Description
Responsibilities:- Participates in the planning and implementation of clinical research projects; contributes technical and clinical operations expertise
- May co-ordinate the activities of relevant colleagues within the Company and investigators to ensure compliance with the overall scientific study objectives. May work with international investigators and key customers as well.
- Travels to field sites to monitor studies.
- Under moderate guidance; plans and prepares studies.
- Reviews study protocols, reports and manuscripts. Contribute technical and clinical operations expertise for these documents
- Works with Data Management and Biostatistics staff on the design of documents and processes for the collection of study data from participating sites.
- Collects and maintains legal and regulatory documentation, as applicable.
- Manages training and coordinating certification of study site personnel.
- Ensures accurate and complete study management/data collection and transfer to data management.
- Ensures site compliance with regulations and study protocol.
- Monitors the sites and provides technical assistance, as necessary.
- Manages material logistics for the studies.
- Conducts reference material testing in-house.
- Organizes investigator meetings, as necessary.
- May act as a lead for assigned projects and/or Project Team Meetings.
- Evaluates and escalates decisions impacting project team and/or work area(s) and/or broader organization.
Education & Experience:
- Bachelors degree in a scientific discipline or related field, required
- MS or PhD, preferred
- Typically requires 6+ years of related Clinical Research Associate experience
To find out more about Real please visit www.realstaffing.com