Lead Regulatory Clinical Research Coordinator - MaineHealth Institute for Research

Description

Professional - Nonclinical
Req #: 66221

Summary:

This position leads a dynamic and fast-paced regulatory team within the Clinical Trials Office at the MaineHealth Institute for Research, Scarborough, ME. The Regulatory Team manages the regulatory requirements of 100+ projects, from study startup through closeout. Under the supervision of the Manager - Regulatory Affairs and Quality, the Lead Regulatory Research Coordinator will plan, coordinate and implement initial orientation and ongoing training of Regulatory staff, lead team meetings, conduct quality assurance on regulatory documents, and establish efficient, effective processes to ensure regulatory compliance. They are expected to effectively collaborate with study Principal Investigators, Clinical Coordinators, and external and internal regulatory bodies. Strong organizational and communication skills as well as attention to detail are necessary for success. Sample responsibilities include:

• Study Coordination

• Create and maintain regulatory documents, including the Institutional Review Board (IRB) application, research plan andthe informed consent.
• Coordinate and track submissions to IRB(s) and other entities as required during study startup and throughout the lifecycle of the project
• Compliance and Audit Coordination
• Comply with FDA regulations and International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) guidelinesfor conducting clinical trials.
• Prepare for inspections, audits, and monitoring visits from industry personnel and regulatory agencies including internal reviews.
• Complete quality assurance activities on regulatory documents created by other members of the regulatory team
• Certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates expected within two years of hire.
• Collaboration
• Develop workflows and integrated standard operating procedures.
• Assess the feasibility of research projects in conjunction with other departments
• Lead team and inter-team meetings as appropriate
• Communication
• Interact with industry personnel involved with potential and ongoing scientific research. This may include obtaining andscreening protocols.
• Communicate clinical trial updates to research team.
• Participate in inter-office and multi-department meetings and work groups. Present and communicate outcomes & guidance to research team when appropriate.
• Professional Development and Trainings
• Adhere to MH/MHIR values, policies and procedures when providing orientation, ongoing trainings and professional development initiatives
• Keep abreast of policy, regulatory, and Good Clinical Practice standards to support compliance through ongoing education of employees and support the organization in audit readiness
• Participate in MHIR and CTO initiatives and teams as assigned

The MaineHealth application, cover letter and a resume or 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: Bachelor's Degree in a Health Science or related field required.
2. License/Certifications: Certification by the Association of Clinical Research Professionals or Society of Clinical Research Associates preferred and required within two years of start date.
3. Experience: Two years of clinical experience in a healthcare setting required.

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Additional Information

If you have questions about this role, please contact lauren.robare@mainehealth.org