Clinical Research Associate Manager
Mass General Brigham
Summary
The Associate Manager works under direct supervision of a more experienced manager. The Associate Manager provides first-line supervision to research staff members and oversees the day-to-day operations of the staff while maintaining some data management responsibilities and a working knowledge of all aspects of clinical research data management.
Job description
Job Summary
The Associate Manager works under direct supervision of a more experienced manager. The Associate Manager provides first-line supervision to research staff members and oversees the day-to-day operations of the staff while maintaining some data management responsibilities and a working knowledge of all aspects of clinical research data management.
Principal Duties and Responsibilities
- Provide first-line supervision to a minimum of 4-6 FTEs and/or assist with specialized management projects of equivalent responsibility.
- Facilitate new hire, corrective action, and performance evaluation processes for research staff
- Train new staff and assess continuing education needs
- Assist staff with task prioritization for project assignments by meeting regularly and maintaining meeting documentation
- Manage staff productivity and quality of work produced by assessing work effort on individual studies
- Work with sponsors to resolve monitoring issues
Management responsibilities may include the following:
- Work with the Clinical Research Manager or Director to identify changes associated with Standard Operating Procedures and develop processes to ensure compliance
- Assist with pre-activation activities including pre-site qualification visits, SIVs, and facility tours
- Assist investigators with the completion of the New Protocol Intake Sheet for regulatory routing
- Proctor meetings, supply meeting materials and develop group-specific tools
Data management responsibilities may consist of the following:
- Verify patient eligibility via chart abstraction and analysis of case data
- Collect and interpret data necessary for enrollment; register patients
- Implement and monitor procedures to ensure protocol compliance
- Manage data collection via chart abstraction and submit data in timely fashion
- Monitor and report adverse events as required by institutional/federal regulations
- Resolve data discrepancies
- Prepare IRB submission of protocol revisions, safety reports, annual progress reports
- Assess impact of new risk information on consent documents and revise appropriately
- Organize and attend on- and off-site Investigator meetings to establish procedures
- Organize and prepare for monitoring visits and both internal/external audits
Requirements
- Bachelor's Degree required
- Master's Degree preferred
- Research Related Experience 3-5 years required
- Supervisory Experience 1-2 years preferred
- Trains, manages and mentors subordinate staff
- Assigns responsibility to subordinates
- Ability to design, prepare, deliver and evaluate clinical research programs
- Exceptional project management skills
- Effectively arranging resources and managing multiple small to large projects in a cross-functional environment
- Effective multitasking and time management skills
- Strong analytical, quantitative and communication skills
Benefits
- Comprehensive Benefits
- Career Advancement Opportunities
- Differentials
- Premiums
- Bonuses
- Recognition Programs
Company overview
Mass General Brigham is one of the largest integrated healthcare delivery systems in the United States, formed through the merger of Massachusetts General Hospital and Brigham and Women's Hospital. Based in Boston, Massachusetts, this academic medical center system operates multiple hospitals, specialty facilities, and community health centers throughout New England. The organization is renowned for its world-class patient care, cutting-edge medical research, and comprehensive medical education programs. As a teaching affiliate of Harvard Medical School, Mass General Brigham trains the next generation of healthcare professionals while advancing medical science through groundbreaking research initiatives. The system provides a full continuum of healthcare services, from primary care and preventive medicine to complex specialty treatments and emergency services. With a focus on innovation and patient-centered care, Mass General Brigham consistently ranks among the top hospital systems in the nation for clinical excellence and research output.