Clinical Research Associate Manager---Regulatory

Mass General Brigham • Boston, MA

7d • $63,253 - $102,596 • Remote

About The Position

Site: Mass General Brigham Incorporated 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. Job Summary 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

• 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
• BA/BS degree required
• Minimum 2 years research experience required, 3 years research preferred.
• Orient and train new staff and supervise a minimum of 4-8 FTEs
• Bachelor's Degree Related Field of Study required or Master's Degree Related Field of Study preferred
• Research Related Experience 3-5 years required and Supervisory Experience 1-2 years preferred

Nice To Haves

• Prior experience within the Cancer Center Protocol Office (CCPO) preferred

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 regulatory monitoring issues
• Lead regulatory meetings with regulatory team
• 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
• Maintain and organize study specific regulatory binders
• Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB
• Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study
• Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required
• Submit Data and Safety Monitoring Reports
• Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process
• Collect, complete, and submit essential regulatory documents to various regulatory entities
• Participate in monitoring visits and file all monitoring visit correspondence
• Ensure appropriate documentation of delegation and training for all study staff members
• Maintain screening and enrollment logs
• 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.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager