Description:
Job Title: Senior Clinical Research Associate

Location: England, UK

Schedule: Part time - 0.2 FTE

TalentSource Life Sciences is searching for an experienced freelance Senior Clinical Research Associate in England, UK to conduct oversight and monitoring activities for an Expanded Access Program. This will be covering up to 15 sites, requiring 1 visit per year and remote monitoring activities. The anticipated start for this role will be July 2019.

The successful candidate will be working on studies dedicated to one client , a leading global pharmaceutical company. As a client-facing role, we are looking for confident candidates with strong site management skills and the ability to work independently whilst establishing a high-trust environment with the client counter-parts.

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your TalentSource Line Manager.

Responsibilities:

• Remote monitoring during whole data collection
• Check EAMS Enrolment forms and provide operational approval for patient's Enrolment in the EAMS treatment program
• Review data entered in the eCRF
• Ensure centres to comply with safety reporting, enter data in eCRF and address queries, if pending
• Answer centres' questions, monitor centres patient status, and contact each centre quarterly
• Co-monitoring visits with Medical Advisor (1 visits per site in the 1st year)
• Check ICF signatures
• Identify data reporting process at each centre
• Confirm drug receipt and dispensing process is in place at each centre
• Help and support centres to avoid inconsistencies in data reporting
• Document tracking and electronic filing, including tracking and checking ICFs at site, and documenting contact with centres.
• Complete Early Access training at start of involvement, including training on the disease area, Sponsor SOPs, data collection, Protocol and processes training, and eCRF & TCS training.
• Attend TCs with Project Manager and Medical Advisor twice per month, in addition to ad-hoc calls as required.

Education/Qualifications:

• BSc in Life Sciences, nursing degree or equivalent.
• Experience, Skills, Knowledge
• Strong monitoring and submissions experience is essential
• Previous experience working on Nutrition studies
• Up to date knowledge of ICH-GCP
• Ability to learn and apply SOPs and other current regulations
• Excellent inter-personal skills and the ability to persuade others
• Strong written and verbal communication skills
• Willingness to travel as required

If you have the experience needed for this position, please apply directly to https://www.talentsourcelifesciences.com/job-information/?job-id=HQ00001796 .

If you would like to discuss the role before applying through the website, please contact Laura.Guascone@cromsource.com for more information.

Why choose TalentSource Life Sciences/CROMSOURCE?

CROMSOURCE is a family owned international, full-service Contract Research Organisation who, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. TalentSource Life Sciences is a fully dedicated flexible resourcing unit within CROMSOURCE and the successful growth has been achieved by putting high quality and client focus at the heart of everything we do.

Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.

Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are providing expert people. Highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world. Our large management team consists of a people with an extended experience within pharma and a high level of market knowledge

CROMSOURCE comes from the merger of MSOURCE and CROM in 2011 and we are great at recruitment and staffing services! We're proud to partner with the industry's leading Pharmaceutical, Biotechnology, Medical Device and Marketing Communications worldwide, securing great global talent. We our open, friendly and approachable and aim to support you through the recruitment process every step of the way.

For the client client-facing positions, the successful candidates must be confident and be able to drive the role and themselves and to work autonomously in close liaison with a line manager at TalentSource, who will provide you with mentoring and guidance. Most of our roles are permanent positions with CROMSOURCE and you will be working on studies for just one client.

How can we help you on your next career move? Learn more on LinkedIn, YouTube, Facebook, Twitter, and Glassdoor.

Keywords: CRA, SCRA, Clinical Research Associate, Clinical, CRO, Pharmaceutical, Monitor, GCP, Early Access, Expanded Access, Freelance, Contractor, Contract, Temporary, Contract Research Organisation, Pharma

Skills: Early Access, Clinical Operations Director, Senior Clinical Research Associate, GCP, Clinical, CRO, Monitoring, Pharma, Pharmaceutical Location: United Kingdom