Responsibilities may include the following:
- Monitors progress of clinical trials at the site level or headquarters and ensures that they are conducted, recorded and reported in accordance with the protocol, standard operating procedures (SOP), good clinical practices (GCP), and other applicable regulatory requirements.
- Develops and maintains liaison with clinical investigators, clinical research organizations (CRO), affiliated hospitals, and research institutions to initiate and expedite clinical studies on products that have investigational new drug or medical devices approval.
- Responsible for reviewing adverse event cases with investigators, determining and monitoring time, budget, schedules, preparing study documents, and issuing status reports.
- May assist with design, development, and monitoring of clinical evaluation projects.
- Trains investigators and site personnel.
- Includes headquarter and field clinical research associates (CRA).
- Implements and prepares the clinical development strategy as outlined by the clinical teams.
- May contact and recommend qualified investigators to perform studies and initiate clinical trials.
- Ensures recruitment and retention of patients.
- Create monitoring visits reports and follows up on monitoring deliverables.
- Knowledge of excel, willingness to prepare excel dashboards and complete documents filing (80% of the job).
- 20% monitoring sites (on site and remotely in Serbia and occasionally Slovenia).
- Mainly home based.
- This role can potentially
Required Knowledge and Experience:
- Requires practical knowledge and demonstrated competence within job area.
- Requires a University Degree and knowledge of English as well as Serbian/Bosnian language.
- Important to note that this person will mainly do non site monitoring related work, such action items trending prep, visit prep, dashboard prep and filing.
For further details, please contact Tim Barratt on +44(0)1727 817 626 or email firstname.lastname@example.org
- Agency: Achieva Group Limited
- Contact: Tim Barratt
- Phone: 01727811634
- Reference: TB-323207
Website: Achieva Group Limited
- Posted: 22nd December 2021
- Expires: 19th January 2022