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Clinical Research Coordinator

Company: The Translational Genomics Research Institute
Location: Phoenix
Posted on: November 23, 2021

Job Description:

Description:
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.

Essential Duties:
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 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 the appropriate documentation.
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 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.
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 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 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 plan.
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 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.
.

Requirements:
Essential Qualifications:
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-paced working environment
Organized and detail-oriented
Candidate may substitute extensive research experience for educational requirements.

Preferred Qualifications:
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 populations

PM21

PI151078512

Keywords: The Translational Genomics Research Institute, Phoenix , Clinical Research Coordinator, Healthcare , Phoenix, Arizona

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