Clinical Research Associate - UK/EU
Charlene Dutchman at CK Clinical is recruiting for a number of Clinical Research Associates to join an expanding international Clinical Research Organisation, on a full time, permanent, basis. In the past 12 months, our client has expanded into 17 new countries, with offices opening across the globe. For these particular positions, our client is seeking candidates to be based in Germany, Austria, Poland, Italy, Scotland and Dublin.
As a Clinical Research Associate you will be involved in some of the most prestigious drug development projects for a number of leading global pharmaceutical companies with the opportunity to develop progress and travel globally. You should have an understanding of the drug development process, and have significant experience within CRA role.
You will identify, select, initiate and close-out appropriate investigational sites for clinical studies. The successful candidate(s) will monitor these sites in order to ensure compliance to the study protocol, Standard Operating Procedures, applicable regulations, and the principles of ICH-GCP. The CRA will also be charged with ensuring the quality and integrity of data, compliance with relevant SOPs and regulatory requirements and study completion on time and within budget.
Key Accountabilities/Responsibilities of a Clinical Research Associate will include the following:
- Monitoring clinical trials to ensure absolute adherence to Good Clinical Practice in accordance with ICH-GCP standards, Declaration of Helsinki, Federal Regulatory Requirements and study procedures.
- Site management to ensure proper adherence to protocol, source data verification and assess CRF entries.
- Developing, reviewing and editing clinical trial related documentation including but not limited to; Case Report Forms, Informed Consent Forms, study specific handbooks, guidelines and checklists.
- Assisting with study protocol design, development and / or review if required.
- Completing and compiling all necessary research, documentation and information to gain appropriate regulatory and ethical committee approval where required.
- Performing pre-study initiation, interim monitoring and close out visits as required.
- Carrying out drug formulation administration procedures and documentation records.
- Ensuring adequacy of drug shipment and drug accountability.
- Liaising with the Medical Monitor, Principal Investigator, clinical operations staff and sponsor representatives as required.
- Organising / attending investigator meetings as required.
- Providing support to the Project Manager / Country Manager with ad-hoc tasks as required.
As a Clinical Research Associate, you will have the following qualifications, skills and experience:- Bachelors degree, equivalent or higher qualification within Medicine, Biological Science, Nursing or a relevant life sciences discipline.
- Clear understanding of the drug development process.
- Significant experience in performing a Clinical Research Associate role.
- Work experience within either a hospital, medical / research centre environment, Contract Research Organisation or Pharmaceutical company.
- Proven track record of adherence to ICH-GCP and applicable local regulatory requirements during the conduct of clinical trials.
- Ability to contribute to the development of clinical trial related documents and materials.
- Ability to independently perform pre-study initiation, interim monitoring and close out visits as required.
- Good communication skills including the ability to present complex information to both clinical and non-clinical disciplines.
- Excellent presentation skills including the ability to meet exacting standards and a keen attention to detail.
- Fluency in local languages (both written and spoken).
- Willingness and ability to travel.
- Willingness and ability to be Home/Office based.
For more information or to apply for this Clinical Research Associate position please contact Charlene Dutchman on 01246 45 77 33 or email firstname.lastname@example.org. Alternatively, please click on the link to apply online now.
CK Clinical is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL34977 in all correspondence.