Clinical Research Coordinator

Company Overview

Shriners Children's is the premier pediatric burn, orthopaedic, spinal cord injury, cleft lip and palate, and pediatric subspecialties medical center.

We are a family that respects, supports, and values each other. We are engaged in providing excellence in patient care, embracing multi-disciplinary education, and research with global impact. We foster a learning environment that values evidenced based practice, experience, innovation, and critical thinking. Our compassion, integrity, accountability, and resilience defines us as leaders in pediatric specialty care for our children and their families.

Job Overview

The Clinical Research Coordinator, Level 1 (CRC1) is a research professional who ensures oversight and compliance of both system-wide and local SHC clinical research activities.

Reporting to the Clinical Research Program Manager (or local Hospital Administrator/Clinic Director) and to the Research Programs Office at SHC International Headquarters, the CRC1 provides support in accordance with SHC's policies and procedures, SHC's hospital regulations, the Code of Federal Regulation, and Good Clinical Practice guidelines, when applicable.

The CRC 1 works collaboratively with research personnel to ethically recruit and consent SHC's vulnerable pediatric subjects and to appropriately collect and safeguard data. Overall, the CRC is the site's primary liaison among research participants, the local investigator(s) and study sponsor(s). This position's main responsibilities are to help ensure proper study conduct, subject safety, and the quality of data and data safeguards.

Responsibilities

• Develops a contemporary knowledge of clinical research regulatory requirements. Has a working knowledge of clinical research process, from protocol development to implementation.

• Supports the investigators' development of SHC investigator-initiated research protocols. Assists with the analysis of proposed research projects in order to determine appropriateness and feasibility at the local site, including the evaluation of resources required and regulatory requirements.

• Supports the implementation of approved research protocols. Ensures studies are conducted in compliance with the approved protocol, Good Clinical Practice (GCP) guidelines, applicable regulatory requirements, SHC policies and standards. Performs study-specific research activities and/or interventions, within the bounds of professional licensure.

• Responsible for oversight and documentation of the delivery, storage, and disposition of investigational products at the site, in accordance with federal and state regulations and sponsor requirements. Effectively provides information about the use of investigational products to patients. Understands and adheres to safety monitoring and reporting requirements of regulatory agencies that oversee use of an investigational product in research.

• Responsible for tracking all aspects of projects including all study, investigator and Institutional Review Board (IRB) information and 30 % patient recruitment activity.

• Actively collaborates with applicable headquarters departments, including Research Programs, Legal, and Compliance related to protocol reviews, IRB submissions, sponsored contracts, material transfers, data use agreements, and HIPAA compliance for projects conducted within SHC. Works closely with investigators, research leadership, study sponsor and regulatory agencies to conduct, and report the results of clinical research.

• Coordinates the collection of data throughout a clinical study including (1) timely data collection, (2) ensuring accurate data entry into secure research databases. (3) verifying data accuracy through internal quality control measures to confirm reported study data is accurate, complete, and verifiable from source documents.

• Participates data cleaning & database lock procedures in preparation for data analysis; provides timely responses to data queries, addresses data discrepancies, and reviews source documents.

Qualifications

Bachelors Clinical Research, science or other healthcare related field Preferred.

One (1) year plus of relevant research experience, e.g. site management, study management, research regulatory experience, data collection, compliance or other applicable experience

CCRP or CCRC certification strongly preferred, not required