Clinical Research Coordinator- Biobank

Overview
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.
Position Summary
Under the direction of the VBRI Biobank Director, Principal Investigators, and CTRO Supervisor, is responsible for all biobank reporting/documentation required for applicable stakeholders and the Institutional Review Board (IRB). Manages the development of bank budgets and implements and oversees biobank specific training in the learning management system.
Responsibilities

• Coordinates the conduct of the Clinical Research biobank/project and protocols from initiation to completion in compliance with regulations and requirements.
• Prepares and manages execution of biobank budgets, ensuring appropriate expenditures and resource utilization, while working with Office of Sponsored Programs regarding local and national budget issues.
• Handling and processing blood. Extracting blood derivatives, aliquoting, and storage per study design and defined SOPs.
• Collect/obtain, process, label, store, and database all samples correctly.
• Tissue processing, DNA and RNA extraction, handling and storage of bone marrow, and isolation of cellular components.
• Prepares a variety of written materials that support the research such as IRB documents, contracts/subcontracts, grants, manuscripts, educational and promotional materials, etc.
• Maintain biobank freezers including scheduled defrosts and moving samples to protect integrity in event of freezer failure.
• Serves as a liaison with stakeholders including members of the research team, IRB (Institutional Review Board), study sponsors, hospitals/hospital staff, Versiti staff, national data coordinating centers, and granting agencies. May include training and education regarding the study.
• Maintain supplies necessary to collect and process samples.
• Ensures receipt of applicable study data, reports, contracts, and information.
• Designs, oversees, evaluates, and improves systems and processes to manage the conduct of the biobank and the flow of information among stakeholders.
• Handles all biobank requests and brings to appropriate committee for review and approval.
• Coordinates the collection and required reporting of applicable data to ensure smooth and accurate flow of information and when required, assists with data analysis.
• Assists with and develops quality assurance procedures; evaluates study forms for completeness, accuracy and compliance with protocols.
• Assists with study audits and performs the necessary steps to resolve any queries.
• 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

Qualifications
Education

• Bachelor's Degree in life sciences or other related field required
• High School Diploma plus an additional 4 years (8 years overall) of related research or healthcare experience in lieu of required degree

Experience

• 4-6 years Clinical Research or Biobanking experience required
• 7-9 years healthcare/research experience preferred
• Phlebotomy experience 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 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
• Strong proficiency with database functionality required
• Ability to work in an independent manner while providing mentorship to others required
• A leader in flexibility and dedication for handling a demanding, irregular schedule under pressure to meet deadlines required

Licenses and Certifications

• CCRC - Certified Clinical Research Coordinator upon hire preferred

Tools and Technology

• Laboratory Inventory Management Systems (LIMS) required
• Electronic Data Capture systems such as Redcap, Medidata, Inform, etc. required
• EPIC Medical Record System preferred

#AJ123
#LI-HT1
#LI-Onsite