Versiti is a fusion of donors, scientific curiosity, and precision medicine that recognize the gifts of blood and life are precious. We are home to the world-renowned Blood Research Institute, we enable life saving gifts from our donors, and provide the science behind the medicine through our diagnostic laboratories. Versiti brings together outstanding minds with unparalleled experience in transfusion medicine, transplantation, stem cells and cellular therapies, oncology and genomics, diagnostic lab services, and medical and scientific expertise. This combination of skill and knowledge results in improved patient outcomes, higher quality services and reduced cost of care for hospitals, blood centers, hospital systems, research and educational institutions, and other health care providers. At Versiti, we are passionate about improving the lives of patients and helping our healthcare partners thrive.

Under the direction of the Principal Investigators (PIs) and applicable sponsors, is responsible for planning and operationally leading the multi-site coordination of research trials from initiation to completion in compliance with applicable regulations and requirements. Manages trial budgets and implements and oversees systems to manage the conduct of the clinical trials and the flow of information among stakeholders and sites.

Benefits
Versiti provides a comprehensive benefits package based on your job classification. Full-time regular employes are eligible for Medical, Dental, and Vision Plans, Paid Time Off (PTO) and Holidays, Short- and Long-term disability, life insurance, 7% match dollar for dollar 401(k), voluntary programs, discount programs, others.

• Responsible for regulatory management including the development of IRB submissions, pharmacy control plans, training materials, questionnaires, case report forms, data analytics infrastructure, amendments, continuing review, study closeout, monitoring, and reporting of adverse events. Oversees review and approval at partner site(s).
• Coordination of all study activities with external and internal resources to complete research aims including managing vendor relationships as needed for the conduct of applicable trials (central lab, home health, etc.)
• Oversee compliance and conduct of the research protocol. Monitors safety and is involved in reviewing and analyzing adverse events and unanticipated events at participating sites. Provides oversight to ensure confidentiality of data, protocol compliance, evaluation of problems and complaints.
• Prepare and manage budgets and provide necessary financial information for grants, subcontracts, and sponsors. May complete study specific invoicing.
• Serves as a liaison between Principal Investigator (PI) and stakeholders (sponsors, IRB, sites, etc.) by assisting the PI in day-to-day operations of the projects.
• Determine data management plans and ensure that all data is collected, entered, analyzed and reported accurately. Performs quality checks and designs systems to monitor and extract data. May include site visits and auditing of data.
• Provide training and create documentation to support the research study (training manuals, educational, promotional materials).
• Design and maintain databases and systems to manage information, data and studies. Evaluate and improve processes for data entry, data extraction and record keeping.
• Generate, extract, analyze and, compose original scientific material for use in abstracts, publications, progress reports and grants. Participate and present at national and international research meetings and conferences.
• Supports in planning and conducting Investigator Meetings
• Reviews and approves release of investigational product or device shipments
• Maintains confidentiality of all subject-related records including written and verbal communications.
• Coordinates on-site and off-site meetings for project planning purposes and educational events as assigned.
• Serve as Project Manager (PM) for studies that do not have one also assigned and may provide coverage for others and/or may supervise, instruct and direct the work of others including Clinical Research Associates (monitors).
• As a skilled specialist, completes tasks in resourceful and effective ways. Tasks involve forward planning and anticipation of needs/issues.
• Performs other duties as required or assigned which are reasonably within the scope of the duties in this job classification
• Understands and performs in accordance with all applicable regulatory and compliance requirements
• Complies with all standard operating policies and procedures

Education

• Bachelor's Degree in a health sciences, biological sciences, nursing, pharmacy, or related field required
• Master's Degree in science or another related field preferred

Experience

• 7-9 years Clinical Research Experience in regulatory and industry operations required
• 10+ years Healthcare/research experience required
• Less than 1 year Experience with related clinical research preferred

Knowledge, Skills and Abilities

• Ability to be an effective liaison between study subjects and sponsors, investigators, health care workers, and collaborating professionals required
• Advanced verbal and written communication skills including the ability to write, interpret and explain research studies and procedures required
• Advanced ability to design, implement and manage projects that include planning, organization, prioritization, problem solving and performance of project tasks to ensure project completion within designated timeframes required
• Very strong attention to detail and ability to evaluate and ensure accuracy of data related to laboratory results, subject health history, and data collection and reporting required
• Ability to evaluate and extract data from medical records with ability to spot errors and trends and address promptly required
• Strong knowledge of regulations associated with human subject research required
• Ability to work in an independent manner while providing mentorship to others required
• Tasks involve a considerable degree of forward planning and anticipation of needs or issues required

Licenses and Certifications

• ACRP CCRC or CCRA or SOCRA CCRP Certification upon hire required

Tools and Technology

• Personal computer (laptop) required
• General office equipment (computer, printer, copy machine) required
• Microsoft Suite (Word, Excel, PowerPoint) required
• Electronic Data Capture systems such as Redcap, Medidata, Inform, etc. required
• Electronic Trial Master File systems such as Florence eBinders required
• Electronic consent platforms such as Redcap or Florence eConsent required
• EPIC medical record system preferred