Clinical Research Associate Manager---Regulatory

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.

Principal Duties and Responsibilities:

Management responsibilities will include the following:
• 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

Management responsibilities may include the following:
• 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

Regulatory responsibilities may consist of the following:
• 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

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

Education:

• BA/BS degree required

Experience:

• Minimum 2 years research experience required, 3 years research preferred.
• Prior experience within the Cancer Center Protocol Office (CCPO) preferred

Supervisory Responsibilities:

• Orient and train new staff and supervise a minimum of 4-8 FTEs

Working Conditions:

• Duties will be performed in a remote setting

 

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.

Does this position require Patient Care?
No

Essential Functions
-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.

 

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.

 

Physical Requirements

• Standing Frequently (34-66%)
• Walking Frequently (34-66%)
• Sitting Occasionally (3-33%)
• Lifting Frequently (34-66%) 35lbs+ (w/assisted device)
• Carrying Frequently (34-66%) 20lbs - 35lbs
• Pushing Occasionally (3-33%)
• Pulling Occasionally (3-33%)
• Climbing Rarely (Less than 2%)
• Balancing Frequently (34-66%)
• Stooping Occasionally (3-33%)
• Kneeling Occasionally (3-33%)
• Crouching Occasionally (3-33%)
• Crawling Rarely (Less than 2%)
• Reaching Frequently (34-66%)
• Gross Manipulation (Handling) Frequently (34-66%)
• Fine Manipulation (Fingering) Frequently (34-66%)
• Feeling Constantly (67-100%)
• Foot Use Rarely (Less than 2%)
• Vision - Far Constantly (67-100%)
• Vision - Near Constantly (67-100%)
• Talking Constantly (67-100%)
• Hearing Constantly (67-100%)

 

Remote

 

101 Merrimac Street

 

40

 

Regular

 

Day (United States of America)

 

Pay Range

$63,252.80 - $102,596.00/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 account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.

 

0100 Mass General Brigham Incorporated is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran’s Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642.

 

Mass General Brigham Competency Framework