Are you passionate about driving innovation in clinical research? We're seeking a detail-oriented and proactive professional to play a key role in supporting the success of clinical trials. As a Clinical (Technical) Documentation Specialist, you'll ensure the seamless coordination, accuracy, and organization of critical trial documents while collaborating with internal teams and investigator sites. If you thrive in a fast-paced environment, have a knack for precision, and are ready to contribute to advancing healthcare, we want to hear from you!
Position Type: 2 year contract position
Schedule/Shift: 1st shift, Mon.-Fri., 100% onsite
Essential Duties and Responsibilities:
- Coordinate collection and processes essential trial documents between investigator sites and Company CRD, including preparation and/or facilitating IRB / IEC submissions.
- Ensure accuracy and quality of site documents included in the site initiation packets and throughout the duration of the study.
- Enter and maintain site information and document tracking in current clinical trial management systems.
- Ensure trial documentation is well organized, available, current, and archived in a timely manner in the sponsor Trial Master File (TMF) and ensure audit readiness.
- Follow applicable work processes, SOPs, communication plans, etc.
- Ensure timely elevation of issues with sites related to preparation / collection of trial documents, initiation packets, site budget and contracts, or other relevant documentation.
- May interact with and advise other functions on CTDM responsibilities. Interactions include but are not limited to Global Clinical Site Development, Clinical Trial Lead, Clinical Site Managers, etc.
- May provide support before and during audits, both internal and external when applicable.
Qualifications:
- Bachelor's degree (BS) in life sciences (Medical, Pharmaceutical, Biology, Chemistry degree or RN)
- 2 years related experience (e.g., business administration)
- 1 year clinical trial experience (e.g., ophthalmology, study coordinator, etc.)
- Proficient in Microsoft Office to include Word, Excel, PowerPoint
- Excellent verbal and written communication skills
- Excellent organization skills with exceptional attention to detail
- History of working with multiple internal and external customers
- Self-starter
- Customer Focus
- Action Oriented
- Communicates Effectively
- Collaborates
