Job Description

Position Overview: The TB Study Coordinator will play a critical role in the planning, execution, and management of the TB Free School Kids Initiative Study being implemented across various sites in India. This position requires a deep understanding of TB, research methodologies, and regulatory compliance. The coordinator will work closely with researchers, healthcare professionals, donors, implementation partners, and government authorities to ensure the successful implementation of research protocols and the ethical conduct of studies.

Location: The position will be based out of Pune with travel to other study sites as needed.

Remuneration: Johns Hopkins India Pvt. Ltd. provides attractive compensation in line with industry standards which commensurate with the experience of the applicants.

Key Responsibilities:

1. Study Coordination:

• Coordinate all aspects of TB research study, including but not limited screening, enrolment, and follow-up visits.

• Maintain study timelines, ensuring adherence to protocols and regulatory requirements.

• Liaise with study sites, investigators, and research staff to ensure smooth conduct of research activities. The position will involve travel to study sites.

2. Regulatory Compliance:

• Receive permissions from govt. Departments to implement the study.

• Ensure compliance with all applicable regulations, guidelines, and ethical standards governing TB research.

• Support the development of regulatory documents, including Institutional Review Board (IRB) submissions, informed consent forms, and protocol amendments.

• Maintain thorough documentation of regulatory approvals and correspondence.

3. Data Management:

• Oversee data collection, entry, and quality control procedures.

• Ensure the integrity, confidentiality, and accuracy of research data.

• Collaborate with the data management teams across the study sites for data analysis and reporting.

4. Participant Engagement:

• Establish rapport with study participants and provide support throughout their involvement in research studies.

• Educate participants about the study procedures, potential risks, and benefits.

• Address participant inquiries and concerns in a timely and compassionate manner.

5. Team Collaboration:

• Lead study implementation team/s, collaborate with multidisciplinary teams, including researchers, clinicians, laboratory personnel, and administrative staff.

• Facilitate communication and coordination among team members to achieve research objectives.

• Participate in team meetings, training sessions, and research planning activities.

6. Study Documentation:

• Maintain comprehensive study documentation, including study logs, regulatory binders, and study-related correspondence.

• Assist in the preparation of study reports, presentations, and publications.

• Ensure accurate and timely completion of case report forms (CRFs) and other study-related documents.

Qualifications:

• MBBS with a master’s degree in a relevant field (e.g., public health, clinical research, epidemiology) with at least 5 years of experience.

• Previous experience in clinical research, preferably in tuberculosis or infectious diseases.

• Knowledge of research methodologies, Good Clinical Practice (GCP) guidelines, and regulatory requirements.

Desirable Skills

• Strong organizational skills with meticulous attention to detail.

• Excellent communication and interpersonal skills.

• Ability to work independently and collaboratively in a team environment.

• Proficiency in Microsoft Office suite and data management software.

• Commitment to ethical conduct and participant safety in research.

About Company

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