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Job Details

Senior Clinical Research Associate (CRA)

Company: ProClinical Ltd
Location: Aberdeen
Reference: CR.BK.15455
Closing Date: 01 Mar 18
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

Our client, a specialist pharma, is seeking a SCRA to join their team. The company is a leading in the live biotherapeutic products (LBPs) field and boasts an innovative pipeline of preclinical programmes in autoimmunity, inflammation, oncology and CNS disease. This position would suit an individual with both CRO and Pharmaceutical experience who is ready for the next chapter in their career, involving less direct on-site monitoring and more internal study management. ...

Requirements:

Our client, a specialist pharma, is seeking a SCRA to join their team. The company is a leading in the live biotherapeutic products (LBPs) field and boasts an innovative pipeline of preclinical programmes in autoimmunity, inflammation, oncology and CNS disease. This position would suit an individual with both CRO and Pharmaceutical experience who is ready for the next chapter in their career, involving less direct on-site monitoring and more internal study management.

Job Role:

* Report to the Clinical Operations Director
* Have line management responsibility for a small growing team of Clinical Trial Associates and Junior CRAs as the company continues to expand
* Managing CROs who have the responsibility of taking the company's pipeline into the Clinic on an international basis
* Co-monitoring and being the primary point of contact for the CRO core team.

Key Areas of Responsibility

* Internal study management (document review and approval/ budget and timeline review) of growing pipeline of compounds outsourced to CROs
* Development of a monitoring program, based on a risk-based approach for all active studies to ensure
* Sponsor oversight compliance
* Develop Monitoring SOPs as required
* Attend site visits with CRO personnel to review processes and develop relationships with investigators
* Form strong and productive relationships with peers and works collaboratively with key cross functional teams within the company structure
* Champions effective coaching and development of more junior members of the team and helps to support the Clinical Operations Director in retention of high value performers
* Involvement with on-going CRO selection
* Helps and support the Clinical Operations Director in the development of Clinical department working practices and processes as required

Essential Experience

* Recent role within a CRO/ Pharmaceutical or Biotech Company
* Direct and recent (within the last two years) on-site monitoring experience
* Detailed knowledge of ICH/GCP, recent updates and adaptive monitoring approaches
* Previous involvement with Investigator Meetings and Site training
* Significant understanding of core teams within the Clinical Trial setting; Regulatory, Safety, Medical writing, Data Management, statistics and IMP management
* Ability to work effectively and independently to fast-moving timelines within a fast-paced working environment
* A flexible and collaborative nature
* Operationally strong and delivery focused
* Ability to travel as required within the UK and outside (current full driving licence and valid passport)
* Fluent in written and spoken English

Desirable Experience:

* Line management
* CRA Team training
* Lead CRA experience on a global study
* Oncology/Respiratory and Gastroenterology Therapy experience
* Global Awareness and cultural sensitivity
* Experience with Electronic Clinical Outcome Assessment (eCOA)
* Qualifications Required
* Degree in a health or scientific discipline or relevant industry experience of 10 years or more
* At least 5 years CRA experience (including feasibility assessments/ site management/ direct sitemonitoring and eCRF processes)

To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Badria Kahie on +44 203 871 8094 or upload your CV on our website - www.proclinical.com. A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Apply for this job: Senior Clinical Research Associate (CRA)

Contact Information:

Address:  ProClinical Ltd
Eldon House Eldon Street London
EC2M 7LS
England
Tel:  0800 988 4437
Fax:  +44 (0)207 834 9470
Website:  Visit Our Web Site

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