Clinical Research Program Manager

PRINCIPAL DUTIES AND RESPONSIBILITIES

• Interface with multiple research groups from various clinical departments within BWH and Mass General Brigham and external academic collaborators, as well as sponsors, clinical sites, central laboratories and third-party vendors, and other groups involved in clinical trials.
• Organize project team meetings and prepares the agenda under direction of the PI.
• Serve as primary liaison with the IRB, ancillary research committees, and Human Research Compliance Office.
• Serve as primary liaison with regulatory offices, oversee audits, and work with study staff to address findings.
• Assist with grant proposals, just-in-time submissions, and clinical trial agreements.
• Prepare and monitor project budgets and sponsor invoices.
• Serve as primary liaison with departmental staff for onboarding interns, student trainees, research staff, associates, and collaborators.
• Manage and oversee the trial lifecycle and clinical trial operations, including site feasibility questionnaires, evaluation and initiation, subject visits, and study closeout. Serve as primary point of contact for IRB, ancillary review committees, and sponsor and affiliated contract research organizations.
• Receive, negotiate, and execute nondisclosure/confidentiality agreements, in collaboration with institutional financial analysts, research directors, legal counsel, and principal investigator.
• Maintain Standard Operating Procedures (SOPs) for the research program, including the modification of existing SOPs and development of new SOPs.
• Enter non-clinical trial data in functional neurosurgery research databases created and maintained by the lab.
• Overseeing procurement of lab equipment and supplies.
• Train new staff as necessary on study protocols and standard operating procedures.
• Edit and submit manuscripts in collaboration with the Principal Investigator.
• Work with investigators and research staff to ensure clinical trials are conducted in accordance with all SOPs, GCP, GLP and FDA regulations.
• Assist in the preparation and hosting of monitoring visits, Sponsor audits and FDA inspections.
• Perform electronic data capture (EDC) entry, resolve EDC queries, and manage clinical trials documentation such as subject records and correspondence, essential documents, trial operations manuals, and Instructions for Use.
• Work with PI and physician assistant to identify and screen appropriate candidates for trial participation and evaluate inclusion/exclusion criteria, per study protocol.
• Obtain necessary approvals, patient informed consent, and demographic and screening information required for patient enrollment.
• Contact patients and/or families via written and telephone communications for the purpose of explaining the nature of studies and setting up visits and interviews.
• Arrange and coordinate scheduling of initial assessment and subsequent assessments as outlined in study protocols.
• Monitor study by gathering information and reviewing materials, visiting patients in the study, discussing problems, and exchanging information with clinical team.
• Function as liaison between research participants and other members of the team during the study; assess learning needs and educate patients and family as appropriate.
• Document study visits, submit expense reports for subject payments/stipends and reimbursement, and prepare and submit Sponsor invoices.
• Represent the PI and lab at meetings when needed.

SKILLS/ABILITIES/COMPETENCIES REQUIRED

• Experience with, or desire to obtain working knowledge of diseases treated by functional neurosurgery (including epilepsy, Parkinson's disease, dystonia, essential tremor, psychiatric diseases) and strong desire to contribute to translational neuroscience.
• Demonstrated understanding and knowledge of the methods, materials, and equipment used in research laboratory activities.
• Exceptional organizational and time management skills
  • Ability to track project milestones/progress digitally, on a daily, weekly, monthly basis
• Ability to apply the same level of effort to remote work as to onsite work
• Superb interpersonal skills
  • Strong ability to interact effectively with many different people and levels throughout the institution and within as well as outside the hospital setting, including patients, doctors, nurses, grant administrators, researchers, etc.
  • Excellent written grammar
  • Willingness to pick up the phone and call someone
  • to interact with colleagues, patients and families, other clinical and academic sites, NIH, sponsors, CROs, vendors, etc.
• Ability to work independently and as a member of a team.
• Excellent Analytical skills and ability to problem-solve.
• Flexibility to meet the demands of the work and the lab.
• Flexibility to accommodate shifting priorities and changes in the PI's schedule
  • to effectively manage team tasks and urgent timelines
• Understanding of REDCap system - Research Electronic Data Capture
• Understanding of laws, regulations, and standards governing clinical trial conduct, Standard Operating Procedures, regulatory audits, and clinical trials documentation requirements
• Efficient use of software programs such as MS Office Suite, Google docs, Dropbox, etc.
• Ability to prepare/monitor budgets
• Ability to work independently, introduce innovations, identify problems, and develop solutions

EDUCATION

• MA/MS degree is required, PhD in neuroscience, biomedical engineering, or a closely related field preferred.

WORKING CONDITIONS

• The Research Program Manager will collaborate with a team of postdoctoral fellows, graduate students, physician-scientists, administrators, clinical research coordinators. Work will be performed in both the laboratory setting and clinical facilities within the hospital. The ability to work a remote/on-site hybrid schedule is offered with supervisor approval. There must be a willingness to work at night and occasionally work on weekends as required.

EEO Statement

BWH is an Affirmative Action Employer. By embracing diverse skills, perspectives, and ideas, we choose to lead. 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.