6 month contract
Works under general supervision and participates in the design, planning, implementation and overall direction of clinical research projects; May co-ordinate the activities of relevant colleagues within the Company and investigators to ensure compliance with the overall scientific study objectives. May work with international investigators and key customers as well.
Travels to field sites to monitor studies.
Receives general instructions; plans and prepares studies.
Reviews study protocols, reports and manuscripts. Contribute technical and clinical operations expertise for these documents
Works with Data Management and Biostatistics staff on the design of documents and processes for the collection of study data from participating sites.
Collects and maintains legal and regulatory documentation, as applicable.
Assumes responsibility for training and coordinating certification of study site personnel.
Ensures accurate and complete study management/data collection and transfer to data management
Ensures site compliance with regulations and study protocol.
Monitors the sites and provides technical assistance, as necessary.
Assists, prepares and manages study timelines
Manages material logistics for the studies.
Conducts reference material testing in-house.
Organizes investigator meetings, as necessary.
Participates in Project Team Meetings.
Keeps informed of trends and developments in clinical research.
Knows and effectively uses the broad concepts of a particular field or speicalization to resolve problems of limited scope and complexity.
Analyzes alternative approaches to solve problems or develop new perspectives n existing solutions.
- Minimum of 2-6 years relevant clinical research experience
- Can travel up to 30% of the time.
- Knowledge of regulations and guidelines required and an understanding of their practical application.
- Minimum of Bachelors degree in a scientific discipline or related field; prefers Masters degree.
Sthree US is acting as an Employment Business in relation to this vacancy.
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Website : http://www.realstaffing.com
Real is a global leader in the provision of pharmaceutical, biotechnology and medical devices recruitment services. We are one of the world’s most extensive pharma, biotech and medical devices recruiters and have one of the largest networks of specialist recruiters globally. Our premise is a simple one: by recognising talent and valuing relationships we are able to consistently deliver local, global and industry expertise which in turn ensures success time after time.