Clinical Trials Operation and Regulatory Support
1 semana atrás
Job Description:
Transmission of practical skills and knowledge through on-the-job training in Clinical Trial Operations and Regulatory Support, such as:
Prepare clinical trials' initial submissions, substantial amendments and notifications to the National Health Authority and Independent Ethics Committee.
Support the negotiation of Clinical Trial Research Agreements (CTRA) with trial sites and subsequent budget and payment supervision.
Support clinical trial documentation activities such as, update and reconciliation of Trial Master Files and prepare Investigator Binders.
Customize Informed Consent Forms and other Patient-facing materials.
Clinical Trials Operational and Regulatory Support
COM/CTC Profile:
Core competencies:
Fluent in Local Language and business proficient in English (verbal and written) and excellent communication skills.
Understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines; (preferred)
Behavioral Competencies:
Positive mindset, growth mindset, continuous learning mindset.
Proactive and creative attitude.
Good interpersonal skills.
Goal-oriented person.
Educational Requirements:
Degree in Life Science /Business Finance/ Administration or equivalent Health Care related experience
Search Firm Representatives Please Read Carefully
Employee Status:
Intern/Co-Op
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1
Requisition ID:
R222606
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