
• Maintaining organized and accessible documentation of all reports from initiation of process improvement initiative.
• Strict adherence to all study protocols to which employee has been granted access.
• QC Study Subject Binders on regular basis Responsibilities for this including but not limited to:
• Ensures adherence to Compass policies and SOPs.
• Performs Compliance reviews on informed consent process documentation.
• Performs compliance review to ensure accuracy of inclusion/exclusion criteria to confirm Subject’s eligibility.
• Performs compliance reviews on staff performance as it relates to adherence to protocol screening and randomization requirements and associated documentation
• Performs routine and/or random compliance checks on overall study performance as directed.
• Other duties as assigned
Knowledge, Skills, and Abilities:
• Excellent interpersonal and communication skills (written and oral)
• Ability to multi-task
• Strong planning and organizational skills
• Strong problem solving skills
• Strong understanding of Root Cause Analysis
• Detail-oriented
• Takes initiative
• Team player
• Ability to adapt and work in a fast paced and changing environment
• Extensive software and internet research skills
• Proficient with various types of office equipment, web-based software, MS Office.
• Strong skills with Microsoft Office and Excel
• Sensitivity to confidential matters
Qualifications:
• Minimum of Bachelor’s Degree is required.
• Experience in Quality Control
At K2, we value our employees and their professional and personal needs, and support these through our benefit offerings: