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Assistant - Clinical StudiesIndia |
|
5 years experience |
Birthday:
Nationality:
Indian
44180841
Register a German-based subsidiary of your company free of charge and start immediately.
If you sign a contract with a specialist and the specialist has started working with you, we will then charge you our recruitment fee, 10% of the first gross annual salary.
We handle the necessary paperwork for obtaining residence permits or qualification certificates at a fixed price, if you wish.
2007-04 – 2009-04
pharmaceutical chemistry
2020-12 – Till now
Coordinates with Principal Investigator and school, department, and central administration to help ensure that clinical research and related activities are performed in accordance with federal regulations and university and sponsoring agency policies and procedures.
Assists the PI in study feasibility assessments as requested.
Reviews and comprehends the protocol.
Attends investigator meetings as required or requested by the PI.
Collaborates with the PI to prepare IRB/HRPO and any other regulatory submission
Reviews and develops a familiarity with the contract or award terms and conditions. Works with the PI to assure that the study is in compliance with all terms and conditions, including but not limited to education, IRB (HRPO) approval, conflict of interest disclosure, health and safety protections for participants and staff and any financial terms or conditions.
Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, and privacy protections.
Assists PI in the communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log.
Collects documents needed to initiate the study and submit to the sponsor (e.g., FDA Forms 1572, CVs, etc.).
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To registerFurther training
2021-04-10 – 2025-04-10
completed
Certificate of examination in level B1
Certificate of examination in level B1
–
excellent communication skills (both written and oral) and the ability to build effective relationships with trial centre staff and colleagues
the ability to motivate others
an eye for detail
the ability to multi-task and think on your feet
Good organizational, IT and administrative skills – the job involves documentation and recording of information through computerised processes such as clinical trial management systems and electronic data capture.
