Renata A Calczynska

Responsibilities:
- Leader of the projects from start up to close out
- Contributes to the feasibility process
- Manage and track to agreed study timelines and budget
- Plan and risks management
- Lead preparation of study documents
- Attend Investigators’ Meeting
- Manage the activities associated with audits
- Work closely with CPM, CRAs, CTAs to share knowledge and perform trainings
- Manage process of payment to sites, investigators and vendors
- Conduct the co-monitoring visits,
- Centralized Monitoring Expert :contribute to the process and perform trainings

Responsibilities:
- Conducting pre-study, initiation, monitoring and close out visits
- Performing site management including IP destruction process
- Managing process of payment to sites, investigators, preparing documents
- Attending investigator’s meeting; delivering trainings to investigators (protocol-related
and GCP training)
- Conducting co-monitoring visits,
- Preparing training materials for CRAs (Mentor),
- Monitoring in Centralized Monitoring (Mentor),

1. Conducting pre-study visits, interim monitoring visits, Site management,
2. Preparing documents for study sites,
3. Preparing and sending used IP for destruction,
4. Attending investigator’s meeting, delivering GCP and protocol-related trainings to investigators
5. Managing process of payment to sites, investigators

- identification of potential investigational sites,
- participating in international blind review meeting,
- monitoring the international sites (in Finland, in Lithuania)
- coordinates and performs comprehensive site management,
- conduct of pre-study, initiation, interim and close out monitoring visits,
- produces comprehensive visit reports and status reports,
- resolve data issues and audit issues,
- adherence to the study timelines and budget,
- preparing documents for study sites,
- preparing regulatory documents submission,
- verifying case report forms against source data( also Electronic Data Capture system)

- preparing documents for study sites
- taking care of reception
- working closely with CRAs and team members
- organizing documents for Polish custom and courier companies
- reviewing documents in study files
- arranging the shipments of study materials and study medications to the study sites

- sending promotional materials to the customers,
- arranging promotional meetings,
- arranging meetings with clients,
- archiving documents,
- coordinating promotional project,
- management the web-site,
- cooperation with promotional agency,