Description:

The successful candidate will be responsible for Quality Control (QC) activities in support of the assigned study. The candidate will be responsible for QC -1 activities initially but may later also perform QC-2/other QC roles.

Required Qualifications:

A minimum of a Diploma in Nursing, Clinical Medicine or any related medical training with at least 3 years’ experience working on clinical research involving women and children. Up to date professional accreditation and certifications in GCP and HSP. Intermediate or advanced computer proficiency (MS Office suite). Experience in Medidata Rave or similar e-data management systems for research would be an advantage. The applicant must possess a high level of professionalism, integrity and good research documentation skills. Ability to multitask and function in a fast-paced environment with minimum supervision is required.

Duties and Responsibilities:

• Keep up to date with the current study specific protocol and procedures as well as related GCP and Human Subjects’ Protection requirements and required training
• Review study records prior to expected visits to ensure required forms are prepared and filed appropriately.
• Review paper and electronic CRFs of all research participants to ensure adequate completion, consistency and accuracy prior to the participant leaving the clinic.
• Complete the visit checklist to document the visit procedures are done according to the study protocol and relevant SOPs.
• Communicate promptly to the Study Coordinator or designee for any participant safety issues as well as any key documentation issues.
• Provide timely feedback of QC findings to the Study Coordinators and study teams to enable implementation of preventive actions and for overall quality improvement.
• Ensure that identified errors are resolved in a timely manner and within approved SOPs and the study protocol.

• Keep up to date with the current study specific protocol and procedures as well as related GCP and Human Subjects’ Protection requirements and required training
• Review study records prior to expected visits to ensure required forms are prepared and filed appropriately.
• Review paper and electronic CRFs of all research participants to ensure adequate completion, consistency and accuracy prior to the participant leaving the clinic.
• Complete the visit checklist to document the visit procedures are done according to the study protocol and relevant SOPs.
• Communicate promptly to the Study Coordinator or designee for any participant safety issues as well as any key documentation issues.
• Provide timely feedback of QC findings to the Study Coordinators and study teams to enable implementation of preventive actions and for overall quality improvement.
• Ensure that identified errors are resolved in a timely manner and within approved SOPs and the study protocol.

• Intermediate or advanced computer proficiency (MS Office suite)
• High level of professionalism
• Integrity
• Good research documentation skills
• Ability to multitask
• Ability to function in a fast-paced environment with minimum supervision

• Diploma in Nursing, Clinical Medicine or any related medical training
• Up to date professional accreditation and certifications in GCP and HSP
• Experience in Medidata Rave or similar e-data management systems for research would be an advantage