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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
Under the guidance of the Principal Investigator and Senior Project Manager the Senior Research Clinical Study Coordinator functions independently and proficiently with minimal oversight. They are responsible for the complete coordination of assigned clinical research activities within all phases and complexities of the clinical trial including investigator-inititiated or other high-profile research. Demonstrates competence in clinical research skills problem solving priority setting and assists with the management of less experienced staff.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Oversees prepares submits and maintains all regulatory submissions (new studies annual reviews amendments) in a timely manner. Has a strong understanding of clinical trial endpoints and the ability to sufficiently evaluate and process data
Oversee and/or responsible for the Institutional Review Board (IRB) submissions and other regulatory forms and adhering to the timelines of the study start-up process.
Develop informed consent documents source documents and other documents as applicable.
Responsible for educating new staff and research participants on protocol expectations and proper conduct of clinical trials.
Interact with potential study participants and study participants to implement protocol with fidelity. Provide participant education procedural instruction and follow-up. Serve as a liaison between study participant and research team.
Responsible for collecting data and maintaining participant information database for study. May be required to input data do minimum analysis and run various reports.
Support the safety of clinical research participants.
Understand and proficiently communicate all components of research documents such as protocol informed consent investigator brochure and research instructions.
Responsible for mailing various study information or packets to study participants.
Answer any phone calls and inquiries regarding study protocol. Refer participants to principal investigator or co-investigators as clinically indicated.
Responsible for training and orienting all new staff.
Interact with study monitors scheduling monitoring visits as indicated and providing timely responses to study queries.
Maintain study inventory and order study supplies when necessary.
Ensures the appropriate delegation of study related tasks (i.e.: Delegation of Authority) on all protocols.
Communicate with participants clinical care providers as needed and document research visits within electronic health record system in compliance with institutional policies.
Contribute to research team environment serving as back-up coordinator to support other studies in department cross-training/peer-mentoring other team members and contributing to research meetings.
All other duties as assigned.
Education
Bachelors Degree Related Field of Study required or Graduate Diploma Related Field of Study preferred
Can this role accept experience in lieu of a degree
Yes
Licenses and Credentials
Experience
Related post-bachelors degree research experience 3-5 years required
Knowledge Skills and Abilities
- Ability to work more independently and as a team member.
- High degree of computer literacy and analytical skills.
- Ability to identify both technical and non-technical problems and develop solutions.
- Ability to interpret acceptability of data results.
- Highly proficient data management skills and working knowledge of data management systems.
- Able to display initiative to introduce innovations to research study.
- Excellent time management organizational interpersonal written and verbal communication skills.
Additional Job Details (if applicable)
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%)
Onsite
221 Longwood Avenue
40
Regular
Day (United States of America)
Pay Range
$49504.00 - $72404.80/Annual
Grade
6
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 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.
The Brigham and Womens Hospital Inc. 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 Veterans 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 .
Mass General Brigham Competency Framework
At Mass General Brigham our competency framework defines what effective leadership looks like by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance make hiring decisions identify development needs mobilize employees across our system and establish a strong talent pipeline.