Clinical Research Activation Specialist
hace 1 día
Job Overview: We are seeking a highly motivated and detail-oriented Clinical Research Activation Specialist to join our team. The successful candidate will be responsible for performing tasks at a country/region level associated with site activation activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and guidelines.
Key Responsibilities:
- Under general supervision, perform feasibility, site activation and some maintenance activities in assigned studies for investigative sites, according to applicable regulations, SOPs and work instructions.
- Review documents for completeness, consistency and accuracy under the guidance of senior staff.
- Prepare site documents, reviewing for completeness and accuracy.
- Inform team members of completion of regulatory contractual and other documents for individual sites.
- Distribute completed documents to sites and internal project team members.
- Support the updating and maintenance of internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information.
- Review, track and follow up the progress, approval and execution of required documents such as questionnaires, CDAs, regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release documents.
Qualifications:
- Bachelor's Degree in Life Science or related field.
- 2 years' experience in clinical research or 6 months in regulatory submissions in clinical research.
- Fluent in conversational (reading and writing) English.
- Established individual contributor who works under general supervision.
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