Clinical Data Coordinator
Responsibilities:
- Generate status reports and distribute to the study team and clinical study sites as appropriate.
- Follow-up with study team members and study sites as appropriate on outstanding items.
- Assist with the CRAs preparation for on-site monitoring activities.
- Assist with the development of CRFs and CRF Completion Guidelines to serve as an aid for site personnel to complete the CRFs.
- Perform user acceptance/database testing to ensure the quality and integrity of the clinical study database design and associated edit check programming prior to the study database being released to collect data.
- Conduct data review and associated query generation/resolution.
- Reconciles data from third party sources (i.e. Lab data) with the clinical study database and communicates discrepancies to the appropriate parties.
- Maintains accurate and complete study records including filing, archiving, inventory of study documents, and shipping to other locations.
- Performs routine audits of study files and security records to ensure compliance with Clinical Standards.
Requirements:
- High School diploma required; undergraduate degree preferred from an accredited program.
- 1 or more years Clinical Research experience or equivalent industry experience, certification or training.
- Experience with MS Word, Excel and PowerPoint.
- Highly organized with the ability to manage multiple activities concurrently.
- Effective communication skills both verbal and written.
- Establishes rapport and collaborates with other (internal and external) team members; builds constructive and effective relationships.
- Ability to travel up to 10% of the time.
- Understands clinical research process and regulatory requirements.
- Able to acquire and apply new technical skills.
- Identifies problems, issues, and delays; proactively escalates as appropriate to minimize the impact to the project.
- Follows through on all tasks and ensures quality results.