Location: Bracknell, Berkshire, UK
Closing Date: 07 Dec 16
Type: Full Time
Salary (£): 30,000 - 40,000
Benefits: Excellent salary, 25 days leave, pension, LI, gum subscription contribution, health benefits
Full Time Office Based UK Study Start Up Specialist Role. Bracknell. Top Class Pharmaceutical Company constantly voted as one of the best companies to work for. You would form part of a dedicated FSP team of start up specialists and CTAs. Excellent benefits, environment and culture.
Our client is one of the best pharmaceutical companies to work for in the UK today.
They are looking for Chiltern to provide them with a UK/Ireland Study Start up Specialist/Co-ordinator. Candidates will be permanently employed by Chiltern and seconded directly to our Client on a 12 months rolling contractual basis. You would be working as part of a Chiltern team of CTAs and start up specialists. This is a full time office based role in Bracknell.
To co-ordinate and facilitate the country and site level set-up activities for clinical trials within the UK and Ireland on behalf of the local study manager (Clinical Scientist, terminology Clinical Monitor Local [CML]), to minimise time to initiation
Where internal resources are limited, to be the primary contact for any 3rd party vendor(s) / CROs required for such set-up services
To support the feasibility process by initiating external research network & site contact under therapy area direction during the initial feasibility request.
Performs set-up activities (national & local site approvals and site contracts) in conjunction with the CML, to ensure the smooth progress of trial set-up.
Pro-actively forecasts the impact of future UK & Ireland trials on set-up resource within the department and makes recommendations of outsourcing trial set-up in order to adhere or decrease submission timelines.
Co-ordinate the outsourcing of trial set-up activities to a 3rd party vendor / CRO, including liaison with Purchasing, CML(s) and other members of the UK & Ireland Clinical Research department where no internal capacity. Liaise with purchasing regarding contracts between our client and 3rd party vendor / CRO to assist in the set-up of clinical trials
Maintain knowledge of and provide specialist advice, support, guidance & training to CMLs concerning external systems, processes & requirements for national & local (ethical/site) approvals in both the UK & Ireland,
in order to improve department knowledge and facilitate the consistent and rapid set up of trials.
Performs feasibility (OPU & site level) activities; coordination of external research network feasibility
and direct contact with sites under therapy area guidance. Also utilize previous site experience to
proactively identify potential issues to enable informed site selection decisions to be made by the CML.
Ensure key dates regarding submissions and approvals are communicated to MAC and CML/CTA in order to keep CTMS up to date. Maintenance of information systems such as the Investigator database and any other repositories as relevant to set-up activities.
Our client is wanting candidates that are confident with IRAS, Ethics submissions and negotiating site contracts etc - possibly sorting out equipment delivery to sites etc and general start up activities......
Benefits to include
25 days leave
contributions towards health/dental/optical costs
Gym subscription contribution
Flexi time – core hours are 10 till 3
One day a month the department goes out to do community/charity work – group bonding etc. Lots of team building days/activities
Personable/friendly team – large open plan office.
Someone who wants to stay long term/career CTA would be ideal
Very high/strong contract culture and virtually no difference for perm staff versus contractors in the way they are treated/rights etc.
They have free car parking on site.
Restaurant/coffee shop access
University Degree preferred, or other significant previous experience in a similar role within Clinical Research.
Good understanding of Ethics Committee submission, Hospital submission and approval systems (e.g. IRAS, CSP), and contracting requirements in the UK & Ireland
Good understanding of feasibility processes in both the UK (NIHR) and Ireland
Proficient and capable in the use of the Microsoft Office Suite (Word, Excel, Outlook etc.)
Trained to a high standard in ICH-GCP
Excellent literacy and numeracy skills
You may have had this experience already within CRO and /or Pharma but we will also look at people from within the NHS if you have experience in governance and have been actively involved in start up activities in the UK to include Ethics and R and D submissions/IRAS
Please call Marc Joseph on 01753 216664 for further discussion/insight into this role. Or send your CV directly to email@example.com
key words study start up specialist, feasibility, CRA, in house CRA, IRAS, ethics, contract negotiation,
171 Bath Road Slough Berkshire
SL1 4AA, UK
|Tel:||+44 (0) 1753 512000|
|Fax:||+44 (0) 1753 511116|
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