Description
We are seeking a Clinical Research Coordinator to support study sites in the coordination of Phase I-IV clinical research studies, ensuring that studies are carried out according to protocol, standard operating procedures, GCP, and other applicable guidelines and regulations.
Key responsibilities include:
- Coordinating clinical research studies conducted by a supervising principal investigator
- Updating and maintaining skills, training and knowledge of current best nursing practice and topics related to clinical research
- Safeguarding the well-being of subjects and ensuring high standards
- Maintaining a safe environment in accordance with Health and Safety policies
- Acting as a volunteer advocate
- Dealing with volunteer and visitor concerns in a proactive manner
- Assisting staff with nursing practices and delivery of care to volunteers
- Reporting any deviations from normal practice to senior staff
- Supporting study conduct through review of study protocols, case report forms, and electronic data capture systems
- Participating in project meetings with the project team as needed
- Performing clinical set-up and preparation for studies
- Planning logistical activities for procedures
- Generating volunteer instructions
- Identifying and obtaining required supplies and equipment
- Preparing and delivering study-specific training materials, documents, and records
- Troubleshooting study issues
- Participating in huddles to ensure daily tasks are executed to expected standards
- Assisting with data quality checking and query resolution
- Recruiting and screening volunteers for inclusion in studies
- Orienting volunteers to the study and site
- Administering and maintaining custody of study drugs
- Performing complex clinical procedures, including ECGs, sample collection, spirometry, and vital signs
- Collecting, recording, and reporting clinical data and findings
- Collaborating with study investigators and monitors
Requirements:
- 1 year of relevant experience
- Good knowledge of clinical trials
- In-depth knowledge of Good Clinical Practices (GCP)
- Good skills in using MS Windows and Office applications
- Effective written and verbal communication skills
- Excellent interpersonal and problem-solving skills
- Effective organisational skills
- Ability to pay close attention to detail
- Current active nursing license in the state, country, or region where the site resides
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