about the company.
Our client, a world leader CRO, offers world class services in clinical trial logistics, development and manufacturing of the drug product. Looking to expand their clinical research team to contribute to the future of drug discovery.
about the team.
In a team of 8, reports into the Country Director.
about the job.
- Monitors investigator sites with a risk-based monitoring approach.
- Assess investigational product through physical inventory and records review.
- Documents observations in reports and letters in a timely manner using approved business writing standards.
- Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
- Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
- Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
- Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations.
skills & experiences required.
about the company.
Our client, a world leader CRO, offers world class services in clinical trial logistics, development and manufacturing of the drug product. Looking to expand their clinical research team to contribute to the future of drug discovery.
about the team.
In a team of 8, reports into the Country Director.
about the job.
- Monitors investigator sites with a risk-based monitoring approach.
- Assess investigational product through physical inventory and records review.
- Documents observations in reports and letters in a timely manner using approved business writing standards.
- Escalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.
- Conducts monitoring tasks in accordance with the approved monitoring plan. Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
- Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
- Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations.
skills & experiences required.