Biorepository Research Coordinator 1 - PM Biorepository

Under general supervision and following established policies, procedures and professional guidelines, the BRC I is responsible for providing study coordination, including screening of potential patients for protocol eligibility, presenting, consenting and documenting the informed consent process. In addition, the BRC I will enroll subjects in order to collect, prepare, preserve and manage diverse biological specimens destined for Research testing. They will be responsible for accurate and timely source documents, data collection, documentation, entry, and reporting, including timely response to sponsor queries.

Essential Functions

• Pre-screens for eligible subjects for assigned studies based on written, broad eligibility criteria.
• Obtaining and documenting written informed consent from potential study subjects as required by the institution and regulations.
• Manages subject registration into all required systems (i.e., CTMS, Velos, EHR, EDC) and maintains relevant logs (i.e., AE log, Deviation log, participant log).
• Collection, processing and preservation of diverse biologic specimens from subjects undergoing a clinically indicated procedure or surgery at TGH, according to established standard operating procedures in a manner that complies with specified quality metrics.
• Reviews study specific lab manuals and obtains and processes lab specimens, as required by the specified research protocol.
• Accurate abstraction, organization and transmittal of complex, disease-specific clinical data and demographics in a HIPAA compliant fashion.
• Performs data entry by transcribing data from the source to the case report form (paper or electronic) and redacts source documents as requested, with timely responses to queries.
• Preparation, preservation, and storage of multiple high quality bioanalytes, including but not limited to serum, plasma, peripheral blood mononuclear cells, cell pellets, cultures, genomic DNA, total RNA and protein from whole blood, fresh and flash frozen tissue specimens, FFPE and Slide procurement.
• Organization, storage, transport and distribution of specimens along with any associated metadata requested by investigators.
• Ensuring timely execution of day-to-day biorepository operations as otherwise required to meet TGH CI programmatic goals.
• Records and maintains accurate and consistent documentation for all assigned clinical studies.
• Serving as liaison and representative of CI Biorepository Research with outside sponsors, including but not limited to National Cancer Institute, academic cancer centers, universities, etc.
• Maintaining up to date certification and training with human subjects research practices, Good Clinical Practice (GCP), HIPAA, Shipment of Biological Specimens (IATA) and/or other topics as required by TGH and TGH CI leadership.
• Promotes a positive image of the department and the organization through professional conduct, appearance, and communication.
• Adheres to established department policies, procedures, and standards.

Education

Bachelor's Degree

Certifications

• Good Clinical Practice (GCP) (upon hire or within 3 months of hire)
• International Air Transport Association (IATA) Shipment of Biologic Specimens, Transportation of Dangerous Goods, or equivalent training (upon hire or within 3 months of hire)

Work Experience and Additional Information

Minimum one (1) year of patient facing responsibilities or one (1) year of experience working with biological samples and processing.

Technical Knowledge, Skills, and Abilities

• Familiarity with Electronic Medical Records (EPIC) and medical terminology.
• Basic computer skills and knowledge of Microsoft Office products.
• Excellent interpersonal skills for working with the study participants and as a member of a highly integrated multi-disciplinary team.
• Exceptional attention to detail and excellent technical problem-solving skills.
• Excellent organizational skills and ability to prioritize and be flexible to manage multiple tasks.
• Excellent oral and written communication skills.
• Demonstrated ability to understand and implement scientific protocols as directed.
• Ability to work with spreadsheets (such as Excel), familiarity with databases (ex: Medidata RAVE, iMedra, Velos, etc.) and querying.
• Ability to travel between clinical/institutional sites, whenever required to transport specimens or consent patients.