What are the responsibilities and job description for the In-House Clinical Research Coordinator (CRC) / Clinical Trial Associate position at Research & Development Institute, Inc.?
Job Title: In-House Clinical Research Coordinator (CRC) / Clinical Trial Associate
Location: Van Nuys, Los Angeles
Job Type: Full-Time
About us: Research & Development Institute (RDI) is a tech-enabled CRO that helps In Vitro Diagnostic manufacturers who struggle to get FDA clearance for their products by sourcing the blood samples they desperately need through physicians and labs.
Overview:
We are seeking a highly organized and detail-oriented Clinical Research Coordinator (CRC) to join our team. This is a great opportunity for a research coordinator to work on the Sponsor side and learn trials from another perspective. The ideal candidate will play a pivotal role in coordinating and managing clinical research studies at our sites, ensuring adherence to protocols, regulatory requirements, and ethical guidelines. This position is an in-house role, meaning the candidate will work directly with sites nationwide and be actively involved in the daily operations of clinical trials.
This is a special opportunity as we are a very site friendly CRO so not many Sponsors have this position on their team. Great way to transition and eventually get on the path to being a Project Manager at a CRO.
Key Responsibilities:
- Coordinate and oversee all aspects of clinical research studies at our trial sites, including helping them with recruitment, enrollment, and retention of participants.
- Assist in the preparation and submission of regulatory documentation (IRB submissions, informed consent forms, etc.).
- Monitor and ensure compliance with Good Clinical Practice (GCP), FDA regulations, and study protocols.
- Schedule and conduct study visits, including administering patient assessments and collecting data.
- Maintain accurate, up-to-date case report forms (CRFs) and study files.
- Communicate regularly with Principal Investigators (PIs), study sponsors, and other research staff to ensure effective study management.
- Ensure proper documentation of adverse events (AEs) and serious adverse events (SAEs) according to protocol.
- Provide support for site initiation, monitoring visits, and close-out activities.
- Coordinate lab tests, imaging studies, and other diagnostic procedures required for the trial.
- Ensure the study site is in compliance with clinical trial standards and federal regulations.
- Assist with training and mentoring new research staff as needed.
- Handle study-related queries from participants, research teams, and sponsors.
Qualifications:
- Bachelor's degree in Life Sciences, Nursing, or a related field (or equivalent experience).
- Minimum of 1-2 years of experience as a Clinical Research Coordinator or Clinical Research Assistant (preferably in an in-house setting).
- Knowledge of ICH-GCP, FDA regulations, and other clinical trial regulations.
- Strong communication and organizational skills.
- Ability to manage multiple tasks and priorities effectively.
- Proficient in Microsoft Office Suite and clinical trial management software (e.g., Veeva, Medidata).
- Ability to work independently and in a team environment.
Preferred Skills:
- Certification in Clinical Research (CCRC, ACRP, or SOCRA).
- Experience with electronic data capture (EDC) systems.
- Familiarity with specific therapeutic areas (e.g., oncology, cardiology, etc.).
Working Conditions:
- In-office work with no travel
Salary : $80,000 - $90,000
