Research Coordinator I or II - Clinical Trails Office - MaineHealth Institute for Research

Description

Professional - Nonclinical
Req #: 79617

This Research Coordinator I or II (depending on experience) will coordinate clinical research studies for the Barbara Bush Children's Hospital Scholars Academy - MaineHealth, via the Clinical Trials Office, a division of the MaineHealth Institute for Research. This Research Coordinator supports MaineHealth pediatric healthcare professionals with the resources needed to conduct research, quality improvement, educational and advocacy projects to address pediatric healthcare gaps and advance knowledge.

This role collaborates with principal investigators, research navigators, the MaineHealth Office of Research Ethics and Compliance, pediatric program staff and research leaders, MaineHealth member and affiliate institutions, and community partners to support project goals. The position may include direct interaction with research participants including obtaining informed consent, conducting interviews, and facilitating focus groups.

Primary duties and responsibilities for this role include:

• Support of The Barbara Bush Children's Hospital Scholarship Academy (BBCH SA) members and their scholarly projects
• Assist in the development and writing of study protocols and other study specific documents including but not limited to: consent forms, case report forms, investigator's brochure, recruitment materials, training slides, visit checklists, Standard Operating Procedures (SOPs), guidance documents, study manuals, etc.
• Facilitation of submissions to the MaineHealth Institutional Review Board for new studies, study amendments, reportable events and continuing review
• Study coordination including data entry, data management, regulatory oversight, and project management to assist investigators with meeting project timelines.
• Grant-writing support, the facilitation/presentation of educational activities for BBCH members and pediatric providers, support with data analysis, and BBCH SA administrative tasks.
• Teaching new investigators how to use available resources to conduct their studies, therefore a successful applicant will be comfortable quickly learning new online platforms (e.g. EDC and IRB systems)

Preferred skills for this role include:

• Excellent communication, organization, and coordination skills in order to manage many projects simultaneously and support multiple investigators
• Knowledge of the research process from study design to dissemination
• High degree of computer literacy including competency in Microsoft Office Suite, electronic data capture systems (e.g. RedCap), IRB submission platforms (e.g. Huron), and electronic health record systems (e.g. EPIC)
• Self-motivated
• Strong critical thinking skills and ability to independently resolve problems
• Working knowledge of data management software and procedures
• Strong understanding of Good Clinical Practice and Human Subjects Protection
• Ability to work independently under minimal supervision

3+ year commitment preferred.

Coordination of studies includes:

* Identifies, screens and interviews potential study subjects.

* Explains the project and all associated benefits/risks and obtains necessary signatures.

* Ensures the safety and protection of subjects enrolled in a research study and schedules subject assessments/visits as necessary.

* Ensures all study tests, visits, and assessments are done at appropriate time intervals.

* Assesses subjects for signs of potential adverse events and reports all suspected adverse events to the appropriate personnel/regulatory agencies.

* Completes case report forms by obtaining, compiling, and maintaining necessary documentation.

* Assists with facilitating inspections and audits from industry personnel and regulatory agencies, including internal reviews.

* Collaborates with other members of the Clinical Trials team to conduct study related tasks.

* Coordinates and maintains regulatory documents, including the Institutional Review Board (IRB) application, research plan, and writing the informed consent under the direction of the appropriate MHRI resources.

* Complies with FDA regulations and International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) guidelines for conducting clinical trials.

This position will report to the Clinical Trials Office CTO Manager, Jamie Saunders.

Current certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates is preferred, or required within four years of start date.

This position is based at Maine Medical Center-Portland and will travel to our research offices in Scarborough. A hybrid work schedule may be available. Time may be spent in clinical settings throughout the MH network requiring travel to our MaineHealth community hospitals.

The MaineHealth application, cover letter and a resume/CV are all required elements for application to this position.

Learn more about the MaineHealth Institute for Research in this short video!

Required Minimum Knowledge, Skills, and Abilities (KSAs)

1. Education: Associate degree preferred.
2. License/Certifications: Current certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates preferred or required within four years of start date.

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Additional Information

If you have questions about this role, please contact sharon.nightingale@mainehealth.org