Clinical Research Associate Manager

Mass General Brigham•Boston, MA

17h•Hybrid

About The Position

The Associate Manager works under the direct supervision of a more experienced manager. The role provides first-line supervision to research staff and oversees day-to-day staff operations while retaining some data management responsibilities and maintaining working knowledge of all aspects of clinical research data management. Management duties may include working with the Clinical Research Manager or Director on Standard Operating Procedure changes and compliance processes; assisting with pre-activation activities, including pre-site qualification visits, SIVs, and facility tours; assisting investigators with New Protocol Intake Sheets for regulatory routing; and facilitating meetings and developing group-specific tools. Data management duties may include verifying patient eligibility, collecting and interpreting enrollment data, registering patients, monitoring protocol compliance, managing and submitting data, reporting adverse events, resolving data discrepancies, preparing IRB submissions and reports, revising consent documents based on new risk information, and preparing for monitoring visits and audits.

Requirements

Bachelor’s degree required.
3–5 years of research-related experience required.
Ability to train, manage, and mentor subordinate staff.
Ability to assign responsibilities to subordinates.
Ability to design, prepare, deliver, and evaluate clinical research programs.
Exceptional project management skills.
Ability to arrange resources effectively and manage multiple small-to-large projects in a cross-functional environment.
Effective multitasking and time-management skills.
Strong analytical, quantitative, and communication skills.

Nice To Haves

Master’s degree preferred.
1–2 years of supervisory experience preferred.

Responsibilities

Provide first-line supervision to at least 4–6 FTEs 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.
Help staff prioritize project assignments through regular meetings and meeting documentation.
Manage staff productivity and work quality by assessing effort on individual studies.
Work with sponsors to resolve monitoring issues.
Work with the Clinical Research Manager or Director to identify changes to 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 completing the New Protocol Intake Sheet for regulatory routing.
Proctor meetings, provide meeting materials, and develop group-specific tools.
Verify patient eligibility through chart abstraction and case-data analysis.
Collect and interpret data needed for enrollment and register patients.
Implement and monitor procedures to ensure protocol compliance.
Manage data collection through chart abstraction and submit data on time.
Monitor and report adverse events as required by institutional and federal regulations.
Resolve data discrepancies.
Prepare IRB submissions for protocol revisions, safety reports, and annual progress reports.
Assess the impact of new risk information on consent documents and revise them as appropriate.
Organize and attend on- and off-site Investigator meetings to establish procedures.
Organize and prepare for monitoring visits and internal and external audits.