Study Startup & Regulatory Specialist
Six Solutions Inc.
- Makati, Philippines12th Flr The Peak Tower, Makati, Metro Manila, PhilippinesMakatiMetro ManilaPhilippinesPhilippines
- Penuh waktuFULL_TIME
Berakhir 4 years ago
2020-04-20T16:00:00+00:00Ditutup.
Deskripsi Pekerjaan
- Ability to track startup of newly awarded studies
- Ability to complete all required paperwork for study startup including regulatory paperwork
- Ability to submit IRB paperwork
- Work with recruitment team and contract team to create compensation language for each upcoming study
- Ability to build e-source study templates (training will be provided)
- Maintain and update CVs, training certificates
- Interact with vendors to ensure all needed study startup forms are completed and submitted to CRO/Sponsor contacts
- Design study process flows and staff workstations
- Conduct and maintain production meetings for new studies
- Interact with marketing and ensure all marketing materials for studies are built and implemented
- Ensure study staff have completed all required trainings, fully comprehended protocols, and have all required system access
- Schedule and coordinate staff travel for Investigator Meetings
- Schedule and coordinate Pre-Site Selection Visits, Site Initiation Visits
- Other miscellaneous tasks assigned by the Company
- Create pre-screening questionnaire and ensure it is entered within CRIO in a timely manner
- Ensure you have reviewed and are knowledgeable on all active and upcoming protocols
- QC daily visits and create queries within the CRIO system
- Send weekly unresolved query report to site manager
- Ability to track and maintain monitor visits
- Review all sponsor follow up letters with the study’s Lead CRC and ensure all action items are resolved prior to the next monitoring visit.
Kualifikasi Minimum
- Prior project management experience
- Strong written and verbal skills
- Proficient with Microsoft Office
- Must be a graduate of any medical field, preferably, a Registered Nurse, Medical Technology, or Pharmacy
- Willing to work on night shift, and holidays
- Willing to work at Mandaluyong City
Ringkasan Perkerjaan
- Tingkat Posisi
- Lulusan Baru / Junior
- Spesialisasi
- Customer Service
- Persyaratan tingkat pendidikan
- Lulus program Sarjana (S1)
- Alamat Kantor
- 10F KMC Rockwell Business Center, Sheridan St. Mandaluyong City
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Tentang Six Solutions Inc.
SIX Solutions provides Employer of Record (EOR) services. We are a third-party local entity placed as an intermediary in an existing employee-employer relationship. We are responsible for the legal and regulatory obligations of employment and payroll as an EOR. Examples are payroll processing, employee onboarding, background checks, human resources, employee relations, and administration. We are not involved in day-to-day job activities.
Our sole focus is hiring roles in software development: desktop, web, and mobile application development, cloud computing, DevOps and QA, and UI and UX. We are serving mid-sized and large businesses and software product companies.