Develop and implement the long-term vision, operational
strategy, and growth plans for the Biorepository Core.
Establish policies, procedures, and quality systems supporting
cohort studies, investigator-initiated research, and external
collaborations.
Collaborate closely with scientific leadership, informatics,
clinical operations, research administration, and external
stakeholders to ensure operational excellence and alignment with
Institute priorities.
Lead development of data governance and biospecimen sharing
policies.
Laboratory & Biorepository Operations
- Direct all biobanking activities including biospecimen
collection, accessioning, processing, aliquoting, storage,
inventory management, retrieval, distribution, and chain-of-custody
documentation.
- Oversee pre-analytical biological specimen processing while
ensuring specimen integrity and standardized laboratory
practices.
- Develop, implement, and continuously improve laboratory
workflows, SOPs, and quality management processes.
- Evaluate and implement new technologies and automation to
improve laboratory efficiency and scalability.
- Monitor specimen quality metrics and operational performance
across all SSLI collections.
- Troubleshoot operational bottlenecks and identify opportunities
for process improvement.
Regulatory & Quality Oversight
- Ensure compliance with institutional policies and applicable
federal, state, and international regulations governing human
biospecimens and research data.
- Oversee laboratory compliance with HIPAA, biosafety, biohazard
handling requirements, and applicable shipping regulations
including IATA.
- Serve as the primary operational lead for the Institute's
biorepository protocol and ensure its continued regulatory
maintenance and compliance, including preparation and submission of
protocol revisions, amendments/modifications, renewals or
continuing reviews, and other required IRB submissions.
- Maintain current and accurate biorepository protocol
documentation and ensure that specimen collection, processing,
storage, use, data management, and sharing activities remain
consistent with the IRB-approved protocol and applicable
institutional requirements.
- Provide regulatory oversight of biospecimen requests and
releases, ensuring that all required use protocols, IRB approvals
or determinations, data/use agreements, and other applicable
authorizations are in place and appropriately documented before
specimens are pulled, transferred, or released for research
use.
- Confirm that proposed specimen use is consistent with the
permissions and limitations established by the applicable informed
consent and biorepository protocol.
- Maintain documentation supporting specimen requests, approvals,
and releases to ensure appropriate traceability and regulatory
accountability.
- Monitor regulatory deadlines and proactively coordinate
required submissions to prevent lapses in IRB approval or
disruptions to biorepository activities.
- Work with Institute leadership, investigators, research staff,
and applicable institutional offices to resolve regulatory
questions and implement changes resulting from protocol revisions
or evolving research requirements.
- Ensure compliance with Good Documentation Practices and
applicable regulatory requirements including 21 CFR Part 11 where
appropriate.
- Support implementation of policies addressing data privacy
requirements including GDPR and applicable genetic privacy
regulations such as GINA.
Laboratory Information Systems & Technology
- Oversee optimization, validation, and ongoing administration of
the Laboratory Information Management System (LIMS).
- Partner with informatics teams to improve specimen tracking,
workflow automation, reporting, and data integration.
- Support future development and enhancement of LIMS
infrastructure and laboratory technologies.
Personnel & Project Management
- Supervise all biorepository and laboratory personnel.
- Recruit, mentor, develop, and evaluate scientific and technical
staff.
- Foster a collaborative, inclusive, and high-performing
laboratory culture.
- Manage multiple concurrent laboratory projects, institutional
initiatives, and sponsored research programs.
- Develop staffing plans, operational budgets, growth
projections, and resource allocation strategies.
- Participate in grant development and provide operational
planning support for new research initiatives.
Scientific Support
- Support investigator-led research from study design through
publication and clinical translation.
- Prepare scientific reports, operational metrics, presentations,
and executive-level communications.
- Participate in institutional committees, leadership meetings,
and strategic initiatives.
Qualifications:
Minimum Qualifications
- Master's degree in Biological Sciences, Molecular Biology,
Biochemistry, Biomedical Sciences, or a closely related discipline
required.
- Ph.D. in Biological Sciences or a related field preferred.
- Minimum of 10 years of progressively responsible experience in
biobanking, biorepository operations, or biological laboratory
management.
- Minimum of 5 years of supervisory or personnel management
experience.
- Demonstrated experience leading complex laboratory operations
and multidisciplinary teams.
- Extensive experience managing biobanking operations and
biospecimen lifecycle management.
- Experience with biological specimen processing and
pre-analytical laboratory workflows.
- Experience preparing and managing IRB submissions, amendments,
and continuing reviews.
- Experience supervising scientific and technical personnel.
- Experience developing, implementing, and maintaining Standard
Operating Procedures (SOPs).
- Experience with Laboratory Information Management Systems
(LIMS).
- Strong project management skills with the ability to oversee
multiple complex initiatives simultaneously.
- Experience handling biohazardous materials in accordance with
applicable regulations and institutional policies.
- Working knowledge of HIPAA regulations governing protected
health information.
- Experience with IATA regulations for shipment of biological
materials or ability to obtain certification upon hire.
- Strong written and verbal communication skills, including
preparation of scientific reports, presentations, and executive
briefings using Microsoft PowerPoint.
- Strong understanding of laboratory operations, biobanking best
practices, and research infrastructure.
- Excellent organizational, analytical, and problem-solving
skills.
- Demonstrated leadership and personnel management
abilities.
- Ability to effectively prioritize competing responsibilities
and manage multiple concurrent projects.
- Strong interpersonal skills with the ability to build
collaborative relationships across multidisciplinary teams.
- Excellent written, verbal, and presentation skills.
- Experience developing operational workflows and driving
continuous process improvement.
- Ability to interpret and apply complex regulatory and research
compliance requirements.
- Demonstrated ability to work in and foster an environment of
respect, professionalism and civility with a population of faculty,
staff, and students from all backgrounds and experiences, or a
commitment to do so as a staff member at VCU.
Preferred Qualifications
Experience with one or more of the following is highly
desirable:
- Histology and tissue processing.
- Molecular biology techniques including DNA and RNA
extraction.
- Next-generation sequencing workflows including library
preparation.
- Omics technologies including genomics, transcriptomics,
proteomics, metabolomics, or single-cell analyses.
- LIMS architecture, system design, implementation, validation,
and administration.
- Laboratory automation technologies.
- Quality management systems supporting translational
research.
Knowledge of the following regulatory frameworks is a plus:
- 21 CFR Part 11
- HIPAA
- GDPR (General Data Protection Regulation)
- Genetic Information Nondiscrimination Act (GINA)
- Biosafety and biohazard handling regulations
- IATA Dangerous Goods Regulations for biological specimens
- Human subjects research regulations and IRB processes
Position will remain open until filled.
VCU is committed to hiring veterans! VCU will include a veteran's
period(s) of military service in the calculation of their annual
leave accrual rate. This may provide veterans with an increased
leave accrual!
Salary Range: $120,000-$180,000; commensurate with
experience & job slotting
Benefits : All full-time university staff are eligible for
VCU’s robust
benefits
package that includes comprehensive health benefits, paid annual
and holiday leave, generous tuition benefits, retirement planning
and savings options, tax-deferred annuity and cash match programs,
employee discounts, well-being resources, abundant opportunities
for career development and advancement, and more.
FLSA Exemption Status: Exempt
Restricted Position: No
ORP Eligible: Yes
Flexible Work Arrangement: Fully Onsite
University Job Title: 3291S - Sr Administrator RS Senior:
Senior Administrator, RS 1-3 (32914Y-32916Y)
Position Classification Note: The working title for this position
is Director, Biorepository Core. The institutional job title is
Senior Administrator, Research Services (Sr. Administrator, RS),
consistent with the University's job classification structure and
the position's current supervisory scope. The working title
reflects the position's responsibility for strategic and
operational leadership of the Biorepository . As the Biorepository
grows and the position's scope, organizational complexity, and
number of direct-report managers evolve, the position may be
reviewed for potential reclassification in accordance with
University classification guidelines and applicable HR
processes.
