Closing Date: 10 Mar 17
Type: Full Time
Salary (£): Competitive
The Clinical Research Associate monitors clinical studies and assures high quality of the clinical data.
Location: Home-based nation wide
Schedule: Full time, 40 hours per week
Therapeutic area: must have respiratory experience
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. We are currently recruiting for a team of staff (CTAs through to Project Managers) to join us for the start of an exciting suite of studies in the respiratory area. We also have a number of opportunities in other therapy areas and this is a unique opportunity to become part of a rapidly growing company.
The Clinical Research Associate III (CRA III) monitors will be home-based within the USA
Main Job Tasks and Responsibilities
•Keeps him/herself professionally abreast of all scientific, regulatory and operative aspects relevant to the clinical projects he/she will be assigned
•Assists in the selection of sites, site evaluation visits, initiation visits and ensuring follow up by obtaining the pre-study documentation to ensure good start-up of the investigation sites
•May acts as Feasibility Associate (FEA) after appropriate and documented training
•Performs training site staff in all study procedures in order to ensure protocol/ICH-GCP compliance
•Conducts and reports periodic monitoring visits in the field and reviews at each visit accuracy, legibility, completeness and quality of Case Report Form (CRF) in compliance with the protocol, SOP's and ICH-GCP requirements in order to ensure data integrity and subject safety
•Conducts source data verification and in house review of clinical data and ensuring timely resolution of data queries to guarantee reliable clinical data
•Manages the investigational products (storage, inventory, dispensing records, packaging and labelling) and the trial material (Investigator study file (ISF), CRF, questionnaires, diaries, etc) to ensure timely and correct supply to the site
•Cooperates with the site staff for ensuring a proper reporting from the site of the safety issues (adverse events and adverse reaction such as AEs/SAEs, SUSARs, etc.) and their follow up, guaranteeing timely and appropriate handling of safety issues
•Conducts and reports study termination and related activities (e.g. archiving) guaranteeing smooth completion of the project
•Is the main contact person for the site in order to ensure close follow up
•Provides general support to the Clinical Research Department North America (CRDT-NA) on quality control of clinical data
•Promptly addresses the Projects Coordinators (PCs)/ Project Managers (PMs)/ Senior Project Managers (SPMs) about any issues that can jeopardize the conduct of the clinical projects assigned
•Reports to the Clinical Research Department North America Vice President (CRDT-NA-VP)/ Clinical Research Department North America Deputy Director (CRDT-NA-DD) on all activities performed during the study and sends all relevant documents according to the timelines and the requirements agreed for each single clinical trial
•Develops training material and gives trainings to CRDT-NA in collaboration with the Training & Qualification Management Unit (TQMU)
•May assist in contract negotiation with sites on study budget after appropriate and documented training
•Assists the preparation of the study including CRF design/development, writes CRF instructions, organizes the study files and documents to ensure good start-up of the investigation sites
•May support the submission process in the project (or region), including submission requirements, timelines, informed consent development, etc. after appropriate and documented training. Accordingly he/she can be required to provide updates on the applicable regulation for the application process in the country of work, whenever relevant
•Guides and supervises Clinical Research Associates I (CRAs I)/ Clinical Research Associates II (CRAs II) in order to coach and train them on the job
Education and Experience
•University Degree in scientific, medical or paramedical degree
•Eight (8) years (at least) of experience as a CRA
•Excellent knowledge of clinical trial operations, GCP/ICH Guidelines and other applicable regulatory requirements
•Fluent in English and local language(s)
•Proficiency in Microsoft Office (e.g. Word, Excel, Outlook)
•Willingness to travel
Benefits we offer!
•Full health insurance benefits that include health, dental and vision.
•401k Plan with 5% company match after satisfying 90 days of employment
•Short term and long term disability insurance
•Paid half day Friday's from July 1st to Labor Day
•Paid vacation, sick leave and holidays
CROMSOURCE Suite 3 Lomond Court Castle Business Park Stirling United Kingdom
|Tel:||+44 (0) 1786 468990|
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