Senior Research Scientist

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.