Clinical Research associate

JOB SUMMARY

This is an exciting opportunity to join a medical device company as a CRA and be part of their innovative technology.

The Clinical Research Associate (CRA) is involved in all stages of the clinical study, including assisting with identifying and assessing investigational sites and investigators and setting up, initiating, monitoring, and closing down the study. However, this role will focus mainly on post marketing and study start up.

There is very limited travel in the role so perfect for the CRA who is looking to get their work life balance back!

REQUIREMENTS

• Contribute to the development of clinical study protocols, case report forms (CRFs) and other study materials
• Assist in identifying and to assess the suitability of facilities to use as the clinical study site
• Assist in identifying/selecting an investigator who will be responsible for conducting the study at the local study site
• Liaise with investigators and site research teams to prepare the necessary documentation for the Ethics Committee (EC) and to manage any EC questions
• Coordinate the execution of study agreements
• Set up the study sites - ensuring each site has the study materials and conduct site initiation visit and site staff study-specific training
• Develop and maintain strong and effective relationships with all site personnel through regular communication throughout the study duration with key focus on driving study recruitment and compliance in accordance with the protocol
• Identify, evaluate, report and ensure adequate follow-up of adverse events per study protocol, company SOPs and applicable regulations
• Prepare and conduct on-site study monitoring visits throughout its duration verifying that data entered on to the CRFs is consistent with patient clinical notes
• Coordinate the collection of completed CRFs from study sites
• Write high quality and accurate visit reports and follow –up with sites on outstanding items Perform the close-out activities on completion of the study
• Maintain and file study documentation in an organised manner and archive following study closure
• Prepare data for final analysis and contribute to final study summary report as requested
• Assist in the preparation and/or review of conference abstracts, manuscripts for the assigned studies
• Monitor the costs of the assigned studies to be in line with the agreed budget and escalate where differences are identified
• Contribute to development of regulatory documentation for Regulatory Authority applications/ approvals and or renewal
• Provide data summary and updates of the assigned studies for the internal Product Annual Brand Risk Reviews
• Participate in the review of departmental SOPs
• Adhere to Quality Management System (QMS) requirements in line with ISO13485 QMS & Good Manufacturing Practice (GMP) FDA21 CFR Part 820
• Ensure that process & timeline requirements for Corrective & Preventive Actions (CAPA) are met in accordance with Standard Operating Procedures (SOP’s) and in support of Global Objectives for CAPA

LOCATION

Cirencester, UK

DURATION

Permanent

SALARY

Competitive

ABOUT PLANET PHARMA

Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its headquarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering.

Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing.

We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.

www.planet-pharma.com

TO APPLY

• If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone on +44 (0) 20 3928 8388 or e-mail on jsmith@planet-pharma.co.uk
• If this role is not suitable for you, please let us know if you can refer anyone – any recommendations are much appreciated! Planet Pharma offers a competitive referral scheme so you will be rewarded for your help!