Senior In-House Clinical Research Associate (CRA)
Premier Research helps highly innovative bio-pharmaceutical and medical device companies transform life-changing ideas into reality. We take on the most challenging areas of study, with a special focus on unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research.
We’re looking for a talented and energetic Senior Inhouse CRA to join our team!
Working at Premier Research means being an individual - you will be recognized for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority. Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
The Inhouse 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 5 years of related 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