Clinical Research Coordinator

Company Overview

Shriners Children's is 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.

We are a premier pediatric specialty, research, and academic teaching hospital with a medical and research partnership with Massachusetts General Hospital. It is the world's leading center for pediatric burn care and is the only American Burn Association (ABA) exclusively pediatric verified burn center in New England and New York. The Boston Shriners Hospital is one of four pediatric burn specialty hospitals in Shriners Children's health system and provide comprehensive care for cleft lip, cleft lep palate and other craniofacial anomalies, with a multidisciplinary care team.

Shriners Children's is committed to our support of Diversity, Equity and Inclusion and encourage applicants from diverse backgrounds and experiences to apply for any of our career opportunities

SHC requires proof of COVID-19 vaccination as a condition of employment in most or all cases, subject to applicable legal requirements that would require further discussion about whether any requested exemptions can be accommodated.

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 Hospital Administrator 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 Practiceguidelines, when applicable.

The CRC1 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. May include, but is not limited to subject recruitment and data/specimen collection for SHC's system-wide projects.

Responsibilities

Responsible for tracking projects including all study, investigator and Institutional Review Board (IRB) information, and patientrecruitment activity

• Actively collaborates with Research Programs related to protocol reviews, IRB submissions, and HIPAA compliance.

• Assists with direction and education to clinical research staff on protocol-related activities.

• Works closely with investigators, research leadership, to conduct clinical research.

• Coordinates the collection of data throughout a clinical study including (1) timely data collection, (2) ensuring accurate data entry intosecure research databases. (3) verifying data accuracy through internal quality control measures to confirm reported study data isaccurate, 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

• Contributes in compiling and preparing study results

• Provides input into the dissemination of research results by verifying all regulatory and compliance criteria are met, confirming that theSHC system is credited appropriately

Responsible for oversight and documentation of the delivery, storage, and disposition of investigational products at the site, inaccordance 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 aninvestigational product in research.

Qualifications

• Bachelor Clinical Laboratory Science

• One (1) year of relevant research experience, e.g. site management, study management, research regulatory experience, , data collection, compliance orother applicable experience required

• CCRP or CCRC certification preferred