The Clinical Research Associate (CRA) is a specialized, independent research professional who supports the Corporate Director of Clinical Research with managing and maintaining system-wide clinical research operations, staff education, and compliance. This position’s responsibilities are to facilitate appropriate and ethical clinical research activities in accordance with the protocol, Shriners Children's (SC’s) policies and procedures, SC’s hospital regulations, the Code of Federal Regulation, and Good Clinical Practice guidelines. The role will further contribute to core support functions that advance system-wide genomics research efforts.

Clinical Research Operations

Coordinates and implements SC system-wide processes and initiatives to standardize clinical research operations system-wide
Facilitates research activities through collaborative, timely communications with SHC sites and external entities to contribute to the development and dissemination of policies and procedures related to research compliance/activities. Maintains and assists with the system wide use and daily operations of the clinical research management system used to oversee and monitor clinical research activities.
Accountable for the initiation and maintenance of all Human Subjects and Regulatory documents necessary for submission to SC’s centralized Institutional Review Board.
Proactively works with study sponsors, and various agencies in order to obtain initial and continued approval of all clinical trials/clinical research protocols.
Has an extensive working knowledge of the complex clinical research process, from protocol development to implementation, including experience with clinical trials.
Demonstrates knowledge of ethical standards set forth by the Belmont Report, the Nuremberg Code and the International Conference of Harmonization GCP standards.
Exhibits a commitment to human subjects’ protection by providing the highest level of ethical and safety practices to protect all participants involved in research studies supported and approved by SC.
Supports coordination of system-wide genomics clinical research activities, including protocol development and executions, incorporating appropriate sample collection, processing, and storage requirements.

Compliance

Performs regular reviews (monitoring) of (1) study specific essential documents, (2) investigator and study personnel qualifications, (3) data, and (4) data safeguards to ensure research is being conducted, recorded and reported in accordance with the protocol, policies and procedures, hospital regulations, Code of Federal Regulation, and Good Clinical Practice guidelines, where applicable.
Evaluates protocols under initial consideration for regulatory requirements including SC mission, feasibility, data collection, entry, storage and reporting.
Facilitates regulatory compliance between investigators, research staff, SC and external regulatory entities.
Confirms appropriate training and education, ensuring that site staff are qualified to safely perform study protocols.
Collaborates with investigators and other research staff to mitigate risk.
Develop and implement strategies necessary for minimizing risk of non-compliance
Reports any concerns or issues directly to the Corporate Director of Clinical Research and/or the Vice President, Research Programs.
Monitors system-wide genomics research activities, associated with clinical research operations.

Education and Training

Interacts with sites providing education and support, with follow up as appropriate
Provides guidance, under supervision of the Corporate Director of Clinical Research to investigators and research staff, in the interpretation of applicable regulations and guidelines, to include but not limited to GCP, GLP, ICH, FDA and DHHS guidelines.
Implements and conducts on-going education and training for SC research personnel related to clinical research activities, SC policies and procedures, Good Clinical Practices, and regulations governing clinical research. Provides expertise, consultation and mentorship to SC staff with respect to research processes and applicable regulations.
Maintains education in human subject protection and good clinical practice principles, and applies knowledge of those ethical principles when interacting with staff, subjects, and other entities.
Works with the SC Genomics Institute staff, SC site location teams, and HQ staff to establish standard clinical research processes associated with the system-wide genomics projects. This includes training, and education related to clinical research operations.

This is not an all-inclusive list of this job’s responsibilities. The incumbent may be required to perform other related duties and participate in special projects as assigned.

Required:

3 years of clinical research experience (site management, study management, IRB's, and federal regulations regarding clinical research compliance)
Bachelor's Degree in clinical research, science or other healthcare related field - or - 5 years of job-related experience in clinical research administration in lieu of degree

Preferred:

Experience in coordination of intergroup of multi-site clinical studies
Job-related experience in development, review, oversight, or performance management of human clinical studies
Experience with clinical research genomics or strong familiarity with genomics concepts in clinical or research settings. Knowledge of CLIA laboratory sample-processing workflows and foundational genomics terminology.
CCRP or CCRC certification
Master's Degree in clinical research, science or other healthcare related field

Shriners Children's

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Clinical Research Associate