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Title:

Tissue Donor Coordinator

BELONG. CONNECT. GROW. with KBR.

Around here, we define the future. We are a company of innovators, thinkers, creators, explorers, volunteers, and dreamers. But we all share one goal: to improve the world responsibly and safely.

KBR is seeking a Tissue Donor Coordinator to support our SPARC Program for KBR’s Science and Space division. The SPARC program (Service Personnel Advancing Research on CTE) seeks to: 1) Provide education to service members, veterans, and their families on brain donation; 2) Register individuals for participation in the Brain Donation Awareness Registry; and 3) Recover whole specimens, process, and prepare for shipping using appropriate methods. The goal of this program is to support research that is ongoing at the Uniformed Services University’s Brain Tissue Repository related to military brain injury and chronic traumatic encephalopathy.

Under the direction of the Senior Program Manager (SPM), Senior Neuroscientist, and contract project manager(s), the Tissue Donor Coordinator will supervise Donor Specialists, Tissue Recovery Technicians, Marketing Specialists, and Peer/Family Educators on site, ensure clear communication with leadership and peers, and maintain compliance with regulatory accreditation agencies and internal quality processes on site. The Tissue Donor Coordinator will establish relationships with local coroners, justice of the peace, medical examiners, and tissue procurement organizations to develop protocols to support logistics surrounding tissue acquisition and processing with guidance from Neuroscientist. The Tissue Donation Coordinator will ensure compliance with protocols and report progress back to the Neuroscientist.

This position will be on-call on a rotating and regular basis.

Supervisory Responsibilities:

· Supervise on-site staff including Donor Specialists, Tissue Recovery Technicians, Marketing Specialists, and Peer/Family Educators.

· Prepare and submit weekly reports to the Program Manager of all activities of the site ; meet with Program Manager weekly to keep Program Manager abreast of all developments of activities on site.

General Administrative Responsibilities:

· Maintains protection of the rights and welfare of all human research participants involved in research in accordance with federal regulations and sponsoring agency policies and procedures.

· Assures that all key personnel involved in human research have completed the required education for the protection of human research participants in accordance with federal regulations and university and sponsoring agency policies and procedures. Maintains proof of all such education for all engaged members of the study team. Coordinates with staff to help ensure that clinical research and related activities are performed in accordance with Federal regulations and sponsoring agency policies and procedures.

· Assists in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training.

Protocol and Review:

· Reviews and comprehends the protocol.

· Attends investigator meetings as required or requested.

· Collaborates to prepare IRB/HRPO and any other regulatory submission documents as required by the protocol. Prepares other study materials as requested. These study materials include but are not limited to the informed consent document, case report forms (CRFs), enrollment logs, and study data.

· Establishes and organizes study files, including but not limited to, regulatory binders, case report forms, study specific source documentation.

Informed Consent:

· Assists in preparation of all documents related to the informed consent process.

· Assists in preparation and submission of informed consent documents to HRPO for review and approval.

· Answer questions from families or individuals who would like to know more about the brain donation program.

Award Acceptance (Terms & Conditions):

· Reviews and develops a familiarity with the contract or award terms and conditions. Works to assure that the study is in compliance with all terms and conditions, including but not limited to education, IRB (HRPO) approval, conflict of interest disclosure, health and safety protections for participants and staff and any financial terms or conditions.

Conduct of Research:

· Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.

· Assists in communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log.

· Collects documents needed to initiate the study for submission to the sponsor (e.g., CVs, training documents, etc.).

· Works with the Marketing Strategist and Peer/Family Educators to implement recruitment strategies in accordance with HRPO (IRB) requirements and approvals.

· Conducts or participates in the informed consent process including interactions with the HRPO (IRB), discussions with research participants, including answering any questions related to the protocol. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.

· Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.

· Coordinates with local coroners, medical examiners, tissue transport providers, to facilitate brain donations for research.

· Collects data as required by the protocol. Assures timely completion of Case Report Forms.

· Maintains study timelines.

· Maintains adequate inventory of study supplies.

· Completes study documentation and maintains study files in accordance with sponsor requirements and DoD policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms, etc.

· Retains all study records in accordance with sponsor requirements and DoD policies and procedures.

· Maintains effective and ongoing communication with sponsor, research participants and supervisor during the course of the study.

· Assists in preparation and submission of any modifications to the scientific protocol in accordance with federal regulations and university and sponsoring agency policies and procedures.

· Works to manage the day-to-day activities of the site including problem solving, communication and protocol management.

Protected Health Information:

· Adheres to and supports all Federal regulations and DoD policies and procedures instituted to safeguard protected health information (PHI).

· Completes the appropriate level of training regarding the access, use, and disclosure of PHI in accordance with Federal regulations and DoD and sponsoring agency policies and procedures. Assists PI to assure that all personnel complete appropriate training.

· Cooperates with compliance and monitoring efforts regarding the access, use, and disclosure of PHI and reports instances of noncompliance to the appropriate compliance office.

Unanticipated Problems:

· Assists in promptly reporting any unanticipated problems involving risks to research participants or others to the HRPO and IRB.

Reporting:

· Assists with scientific and compliance reporting requirements in accordance with federal regulations and sponsoring agency policies and procedures.

· Provides reporting on the status of regulatory agreements/ actions, educational events, individuals in attendance at each event, methods of outreach, number of individuals registered to Brain Donation Awareness Registry, number of interactions with decedent next of kin, number of pending or executed brain recoveries, brain specimens processed, brain specimens shipped, and data collection progress to funding agency.

Project Closeout:

· Assists in preparation of accurate and timely closeout documents to applicable federal agencies and the sponsoring agency in accordance with federal regulations and sponsoring agency policies and procedures.

· Arranges secure storage of study documents that will be maintained according to DoD policy or for the contracted length of time, whichever is longer.

REQUIRED EDUCATION/EXPERIENCE:

· Education: Must have a bachelor’s degree with at least 2 years of experience in human subject research or tissue donation. An additional 8 years of experience will be accepted in lieu of a degree.

PREFERRED EDUCATION/EXPERIENCE:

· Prior experience working in military environments and interacting with service member personnel and their families.

· Ability to speak, read, and write in Spanish.

· Supervisory experience.

· Experience in the field of tissue or organ donation.

· AATB CTBS certification

KBR is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, disability, sex, sexual orientation, gender identity or expression, age, national origin, veteran status, genetic information, union status and/or beliefs, or any other characteristic protected by federal, state, or local law.