Company: Docs Global (Continental Europe)
Reference: Ref AS-019418
Closing Date: 25 Feb 17
Salary (£): Competitive
Benefits: Excellent & Comprehensive
DOCS has partnered with a highly prestigious organization with one of the most robust pipeline within the industry. A fantastic opportunity for an experienced clinical research professional that is ready to take on a new challenge and further develop their career!
Roles & Responsibilities of the position
1. 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
2. Acts as primary local company contact for assigned sites for specific trials.
3. Attends/participates in investigator meetings as needed.
4. Responsible for executing activities within site initiation and start-up, site monitoring, site management and site/study close-out according to internal SOPs/WIs/IFUs and policies.
5. Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases.
6. Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
7. Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.
8. Ensures that clinical drug supplies are appropriately used, handled and stored and returns are accurately inventoried and documented.
9. Arranges for the appropriate destruction of clinical supplies
10. Ensures site staff complete the data entry and resolve queries within expected timelines.
11. Ensures accuracy, validity and completeness of data collected at trial sites
12. 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.
A minimum of a BA/BS degree is required.
A degree in a health or science related field is preferred.
A minimum of 2-3 years of clinical trial monitoring CRA experience is a must.
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 with occasional overnight stay away from home.
Proficient in speaking and writing the country language and English. Good written and oral communication skills.
For an immediate consideration please send your most recent resume to firstname.lastname@example.org or contact me on 0036703831286
This is an excellent opportunity that should not be missed, don’t miss out and apply today!
DOCS has grown to become the premier resourcing provider of global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997 we are driven by our core values that guide our culture and support our goal to become a Trusted Partner. Our five core values are: Our People, Excellence, Accountability, and Integrity.
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2 Globeside, Globeside Business Park
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