In-House Clinical Research Associate (CRA)
Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality, targeting unmet needs in analgesia, neuroscience, oncology, pediatrics, and rare diseases.
We’re looking for an exceptional In-House Clinical Research Associate to bring your passion to our team. You will be encouraged to grow professionally and personally while enjoying cross-functional partnerships with genuinely supportive colleagues, regardless of location or seniority. Most importantly, you will be using your skills to bring tangible hope to critically ill patients around the world.
At Premier Research, we are science-minded and heart-centered. Join us.
The In-House Clinical Research Associate (CRA) works with clinical project teams and Clinical Research Associates to support the completion of clinical trial documentation processes, budgets, contracts and device management. Provides support to clinical functions and site customers through study and site start up, enrollment, follow up and closure phases of clinical trial activities.
You’ll be accountable for:
- Managing Study Master Files
- Collecting contracts, requesting/collecting relevant (i.e. Regulatory Docs, FDF, CV/ML) investigator/site documentation, reviewing and approving documents in applicable database
- Processing core study documents (upload, assign attributes, file, review and approval in eTMF)
- Ensuring successful study start-up (e.g site initiation visit preparation, product shipment, start of patient enrolment) and study conduct throughout the study
- Ensuring the validity, correctness, and completeness of clinical data reviewed and collected at assigned sites as dictated by trial protocol, ICH-GCP/ISO 141155, and customer requirements, as needed
You’ll be responsible for:
- Monitoring data remotely, as needed, with a focus on data integrity and patient safety, in accordance with specific country regulations
- Working with the line manager and CM to ensure that visit metrics are maintained as required.
- Gauging the quality of clinical deliverables and addressing quality issues with team members
- Managing query resolution with study sites and Premier Research data management operations.
- Maintaining the project tracking system of subjects and site information
- Maintaining contact with investigator sites via telephone calls
- Ensuring adherence to study timelines and budgets.
- Identifying and escalating potential risks and identifying retraining opportunities for site study teams.
- Perform budget negotiations and/or interact with internal legal team , as needed
You'll need this to be considered:
- Bachelor’s Degree or equivalent experience required
- At least 3+ years of relevant clinical research experience
- Background in human clinical study experience required
- Experience working with CTMS and eTMF systems
- Experience with Informed Consent review
- Experience working with Institutional Review Board(s)
- Medical device experience preferred, not required
- Must be located in the Greater Los Angeles area