Job Details

Job Summary:

Chiltern work in collaboration with Allergan, a global healthcare company, through a Functional Service Provider contract to provide CRA resource across Europe (primarily Western Europe).

Requirements:

Founded in 1950, Allergan has approximately 5,000 employees worldwide and is global specialty pharmaceutical company that develops and commercializes innovative products for the eye care, neuromodulator, skin care and other specialty markets. Therapeutic areas covered by Allergan include glaucoma, retinal disease, dry eye, pain, movement disorders, plus retinoid technology platforms with applications in psoriasis, acne, photo-damage, metabolic disease and various types of cancer.

As part of the FSP programme, we are now looking to recruit a CRA within the UK to join the Chiltern Monitoring Team. This will start in Autumn 2012, field based anywhere in the UK, full time.

Expectations of the role:

The primary duties for the CRAs placed within the Allergan FSP are as follows:

To prepare and conduct all site visits including, but not limited to, qualification visits, initiation visits, monitoring visits, motivational visits, audit support visits, and termination visits in accordance with study monitoring plan and ALLERGAN’s SOPs.

Develop and maintain good working relationships with assigned study sites in order to effectively manage each site through the clinical trial and be proactive in dealing with any issues, e.g. recruitment

Document all site visits within visit reports in a timely manner (first draft submitted within 5 working days; final report within 10 working days)

Appropriate follow-up with sites after monitoring visits to document findings and resolution of identified issues.

Be an integral team member and support the study team to ensure the smooth-running of the clinical trial

Update all Allergan Clinical Trial Systems as required to provide effective study status updates for assigned sites

Sites to be maintained to an inspection-ready standard. CRAs will be expected to prepare and attend any audit / inspection as required and complete any corrective and preventative actions as required from audit / inspection reports.

An FSP CRA can expect to be assigned to 10 to 12 sites across 2 – 3 protocols

Performance and Quality Expectations:

To perform 8-10 site visits per month

To complete a first draft of the site visit report within 5 working days of the site visit and to ensure finalization of the visit report within 10 working days of the site visit

To attend, actively participate and complete required training documentation in all relevant training and SOP training sessions in a timely manner or as directed by the Chiltern Line Manager or Allergan RAM.

CRAs with a minimum of 2 years experience

Life science degree or equivalent

CRA has not been barred or otherwise sanctioned by a relevant regulatory agency

Experience in performing all visits types: SQV, SIV, SMV, and COV

Experience across a number of phases (primarily Phase III)

Demonstration of knowledge and competence using electronic systems e.g. CTMS, eCRF

Basic IT competence required (email, internet, word, excel)

Good standard of oral and written English

Previous home-working experience (if not, need to work from the office for a period of time first before becoming home-based)

Profile and ambition consistent with a “career CRA”

 

Key Words Clinical Research Associate, Monitor, Clinical Research Monitor, Senior Clinical Research Associate