Clinical Research Associate Manager
About The Position
Site: The General Hospital Corporation 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. 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. Summary Oversees all operational and financial activities related to clinical trials for anterior and posterior segment research services. Supervises the daily organization and functioning of assigned projects to subordinates. Serves as a resource to Program Administrators, Principal Investigators, and Grants Administration personnel.
Requirements
- Bachelor's Degree Related Field of Study required or Master's Degree Related Field of Study preferred
- Research Related Experience 3-5 years required
- Supervisory Experience 1-2 years preferred
- Demonstrated time management and organization skills
- Strong written and verbal communication skills
- Knowledge of current and developing clinical research trends
- Sound interpersonal skills
- Ability to work independently and display initiative
- Demonstrated ability to successfully manage multiple projects
- Established rapport with investigators and sponsors with the ability to resolve operational matters within a disease group
- Potential to effectively supervise and train staff
- 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 communications skills.
Responsibilities
- Provide first-line supervision to a minimum of 4-8 FTEs that may be across multiple different specialties of varying complexity and/or have management duties of equivalent responsibility.
- Facilitate new hire, correction action, and performance evaluation process 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
- 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
- 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
- Supervises and trains subordinates and all involved personnel to promote adherence to protocols.
- Independently judges suitability of research subjects.
- Responsible for quality control and may develop systems for QA/QC.
- Designs research protocols in conjunction with PI; recommends protocol changes and contributes to writing protocols and manuscripts.
- Files adverse events with IRB and acts as liaison with Research Affairs.
- Responsibly for safety, confidentiality and adherence/compliance to federal guidelines (HIPAA, OHRP etc.) of all study documentation.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
