Sitero is Hiring Bachelors or master degree candidates as Clinical trial associate for clinical operation. An emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation. Hiring Bachelors or master degree candidates as Clinical trial associate for clinical operation.
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Position |
Clinical Trial Associate |
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Function |
Clinical Operations |
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Education and experience required |
At least 2 years experience in the CRO or Pharmaceutical industry Bachelors or Masters degree in Life Science from an accredited university |
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Preferred skills |
IT Skills: Microsoft 365, Medidata, CTMs Good written and verbal communication skills. |
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Compensation & benefits |
Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, Variable pay, paid time off, and healthcare and retirement benefits. |
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Commitments |
Standard Hours 40 hours per week, one hour lunch, Monday – Friday. Additional hours as needed. Willing to work in shifts as and when needed. |
ESSENTIAL DUTIES AND RESPONSIBILITIES:
1. Provides high quality assistance in managing and overseeing clinical trials in accordance with ICH GCP and applicable guidelines, company and sponsor SOPs, project plan, study-specific processes, and local regulatory requirements.
2. Support Clinical Trial Managers on project related activities and deliverables as required which may include contracts and budget activities.
3. Completes essential document collection and review throughout the study lifecycle, organizes and maintains site clinical trial master file (TMF) documents, and maintains site-related data in applicable clinical systems according to procedures and guidelines for record retention.
4. Perform ICF customization in accordance with applicable guidelines and local regulatory requirements.
5. Support the setup, data entry, and QC of the system to ensure accuracy and quality of data.
6. Support submission of new trials to include updating protocols to the IRBs.
7. Support study data as the EDC administrator while assisting with site monitoring via EDC and EDX applications.
8. Support site CRAs with CTMS data entry and follow-up activities with investigator sites on pending actions, as needed.
9. Compilation of Site File Documents per project specifications.
10. Coordinate with printing vendor for preparation of Site Files, perform Site File QC and assist with dispatch of files to investigator sites in APAC region.
11. Performs risk assessment and management responsibilities throughout the project including site process evaluation, addressing follow up items and issue escalation.
12. Coordinate with other departments within the company, such as research and development, marketing, and accounting, to ensure that all aspects of a study are carried out successfully.
EMPLOYMENT TYPE: Full Time, Permanent
DISCLAIMER: Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
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