Clinical Research Project Manager

Site: The General Hospital Corporation

Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.

Job Summary
Responsible for the management of multiple clinical research studies and the direct hiring and supervision of Clinical Research Coordinators. Serves as the key liaison with the sponsor, IRB, core laboratories, site P.I.'s, as well as all levels of study staff. Will also coordinate trial initiation, patient recruitment, and expedite project approval and study start-up time. Responsibilities also include participation in developing and maintaining standard operating procedures for the projects, developing advertising strategies to support recruitment activities.

Responsible for managing all aspects of a program and corresponding projects. Implements initiatives that support alignment with organizational goals and strategic planning. Leads the communication and collaboration with stakeholders. Develops the program schedule, budget, and various program and project plan details. Prepares project reports and provides regular updates to program leadership. Identifies and escalates issues and risks and recommends solutions. Leads and provides guidance and support to other administrative team members.

This role may be ideal for individuals who have a Master’s or above and who are interested in community-based mental health interventions, clinical neuroscience, prevention of mental health conditions in at-risk youth, and outcomes research.

Qualifications

A full-time Clinical Research Project Manager position is available within the MGH Resilience and Prevention Program (RAPP) and the Emotion and Social Neuroscience Laboratory (ESNL), located at the Martinos Center for Biomedical Imaging and the MGH Psychiatry Department. The mission of RAPP is to develop and test psychosocial interventions that increase emotional resilience in youth who are at risk for serious mental illnesses. The ESNL focuses on the studying the neural correlates of emotion and social cognition abnormalities in people affected by or at risk for serious mental illnesses. The Clinical Research Project Manager will be responsible for overseeing and coordinating on-going and new research projects which span both RAPP and ESNL research programs.

Specifically, this position entails managing multiple clinical studies (e.g., including a randomized controlled trial), with day-to-day supervision and training of research coordinators and other staff, often involving multiple sites or stake-holders. Additional key duties include the management of clinical intervention and neuroimaging research protocols, including oversight of subject recruitment, intervention procedures and fidelity; creation, management and QA of standard operating procedures, study workflows and timelines for recruitment and longitudinal data collection events. In addition this role can involve building REDCap instruments and case report forms with validation and branching logic, and coordinate data requests from clinical sites, and subsequent data-quality review.

Other responsibilities include: assuming the regulatory lead for IRB protocol submissions, modifications, continuing reviews, reportable new information, and consent revisions; maintaining the study regulatory binder under single-IRB oversight at MGB, and maintaining compliance with Federal, State and sponsor (e.g., NIMH) guidelines, audits, and sponsor progress reports.

The Clinical Research Project Manager role will report directly to the Principal Investigator and work closely with senior program managers, post-doctoral fellows and clinical research coordinators.

Essential Functions :

-Supervises operations of all study staff on project teams, and coordinates and delegates cross-project initiatives.

-Conducts research, manages data in systems, and develops reports and presentations to support programs.

-Identify potential risks, issues, and challenges associated with programs and develop mitigation strategies to minimize impact.
-Monitor program progress and proactively address deviations from plans, timelines, or budgets.
-Communicate cross-functionally with Research Management/Clinical Trials Office, MGB Healthcare Finance, and scientific collaborators.
-Writes operations manuals.
-Participates in the formulation of policies and procedures for the study.
-Coordinates multi-site trials with NIH, FDA and Private foundations.
-Reports study progress at investigators' meetings.

Education:
Bachelor's Degree Related Field of Study required or MS/MA/MPH/MPP or other Master’s equivalent or above degree preferred.

Experience:
Research Related Experience 5-7 years and Supervisory Experience 1-2 years preferred

Knowledge, Skills and Abilities:
- Ability to make independent effective decisions.
- Strong organizational and communication Skills.
- Ability to effectively supervise and train Staff.
- Strong database management (e.g., REDCap) and computer skills (Microsoft Suite, R, and Python).
- Demonstrated analytical skills to problem solve effectively.

Preferred Skills:

-Experience at managerial levels of at least 2 years working in clinical research or grant coordination.

-Experience working in MRI environments is applicable but not required.

Additional Job Details (if applicable)

63,252.80 - 102,596.00 - 141,939.20

Remote Type
Hybrid

Work Location
149 Thirteenth Street Building 149

Scheduled Weekly Hours
40

Employee Type
Regular

Work Shift
Day (United States of America)

Pay Range
$63,252.80 - $102,596.00/Annual

Grade
7
At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.

EEO Statement:
1200 The General Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran’s Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642.

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