Lead Clinical Trial Coordinator TIMI Study Group BWH at Partner's Healthcare in Boston, Massachusetts

Job Description:

Site: The Brigham and Women's Hospital, Inc.


At Mass General Brigham, we know it takes a surprising range of talented professionals to advance our mission-from doctors, nurses, business people and tech experts, to dedicated researchers and systems analysts. As a not-for-profit organization, Mass General Brigham is committed to supporting patient care, research, teaching, and service to the community. We place great value on being a diverse, equitable and inclusive organization as we aim to reflect the diversity of the patients we serve.


At Mass General Brigham, we believe a diverse set of backgrounds and lived experiences makes us stronger by challenging our assumptions with new perspectives that can drive revolutionary discoveries in medical innovations in research and patient care. Therefore, we invite and welcome applicants from traditionally underrepresented groups in healthcare - people of color, people with disabilities, LGBTQ community, and/or gender expansive, first and second-generation immigrants, veterans, and people from different socioeconomic backgrounds - to apply.



Job Summary
The Clinical Trial Protocol Lead is fully knowledgeable of the department/trial(s) protocol requirements, works with a high degree of independence, and contributes to implementing process improvements. By virtue of their experience, this individual is expected to provide guidance and mentorship to staff regarding department/trial operations, interact with senior level study management personnel within and outside of TIMI, and complete work in a resourceful, self-sufficient manner.



Qualifications



PRINCIPAL DUTIES AND RESPONSIBILITIES:



1. Contribute to the preparation of the department/trial specific SOPs and working instructions in accordance with TIMI operations guidelines, sponsor protocol, FDA requirements, and audit procedures.


2. Contribute to the identification and implementation of process improvement opportunities.


3. Prepare and maintain study aides and training materials.


4. Assist in the training and development of other junior staff members in key processes and procedures.


5. Work with the department/trial manager(s) to address issues identified through periodic quality monitoring activities and/or audits


6. Prepare official trial correspondence (i.e. numbered memos). Develop and maintain databases. Generate reports as needed from internal and external databases.


7. Understand audit trails and discoverable information.


8. Collaborate with internal and external stakeholders.


9. Assist and support other team members as needed.


10. Maintain department service standards, with particular attention to person/behavioral, staff teamwork, and customer-staff interacting guidelines as outlined in the BWH Code of Conduct.


11. Demonstrate and maintain knowledge of regulations, clinical research conduct, laws, guidelines and standards relating to department/trial(s).


12. Performs other tasks and responsibilities as directed.



Qualifications

• Bachelors degree required


• 2 to 3 years of Industry (domestic/international clinical trials) and/or Relevant experience


• Data Management experience preferred

SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:


Demonstrated high level proficiency in MS Office products (Word and Excel) and familiarity with databases


Preferred, but not required, proficiency in Adobe Acrobat applications


Ability to work independently and display initiative


Detail oriented


Customer service oriented


Strong organizational skills


Strong sense of accountability and an ability to work autonomously, as well as act as a strong team player


Ability to communicate effectively in a matrix environment


Solid written and verbal communication skills


Ability to manage multiple tasks concurrently


Ability to demonstrate professionalism



WORKING CONDITIONS:



Busy Office environment with frequent deadlines



Additional Job Details (if applicable)


Additional Job Description



Remote Type


Hybrid



Work Location


350 Longwood Avenue



Scheduled Weekly Hours


40



Employee Type


Regular



Work Shift


Day (United States of America)



EEO Statement:


The Brigham and Women's Hospital, Inc. is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. 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.



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. Apply Now