
Senior Research Scientist
5 days ago
Job Description:
The Senior Research Scientist will contribute in the following manner:
Oversee the administration of clinical research activities of the study.
Ensure regular training of all the study staff in Good Clinical Practice (GCP), study related trainings and
certifications, and documentation of all such training certifications.
Documentation of all the study-related documents.
Periodic reviewing of the Study Master Files.
Working with the Principal Investigator (PI) and/or assigned research staff in the preparation of reports
including completion of due diligence, administrative requirements, and any other requirements as required
for the study.
Assist the PI or designee in liaising with the sponsors for preparation of study related Standard Operating
Procedures (SOPs).
Assist the PI or designee in the site identification, selection and set-up including development of study
agreements, preparation of the Investigator Site File (ISF).
Oversee the Site Visits (pre-set-up, initiation, monitoring, training, and close-out) by the study team and
conduct such visits as and when needed.
Coordinate with the Institutional Ethics Committee (IEC) of CCDC for any new submissions and notifications as
needed for the study.
Ensure obtaining necessary regulatory approvals such as Drug Controller General of India (DCGI) and Health
Ministry Screening Committee (HMSC) as appropriate.
Competencies/ Skill sets required:
Essential:
MBBS, BDS or related field with a Master's in Public Health, Clinical Research, Clinical Trials or related field.
Minimum of 10-12 years of research experience in the conduction and coordination of clinical trials and
registries.
Strong organizational and coordination skills.
Excellent communication and interpersonal abilities.
Excellent scientific writing skills
Proficiency in data analysis.
Willingness to travel to the project sites as needed.
Desirable:
PhD or Advanced degree or specialized training/certification in clinical trials or clinical research.
Experience with working in multicentric research studies.
Publications in reputed journals
Ability to work collaboratively with diverse teams and stakeholders.
Strong problem-solving skills and attention to detail.
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