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As a Clinical Research Associate / CRA II, you will conduct site monitoring responsibilities for Clinical trials, according to my clients’ SOPs, ICH guidelines and GCP, including Pre-study qualification, Initiation Meetings, Routine, Interim monitoring Visits and Close-out Visits.
Duties and Responsibilities:
- Assists with the implementation of Project Plans related to the Clinical Monitoring responsibilities
- Participates in initial and on-going protocol and CRF training at study site
- May serve as the Primary contact for the clinical sites/Sponsor
- May develop materials for site reference manual
- May assist with creation of site training materials
- Participates in the generation of study specific monitoring plans
- May participate in the development of Case Report Forms
- Participates in the development of conventions for CRF transcription
- May participate in identification and recruitment of investigators, collection of investigator documents and Pre-Study Qualification Visits
- Participates in Sponsor and Investigator/Initiation Meetings
- Tracks progress of projects and identify appropriate actions to achieve target objectives.
- General on-site Monitoring Responsibilities:
- Ensures study staff conducting the protocol have received the proper materials, instructions and training to safely enter subjects into the study and complete the protocol requirements, as written.
- Ensures the protection of subjects by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
- Ensures the integrity of the data submitted on CRFs or other data collection tools by careful source document review.
- Ensures that the Site Regulatory Documents are complete and current throughout the duration of the trial.
- Ensures that the study compound inventory and accountability is accurate and that study materials are stored securely and per protocol requirements
- Prepares accurate and timely trip reports.
- Identification and follow up of SAEs at study site for which he/she is responsible
- Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems.
- Assists with training of new employees, e.g. co-monitoring
- Perform other related duties as assigned.
- Advanced computer skills with good working knowledge of a range of computer packages.
- Current Institute of Clinical Research status: Registered Member level.
- University/college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure, medical or laboratory technology).
- Thorough knowledge of ICH guidelines, GCP and the clinical trial process.
- Knowledge of the drug development process.
- Excellent verbal and written communication skills.
- Valid Drivers License.
- Typically 1-2 years Clinical Monitoring experience.
- Additional experience may be substituted for education requirements.
For more information, please contact me directly:
+44 (0) 203 189 0165