Role: Clinical Research Coordinator
Location: Onsite
- There is the possibility for role to transition to hybrid after the coordinator is trained
- Relocation candidates will NOT be considered for this position
Therapeutic Area: Oncology - solid tumors
Employment Type: Position is a contract, project based support role - current contract duration is estimated to be 4-6 months, possibility for extension
Schedule/ Shift:
- Full time, 40 hours a week - may fluctuate slightly depending on project needs
- 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 2 years experience with clinical trial coordination required
- Minimum 2 years EDC data entry experience required (ideally with multiple different EDC platforms)
- Minimum 2 years experience managing regulatory documentation / binders
- Oncology experience preferred
- Experience using EPIC EMR preferred
Benefits:
- Paid Sick Leave (Medix provides paid sick leave according to state and local sick leave ordinances)
- Health Benefits / Dental / Vision (Medix Offers 6 different health plans: 3 Major Medical Plans, 2 Fixed Indemnity Plans (Standard and Preferred), and 1 Minimum Essential Coverage (MEC) Plan. Eligibility for health benefits is based on verifying that an average of 30 hours per week during the first 4 weeks of the work assignment has been met. If you meet eligibility requirements and take action to enroll, you will be covered no earlier than 60 days into your assignment, depending on plan selection(s).)
- 401k (eligible on the first 401k open enrollment date following 6 consecutive months on assignment. 401k Open Enrollment dates are 1/1, 4/1, 7/1, and 10/1)
- Short Term Disability Insurance
- Term Life Insurance Plan