Responsible for the administration of study drug to volunteers and monitoring the safety of all volunteers through health status assessment and the performance of safety requirements. Responsible for the accurate, timely, organized completion of assigned tasks within the Clinical Operations department in accordance with study protocols, directives, SOP’s, GCP and applicable regulatory requirements.
- Drug Administration
- To ensure accuracy and timely completion of medical screening files, and follow up through resolution of any quality assurance/control findings.
- Participate in the ongoing assessment of medical screening activities, industry trends, subject feedback and quality concerns for continuous improvement of quality and efficiency.
- To conduct the Informed Consent process and ongoing communication of study information to study volunteers.
- Reporting of all adverse events, irregularities and non-compliances occurring during the study, as well as appropriate communication to other personnel to ensure continuity of care.
- Maintenance of emergency cart, medications and equipment.
- Liaise with physicians as required.
- Ensure neat, accurate and timely documentation of all study activities.
- Participate in training as required, maintain training records and read all applicable SOPs in a timely matter with appropriate documentation completed.
- Additional tasks may also be assigned based on training and qualifications e.g. Blood Collection, Catheter Insertion, ECGs, Meal and Fluid Distribution, Training, etc.
- Adhere to assigned tasks and other duties associated with general Clinical Operations department.
- Monitoring subject safety including health status monitoring, safety requirements, treating and reporting adverse event.
- Quality is integral to clinical operations. As such it is imperative that all aspects of the job are conducted with accuracy to ensure study integrity and volunteer safety with minimum or no deviations.
- The work can be quite complex with specialized knowledge required. Ongoing training will be required to maintain technical expertise.
- Work is generally performed indoor and involves standing and/or sitting for long periods of time. Ability to multitask in a fast-paced environment and adapt to changing priorities. Must also be able to accommodate a flexible work schedule. Some light to moderate physical work is required.
- Perform any other duties as assigned.
- Internationally Trained Medical Doctor or Internationally Trained Nurse
- Current BCLS & First Aid certification.
- Good reading and writing skills and a strong command of the English language is required.
- CRO experience required.
- Ability to interact with colleagues and volunteers on a professional level.
- Ability to organize and maintain manual information sources, files and automated systems for storage and retrieval of data
- Intermediate computer skills.
- Ability to respond quickly and efficiently in an emergency situation
- Provide analytical support to protocol review meeting
- Excellent multi-tasking skills
- Strong team player.
- 1 – 2 years previous experience in CRO/pharmaceutical industry required