Job Description
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 skilled Clinical Research Coordinator responsible for coordinating clinical research projects from inception to completion, ensuring compliance with regulatory requirements, and maintaining integrity in data management. Responsibilities - Manage and oversee enrollment of clinical trials according to protocol and identify strategies to exceed enrollment goals.
- Collaborate with the recruitment department and site management to determine best recruitment practices for assigned studies.
- Inform patients or caregivers about studies and associated procedures.
- Monitor study activities to ensure compliance with protocols and all relevant local, federal, and institutional regulations.
- Maintain assigned study e-regulatory binders and ensure all required documentation is accurate and complete.
- Follow all site policies, SOPs, and controlled documents; assist CRC Is with guidance and training as needed.
- Schedule study visits and monitoring activities according to protocol and study plan.
- Complete source documentation in real time during patient visits, ensuring accuracy and adherence to good documentation practices.
- Enter source data into the electronic data capture (EDC) system within one business day of the patient visit; resolve data queries within 48 hours.
- Maintain adequate inventory of laboratory and study supplies to support ongoing enrollment and study visits.
- Attend investigator meetings and site initiation visits, collecting and sharing pertinent study information with the team.
- Maintain accurate and complete study records, including case report forms and drug accountability logs.
- Perform study procedures such as vital signs, ECGs, and specimen collection as required by protocol.
- Communicate laboratory findings and adverse event information to investigators, ensuring timely reporting and documentation.
- Manage data entry and ensure all study timelines are met.
- Handle requisition, labeling, storage, and shipment of specimens per protocol.
- Dispense investigational products or medical devices as required, ensuring accurate calculation of dosages and proper documentation.
- Identify, report, and resolve protocol deviations and unanticipated events.
- Maintain investigational product (IP) accountability and ensure secure, restricted storage.
- Maintain study master logs (e.g., informed consent, patient ID, enrollment, delegation, and training logs).
- Participate in site quality assurance audits as needed.
- Ensure proper handling and awareness of all safety reports, confirming PI review and required signatures.
- Maintain strict confidentiality of participant protected health information (PHI) and sponsor data.
- Perform other duties as assigned.
Required Skills and Abilities - Experience serving 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.
- 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).
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.
Job Tags
Full time, Temporary work, Local area,