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Clinical Research Associate

Employer
Hobson Prior
Location
Homeworking
Salary
£40.00 - £45.00 per hour
Start date
14 Oct 2019
Closing date
11 Nov 2019

View more

Discipline
Clinical Research, Clinical Operations
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

Job Details

Hobson Prior are looking for a Clinical Research Associate to join a biopharmaceutical organisation where you will work 1 day in the office and 4 day working from home. Our client is focused on developing specific therapies that harness the immune system to destroy cancer cells.

Job Responsibilities:

  • Accountable to accelerate the sites qualification and study site initiation processes including the conduct of Site Qualification and Site Initiation visits.
  • Conducts Site Initiation visits in collaboration with Medical Monitors and/or Clinical Project Managers where applicable, to orient and train site personnel regarding the protocol and applicable regulatory requirements regularly.
  • Self-sufficiently performs monitoring visits including site initiation, qualification, routine monitoring and close out visits.
  • Critically reviews and analyses site activities through frequent visits and contacts to monitor study sites following the applicable study plans and applicable SOPs, to assure compliance with the protocol, ICH and/or FDA GCP Guidelines and other local regulations.
  • You will manage multiple protocols, across therapeutic areas, which may require travel, based upon assigned site location and/or geographic territory.
  • Ensures quality of data submitted from study sites, collects data from sites within established timelines and ensures timely follow up/submission on any requested information.
  • Works across functions in the Company to ensure the readiness of supply kits.
  • Ensures site compliance, safety and protection of study patients according to the clinical study plans, SOPs, and ICH and/or FDA GCP Guidelines. Works with site personnel/study team to prevent address and resolve issues
  • Reviews adverse event reports (where required) and ensures site reporting of safety events in a timely manner.
  • Prepares and submits written reports, both monitoring and administrative, in a timely, accurate, concise and objective manner.
  • Interacts and builds professional and collaborative relationships with all study personnel (study coordinator, investigator, pharmacist & cell therapy team members), peers and office-based personnel.

Key Skills:

  • Excellent communication, interpersonal and organisational skills.
  • Effective problem-solving skills.
  • Attention to detail and meet specified timelines.
  • Computer literacy, proficiency in Microsoft Office.
  • Preferably experienced with the use of eCRFs.

Requirements:

  • Previous small pharmaceutical/biotech experience would be preferred.
  • A minimum of 3-5 years' monitoring experience, working as a CRA.
  • Experience in monitoring oncology early phase studies.
  • Experience with ATIMPs an advantage.
  • Strong clinical, technical or disease area expertise.
  • Knowledge of medical terminology and clinical patient management.
  • Bachelor's degree (BSc, BA or RN equivalent) in biological or science-related field is essential.
  • A valid driving license.
  • Thorough knowledge of ICH Guidelines and GCP including a basic understanding of regulatory requirements.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

Company

Providing recruitment solutions across the life sciences industry

Hobson Prior is a leading specialist life sciences recruiter focused on finding and placing outstanding candidates across Europe and the Asia Pacific. We work proactively and with integrity, communicate in a professional and honest manner and invest time to understand and match the exact requirements of our clients and candidates.

Our highly selective clients trust us to source and secure interim and permanent candidates who’ll make a real difference to the success of their business. Our candidates, the best in the industry, often choose to work with us exclusively because we offer the best opportunities in their specialist field.

Representing who we are and what we stand for, our values influence the way we serve our clients and candidates and the way we interact with each other.

We identified them collaboratively – as a team – and so feel 100% invested in them. Together, we think they provide the best possible outcomes all who work with us.

Professional
Our standards are set high. We work to a rigorous set of processes to ensure that our conduct is professional, ethical and delivered with integrity at all times.

Dedicated
We are dedicated to finding the very best solutions for our clients and candidates, always going the extra mile to deliver measureable value.

Experienced
We are guided by our experience and knowledge to provide the best possible service and support to our candidates, clients and colleagues. Our approach is consultative and collaborative.

Specialist
We focus solely on our chosen market, developing expert consultants who know their industry in depth and specialise within it.

Proactive
We find great candidates, developing relationships with them regardless of whether they are actively looking. This means we are able to provide both candidates and clients with unique opportunities.

Ambitious
Driven by results, we have plans to expand across different global regions and markets and have confidence in our ability to grow successfully through our core focus.

Company info
Website
Telephone
01892 612 612
Location
Wellington Gate
7-9 Church Rd
Tunbridge Wells
TN1 1HT
United Kingdom

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