Position: Clinical Trial Coordinator Lead
Location: Hybrid (2 days on site)
Duration: 6 months with full-time possibility after
Our client is looking for a Clinical Trial Coordinator Lead, 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.
- Bachelor’s degree required
- 2 to 3 years of Industry (domestic/international clinical trials) and/or Relevant experience
- Data Management experience preferred
- Detail oriented, strong organizational skills, customer service oriented, proficiency in MS Office products, strong written and verbal communication, ability to multi-task.
1. Identify and initiate communications with sites to obtain all relevant documents for project/trial.
2. Manage 30+ clinical trial sites for the duration of the trial – start up to close out.
3. Collect and review site’s essential regulatory documents for completeness prior to submitting to Regulatory for final review and/or approval.
4. Advise research sites on protocol conduct, interpretation of protocol, and ensure resolution of issues.
5. Evaluate the quality and timeliness of data entry, issue, track and resolve queries, implement corrective action plans as needed.
6. Identify issues/trends that require escalation to management and provide input to resolution as appropriate.
7. 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.
8. Contribute to the identification and implementation of process improvement opportunities.
9. Prepare and maintain study aides and training materials.
10. Assist in the training and development of other junior staff members in key processes and procedures.
11. Work with the department/trial manager(s) to address issues identified through periodic quality monitoring activities and/or audits.
12. Prepare official trial correspondence (i.e., numbered memos). Develop and maintain databases. Generate reports as needed from internal and external databases.
Medasource provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, gender, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.