You are applying for a position through Medix, a staffing agency. The actual posting represents a position at one of our clients.

Job Summary

Our client is seeking a Clinical Research Coordinator II, responsible for the daily operations and management of assigned clinical trials. The role includes administrative duties, regulatory functions, and guiding CRC Is on site SOPs, study protocols, and compliance. Professionalism, ethical conduct, and problem-solving skills are essential in this role.

Key Responsibilities

• Manage and oversee enrollment of clinical trials according to protocol; identify strategies to exceed enrollment goals.
• Collaborate with recruitment and site management to determine best recruitment practices for studies.
• Inform patients or caregivers about studies and associated procedures.
• Monitor study activities to ensure compliance with protocols and relevant regulations.
• Maintain study e-regulatory binders ensuring documentation is accurate and complete.
• Follow site policies, SOPs, assist CRC Is with training as needed.
• Schedule study visits and monitoring activities according to protocol.
• Complete source documentation in real time during patient visits, ensuring adherence to good documentation practices.
• Enter source data into EDC system within one business day; resolve data queries within 48 hours.
• Maintain inventory of laboratory and study supplies to support enrollment and visits.
• Attend investigator meetings, site initiation visits; share study information with the team.
• Maintain accurate study records, including case report forms and drug accountability logs.
• Perform study procedures such as vital signs, ECGs, and specimen collection as required.
• Communicate laboratory findings and adverse events to investigators, ensuring timely reporting and documentation.
• Manage data entry; ensure study timelines are met.
• Handle requisition, storage, and shipment of specimens per protocol.
• Dispense investigational products, ensure accurate dosages, and proper documentation.
• Identify, report, and resolve protocol deviations and unanticipated events.
• Maintain investigational product (IP) accountability and secure storage.
• Maintain study master logs (e.g., informed consent, patient ID, enrollment logs).
• Participate in site quality assurance audits as needed.
• Ensure handling and awareness of safety reports, confirming PI review and required signatures.
• Maintain confidentiality of participant PHI and sponsor data.
• Perform other duties as assigned.

Skills

• Experience as lead CRC on multiple clinical trials preferred.
• Ability to work both independently and collaboratively in a team environment.
• Strong mentoring and training abilities.
• Excellent verbal and written communication skills.
• Proficiency in English (reading, writing, speaking).
• Knowledge of advanced medical terminology.

Education

• High school diploma or GED required (some college preferred).
• Phlebotomy certification as required by state law.

Experience

• 2–5 years of clinical research experience required.

Additional Requirements

• Occasional travel may be required to assist or train at other research sites.

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.

^*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).

Medix Overview:

With over 20 years of experience connecting organizations with highly qualified professionals, Medix is a leading provider of workforce solutions for clients and candidates across the healthcare, scientific, technology, and government industries. Through our core purpose of positively impacting lives, we’re dedicated to creating opportunities for job seekers at some of the nation's top companies. As an award-winning career partner, Medix is committed to helping talent find fulfilling and meaningful work because our mission is to help you achieve yours.

^*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.