One thing we all have in common is the drive to produce great results for our clients and to advance treatment options available to patients worldwide. We always have a desire to keep seeking new and better ways to operate, to achieve these results. Enter: the Strategic Solutions Division.
Leveraging the advantages of working for a top-5 CRO, whilst simultaneously working fully-dedicated to a leading pharma company, will guarantee that the results you help accomplish in drug development are matched by your own career achievements.
As a Site Activation Partner, you are responsible for supporting operational activities related to site evaluation, activation, initiation, monitoring and close out for assigned investigator sites/studies to ensure compliance with study timelines and in accordance with prevailing laws, Good Clinical Practices, and standards.
The main responsibilities are:
- Assist with study site activation activities to ensure timely site activation
- Support and/or coordinate the whole regulatory submission process in collaboration with the investigator sites (confidentiality agreements, study contracts, clinical supply shipment information, payment information, etc.)
- Follow-up with investigator sites on status of study documentation and resolve or escalate issues in a timely manner
- Submit within required timeframes all needed documentation, updates and tracking including, but not limited to, Trial Master File documentation, site activation status, protocol amendment status.
- Support investigator sites and clinical operations team in preparation for and providing responses to site audits/inspections
- Act as a point contact for the GSSO team members for designated project site communications, correspondence and associated documentation
- Provide support with coaching and training of site personnel to ensure ongoing compliance with study documentation is in accordance with prevailing laws, Good Clinical Practices, and standards
- In collaboration with other team members oversee site budget and contract negotiations, facilitate site payments, conduct remote monitoring activities
- Provide other technical or logistical supportive activities that facilitate inspection readiness
- In collaboration with other team members identify and resolve and investigator site issues within required time frames
Organised, creative and confident in taking independent action.
To ensure success within this role, the following are required:
- Undergraduate degree or its international equivalent in clinical, science, or health related field
- Minimum of 2 years of experience in clinical site management
- Experience with PC-Windows, word processing, and electronic spreadsheets required
- Knowledge of ICH and local regulatory authority drug research and development regulations required
- Clinical trials support or pharmaceutical industry experience required
- Fluent in English and Polish with effective verbal and written communication skills
- Proven ability to work independently and also as a team member
- Ability to organize tasks, time and priorities
Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.