SCRA / Senior CRA / Senior Clinical Research Associate - Spain in Madrid

Sr. Clinical Research Associate / SCRA / Snr CRA / Senior Clinical Research Associate

Spain, Home-based, 18-24 month Fixed term contract, one position.

Scope:

* Perform all required activities to ensure appropriate monitoring of investigator sites and trial execution under the supervision of the COM - typically for clinical trials of larger scope and/or higher complexity which, as compared with the CRA level, may include:

o Greater number of sites

o Greater number of trials

o Complex design and protocol

* Primary person responsible for management of assigned sites, including acting as central point of communication between Novartis and Investigator sites (except when assigned to a trial performed through a CRO - see below)

* May have management responsibility of CRA and Jr. CRAs

Main Activities:

When Assigned to In-House Studies:

* Perform monitoring visits according to monitoring plan (including trial initiation, training and closeout activities)

* Participate in site nomination process, perform evaluation of site capability and make recommendation for inclusion in clinical trial

* Point of contact for sites and facilitator of communication between sites and key Novartis line functions

* Ensure preparation, collection and distribution of trial master file documents and maintenance of investigator site file

* Timely write-up of study monitoring visit reports

* Set up and ensure maintenance of investigator site file

* Manage site vaccine supply and sample management during course of study

* Ensure site performance in line with milestones and KPI's (i.e. start-up, recruitment, closeout, etc.)

* Support investigator in implementing appropriate contingency plans as needed

* Assure continual compliance with GCP, ICH and Novartis SOPs in informed consent process, source data verification, AE and SAE reporting, protocol execution, vaccine accountability, and other tasks as specified. Resolve deviations to standard through remedial action and training

* Escalate any issues regarding study conduct to his/her manager as needed

When assigned to CRO Trials:

Many of the above responsibilities could still apply but primarily their role in these cases is:

* Support CTM as required in relationship management tasks (e.g. contracts, sample management, supplies, etc) and evaluating CRO and site performance

* Review CRO monitoring visit reports and ensure appropriate follow up and escalation of issues identified; occasionally, co-monitoring with CRAs from CROs

Required education and experience:

* A higher education degree in a scientific, health care, or other re-lated discipline required. Relevant experience in lieu of formal education as an exception only

* Excellent knowledge of written and spoken English (and local language as applicable)

* 3-5 years field monitoring experience

* Understands and can apply knowledge of clinical trial designs to trial execution

* Advanced knowledge and experience with international standards (GCP/ICH), international and national (FDA, EMEA) and local regulations

* Expertise in communication, managing multiple priorities and computer literacy

Keywords: "Senior Clinical research associate" "scra" "snr cra" "snr clinical research associate" "cra" "senior monitor" "senior clinical monitor" "clinical research" "clinical trials" "clinical studies" "pharmaceuticals" "pharmaceutical" "cro" "clinical research organisation" "clinical" "ich gcp" "ich-gcp" "spain" "madrid" "barcelona" "alicante" "granada" "infectious disease" "immunology" "IID" "Respiratory"

This position, SCRA / Senior CRA / Senior Clinical Research Associate - Spain in Madrid, was posted on July 30, 2010. The job is located in Madrid. The employer is Novartis. Since this job has been published, it has been viewed 69 times.