Currently we are looking for a Senior Clinical Research Associate (srCRA) to join our team!
The Clinical Research Associate will perform monitoring and site management activities for Phase I-IV clinical research projects to assess the progress of clinical projects and to ensure they are conducted, recorded, and reported in accordance with the protocol, Company and Sponsor standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.
- Performing site selection, initiation, monitoring and close-out visits (on-site or remotely), according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
- Evaluating the quality and integrity of site practices
- Supporting the development of a patient recruitment, retention, and awareness plan
- Managing progress by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolution
- Preparation and attendance of Investigator Meetings
- Act as a primary liaison with Sponsor and study site personnel
- Assists the Clinical Project Manager in the administration and/or management of a clinical trial, by developing timelines, milestones, and monitoring strategies.
- Performs training to the CRAs with little experience, as well as co-monitoring visits, as needed.
- Develops clinical management plan and associated study documents (i.e., monitoring guidelines and tools, reference manuals etc.).
- University degree in life sciences, pharmacology, biology or chemistry
- At least 3 years of previous demonstrated experience in the clinical field, including a minimum of 3 years’ experience in clinical monitoring (pre-study, initiation, routine monitoring and closeout visits).
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Excellent command (written and verbal) of English language and proficient knowledge of medical terminology
- IT literacy (MS Windows, MS Office, Internet Use)
- Solid understanding of the drug development process and pharmaceutical legislation
- Excellent organizational, prioritizing and communication skills
- Ability to manage multiple and varied tasks with attention to detail
- Effective time management to ensure project deadlines are met
- Ability to manage required travel of up to 40% on a regular basis
If you are interested in this new professional challenge, we are looking forward to receiving your application. Please send your complete application documents in English or Greek to firstname.lastname@example.org