The Senior Clinical Research Associate 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 ensuring 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.
Responsibilities of the Senior Clinical Research Associate:
Monitor 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
Develop, review and edit clinical trial related documentation including but not limited to; Case Report Forms, Informed Consent Forms, study specific handbooks, guidelines and checklists
Assist with study protocol design, development and / or review if required
Complete and compile all necessary research, documentation and information to gain appropriate regulatory and ethical committee approval where required
Perform pre-study initiation, interim monitoring and close out visits as required
Carry out drug formulation administration procedures and documentation records
Ensure adequacy of drug shipment and drug accountability
Liaise with the Medical Monitor, Principal Investigator, clinical operations staff and sponsor representatives as required
Organise / attend investigator meetings as required
Provide support to the Project Manager / Country Manager with ad-hoc tasks as required
Bachelors degree, equivalent or higher qualification within Medicine, Biological Science, Pharmacology, 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 English and German (both written and spoken)
Willingness and ability to travel
Willingness and ability to be Home based in Country
Experience across a wide range of clinical indications / therapeutic areas
Ability and experience to work with an electronic case report form (eCRF)
Membership of local professional bodies or international clinical groups
Ability to mentor, train, supervise and inspire confidence in newcomers to the industry
Clintec is a dynamic, UK headquartered, privately owned, full service Contract Research Organisation with a presence in over 50 countries worldwide. We have been providing clinical research support services to clients in the pharmaceutical, biotechnology and medical device industries and assisting in their key product development efforts for over two decades. At Clintec we have experience in managing clinical trials in all major therapeutic areas including oncology, rare disease, neurology, cardiovascular, psychiatry, infectious disease, rheumatology, immunology, respiratory and gastroenterology.
Clintec employees can expect to receive expert training and guidance throughout their careers as well as the opportunity to be involved in every aspect of Clinical Trials across the full life-cycle of the drug development process from the CRO perspective.
We have strong partnerships with some of the world's leading pharmaceutical companies and employees can expect to be involved in some of the most prestigious drug development projects with the opportunity to develop, progress and travel globally. Clintec offers a competitive salary and rewards package.