- SRP review and approval
- ICF review and approval
- Study document preparation and collection
- Contract preparation and negotiation
- Investigator payments
- Patient Insurance agreements
- Feasibility studies
- Study site selection
- Investigator database maintenance
Responsibilities may include one or more of the following items:
- Review and approve investigator site regulatory package documents as defined by effective SOPs and according to applicable local law and study specific guidelines
- Review and approve country/site specific ICF
- Maintain tracking systems on an ongoing basis to ensure that the progress of regulatory documents can be tracked to meet regulatory and ethics committee deadlines
- Maintain a working knowledge of, and ensure compliance with applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements
- Participate in Regulatory training initiatives, project team meetings (as appropriate), and maintain relationships with other departments/clients.
- Perform internal and external feasibilities in close cooperation with the FEG (Feasibility Group) Manager
- Identify and qualify potential investigators to assist project teams in expedited study start
- Check study specific site selection lists against internal DB and perform internet investigation to assure highest quality of selected sites
- Maintain internal investigator DB on an ongoing basis
- Organise process for obtaining translations as required
- Support other clinical activities as required to assist with expedited study start up to ensure that the clinical deliverables are met
- Assist in the preparation of investigator / client meetings as required
- Complete routine administrative tasks in a timely manner (eg. Timesheets, metrics, travel expense claims)
- Attend staff meetings and training sessions as required to complete the worldwide curriculum in a timely manner
- Negotiate Investigational Sites Contracts and Investigators Agreements as defined by effective COG Handle the study payments related to them as required Communicate actions between Investigational sites, investigators, clients, team members and the Clinical Research Associates (CRAs) involved in the study to ensure that the timelines are met during the course of the clinical trial
- Arrange and track payments related to investigational site contracts
- Mentor new staff as appropriate
- Review qualification reports generated by other CRA’s assigned to projects in the region. Highlight common issues and address these with the team as a training need. Raise concerns with the PM/CL or line manager as appropriate
- Perform co-qualification visits with less experienced CRAs or at problem sites, as required to identify possible areas for training and address these with the local QPTG manager where applicable (depending on level of monitoring experience)
- Assist with QC/audit of central files and liase with Quality Assurance personnel as required.
| Qualifications/Skills
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- Degree in a life science, nursing qualification or other relevant experience
- Fluent English in addition to local language
- Good written and oral communication skills
- Experience with Microsoft based applications and general knowledge of PC functions. Word-processing, spreadsheet and presentation skills
- Ability to manage multiple and varied tasks with enthusiasm, and prioritise workload with attention to detail
- Willingness to work with multiple supervisors in a matrix environment, and to value the importance of teamwork
- Able to take initiative and work independently
- Sense of urgency
- Flexibility towards work assignments, new learning and travel as required by the project (may include overnight, weekend and occasional international travel)
| | Contactinformatie
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Heb je interesse in deze vacature, meld je direct aan middels de button 'aanmelden' of neem contact op met:
Drs. Andrea Dorssers
Consultant Clinical
Biltstraat 443
3572 AW Utrecht
tel 030 231 7350
mobiel 06 22242929 |
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Geïnteresseerden kunnen hun c.v. ook rechtstreeks mailen naar andrea@pharmamediair.nl.
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