DOCS Global

CRA opportunity with top Admired Pharma 2021/ Home-based/ permanent

2 days left

Location
United Kingdom, UK
Salary
Competitive
Posted
05 Feb 2021
Closes
07 Mar 2021
Ref
26485
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
The role offers ample opportunity to gain ownership of your studies.
Our client are one of very few companies that takes on board your interest whether it is in TA areas, phases or where you would like to be in 5 years' time.

The role will suit and experienced CRA II wanting to utilse their transferable skills within a reputable pharma and take the next step into a Senior CRA or an established Senior CRA wanting to gain the opportunity to work for our top global client.

Responsibilities:

Participates in site feasibility and/or pre-trial site assessment visits, providing recommendation from local area about site/investigator selection in collaboration with the trial team
Acts as primary local company contact for assigned sites for specific trials.
Attends/participates in investigator meetings as needed.
Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs and policies.
Ensures site staff is trained and the corresponding training records are complete and accurate at any time point during all trial phases.
Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.
Ensures that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented as appropriate. For AEs/SAEs, ensures that they are consistent with all data collected and with the information in the source documents.
Maintains complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS, eTMF/IF, Trial Master Source and SharePoint).
Mentoring Junior CRAs

Qualifications/Experience:

A minimum of a BA/BS degree is required. A degree in a health or science related field is preferred.
Must have experience in Clinical Research or equivalent qualification
3 years + experience monitoring on site
Specific therapeutic area experience may be required depending on the position.
Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
Strong IT skills in appropriate software and company systems.
Willingness to travel 2-3 times a week on average across nationwide with occasional overnight stay away from home.
Proficient in speaking and writing the country language and English.
Good written and oral communication skills.
Must have a UK drivers license and a car
Must have the right to work in the UK as we do not provide sponsorship

#cra

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