TGen – an Affiliate of City of Hope Positions in Phoenix, AZ – Clinical Research Coordinator

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About the work

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 a demonstrated ability to deal effectively and confidentially with difficult situations.

Essential duties:

Act as Clinical Research Coordinator (CRC) in TGen’s Research Administration department. This role includes implementing research studies, assisting and/or evaluating new protocols, and maintaining regular communication with others in the Research Administration department (contracts, project management, regulation and compliance, etc.)

This particular CRC will be supported and dedicated to a specific funded research study within TGen.

Duties and responsibilities may include:

• Support, plan and implement research studies from inception through the development of protocols, informed consent forms (ICF), SOPs, laboratory manuals and training.
• Facilitate and coordinate the start of the study.
• Participation in the informed consent process as needed. This study uses an electronic consent form for registration, however some participants may have questions that they will needbe answered.
• Effectively communicate the objectives, procedures, benefits, and risks of the study to participants as needed.
• Establishes and organizes study files including regulatory binders, study-specific source documentation, screening records and records, protocol deviation records, 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.
• Encodes and interprets the collected data and prepares the appropriate documentation.
• Coordinate and implement procedures to collect data from patient records, medical records, interviews, questionnaires, diagnostic tests, and other sources.
• Make sure all procedures are followed according to the TGen protocol.
• Manage and track study schedules.
• Serving as a point of contact for the TGen lab that will be processing specimens.
• Serving as a point of contact for researchers, participants, external and internal collaborators, pathologists, regulatory staff and other additional contacts related to the study.
• Participate and assist in study-related meetings.

Ensure compliance with protocol guidelines and requirements agencies. Duties and responsibilities may include:

• Review and understand the study protocol, including study procedures and schedules, inclusion and exclusion criteria, confidentiality, and protections fromprivacy.
• Identify problems and/or inconsistencies and report adverse events; recommend corrective action as needed.
• Identify and communicate important data management and protocol issues to the appropriate parties; Identify and report study deviations applicable to the ORCQM.
• Assist in annual audits and supplemental review of protocols involving research on human subjects. Prepare writing reports that describe corrective measures as needed for review and approval by the ORCQM Director.

Assist the Office of Research Compliance and Quality Management (ORCQM) and TGen investigators. Duties and responsibilities may include:

• Assist in writing protocols, consent forms and supporting documents for studies.
• Assist in preparing protocol amendments and/or study design modifications, as appropriate.
• Assist in the development of materials and tools necessary to adequately train individuals involved in conducting the study on issues related to (but not limited to) protocol requirements, visit schedules, and execution of the research plan.
• Maintains records and other training documentation.

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 questions from the TGen Foundation, inquiries from the public, or potentially interested study participants.

Provide additional support forResearch Administration and ORCQM as needed.

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Requirements:

Essential Qualifications:

Bachelor’s Degree and at least 1 year of related work experience.

Interpersonal skills demonstrated

Ability to innovate and solve problems

Ability to adapt to a fast-paced work environment

Organized and detail-oriented

The candidate can substitute extensive research experience for educational requirements.

Favorite Qualifications:

Bachelor in a related field of science

Understanding Biospecimen Research and Genomic Data

Research experience in neuroscience and/or neurological diseases; especially in the area of ​​cognition

Experience with studies involving the recruitment of older adult populations

PM21

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Company: TGen – an Affiliate of City of Hope

Vacancy Type: Full-time · Entry level 

Job Location: Phoenix, AZ

Application Deadline: N/A

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