Project Director, Pcori Clinical Trial

Project Director, PCORI Clinical Trial

GENERAL SUMMARY/ OVERVIEW STATEMENT:

The Center for Aging and Serious Illness (CASI) within the Mongan Institute and affiliated with the Division of Palliative Care and Geriatric Medicine is seeking a PhD or Masters-level Project Director with training and experience in multi-site Clinical Trials to oversee a large comparative effectiveness study focused on older adults with complex care needs. The candidate will work with a multidisciplinary team from Massachusetts General Hospital (Center Director, and Clinical Research Coordinators), alongside close collaborators from several other institutions across the nation. The team’s research is focused on the improvement of patient and caregiver outcomes for high-risk older adults (ages 65+) with chronic and serious healthcare conditions. The Research Project Director will lead research study administration and operations, including supervision of research activities, staff training, and directing recruitment staff at distant sites.

We are seeking a candidate who is dedicated to improving care delivery for older adults, who has excellent organizational and communication skills, and who has prior experience in planning, overseeing, and effectively implementing large-scale projects in the healthcare sector. The candidate must be able to lead teams across multiple settings and the demonstrated ability to address complex challenges in environments with diverse stakeholder groups. They must have knowledge of health systems with a focus on outpatient and community settings. They will have exemplary organizational and project management skills, verbal and written communication skills, knowledge of multi-site Clinical Trials organizational and regulatory requirements, experience developing and communicating study protocols within a multi-team operation, and the ability to direct and oversee the creation of study protocols and adherence to all regulatory requirements.

Interested candidates should apply via www.massgeneral.org/careers.

Please submit a resume and a cover letter describing your training and experience in clinical research and/or clinical research education program support.

For more information regarding our research center and team, please visit https://www.mghagingandseriousillness.org/

For more information regarding our PCORI-funded study please visit: https://www.pcori.org/research-results/2023/annual-wellness-visits-versus-grace-augmented-annual-wellness-visits-older-adults-high-needs

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Work with Clinical Trial leadership leadership and research assistants alike to manage this large scale trial. orchestrating competing priorities, deadlines, and workload in a group with 20+ investigators and stakeholders

• Supervise, coach, and develop research assistants, including:

• Work with the research team to recruit new team members as needed, and facilitate recruitment efforts at collaborating sites including job description development, posting employment opening advertisements in setting-appropriate channels, screening applicants, and interviewing selected candidates

• Meet regularly with programmatic leadership to discuss strategic planning, opportunities to enhance operations, and management approaches

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

• Monitor personnel resource allocations and advise research leadership on factors affecting delivery of milestones

• Coordinate all administrative aspects of multiple data, programmatic, and clinical sites

• At project outset, clarify project goals, deliverables, tasks, timeline, and research team

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

• Delegate project tasks among project team

• Proactively take steps to help others move forward, whether it is planning project-specific meetings, getting people to make decisions, bringing in additional resources, etc.

• Ensure research quality by closely monitoring adherence to research protocols

• Serve as a liaison between team members at various US collaborative research sites

• In conjunction with the Program Manager, coordinate and monitor Institutional Review Board applications and reporting for sites, including all applicable review dates and deadlines to prevent lapses in approval

• Serve as the liaison between the MGB Human Subjects Research Committee and the sIRB and ethics boards to ensure complete, accurate, and consistent regulatory submissions

• Create and maintain REDCap databases including the design of data collection forms, extraction and uploading of datasets, and creation of reports

SKILLS & COMPETENCIES REQUIRED:

• Skilled in identifying opportunities to improve efficiency of research operations and subsequently execute improvements

• Time management skills with the capability to prioritize among multiple requests from multiple individuals and the ability to change direction in response to a fluctuating work environment

• Ability to work successfully in a collaborative environment

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

• High personal work standards and sense of urgency about results

• Ability to anticipate the needs of the group in a fast-paced environment

• Problem-solving ability, including the ability to gather information, identify resources, and imagine alternatives

• Demonstrates initiative and identifies key priorities, even in ambiguous situations with limited direction

• Ability to work effectively under pressure and within short time constraints

• Consistently demonstrates a positive, "can-do" attitude

• Excellent written and verbal communication skills

• Ability to clarify and distill complex issues to a variety of stakeholders with varying expertise

• Cognizant and respectful of cultural differences in communication approach

• An ability to build strong relationships, read a room, and influence people at all levels

• Ability to represent the CASI with the utmost professionalism and ability to build strong relationships inside and outside the team

• Intellectual curiosity and willingness to learn

• Rigorous academic and/or professional background including clinical or research work

• Basic familiarity with health outcomes/epidemiology research and/or Clinical Trials

SUPERVISORY RESPONSIBILITY:

• The candidate will be responsible for providing daily supervision, guidance, and expertise for Program Managers and Research Assistants.

FISCAL RESPONSIBILITY:

• Develop and implement complex multi-site, multi-year budgets with Center Director and Co-Investigators.

WORKING CONDITIONS:

• Duties will be carried out in a typical office environment.
• Occasional evening or weekend work may be required.
• Occasional travel to domestic research sites may be required.

QUALIFICATIONS:

• Qualified applicants must have experience conducting, implementing, and overseeing multi-site Clinical Trials, including preparing and modifying study protocols and informed consent documents for IRB submission. They must also be able to work independently and have excellent communication and organizational skills.
• Additionally, qualified applicants should be comfortable working in a team-oriented environment, often reporting to multiple principal investigators and managing as well as collaborating with clinical research coordinators. Ideal candidates will have an attention to detail, the ability to handle fluctuating priorities and deadlines, and strong interpersonal skills. Proficiency in Microsoft Office is required.
• A PhD in a medical or public health field or a Master’s degree in public health or related field, as well as a background in the conduct of Clinical Trials is required.