Hybrid In-House Clinical Research Associate

Job Summary

Hybrid In-House Clinical Research Associate position for a CRO

Responsibilities / Job Duties

• Retrieve, file, and maintain essential regulatory documents from clinical trial sites for the Trial Master File (TMF) or another central documents file platform or system
• Review site essential regulatory documents for accuracy and completeness as required by FDA regulations, ICH GCP, Sponsor requirements, and corporate or Sponsor SOPs.
• Track essential regulatory documents in a centralized web-based system and/or other database.
• Troubleshoot essential regulatory document issues by applying existing knowledge to solve new problems.
• Coordinate or assist in distribution of trial-related materials to study sites.
• May assist in monitoring visit preparation and/or follow up such as teleconference arrangements, regulatory file review, and agenda preparation

Education

• Bachelor's Degree

Qualifications

• Understanding of medical and clinical trials terminology.
• Ability to negotiate with investigators, research nurses, and site staff to reach desired resolution.
• Able to work independently or with minimal supervision as well as within a team.
• Excellent attention to detail with organizational and prioritization skills for efficient productivity.
• Proficiency with Microsoft Office is required (MS Word, Excel, Outlook at a minimum).
• Excellent professional writing and verbal communication skills (position requires clear phone and email communication).
• Able to multi-task during the review/processing and preparation of essential regulatory documentation.
• Must be self-motivated, with a positive attitude, and willing to ask questions to get the job done right.
• Must have excellent time management skills, able to adhere to strict timelines and expectations.

Experience

• Must have at least 2 years experience working at a CRO.

Schedule/Shift

Monday-Friday 9am-5pm

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).

* 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.