Brigham & Women's Hospital(BWH)
Lead Clinical Trial Coordinator TIMI Study Group BWH
Brigham & Women's Hospital(BWH), Boston, Massachusetts, us, 02298
GENERAL SUMMARY/ OVERVIEW STATEMENT:
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.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
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.
Contribute to the identification and implementation of process improvement opportunities.
Prepare and maintain study aides and training materials.
Assist in the training and development of other junior staff members in key processes and procedures.
Work with the department/trial manager(s) to address issues identified through periodic quality monitoring activities and/or audits.
Prepare official trial correspondence (i.e. numbered memos). Develop and maintain databases. Generate reports as needed from internal and external databases.
Understand audit trails and discoverable information.
Collaborate with internal and external stakeholders.
Assist and support other team members as needed.
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.
Demonstrate and maintain knowledge of regulations, clinical research conduct, laws, guidelines and standards relating to department/trial(s).
Perform other tasks and responsibilities as directed.
MINIMUM REQUIREMENTS:
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.
EEO Statement:
BWH 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.
Primary Location:
MA-Boston-BWH Longwood Medical Area
Work Locations:
BWH Longwood Medical Area 75 Francis Street Boston 02115
Job:
Clinical
Organization:
Brigham & Women's Hospital(BWH)
Schedule:
Full-time
Standard Hours:
40
Shift:
Day Job
Employee Status:
Regular
Recruiting Department:
BWH Department Of Medicine / Cardiovascular Medicine
Job Posting:
Oct 11, 2024
#J-18808-Ljbffr
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.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
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.
Contribute to the identification and implementation of process improvement opportunities.
Prepare and maintain study aides and training materials.
Assist in the training and development of other junior staff members in key processes and procedures.
Work with the department/trial manager(s) to address issues identified through periodic quality monitoring activities and/or audits.
Prepare official trial correspondence (i.e. numbered memos). Develop and maintain databases. Generate reports as needed from internal and external databases.
Understand audit trails and discoverable information.
Collaborate with internal and external stakeholders.
Assist and support other team members as needed.
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.
Demonstrate and maintain knowledge of regulations, clinical research conduct, laws, guidelines and standards relating to department/trial(s).
Perform other tasks and responsibilities as directed.
MINIMUM REQUIREMENTS:
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.
EEO Statement:
BWH 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.
Primary Location:
MA-Boston-BWH Longwood Medical Area
Work Locations:
BWH Longwood Medical Area 75 Francis Street Boston 02115
Job:
Clinical
Organization:
Brigham & Women's Hospital(BWH)
Schedule:
Full-time
Standard Hours:
40
Shift:
Day Job
Employee Status:
Regular
Recruiting Department:
BWH Department Of Medicine / Cardiovascular Medicine
Job Posting:
Oct 11, 2024
#J-18808-Ljbffr