Description
ESSENTIAL DUTIES AND RESPONSIBILITIES:- Provides support to clinical research including, but not limited to, maintenance of documentation, clinical tracking and information retrieval.
- Collects, disseminates, maintains and/or tracks regulatory documents as required
- Ensures all documentation are in a state of audit-readiness
- Collects, logs and files documents received from the clinical sites, CROs, vendors, etc.
- Provides the coordination of study logistics, documents, drug shipments, enrollment and safety reporting information
- Creates and maintains enrollment update logs
- Requests CDAs, CSAs and clinical site budgets. Tracks progress for successful execution of documents.
- Performs data entry and verification into designated clinical tracking systems in accordance with project requirements, including collection of information from designated clinical team members, CROs, vendors, etc.
- Prepares study binders, spreadsheets, site visit packets
- Coordinates the shipment of study-related supplies to the clinical sites
- Disseminates study information to Study Management Team
- Assists with planning, preparation and participation in Investigators' meetings
- Performs all responsibilities in accordance with Standard Operating Procedures, established guidelines and work instructions, and appropriate industry, FDA, ICH guidelines and Good Clinical Practices
Education:
* BS/BA degree in related discipline and one year of related experience; or High school diploma or general education degree (GED) and four years of related experience
Experience / Skills:
* Typically requires a minimum of four years of related experience and/or combination of experience and education/training.
* Experience in Biotech/Pharmaceutical industry; Familiarity with medical terminology and/or GCP guidelines strongly preferred.
* Excellent organizational skills are required.
* Demonstrated success in problem solving.
* Good communication skills both oral and written are a must. Applies strong analytical and business communication skills.
* Good computer skills are required. Working knowledge of MS Word, Excel, and PowerPoint is required, and applications as needed for job.
* Detail oriented.
* Ability to work in a team environment.
* Self-motivation, eagerness to grow professionally and commitment to self-development.
* Occasional travel may be required
To find out more about Real please visit www.realstaffing.com