Clinical Research Coordinator - Comprehensive Center for Bleeding Disorders

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 CTRO Supervisor, is responsible for coordinating research trials from initiation to completion in compliance with regulations and requirements. Assists in the management of trial budgets and implements and oversees systems to manage the conduct of the clinical trials and the flow of information among stakeholders.

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.

Subject Interaction: * Obtains consent and enrolls study subjects * Communicates with study subjects, ensuring they receive applicable information. May include training and education regarding the study * Serves as a liaison between study subjects and Principal Investigator/research team to provide proactive communication * May collect samples from subjects as applicable/assigned
• Stakeholder Interaction: * Serves as a liaison with stakeholders including members of the research team, IRB (Institutional Review Board), study sponsors, hospitals/hospital staff, BCW staff, national data coordinating centers, and granting agencies. May include training and education regarding the study * Ensures receipt of applicable study data, reports, contracts, and information
• Administrative Responsibilities: * Coordinates the conduct of the clinical research project and protocols from initiation to completion in compliance with regulations and requirements * Designs, oversees, evaluates, and improves systems and processes to manage the conduct of the clinical trial and the flow of information among stakeholders * Prepares a variety of written materials that support the research study such as IRB documents, contracts/subcontracts, grants, manuscripts, educational and promotional materials, etc. * Coordinates the collection and required reporting of applicable data to ensure smooth and accurate flow of information and when required, assists with data analysis * Prepares and manages clinical trial budgets, ensuring appropriate expenditures and resource utilization, while working with Versiti grants administration regarding local and national budget issues * Designs, maintains and modifies databases, data entry/retrieval and record keeping systems * Supervises sample handling, storage, and shipment * Assists with study audits and performs the necessary steps to resolve any queries * Assists with and develops quality assurance procedures; evaluates study forms for completeness, accuracy and compliance with protocols * Confirms and Documents all study activities on the appropriate financial documents. May complete study specific invoicing. Participates in study budget design and review.
• General Responsibilities: * Maintains confidentiality of all subject-related records including written and verbal communications * Assists the Principal Investigator in day-to-day operations of the projects * Coordinates on-site and off-site meetings for project planning purposes and educational events as assigned * Participates in process improvement activities * Participates in meetings, professional activities, etc. to keep current in skills and knowledge * May serve as the Clinical Trial Management Software (CTMS) Administrator * May provide coverage for others and/or may instruct and direct the work of others
• Performs other duties as assigned
• Complies with all policies and standards

Education

• High School Diploma or equivalent required
• Bachelor's Degree in science or another related field or equivalent work experience required

Experience

• 1-3 years of experience in a health care or research setting required
• 4-6 years of healthcare/research experience preferred
• 1-3 years of Clinical Research Experience preferred
• Experience with related clinical research preferred
• Phlebotomy experience preferred

Knowledge, Skills and Abilities

• Strong customer service and interpersonal skills
• Ability to be an effective liaison between study subjects and sponsors, investigators, health care workers, and collaborating professionals
• Proficient verbal and written communication skills including the ability to write, interpret and explain research studies and procedures
• Strong ability to implement and manage projects that include planning, organization, prioritization, problem solving and performance of project tasks to ensure project completion within designated timeframes
• 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
• Strong proficiency with database functionality
• Ability to evaluate and extract data from medical records with ability to spot errors and trends and address promptly
• A leader in flexibility and dedication for handling a demanding, irregular schedule under pressure to meet deadlines
• Strong knowledge of regulations associated with human subject research preferred
• Ability to work in a highly independent manner
• Valid WI driver's license and access to a vehicle
• Consistently strives to enhance existing services and influence resulting action plans
• Builds teamwork, works collaboratively with team members and colleagues
• Has substantial understand of the job and applies knowledge and skills to complete a wide range of tasks
• Typically encounters differing situations requiring the identification of issues, the application of judgement, and the selection of solutions within the area of expertise and acquired knowledge. Requires objective review of difficult work problems, obtaining cooperation or approval. Requires resourcefulness
• Has substantial understanding of the technical scope of the job and applies knowledge and skills to complete a wide range of tasks

Licenses and Certifications

• ACRP CCRC or SOCRA CCRP certification preferred

Tools and Technology

• Personal Computer (desk top, lap top, tablet) required
• General office equipment (computer, printer, fax, copy machine) required
• Microsoft Suite (Word, Excel, PowerPoint) required
• EPIC medical record system required
• Electronic Data Capture systems such as Velos, Redcap, Medidata, Inform, etc. required