Clinical Research Coordinator - 257607

Medix™; Long Beach (CA); Hybrid; USD 60,000 - 90,000; Full time

Benefits offered by this job

Health benefits

Dental & Vision

401k

Paid sick leave

Life insurance

Disability insurance

Job summary

Medix is seeking a Clinical Research Coordinator in California to coordinate protocols from start-up to close-out while working with research staff to ensure data is collected, stored, and maintained in compliance with FDA, ICH and GCP.

The role involves source documents, data entry in EDC, regulatory submissions support, site feasibility, and coordination with sponsor/CRO. Hybrid work model with majority onsite; local candidates only.

Qualifications

• Coordinating clinical research protocols from start-up to close-out.
• Collect, store and maintain data in accordance with FDA, ICH and GCP.

Responsibilities

• Coordinate source documents, data collection and query resolution.
• Participate in data entry and reconciliation in EDC systems.
• Liaise with sponsor/CRO and research staff.
• Assist in regulatory submissions and IRB requirements.
• Support site feasibility, qualification visits and initiation visits.
• May recruit clinical trial participants.

Skills

Clinical coordination

Data entry

EDC systems

Regulatory submissions

Tools

EDC software

Job description

• Great opportunity to work with a big name sponsor on an Asthma study
• Contract Duration: 6 months, NO possibility for permanent role
• 40 hours per week, M-F
• HYBRID, majority of days onsite.
• Candidates MUST be local to the area
• This is NOT a patient facing CRC role, the majority of responsibilities will be administrative.

Position Summary

The candidate will be coordinating clinical research protocols from study start up to close out. 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
• Participates in the identification of potential clinical trial participants, screens them for eligibility, Coordinates the schedule of events for clinical trial participants from screening to follow up according to protocol
• 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
• May be responsible for regulatory submissions - Need working knowledge of essential documents and IRB requirements
• Participates in site feasibility determination, site qualification visits, site initiation visits and research related meetings
• May be responsible for recruiting clinical trials to site
• 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

Important Information for California Residents

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).

As a job position within our Clinical Sciences division, a successful completion of a background check may be required as a condition of employment. This requirement is directly related to essential job functions including but not limited to: high-risk working environments (laboratories, clinical settings), handling hazards chemicals or lab specimens, conducting direct patient care, accessing medical and confidential records, access to prescription medication or other drugs, and job duties that can cause serious injury or death as a result of error. 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