Senior Clinical Research Associate
- Experience Level
- Experienced (non-manager)
Do you want to watch clinical development change, or do you want to be the one to shape it?
Because we’re hoping you’re here for the latter.
PRA remains at the forefront of digital health and our Mobile Health Platform allows for decentralized clinical trials which enables us to engage with patients virtually and in real time wherever they are in the world. Our digital health solutions leverage the technology at our patients fingertips – smartphones, laptops, activity trackers , tablets and more – to engage them in real time.
Be part of a company that is leading the way in shifting clinical research away from traditional models and creating the opportunity for better science.
As a Senior Clinical Research Associate, you will be dedicated to one of our global pharmaceutical clients; a prestigious organization, specialising in a niche rare disease, complemented by a pipeline in other therapeutic areas, including oncology. A company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership.
What will you be doing?
As a Clinical Research Associate, you will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
- Applies knowledge of PRA’s policies and procedures
- Demonstrates excellent written and oral communication
- Demonstrates excellent knowledge of ICH/GCP
- Displays ability to manage investigative sites to facilitate trial deliverables
- Demonstrates ability to escalate issues appropriately
- Conducts monitoring to confirm subject safety and data ntegrity
- Describes and demonstrates the principals of IP accountability
- Identifies scientific misconduct at the site level
- Demonstrates working knowledge of Microsoft Office applications, Clinical Trial Management Systems, IVRS/IWRS and Electronic Data Capture platforms
- Mentors CRAs new to the position or company
- Serves as an observation visit leader
- Conducts monitoring evaluation visits
- Assists team lead in the development of trial tools or documents
What do you need to have?
Education: Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required
- Read, write and speak fluent English; fluent in host country language required.
- 4+ years of clinical monitoring experience required
- Knowledge of ICH and local regulatory authority regulations regarding drug
- Clinical research experience
- An advanced degree (e.g., M.S., M.B.A., PharmD, etc)
- Experience in monitoring all trial components (PSSV to COV)
- Experience in coaching/mentoring other CRAs
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.