Mass General Brigham · 5 hours ago
Clinical Research Associate Manager
Boston, MA
Full-time
Onsite
Mid Level
$63K/yr - $103K/yr
3+ years expMass General Brigham is a not-for-profit organization that supports patient care, research, teaching, and community service. The Associate Manager oversees operational and financial activities related to clinical trials, providing first-line supervision to research staff and ensuring compliance with protocols.
Health CareHome Health CareMedical
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
Builds strong, positive working relationships with clinical research associate (CRA) managers and maintain them over time
Work with the Clinical Research Manager or Director to identify changes associated with Standard Operating Procedures and develop processes to ensure compliance
Proctor meetings, supply meeting materials and develop group-specific tools
Participate in pre-activation activities including attending SIVs and assisting with CRDSP activation readiness
Assist Clinical Research Manager to identify new program-wide data entry training needs
Proactively track assigned research subject’s upcoming protocol appointments and visits and document on central clinical research data specialist (CRDSP) tracker
Effectively monitor research subject condition and take appropriate action to ensure compliance with research protocol data entry requirements
Proactively take steps to obtain missing source documents from all relevant sources
Identify inaccurate source documents and track source document inconsistencies until resolved
Ensure accurate and timely entry of required data into various study-specific electronic data-capture systems
Ensure appropriate documentation of own study-specific delegation and training prior to entering data
Ensure adequate source documentation is in place prior to entering data
Obtain and abstract complex clinical information from multiple sources (medical records, research records, etc.) for research subjects
Independently manage adverse event (AE) and concomitant medication (CM) data as required by the sponsor, institution, and federal regulations
Independently manage tumor response data entry
Enter vital signs and EKGs into study-specific electronic data-capture system independently as required for individual studies
Enter quality of life assessments into study-specific electronic data-capture system independently as required for individual studies
Enter all required correlative research blood samples and clinical safety laboratory specimen results into study-specific electronic data-capture system independently as required for individual studies
Enter all protocol required tests and procedures independently into study-specific electronic data-capture system as required for individual studies
Work professionally with sponsor representatives to review and correct data recorded in the case report forms
Track and appropriately manage sponsor data entry deadlines
Resolve and answer data queries with minimal errors
Perform standard data management quality control steps
Maintain awareness of details of clinical data to identify missing or inaccurate data; and track data inconsistencies for team to review and report accordingly
Remain flexible and adapt to change and variety on the job
Effectively handle unexpected situations and changing research subject and protocol conditions
Qualification
Required
Bachelor's Degree Related Field of Study required
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
Preferred
Master's Degree Related Field of Study preferred
Benefits
Comprehensive benefits
Career advancement opportunities
Differentials
Premiums and bonuses
Recognition programs designed to celebrate your contributions and support your professional growth
Company
Mass General Brigham
Mass General Brigham specializes in providing medical treatments and health diagnostics services.
10001+ employees
H1B Sponsorship
Mass General Brigham has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (77)
2024 (61)
2023 (93)
2022 (70)
2021 (80)
2020 (29)
Funding
Current Stage
Late StageLeadership Team
E
Erin Flanigan
SVP, Human Resources, Community, Specialty Hospital Division
O’Neil A. Britton
Chief Integration Officer, Executive Vice President
Recent News
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