SITE MANAGEMENT & MONITORING

Conduct onsite and remote monitoring visits in accordance with the protocol plan and study Standard Operation Procedures (SOPs)
Site in-service training
Coordination of site contracts and site payments
Enrolment and retention strategies
Manage and monitor national and international clinical sites
Ensure rights and well-being of human subjects
Provide appropriate verbal and written feedback to site, listing overall site performance, deficiencies and corrective action required
Monitor site performance through the trial and communicate any issues as appropriate
Serve as the main line of contact between the sponsor and the investigator
Maintaining central study les

PROJECT & RESOURCE MANAGEMENT

Study and protocol design
Budget and project timeline projection
Resource management and project staff
Development of project specific study materials, documentation and newsletters
Development of project specific Standard Operating Procedures
Site assessment/qualification
Site and investigator selection
National and international regulatory submissions, including ongoing correspondence and regulatory reporting requirements
National and international Ethics Committee submissions including ongoing correspondence and reporting requirements
Regulatory document collection, review and approval
Preparation of project specific reports
Event management (investigator meetings, update meetings and trial presentations)
Archiving plans

CLINICAL OPERATIONS MANAGEMENT

Act as a main line of communication between academic leadership and sponsors
Provide leadership and oversight to the Clinical Operations Team
Oversee all operational aspects of clinical trials
Strategic management
Management of Quality Assurance
Contract management
Financial management
Regulatory affairs management
Human resources

TESTIMONIALS

Many thanks Caroline, I learnt a lot from the course today. Excellent! Mahi pai, kia ora! An excellent update of GCP. Really interesting and the practical examples you gave were great.
- Mary

I have no words to convey to Ms Caroline Alsweiler for her amazing lecture. It was an incredible amount of knowledge and experience imparted from such a wonderful and passionate expert in the field.
- Dr John

Great presentation style and very interesting content.
- Victor

It was excellent. Caroline made a previously dry subject come alive.
- Serena

Very good coverage of the topic in the time available.
- Natalia

An excellent and interesting day. Caroline is very knowledgeable and great at explaining issues.
- Jo

Excellent, well timed, very interesting the entire time. Day went fast!
- Kate

Caroline, you present clearly and concisely. Very interesting and very relevant.
- Amelia

Caroline was a great presenter. Kept me engaged throughout the seminar. Provided lots of real-life examples that were very informative.
- Masar

Caroline is very knowledgeable and a great teacher of this topic.
- Lauren

Impressed with the clarity of explanations.
- Murray

Great presentation style and very interesting content.
- Chris

Very good coverage of the topic in the time available.
- Anda

THE BEST SOLUTION FOR YOUR BUSINESS

SITE MANAGEMENT & MONITORING

PROJECT & RESOURCE MANAGEMENT

CLINICAL OPERATIONS MANAGEMENT

TESTIMONIALS

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