Brigham and Women's Hospital
Specifically, the Clinical Project Manager will be responsible for the recruitment and retention, data collection, processing, quality control, ethics, and monitoring of multiple complex human-subjects research studies with complex measurements and pharmacological interventions all aimed towards development of novel treatment approaches for sleep apnea.
Experience and adeptness are required for study coordination, data management, research regulation, analysis, report preparation, and implementation of research protocols.
Principle Duties And Responsibilities
- Responsible for the coordination and implementation of research design process and study protocol at one or multiple sites.
- Coordinates recruitment of research subjects from sleep clinics and the community. Will involve management of junior recruitment staff and/or management of third party recruitment services to find research participants. Will involve:
- early detection of unrecognized exclusion criteria.
- scrutiny of appropriateness of participants for research studies.
- Scheduling, and management of appropriate rescheduling in unexpected/emergency situations.
- Design and refinement of systems and coordination of data collection including real-time recognition of unexpected results. Will involve:
- interpretation of data, quality improvement, and data integrity.
- development and implementation of procedures for collecting and annotating clinical and physiological sleep studies and accompanying health outcomes data.
- training others to use your procedures.
- working with a team to ensure efficient and complete data collection.
- develops and update SOPs and other key study documents.
- Design and refinement of systems and coordination of data analysis and management of study database(s),
- Design and refinement of systems and coordination of drug orders from pharmacy, study MD sign-offs, and drug delivery to patients. Will involve:
- Ensuring participants reliably have study medications when needed.
- Participants reliably start their medications on time, and take appropriate doses on the appropriate days.
- Participants bring their medications with them to their studies.
- Backup strategies to address failures of the above steps.
- Regulatory:
- IRB submission and continuing reviews
- Clinical trials registration and updates
- FDA IND exemptions and updates
- DSMB meeting reports, minutes, agenda.
- Has direct management responsibility for all study personnel, including hiring, firing, discipline, evaluation, orientation and training.
- Will involve management of junior recruitment staff.
- Will involve management of per-diem support person/s
- Will involve co-management of sleep scientist who scores study data
- On a daily basis, executes the procedural, managerial, and policy decisions made for the study.
- Participates in all decisions made for the study and the formulation of policies and procedures. Identifies modifications needed and works to implement solutions.
- Responsible for the development and oversight of project budget.
- Participates in grant writing and proposals.
- Serves as the primary contact for outside vendors utilized to ensure efficient operation of the study.
- Facilitates the arrival and orientation of new lab members and visiting researchers.
- Responsible for the oversight of all supplies, equipment, and files.
- Directly responds to inquiries regarding study protocol and policy. Serves as liaison to internal and external population.
- All other duties as assigned, as needed to ensure the success of the research studies in our lab.
Qualifications
- BS/BA required, MS/MA preferred.
- Minimum of 5 years of progressively more responsible research work experience. Prior supervisory experience required.
Skills/Abilities/Competencies Required
- Must possess good organizational and interpersonal skills.
- Demonstrated teamwork abilities. Display leadership, initiative and sound judgment in crisis or unexpected situations.
- Technically competent with various software programs such as Microsoft Excel, Microsoft Word, Microsoft Power Point. Existing skills in MATLAB and Spike or similar software is advantageous. Must be able to continually learn new computer skills and update existing skills.
- Ability to learn quickly how to maintain accuracy and completeness of research databases
- Ability to supervise and train staff effectively
- Excellent communication skills, including with patients, staff, and investigators
- Ability to inspire/motivate participants to take part in important research studies for future community benefit
- Ability to inspire/motivate clinicians and others to facilitate recruitment for our research studies
- Excellent organizational and time management skills
- Able to juggle multiple competing priorities in a fast-paced environment
- Able to work independently with minimal supervision
- Excellent oral and writing skills
- Strong database management and computer skills.
- Understanding of human physiology
- Ability to learn quickly multiple scientific studies (including purpose and criteria for participation)
- Ability to learn quickly common and uncommon medications
- Ability to learn quickly how to interpret physiological signals
- Must possess aptitude for budget management.
- Ability to learn quickly local and federal regulatory procedures for research
Working Conditions
Work takes place in a busy academic research office setting.
The work schedule will involve M-F day shifts. Studies run M-Th evenings; in rare circumstances we may ask the coordinator to be available to oversee activities outside the daytime hours (in person or remotely).
Supervisory Responsibility
Responsible for supervising staff including hiring, firing, evaluating and disciplining. Will orient and train new staff members. Will supervise the work of 2-3 junior staff members.
Primary Location
MA-Boston-BWH Longwood Medical Area
Work Locations
BWH Longwood Medical Area
Job
Research-Management
Organization
Brigham & Women’s Hospital(BWH)
Schedule
Full-time
Standard Hours
40
Shift
Day Job
Employee Status
Regular
Recruiting Department
BWH Department Of Medicine / Sleep Medicine
Job Posting
Mar 8, 2022
To apply for this job please visit partners.taleo.net.