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:
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 :
SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:
- Bachelors degree required
- 2 to 3 years of Industry (domestic/international clinical trials) and/or Relevant experience
- Data Management experience preferred
(MUST be realistic, neither overstated nor understated, and related to the essential functions of the job.)
- 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
Busy Office environment with frequent deadlines