Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in Analgesia, Neuroscience, Oncology, Dermatology, Pediatrics, and Rare Diseases.
We’re looking for a talented and energetic Sr. Clinical Research Associate to join our Functional Services team! This is a very exciting opportunity to join a dynamic and innovative team and grow with a forward-thinking organization that is changing to course of medicine.
Working at Premier Research means being an individual - you will be recognized for what you do and you will truly have an impact in an aspiring, empowering and caring culture where people truly work as one team. You can grow and contribute your expertise 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!
As a CRA at Premier Research, you’ll have the opportunity to monitor in diverse therapeutic areas and contribute your monitoring expertise and knowledge to move Premier Research into the future. You’ll perform the management of study site activities to ensure the collection of accurate clinical data within given timelines. You’ll proactively identify, resolve/mitigate and escalates risks and/or issues, may be responsible for multiple studies and must work independently with team support.
What you’ll be doing:
- Monitor data — remotely, on site, and via other approved modes — with a focus on data integrity and patient safety. Ensuring the validity, correctness, and completeness of clinical data reviewed and collected at sites as dictated by trial protocol, ICH-GCP/ISO 141155, and customer requirements.
- Schedule and plan day-to-day activities for study monitoring and setting priorities by site. Maintain contact with investigator sites via telephone calls between visits.
- Gauge the quality of clinical deliverables and addressing quality issues with team members.
- Deliver high-quality, timely monitoring reports for sponsor approval per Monitoring Plan timelines.
- Work with your Line Manager and Clinical Lead to ensure that visit metrics are maintained.
- Participate in Investigators’ Meetings as assigned by Project Managers.
- Ensure adherence to study timelines and budgets.
- Manage query resolution with study sites and Premier Research data management operations. Identify and escalate potential risks and possible retraining opportunities for site study teams.
- Act as a resource for other CRAs, mentor CRAs, sharing your knowledge, expertise and best practices.
- Participate in training offered to increase therapeutic knowledge and keep current with regulations and FDA guidance.
You’ll need this to be considered:
- Bachelor’s Degree or equivalent experience required along with a 5 to 7 years of practical experience conducting continuous independent onsite monitoring of clinical research sites and site management activities.
- Knowledge of ICH/GCP and ISO14155 requirements as well as detailed knowledge of the relevant country specific regulatory requirements for conducting clinical trials.
- Known for being customer-focused in approach to work and communications with the ability to professionally interact with sites, clients, vendors and other functional areas; strong verbal and written communication and negotiation skills
- Maintains a positive, results orientated work environment; excellent team player, collaborative and able to build an effective team.
- Excellent organizational and time-management skills, able prioritize work to meet deadlines; ability to multitask and work effectively in a fast-paced environment with changing priorities; accountable, dependable and strong commitment.
- Ability to travel up to 80%