Role: Clinical Research Coordinator (part time)
Location: Onsite
Therapeutic Area: Pulmonary Arterial Hypertension
Employment Type: Position is a contract, project based support role - current contract duration is estimated to be 3-6 months, possibility for extension
Schedule/ Shift:
- Part time, 16 hours a week
- Weekly schedule is TBD, open to reviewing candidates' preferences
Responsibilities/ Job Duties:
This candidate will work closely with all research staff to collect, store and maintain data in accordance with FDA Regulations, International Council of Harmonization and Good Clinical Practices.
Responsibilities -
- May be the sole coordinator or work in collaboration with a research nurse on studies, responsible for source documents, data collection, data entry, query resolution, triggering financial payments, study close out and liaison with the sponsor/CRO
- Collects, verifies, organizes and records clinical information and data in electronic data capture systems EDC.
- Abstracts data from necessary sources to complete the EDC and resolve queries.
- Performs the following data related activities: EDC tracking, reviewing validation, updating, SAE reconciliation, lab data reconciliation and safety coding
Minimum Education and Experience Qualification Requirements:
- Minimum 1 year experience with clinical trial coordination required
- Minimum 1 year EDC data entry experience required (ideally with multiple different EDC platforms)