Research Assistant - WVU Cancer Institute/Clinical Research Trials

About the role

The primary responsibility of this position is to provide comprehensive research support to the Biospecimen and Translational Research Analysis Core (BioTRAC) by coordinating participant screening and enrollment, obtaining informed consent, collecting and processing human biospecimens, managing specimen inventories and distribution, and collecting and maintaining associated clinical research data. This position supports translational and basic science research conducted through the WVU Cancer Institute by ensuring the accurate, timely, and compliant execution of research activities in accordance with approved protocols, institutional policies, regulatory requirements, and Good Clinical Practice (GCP) guidelines.

Responsibilities

• Screen clinic schedules and evaluate potential research participants for eligibility according to approved study protocols.
• Obtain informed consent from research participants in accordance with IRB-approved protocols, institutional policies, and regulatory requirements.
• Coordinate with investigators, physicians, clinic staff, and research personnel to facilitate participant enrollment, specimen collection, and study activities.
• Monitor participant treatment schedules and follow-up visits to coordinate research specimen collection and associated clinical data acquisition.
• Serve as a liaison between BioTRAC and investigators by coordinating research activities, scheduling meetings, assisting with study implementation, and resolving routine operational issues.
• Receive and process human blood, tissue, and other biological specimens collected through approved clinical and research workflows, including specimens obtained from patient care areas, clinics, and the surgical pathology gross room.
• Receive, accession, process, aliquot, preserve, store, and distribute biospecimens following BioTRAC standard operating procedures.
• Perform thromboelastography (TEG) testing on human blood samples and accurately document and report results according to established protocols.
• Prepare reagents, media, and laboratory solutions required for specimen processing and research procedures.
• Perform laboratory procedures and operate laboratory equipment in accordance with established protocols.
• Clean, disinfect, and maintain laboratory equipment, glassware, and work areas while ensuring the proper handling and disposal of biological and hazardous materials.
• Collect, abstract, enter, and maintain clinical and research data in electronic databases, laboratory information management systems (LIMS), and other research databases.
• Design, build, maintain, and update research databases used for biospecimen tracking, clinical data collection, and research studies.
• Maintain accurate specimen inventories, chain-of-custody documentation, and specimen distribution records.
• Coordinate preparation and release of biospecimens to internal investigators in accordance with approved protocols, BioTRAC policies, and specimen request procedures.
• Prepare de-identified clinical data extracts, research summaries, and study documentation for investigators in accordance with approved protocols and BioTRAC policies.
• Review research data and laboratory records for accuracy, completeness, and quality, resolving discrepancies as appropriate.
• Compile reports, maintain required research records, and assist with data analysis and study reporting as requested.
• Adhere to approved research protocols, BioTRAC standard operating procedures, Good Clinical Practice (GCP), Human Subjects Protection requirements, HIPAA regulations, biosafety standards, and institutional policies.
• Maintain confidentiality, security, and appropriate access controls for participant information, biospecimens, and research data.
• Participate in required regulatory, safety, and continuing education training (e.g., CITI training) and assist with protocol implementation, quality improvement initiatives, and other duties as assigned.

Requirements

• Bachelor’s degree in life sciences, biology, health informatics, or other related field.
• A minimum of six (6) months of experience in the following:
  • Lab experience
• All qualifications must be met by the time of employment.

Knowledge, Skills, and Abilities

• Knowledge of clinical research principles, human subjects protections, Good Clinical Practice (GCP), and applicable regulatory requirements, including HIPAA, IRB policies, OSHA Bloodborne Pathogens standards, and institutional procedures.
• Knowledge of biospecimen collection, processing, storage, laboratory safety practices, and quality assurance/quality control principles.
• Knowledge of medical terminology, diagnoses, treatment modalities, and medical record review.
• Knowledge of database management, electronic data capture systems (e.g., REDCap), and clinical research documentation.
• Strong organizational, time management, and problem-solving skills with the ability to manage multiple priorities and meet deadlines.
• Excellent verbal and written communication skills, including the ability to communicate effectively with patients, investigators, clinical staff, and research personnel.
• Strong attention to detail and commitment to maintaining specimen integrity, data accuracy, and research quality.
• Proficiency with Microsoft Office Suite and other research-related software applications.
• Ability to receive, process, document, track, and distribute biological specimens while maintaining specimen integrity, chain of custody, and regulatory compliance.
• Ability to read, interpret, and apply research protocols, standard operating procedures, and regulatory documents.
• Ability to exercise sound judgment, maintain confidentiality, and work both independently and collaboratively in a multidisciplinary research environment.
• Ability to learn and operate specialized laboratory equipment, including thromboelastography (TEG) instrumentation.
• Experience working in a clinical research, laboratory, healthcare, or biomedical research environment preferred.
• Experience obtaining informed consent, interacting with research participants, processing human biospecimens, maintaining research databases, and performing research data entry and quality control preferred.
• Understanding of the role of biospecimens and clinical data in supporting translational and clinical research.

Benefits

• 37.5-hour work week
• 13 paid holidays (staff holiday calendar)
• 24 annual leave (vacation) days per year
• 18 sick days per year (for illness, caring for sick family, or medical appointments)
• WVU offers a range of health insurance and other benefits
• 401(a) retirement savings with 6% employee contribution match
• Wellness programs