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
- Experience with iMedidata platform highly preferred
- Experience with Oncology (solid tumor) trials and data management highly preferred
Schedule/ Shift:
- Part time, 16 hours a week
- Weekly schedule will likely be Thursdays and Fridays (8 hours per day) but subject to change with onsite monitoring visit
- Position is a contract, project based support role - current contract duration is estimated to be 6 months
Benefits (ONLY AVAILABLE FOR 30 hr/week + ASSIGNMENTS):
- 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
Further Information:
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO) , and the California Fair Chance Act (CFCA).
This position is subject to a background check based on its job duties, which may include patient care, working with vulnerable populations, access to financial and confidential information, driving, working with heavy machinery, or working in a warehouse or laboratory environment. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.
