Clinical Research Associate

Assist in the preparation and review of study protocols, informed consent documents, case report forms, questionnaires, study manuals, standard operating procedures, and related research documents.

Support the development of study implementation plans, timelines, responsibility matrices, document checklists, and project-specific trackers.

Ensure that approved and current versions of study documents are appropriately maintained and distributed to relevant project teams and study sites.

Prepare and coordinate submissions to the Nepal Health Research Council, institutional review committees, ethics committees, and other regulatory bodies, as applicable.

Support the preparation of initial applications, protocol amendments, continuing-review submissions, progress reports, safety-related submissions, and study-closure reports.

Maintain regulatory submission trackers, approval records, correspondence, and submission deadlines.

Follow up with investigators, study sites, and regulatory authorities regarding pending documents, responses, and approvals.

Coordinate day-to-day office-based activities for assigned clinical and epidemiological research projects.

Organize project meetings, prepare agendas and minutes, document decisions, and follow up on assigned actions.

Coordinate communication among investigators, project staff, data-management teams, study sites, collaborators, laboratories, and other relevant stakeholders.

Serve as an office-based contact point for study sites and institutional collaborators.

Communicate study requirements, timelines, document requests, protocol updates, and operational instructions to relevant teams.

Support orientation and training of study staff on protocols, study procedures, data-collection tools, documentation requirements, and applicable SOPs.

Follow up with study sites regarding recruitment status, data submission, missing documentation, protocol-related questions, and pending study activities.

Review study progress against approved protocols, work plans, timelines, recruitment targets, and project deliverables.

Maintain centralized trackers for participant enrollment, study activities, approvals, training, deviations, data submission, and outstanding actions.

Identify delays, documentation gaps, compliance concerns, and operational challenges, and escalate significant issues to the Project Lead or Principal Investigator.

Support the documentation and follow-up of corrective and preventive actions when study-related issues are identified.

Coordinate with study sites, data-management personnel, and biostatisticians to support timely and complete submission of study data.

Conduct routine checks of case report forms, questionnaires, study logs, and submitted datasets for completeness, consistency, and compliance with the study protocol.

Generate, communicate, track, and follow up on data clarification requests and queries until resolution.

Support data reconciliation, database-lock preparation, and documentation of data-quality activities.

Assist with the preparation of basic study summaries and descriptive outputs under the guidance of the data-management or biostatistics team.

Maintain records of protocol deviations, protocol violations, non-compliance events, and corrective actions.

Coordinate the collection and submission of adverse-event and serious-adverse-event documentation where applicable to the study.

Ensure that safety information and significant protocol-related issues are promptly communicated to the Principal Investigator, Project Lead, sponsor, and ethics committee according to applicable requirements.

Support follow-up and documentation of decisions arising from safety or compliance reviews.

Establish and maintain organized electronic and physical study files, including investigator files, regulatory files, training records, correspondence, approvals, reports, and study logs.

Ensure appropriate document naming, version control, filing, confidentiality, accessibility, and retention.

Periodically review essential study documents for completeness and accuracy.

Support preparation of study files for internal review, sponsor review, audit, inspection, or study close-out.

Prepare routine study-status updates, progress summaries, meeting reports, activity reports, and documentation required by investigators, sponsors, donors, or regulatory bodies.

Compile information on study milestones, recruitment, data completion, protocol deviations, unresolved issues, and project deliverables.

Support study close-out activities, including document reconciliation, resolution of outstanding actions, final reporting, and archiving of study records.

Contribute to lessons-learned reviews and documentation of recommendations for future studies.

Conduct focused literature search and prepare summary of evidence relevant to assigned studies.

Assist with the preparation of study reports, abstracts, presentations, posters, manuscripts, and dissemination materials.

Support research proposals and grant applications.

Perform other research-related duties assigned by the Principal Investigator and Project Lead that are consistent with the scope of an office-based CRA position.

Master's degree in public health, Nursing, Global Health, Clinical Research, Epidemiology or relevant subjects. Bachelor's degree in public health, Nursing, Global Health, Clinical Research, Epidemiology or relevant subjects with previous health research experience. 

Previous research experience is preferred; relevant academic research, internships, or research assistantships will also be considered.

Fresh graduates with strong research and organizational skills are also encouraged to apply.

Basic knowledge of clinical and epidemiological research, research ethics, and Good Clinical Practice.

Able to write and draft study documents (Study proposal, ICF, CRF), timelines, regulatory records, and follow-up activities.

Ability to work both independently and collaboratively.

Strong attention to detail, organization, communication, and report writing skills.

Basic skills in data review, literature searching/review, and scientific writing.

Proficiency in Microsoft Office or Google Workspace.

Familiarity with REDCap, KoboToolbox, ODK, or similar systems is an advantage.

Ability to communicate effectively in English and Nepali.

Full-time, office-based position in Kathmandu (Office hours: 9:00 AM – 4:30 PM).

Occasional site visits or travel depending on project needs.

Competitive salary based on qualifications and experience.

Enrollment in the Social Security Fund.

Exposure to national and international research projects.

Opportunities for professional training, mentorship, and career development.