The Clinical Research Coordinator (CRC) supports, facilitates, and coordinates research study activities. The CRC is responsible for evaluating, planning, implementing, and documenting (to meet regulatory requirements) research studies involving human subjects. This position requires excellent interpersonal skills as well as demonstrated ability to deal effectively and confidentially with difficult situations.
Serve as the Clinical Research Coordinator (CRC) in the TGen Research Administration department. This role includes implementation of research studies, assisting and/or evaluating new protocols, and maintaining regular communication with other individuals in the Research Administration department (contracts, project management, regulatory and compliance, etc.
Serve as CRC on assigned TGen research studies involving biospecimens and annotated data. Duties and responsibilities may include:
Support, plan, and implement research studies from initiation through development of protocols, Informed Consent forms (ICF), SOPs, laboratory manuals, and trainings.
Facilitate and coordinate study start-up
Participation in the informed consent process.
Effectively communicate study objectives, procedures, benefits and risks with participants.
Establishes and organizes study files including regulatory binders, study specific source documentation, enrollment and screening logs, protocol deviation logs, tracking updates, and additional study-specific documents.
Coordinates and tracks biospecimens as they move through the laboratory and analysis pipeline.
Assist in the acquisition of biospecimens from medical centers, research institutes, and collaborators.
Codes and interprets collected data and prepares appropriate documentation.
Coordinate and implement procedures to collect data from patient charts, medical records, interviews, questionnaires, diagnostic tests, and other sources.
Work with clinical staff to ensure biospecimens are collected properly.
Ensure all procedures are followed per TGen’s protocol.
Manage and track study timelines
Serving as a point of contact for each laboratory processing specimens.
Serving as a point of contact for investigators, participants, external and internal collaborators, pathologists, regulatory staff, and other additional study-related contacts.
Attending and assisting with study-related meetings; this may include tumor boards and laboratory meetings.
Ensure compliance with protocol guidelines and requirement agencies. Duties and responsibilities may include:
Review and comprehend each assigned protocol including study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections.
Identify problems and/or inconsistencies and report adverse events; recommend corrective action as needed.
Identify and communicate important protocol and data management issues to the appropriate parties; Identifies and reports applicable study deviations to ORCQM.
Assist with annual audits and supplemental review of protocols involving human subject research. Prepare written reports outlining corrective measures where needed for review and approval by the Director of ORCQM.
Assist the TGen Office of Research Compliance & Quality Management (ORCQM) and Investigators. Duties and responsibilities may include:
Assist in writing protocols, consent forms and supporting documents for studies.
Assist in the preparation of amendments to protocols and/or modifications to study design as appropriate.
Assist 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, and execution of research plan.
Maintains records and other documentation of training.
Assist in the development of new standardized processed and procedures. Complete annual review of SOPs to ensure everything is up-to-date.
Serves as a point of contact for inquiries from the TGen Foundation, inquiries from the public or potentially interested study participants.
Provide additional support to Research Administration and ORCQM as needed.
Bachelor’s degree and at least 1+ years of related job experience.
Demonstrated interpersonal skills
Ability to innovate and problem solve
Ability to adapt to fast-pace working environment
Organized and detail oriented
Candidate may substitute extensive research experience for educational requirements.
Bachelor’s degree in science-related field
Understanding of biospecimen and genomic data research
About Translational Genomics Research Institute (TGen)
Translational Genomics Research Institute (TGen) is a Phoenix, Arizona-based non-profit organization dedicated to conducting groundbreaking research with life changing results. TGen is focused on helping patients with neurological disorders, cancer, and diabetes, through cutting edge translational research (the process of rapidly moving research towards patient benefit). TGen physicians and scien...tists work to unravel the genetic components of both common and rare complex diseases in adults and children. Working with collaborators in the scientific and medical communities literally worldwide, TGen makes a substantial contribution to help our patients through efficiency and effectiveness of the translational process. TGen is allied with City of Hope, a world-renowned independent research and cancer and diabetes treatment center. This precision medicine alliance enables both institutes to complement each other in research and patient care, with City of Hope providing a significant clinical setting to advance scientific discoveries made by TGen. For more information, visit: www.tgen.org.