Senior CRA, Medical Device (Home-based, US)
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 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 Clinical Research Associate (CRA) is accountable for conducting monitoring activities of assigned clinical trials in compliance with the protocol, ICH-GCP/ISO14155 and all applicable local laws and regulations, company policies and quality standards. He or she performs the management of study site activities to ensure the collection of accurate clinical data within given timelines. The CRA proactively identifies, resolves/mitigates and escalates risks and/or issues, may be responsible for multiple studies and must work independently with team support.
You’ll be accountable for:
- Delivering high-quality, timely monitoring reports for sponsor approval per Clinical Monitoring Plan timelines.
- Scheduling site visits for monitoring as required by protocol monitoring visit windows.
- 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.
You’ll be responsible for:
- Monitoring data — remotely, on site, and via other approved modes — with a focus on data integrity and patient safety, in accordance with specific country regulations.
- Planning day-to-day activities for study monitoring and setting priorities by site.
- Preparing for and conducting qualification, study initiation, interim monitoring, and close-out visits at investigator sites.
- 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.
- Providing accurate and timely trip reports and records of hours worked.
- Managing query resolution with study sites and Premier Research data management operations.
- Maintaining the project tracking system of subjects and site information.
- Participating in Investigators’ Meetings as assigned by Project Managers.
- Maintaining contact with investigator sites via telephone calls between visits.
- Ensuring adherence to study timelines and budgets.
- Identifying and escalating potential risks and identifying retraining opportunities for site study teams.
You’ll also contribute by:
- Being a resource for other CRAs, mentoring CRA's as appropriate and sharing knowledge and best practices.
- Participating in training offered to increase therapeutic knowledge and keeping current with regulations and FDA guidance.
- In specific countries or situations, assuming country-specific responsibilities and/or being named a subject-matter expert in one or more areas; e.g.: start-up, regulatory, site contracts, office management.
- Assuming additional duties on certain projects, such as clinical management for smaller or less complex studies.
Experience and Qualifications
- Bachelor’s Degree or equivalent experience required
- At least 7 years of on-site monitoring experience with all types of site visits
- Travel requirement up to 75%
- Medical device experience preferred, not required