Location: South East, UK
Closing Date: 11 Nov 16
Salary (£): Competitive
Benefits: 25 days leave, pension, LI, gym subscription contribution, car or car allowance, healthcare benefits
One of our Clients, a top ten pharmaceutical company based in Middlesex is urgently seeking a home based CRA in the London/Southeast area. The role is a permanent position with Chiltern on a very competitive PAYE salary plus benefits. This is NOT a freelance role. You would be employed by CHILTERN and seconded/contracted to the pharma company in question on a 12 months rolling contract.
You would be working from home and managing sites in the London and Southeast - generally between Southampton and Oxford, but there may be the other odd sporadic site in the North of the UK or Ireland. So you need to be OK with the odd overnight stay.
We are looking for someone with passion for what they do, someone who enjoys taking ownership and accountability for their sites performance and essentially someone who has ONCOLOGY experience.
You would work on up to 6 protocols, in different stages of a trial (e.g. start up, recruitment, maintenance, close out), up to 15 sites in total, average 6 patients per site across 6 oncology protocols but there will be chances later on to work on all therapeutic areas (TA) across Phases I to III.
There could be good opportunities to mentor others, take on Subject Matter Expert roles and Lead Site Monitor roles are available.
Key objectives – ownership of site recruitment at a site level – 100% target to be met, data quality, site adherence to data entry timelines, supporting site’s meet database locks.
All new studies will apply Risk Based Monitoring (RBM) – This is an adaptive approach to clinical trial monitoring that directs monitoring focus and activities to the evolving areas of greatest risk which have the most potential to impact subject safety and data quality. RBM involves, on-site, off-site and Central Monitoring.
TO EMPHASISE - this is a FULL TIME HOME BASED role - PAYE paid salary (competitive) with CHILTERN SOURCE - the recruitment arm of CHILTERN INTERNATIONAL. You would be seconded to the pharmaceutical company on a rolling 12 months contract.
Identifies new potential Investigators, through ongoing collaborations with medical monitors (including local staff), field medical personnel, and other medical contacts. Assess potential Investigators and their sites.
Documents the visit, and communicate findings. Provides feedback on Potential Site Assessment findings to collaborators.
Recommends sites for consideration in future studies, as needed.
Expedites the pre-study and study initiation processes including the conduct of Pre-Study Evaluation and Site Initiation visits. Conducts initiation visits in collaboration with Clinical Site Managers, Field Medical and/or Protocol Managers. Orients and trains site personnel regarding the protocol, study related processes and procedures and applicable regulatory requirements.
Reviews site activities and quality through on-site visits in addition to emote management capabilities. Monitors study sites following the monitoring plan, Sponsor SOPs, protocol, ICH/GCP Guidelines and other local regulations as applicable. This includes, but is not limited to: Managing multiple protocols, across multiple therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory.
Ensures safety and protection of study subjects according to the monitoring plan, SOPs, and ICH/GCP Guidelines and local regulations. Ensures quality of data submitted from study sites and assures timely submission of data by using the available systems to follow site activities.
Supervises overall activities of site personnel over whom there is no direct authority. Motivates/influences them to meet study objectives, including enrollment and retention goals. Resolves study site problems/issues as they occur. More complex issues may be resolved jointly with management. Initiates, recommends, documents and communicates corrective actions as needed and follows up to ensure corrective actions are implemented.
Ensures documented follow-up to all outstanding issues/corrective actions, within the scope of this position profile, in the available systems. Appropriately documents and promptly escalates serious or persistent outstanding issues to management and project team.
Facilitates the Regulatory Compliance audit process, as needed.
Prepares and submits written reports, both monitoring and administrative, in a timely, accurate , concise, professional and objective manner.
Identifies opportunities to interact, builds and strengthens professional and collaborative relationships with all internal and external stakeholders (e.g., site and institutional personnel, Thought Leaders, internal colleagues , etc.).
Uses multiple technologies to maintain open and frequent communication with all stakeholders . Exhibits flexibility and adaptability when facing change.
Employs good fiscal management for travel expenses, etc. Ability to perform site management activities, as required.
Performs other tasks, as assigned or requested by line manager.
Please call Marc Joseph on 01753 216664 for further detail or send your CV/application directly to Marc at email@example.com
key words oncology, monitoring, clinical research associate, clinical monitor, CRA, senior clinical research associate, lead CRA, mentoring
171 Bath Road Slough Berkshire
SL1 4AA, UK
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