(Sr) Clinical Research Associate
The 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 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 languages (both written and spoken);
- Willingness and ability to travel;
- Willingness and ability to be home-based in Germany.
- 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.