Senior Clinical Research Coordinator

3 weeks ago

Boston, United States Massachusetts General Hospital Full time

GENERAL SUMMARY/ OVERVIEW STATEMENT:

The DCR's mission is to increase the quantity, quality, and efficiency of clinical research at MGH. DCR nurtures and empowers the next generation of clinical research investigators, supports study staff, and provides guidance, resources, and tools to all members of the clinical research community. DCR provides navigation, consultation, hands-on direct support, and education through fifteen Units, nine Centers, and the Support Services Core.

The DCR Sr. Clinical Research Coordinator provides support and oversight of clinical research projects across MGH. Through the DCR, supports faculty members, MGH researchers, research coordinators and research nurses on their clinical research projects. Acts as a resource to MGH researchers and ensures clinical research operations are conducted according to the ICH Good Clinical Practice (ICH GCP) guidelines, FDA, IRB, and applicable state and local regulations. Supports the DCR consult services by triaging consults, managing the consult database, and reporting on the consult metrics. May provide guidance to and train study coordinators through the DCR.

This position requires excellent organizational and communication skills, building and sustaining professional relations with PIs and study staff, sponsors and CROs, management and financial skills and the experience to handle confidential information.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

The incumbent will engage in a wide range of efforts to provide clinical research operations support to MGH and MGB clinical researchers and will effectively engage and collaborate with stakeholders, PIs, and study staff to meet their clinical research project needs. They will ensure strict adherence to institutional policies and guidelines, ICH GCP, FDA, and federal regulations.

* Supports the operations of new and existing clinical research projects through processing IRB, regulatory and other study requests.
* Provides short- or long-term regulatory documentation support to investigators, including logs and disclosures.
* Completes IRB submissions of initial and continuing reviews in Insight.
* Collaborates with PIs and study staff to support study start-up, study conduct and study close-out activities.
* Maintains regulatory binders, case report forms, source documents, and other study documents.
* Utilizes EPIC and other electronic systems to register, track, and capture data.
* Collaborates with and advises study teams with preparing for audits and compliance checks.
* Performs QA/QC checks of study documents, data, and case report forms.
* Serves as a resource for DCR consult services.

o Triages, and tracks requests in the DCR consult database.

o Liaises with the Research Informatics Core team to update, add new consult services, and maintain the DCR consult database.

o Collects and presents regular reports on consult services.

* Works closely with the DCR Education Unit to develop educational offerings and course content for clinical research staff.
* Provides training and guidance to clinical research coordinators when needed.
* Serves as a liaison for Research Match, providing information, review service and related activities to facilitate participation in the program.
* Serves as the Resource Librarian for MGH clinical researchers and ensures adherence to institutional policies, guidelines, and SOPs.
* Develops and maintains workflows, checklists, and SOPs for clinical research conduct.
* Represents the DCR at Harvard Catalyst committee and the Translational and Clinical Research Center (TCRC) meetings.
* Performs other related duties as required.

Fiscal support:

* Develops methods and tools to help investigators review the appropriateness of charges on their study funds in order to identify missing and/or erroneous charges, establish processes to make the necessary corrections.
* Tracks and reports time for services rendered in Insight.
* Acts as MGH point-of-contact for OnCore Clinical Trial Management System (CTMS) and provides financial oversight and management of clinical trial budgets and invoices

EDUCATION:

* Bachelor's degree in related field of study required.

EXPERIENCE:

* A minimum of 3 - 5 years of related work experience in clinical research as a research coordinator or research project coordinator.
* Administrative experience

SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:

* Strong understanding of clinical research programs and methodologies.
* Demonstrates expertise in working with local, commercial, and single IRBs.
* Ability to work flexibly and adapt to a dynamic and fluid work environment.
* Superb organizational and multitasking skills.
* Detail oriented and meticulous.
* Ability to work independently, learn quickly and handle fluctuating priorities and deadlines.
* Strong verbal and written communication skills.
* Excellent analytical and project management skills.
* Proficiency with word processing, spreadsheet, and presentation tools (e.g., Microsoft Word, Excel, and PowerPoint).
* Highly motivated team player.

Preferred:

* Professional certification (e.g., ACRP, SOCRA)

FISCAL RESPONSIBILITY:

Prudent use of hospital resources.

WORKING CONDITIONS:

Normal office conditions. Prolonged periods of sitting and keyboarding may occur. Work schedule may require non-standard hours for meetings or other activities. Position is based in Boston. May be able to work remotely on occasion.

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