Job description
RESPONSIBILITIES
Maintains regulatory documents and ensures that they are up to date.
Provide clinical and technical support for CRAs and administrative staff
Perform management of study site activities to ensure integrity of clinical data in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs).
Manages investigator site activity for multiple protocols / indications and provides ongoing updates of site status to Clinical Trial Manager / sponsor.
Ensures proper storage, dispensation, and accountability of all investigational product (IP) and trial-related material at investigator sites.
Increase knowledge of drug development processes, therapeutic areas, GCPs, and any applicable local regulatory requirements.
Assist with IRB/IEC Submissions.
Ensures all adverse events are documented accurately and in a timely manner.
Monitors Data (on-site or remotely). Reviews CRFs/eCRFs for patient eligibility, protocol compliance, omissions, errors, etc. and performs source data verification.
Assist with the creation of training materials and train investigator site staff.
Coordinate shipping of supplies to and from study sites.
Carry out any ad-hoc task as assigned by the Line Manager, Department Head and/or Senior Management.
MINIMUM REQUIREMENTS
Five years working experience in clinical research, as a CRA, Study Nurse or related profession preferred
Two years of experience in on-site monitoring preferred
Degree or postgraduate qualification in life sciences, medical sciences, or nursing.
Experience handling clinical trial management systems and electronic data capture.
Thorough understanding of ICH-GCP guidelines.
SKILLS
Excellent communication skills (both written and oral)
Ability to coordinate with trial site staff, CRO and clients/sponsor
Ability to multi-task and think on your feet
Good organizational, IT and administrative skills
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