Clinical Research Program Manager

Site: The Brigham and Womens Hospital Inc.

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.

Hybrid Neurosurgery department

Job Summary

The Mapping & Engineering Neural Dynamics (MEND) Lab ( within the Department of Neurosurgery at Brigham & Womens Hospital is a human neural engineering laboratory that uses electrophysiological recordings and advanced imaging to understand the brain. We are particularly focused on diseases where brain activity is changed like epilepsy tremor pain and psychiatric disorders. Our research in understanding brain activity is combined with methods of changing brain dynamics like electrical stimulation to better treat these disorders with or without neurosurgical interventions. The laboratory led by Dr. John Rolston MD PhD is seeking a motivated and talented individual to serve as the Clinical Research Program Manager for our dynamic team.
The Clinical Research Program Manager is responsible for the administrative management and support of all research projects conducted within the clinical and research practice of the PI Dr. John Rolston.
The MEND Lab is involved with multiple NIH foundation and industry-sponsored studies. The Clinical Research Program Manager will support multiple active human protocols at any given time will maintain standard operating procedures and train new staff members to ensure compliance. The incumbent will have the lead administrative role in preparing/submitting new grant proposals (in conjunction with the departments Grant Administrator) coordinating Data Use and Confidentiality Agreements as well as coordinating the development of IRB protocols and amendments.
With oversight by the department Research Administrator the Clinical Research Program Manager will manage project budgets throughout the project lifecycle. The Clinical Research Manager also oversees the development and refinement of the labs Standard Operating Procedures ensuring adherence to regulatory requirements including Good Clinical Practices (GCP) 21 CFR Part 11 HIPAA etc.

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 Parkinsons 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 PIs 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.

Hybrid

60 Fenwood Road

40

Regular

Day (United States of America)

Pay Range

$62004.80 - $90750.40/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 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.

The Brigham and Womens Hospital Inc. 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 Veterans 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 .

Mass General Brigham Competency Framework