Clinical Research Coordinator
Company: The Translational Genomics Research Institute
Posted on: November 23, 2021
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
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.)
This particular CRC will be supported by and dedicated to one
specific funded research study within TGen.
Duties and responsibilities may include:
Support, plan, and implement research studies from initiation
through the development of protocols, Informed Consent forms (ICF),
SOPs, laboratory manuals, and trainings.
Facilitate and coordinate study start-up.
Participation in the informed consent process as needed. This study
utilizes an electronic consent form for enrollment, however, some
participants may have questions that will need to be addressed.
Effectively communicate study objectives, procedures, benefits, and
risks with participants as needed.
Establishes and organizes study files including regulatory binders,
study-specific source documentation, enrollment and screening logs,
protocol deviation logs, tracking updates, and additional
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 the appropriate
Coordinate and implement procedures to collect data from patient
charts, medical records, interviews, questionnaires, diagnostic
tests, and other sources.
Ensure all procedures are followed per TGen's protocol.
Manage and track study timelines.
Serving as a point of contact for the TGen lab that will be
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.
Ensure compliance with protocol guidelines and requirement
agencies. Duties and responsibilities may include:
Review and comprehend the study 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; Identify and report 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
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 the 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
Maintains records and other documentation of training.
Assist in the development of new standardized processes and
procedures. Complete annual review of SOPs to ensure everything is
Serves as a point of contact for inquiries from the TGen
Foundation, inquiries from the public, or potentially interested
Provide additional support to Research Administration and ORCQM as
Bachelor's degree and at least 1+ years of related job
Demonstrated interpersonal skills
Ability to innovate and problem solve
Ability to adapt to fast-paced working environment
Organized and detail-oriented
Candidate may substitute extensive research experience for
Bachelor's degree in a science-related field
Understanding of biospecimen and genomic data research
Experience in neuroscience and/or neurological disease research;
especially in the area of cognition
Experience with studies involving the recruitment of older adult
Keywords: The Translational Genomics Research Institute, Phoenix , Clinical Research Coordinator, Healthcare , Phoenix, Arizona
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