• This position is for 30 hours/week, and includes full benefits.
• The Division of Rheumatology, Allergy and Immunology (DRAI) at Massachusetts General Hospital (MGH) is seeking an intellectually curious and highly organized individual with supervisory experience to serve as a Research Project Manager in a clinical trial which will test two different treatment strategies for gout. The candidate will work with an internationally recognized, multidisciplinary team from Massachusetts General Hospital and Harvard Medical School, alongside collaborators from many institutions, including Brigham and Women's Hospital, the Harvard T.H. Chan School of Public Health, and Boston University, among others. Reporting to the principal investigator (PI), this position will be responsible for day-to-day coordination and overall management of activities related to the TRUST trial.

The Treat-to-Target Serum Urate versus Treat-to-Avoid Symptoms in Gout: A Randomized Controlled Trial (TRUST trial) is funded by the National Institutes of Health (NIH). This multi-site clinical trial will be conducted at six institutions overseen by the MGH PI and team. The trial will require program manager who manages the multidisciplinary protocol. This position is hybrid, split between on-site and remote work, and will require 75% effort for a minimum of two years (likely three).

The Research Project Manager will play a key role in research program administration, including supervision of research activities, training, and staff, in addition to ensuring regulatory compliance, and potentially contributing to projects as a researcher, if interested.

PRINCIPAL DUTIES AND RESPONSIBILITITES:

The position requires a high degree of independent functioning and responsibilities include but are not limited to the following:

Research Project Management

Responsible for day-to-day oversight and management of assigned projects

Responsible for development and maintenance of Trial Master File (TMF)

Initiates, plans, facilitates, and oversees the research project start-up, active and close out phases for PI Initiated / Multi-Center clinical trial

Ensure research quality by closely monitoring adherence to research protocols

Serve as a liaison between team members at various study sites

Throughout project duration, plan, track, and report on project tasks, responsible parties, timelines, etc.

Provide mentorship and development for research assistants

Work with recruiting team to recruit 1-2 new research assistants and other staff each year, as needed

Delegate project tasks among project team

Conduct weekly meetings with research team and collaborators (e.g. meeting minutes, scheduling, booking)

Help prepare grant progress reports and related documents

Work with programmatic leadership and research assistants alike to manage the research portfolio by orchestrating competing priorities, deadlines, and workload of the research team

Coordinate administrative aspects of projects (e.g. expense reports, study participant stipends, invoices, purchase orders)

Regulatory Coordination

Ensure research integrity, including data documentation and data management, by developing best practices, provide ongoing training, and monitoring for adherence

Assist in the preparation and submission of IRB protocol, consent form amendments and continuing reviews to the Institutional Review Board (IRB)

Responsible for Case Report Form design with PI directives. Maintain study-related databases and prepare protocol-related reports as needed

Ensure protection of human subjects via adherence to all IRB-approved procedures and timely reporting of events to the IRB

Coordinate and monitor IRB applications and reporting, including all applicable review dates and deadlines to prevent lapses in approval

Maintain current and working knowledge of MGB IRB policies and guidelines related to human subjects research

Ensuring the transfer of research data and biospecimens between MGH and collaborating sites is in accordance with applicable regulations and policies

Maintain electronic and paper study binders to ensure compliance with applicable regulations

Coordinate and comply with industry related regulation for sponsor-funded projects

Ensure adherence to privacy and confidentiality policies and laws regarding safe data collection, storage, and transmission within MGB and with collaborators

Perform data and study quality assurance (e.g. Redcap reports, self-auditing)

Research

Manage existing and build new databases in Research Electronic Data Capture REDCap (databases, survey instruments, data collection instruments, consent forms, tracking forms, regulatory binder)

Generate data queries and participate in data cleaning efforts

Ensure safe storage of all primary and secondary data collected and utilized in all projects

Assist with patient interaction as needed (patient recruitment, completing informed consent, study visits)

Manage biospecimen collection, storage, and shipping per institutional and other related policies, guidelines, and laws

Planning, Organizing, and Coordinating

Skilled in identifying opportunities to improve efficiency of research processes and procedures and subsequently execute improvements

Excellent time management skills

Capable of prioritizing among multiple requests from multiple individuals and able to change direction in response to fluctuating work environment

Excellent attention to detail

May be responsible for scheduling research team meetings and conference calls, facilitating mailings and other project-related administrative tasks.

Team Management

Ability to work successfully in a collaborative environment

Ability to manage diverse teams with different skillsets, work styles, and professional roles

Interest in and proven record of managing and cultivating direct reports

Takes Initiative

High personal work standards

Excellent ability to anticipate the needs of the group in a fast-paced environment

Keen ability to anticipate and solve problems proactively

Demonstrates initiative and identifies key priorities

Consistently demonstrates a positive, "can-do" attitude Communication Skills

Excellent written and verbal communication skills

Ability to clarify and distill complex issues to a variety of stakeholders

Analytical Skills

Intellectual curiosity and willingness to learn.

3 years of experience in an academic, research, or related setting with proven project management and supervisory skills;

Bachelors Degree required; Master's degree in clinical epidemiology, public health, public policy, management, or related field preferred but not required.