- 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).
- Performs other tasks and responsibilities as directed.
- Bachelors degree required
- 2 to 3 years of Industry (domestic/international clinical trials) and/or Relevant experience
- Data Management experience preferred
- 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
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Lead Clinical Trial Coordinator TIMI Study Group - Boston, United States - Partners Healthcare System
Description
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:
COMPETENCIES REQUIRED:
(MUST be realistic, neither overstated nor understated, and related to the essential functions of the job.)
WORKING CONDITIONS:
Busy Office environment with frequent deadlines
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