Clinical Research Coordinator - Clinical Trials & Research Office

Located in Milwaukee Wisconsin the Versiti Blood Research Institute (VBRI) is the largest blood-focused research institute in the United States. With over 30 basic translational and clinical investigators the institute is dedicated to advancing scientific knowledge and developing innovative therapies related to blood and blood disorders. The institutes research interests encompass a wide range of topics including transfusion medicine cellular therapy thrombosis/hemostasis immunology and hematologic malignancies. As a vital part of Versiti a non-profit organization with a blood bank at its core the VBRI strives to improve lives through innovative research and the development of novel diagnostics and treatments.

VBRI is part of the Milwaukee Regional Medical Campus a rapidly growing clinical-translational research hub. VBRIs proximity to the Medical College of Wisconsin Childrens Hospital of Wisconsin and Froedtert Hospital facilitates seamless interdisciplinary collaborations. A range of exemplary core facilities support highly competitive research. In the summer of 2024 construction of a new research building began doubling existing VBRI research space to enable the recruitment of 10-15 new faculty. With its renowned researchers strategic expansion plans and location in a highly collaborative environment the VBRI is poised to maintain and expand its position as one of the leading hematology institutes in the world.

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
• Bachelors 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 drivers 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