Job Overview: The Sr. CTA will manage the throughput of data inquiries and tracking of clinical data and information. The incumbent will help to fine-tune the tracking, distribution, and storage of critical information that develops during the course of clinical trials.
Responsibilities
- Manage diagnostic clinical studies (these are relatively simple medical device studies when compared to pharmaceutical trials)
- Develop and manage the protocol, case report form, budget/contract negotiation, and regulatory document management
- Assist clinical sites with IRB submission/documentation, as needed
- Setup and keep Diagnostica (our remote clinical trial management system up to date)
- Monitor clinical studies -- develop monitoring plans, identify, issue and resolve queries, and ensure site regulatory binders are compliant
- Manage site relationships - help them with startup, answer questions during the study, ensure timely payments and close out activities
Skills & Requirements
- A minimum of 3 years Clinical Research experience (either as a high-achieving research coordinator or CRA)
- Knowledge of accepted good Clinical Research practice (GCP) and procedures
- Excellent organizational, time management, budget management, and problem-solving skills
- Hustle: Comfortable in a fast-paced small company environment
Job Type: Contract
Pay: $33.69 - $40.57 per hour
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Experience level:
- 3 years
- 5 years
- 7 years
Schedule:
- Day shift
- Monday to Friday
Work Location: Remote