Clinical Research Project Manager

3 weeks ago

Boston, United States Mass General Brigham Full time
Clinical Research Project Manager-(3287429)

Description

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 . 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 (. 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 (. 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 (. 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.

Qualifications

•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.

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