Clinical Research Associate
A pharmaceutical consultancy is looking for an experienced CRA (Clinical Research Associate) to join their team in London. This position is a homebased vacancy but gives you an opportunity to establish your clinical career at a well-respected CRO.
- The Clinical Research Associate (CRA) 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.
- Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines
- Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites
- Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely
Provides regular site status information to team members, trial management, and updates trial management tools
- Completes monitoring activity documents as required by PRA SOPs or other contractual obligations
- Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues
- Escalates site and trial related issues per PRA SOPs, until identified issues are resolved or closed
- Performs essential document site file reconciliation
- Performs source document verification and query resolution
- Assesses IP accountability, dispensation, and compliance at the investigative sites
- Verifies Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines
Skills and Qualifications
- Academic degree in life science, health care or similar
- At least 5 years of experience from managing clinical studies
- Good understanding of ICH-GCP and regulatory requirements
- Good ability to express him-/herself both verbally and in writing, in English and Danish.
- Ability to prioritize and handle several studies/tasks simultaneously
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical and medical device companies.