• Bachelor’s Degree in a science or related field
• Oncology experience phase I – II experience
• willing to travel970% )
1. Understand and apply medical and business know-ledge to clinical trial execution.
2. At least 3 years experience in clinical research or having demonstrated adequate level of proficiency within the CRA I and II competency profile.
3. Solid understanding of clinical trial design, trial execution and operations.
4. Knowledge of international standards (GCP/ICH), international (FDA, EMEA) and local regulations.
5. Expertise in communication, managing multiple priorities and computer literacy.
6. Proven people management skills with demonstrated expertise in working on teams.
Therapeutic knowledge of oncology in Phase I & Phase II
1. Ensure for Country trial start up activities, i.e. Translation of study documents, HA submission, and Clinical supplies check up/import at project level
2. Ensure to set up proper recruitment/maintenance plan based on appropriate analysis of capability of sites selected
3. Support the site initiation and training executed by CRAs.
4. Ensure Country Specific master file and facilitate preparation and monitor the collection of site level documents by CRAs; resolve problems as required
5. Ensure Planning and Set up the local trial timeline with CRA for the key metrics i.e. IRB submission, site contract, site initiation, patient recruitment, routine monitoring, close out activities
6. Monitor on status of planned versus actual patient recruitment/timeline and implement strategies to correct deviations from proposed plan according to metrics.
7. Ensure the site level compliance/adequate site management through co-monitoring visit with the CRA if necessary
8. Liaise with global TA/BU clinical teams and CPOs to identify issues and mediate resolution in a timely manner at a project level.
9. Review study monitoring reports which monitor generated, as assigned.
10. Identify project and Clinical Operations issues that will impact the successful conduct of a trial and bring to the attention of the GMO Head for information and/or resolution in a timely manner
11. Supervise the monitor of the implementation of site closeout activities.
12. Act as local and/or global CRA lead and author global monitoring plan, as assigned.
13. Act as a mentor to new associates for purposes of field training, as assigned.
14. Work to coordinate for audits if necessary
15. Participate in multi-disciplinary teams within CPO and globally to evaluate and implement process improvement.
16. Basically, conduct site level activities as a CRA which she/he is responsible for.
- Execute site initiation and training
- Implement total site management including monitoring visits and closeout activities
MUST have Oncology Experience, and willing to travel nationwide 70%
Website : http://www.inventivhealth.com/