Clinical Research Associate Manager

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.

Job Summary
General Summary/Overview Statement:

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
Management responsibilities will include the following:

Provide first-line supervision to a minimum of 4-6 FTEs and/or assist with specialized management projects 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

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

Skills/Abilities/Competencies Required
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

Supervisory Responsibilities

Orient and train new staff and may supervise a minimum of 4-6 FTEs

Working Conditions

Duties will be performed in a hybrid setting

Qualifications
Education

Bachelor's Degree Related Field of Study required or Master's Degree Related Field of Study preferred

Can this role accept experience in lieu of a degree? No

Licenses and Credentials

Experience
Research Related Experience 3-5 years required and Supervisory Experience 1-2 years preferred

Knowledge, Skills And Abilities

• 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.

Additional Job Details (if Applicable)
Remote Type
Hybrid

Work Location
55 Fruit Street

Scheduled Weekly Hours
40

Employee Type
Regular

Work Shift
Day (United States of America)

Pay Range
$62, $90,750.40/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