Interim Clinical Research Associate / CRA

Recruiter
Axess Ltd
Location
Buckinghamshire
Posted
12 Jan 2018
Closes
11 Feb 2018
Sector
Healthcare
Contract Type
Contract
Hours
Full Time
Our global pharma company client is looking for a CRA to join their team on a 12 month contract and provide monitoring support in late phase development across multiple therapeutic areas.

BACKGROUND:

12 month day rate contract

Office based with 40% UK travel and occasional EU travel

Global organisation - top 20 pharma

PRIMARY DUTIES

- Conduct feasibility, pre-selection, initiation, monitoring and close-out visits of company clinical studies in accordance with relative SOPs and regulations. Ensure complete and efficient exchange of information between the investigator site and company by regular on-site visits, telephone calls, email etc.
- Assure rapid retrieval of all clinical data, especially with regards to reporting of (serious) adverse events, in accordance with relevant protocol and company SOPs.
- Establish/maintain a working relationship with investigators and relevant site staff.
- Ensure high quality clinical data by detailed monitoring of data, source data verification, query resolution and maintenance of equipment etc.
- Ensure that all necessary documents are in place for release of study medication to site, monitor drug accountability at site, account for all medication (used/unused) and ultimate destruction.
- Be responsible for filing and maintenance of Site Files for assigned sites, and where relevant, Country Files (ie periodically reviews files and maintains checklist).
- Assist in MREC and R&D application for studies.
- Assure that all necessary approvals and documents are available/signed before/at site initiation.
- Liaise with CTA in preparing site payments and track payments versus schedules.
- Maintain site status in relevant CTMS and ensure training is maintained

QUALIFICATIONS / EXPERIENCE REQUIRED:

- Monitoring experience (Phase II/III or IV) preferred but an experienced CTA would be considered
- A good understanding of clinical guidelines & SOPs
- Knowledge of RAVE & IMPACT would be useful but not essential
- The ability to communicate effectively across a broad group from Medics & Patients to Investigators and internal colleagues
- A clean, current UK driving licence

Benefits:

Day rate

TO APPLY:

For a confidential discussion please telephone Sukhveer Gill at AXESS Limited on ************** To apply, please send your CV to **************** quoting reference EM-7014.

ABOUT AXESS:

AXESS has been operating since 1990

We are a recruitment business dedicated to the pharmaceutical industry, specialising in Medical Affairs, Regulatory Affairs & Clinical Development

We match professional candidates to the best permanent, contract and interim roles in the market