Clinical Trial Assistant

**Location: DNDi India (Delhi) **

Term : 2 years fixed term employment, with a possibility of extension

The Drugs for Neglected Diseases initiative (DNDi) is an international, not-for-profit research and development (R&D) organization that develops and delivers new treatments for neglected diseases that affect millions of the world's poorest people.

Together with more than 200 public research and industry allies worldwide, we use the power of partnership, innovation, open science, and advocacy to find solutions to a great injustice: the lack of medicines for life-threatening diseases that disproportionately impact poor and marginalized people. Driven by collaboration, not competition, and by patients' needs, not profits, we promote equitable access, foster inclusive and sustainable solutions, and advocate for a more effective global biomedical R&D system that meets the needs of neglected patients.

Since our inception, DNDi has delivered nine new treatments for people with sleeping sickness, visceral leishmaniasis, Chagas disease, HIV, hepatitis C, and malaria that have saved millions of lives. We now aim to deliver an additional 15-18 new treatments by 2028 – addressing R&D gaps for neglected tropical diseases and viral infections, including new pandemic-prone diseases (such as COVID19) and climate-sensitive diseases (such as Dengue) with a focus on the needs of patients in low- and middle-income countries.

With 250 employees of 37 nationalities located in nine offices on four continents, DNDi is committed to diversity, equity, and inclusion as essential parts of our culture and key drivers of our success. We encourage candidates of diverse profiles and backgrounds to apply.

Role and Overall Purpose:

As a Clinical Trial Assistant (CTA) need to assist the clinical research teams in ensuring the most effective and efficient conduct of clinical research studies by providing administration and project tracking support.

Contribution

This role delivers complex or specialized support process or activities requiring certain level of interpretation and adaptation of rules and procedures in force.

Scope of Work (Results)

This role affects all aspects of the support services and has an impacts on DNDi activities.

Tasks and Responsibilities

· Provide general administrative support to the Clinical Operations Department and assistance to CRA and Project Manager.

· Assist the Clinical Operations teams in completion of all required tasks to meet departmental and project goals.

· Support the Clinical Operations teams with ongoing conduct of studies.

· To be familiar with ICH GCP, appropriate regulations and familiar with the roles of the Clinical Research Associates (CRA) including site visits, if appropriate.

· Assist project teams with study specific documentation and guidelines as appropriate.

· To set up, organize and maintain clinical study documentation (e.g. Main Study Files, CRFs, etc.) including preparation for internal/external audits, final reconciliation and archival.

· To process Data Collection Forms i.e. log in, tracking, quality control as appropriate for the study.

· To assist in quality control audits of clinical study documentation (e.g. Main Study Files, CRF Files, Monitoring Files, etc.).

· To co-ordinate ordering/dispatch and tracking of trial materials (e.g. CRFs, diary cards, lab supplies, drug supplies etc.) as appropriate.

· To assist project teams with trial progress tracking by updating the Clinical Trial Management systems.

· To copy and route incoming correspondence, internal documentation, CRFs, etc.

· To assist in co-ordination of Investigator payments, if applicable.

· To contact clinical sites for specific requests (e.g., enrolment updates, missing documentation, meeting arrangements, etc.).

· To assist in the tracking and distribution of safety reports.

· To co-ordinate document translation, if required.

· To attend project team meetings and generate meeting minutes.

· To assist the Project Manager & project team with Investigator Meeting coordination, activities preparation, generate meeting minutes.

· To assist in the production of slides, overheads, etc., as needed for project, departmental, sponsor and/or business development presentations.

· To assist with the coordination of team member tracking and prepare meeting MOMs.

· Other duties as assigned by PM or CRA

The above list of responsibilities is not exhaustive, and you may be required to undertake other responsibilities appropriate to your grade. This job description may be subject to review.

Reporting line

· Clinical Trial Assistant reports to Sr Clinical Project Manager

Interactions

· Works with VL team, and rest of the DNDi India team and other transversal R&D units.

This role maintains relationships with several organizational units including some outside DNDi, projecting image of a reliable service provider or partner. Interaction assesses issues and performance that facilitate or restraint service delivery

Skills and Attributes

· Ability to use initiative, prioritize, multi-task, and work well under pressure to meet deadlines

· Clear and systematic thinking that demonstrates good judgment and problem solving competencies

· Good communication skills in multicultural, multi-lingual environments

· Ability to work effectively as part of a multicultural team

· Well organized and structured

· Good analytical skills

· Ability to contribute to the project delivery under supervision

· Ability to manage small projects if delegated by upper levels with close supervision

· Ability to supervise an Intern or Apprentice

R& D Technical Skills

· Good knowledge of Drug Discovery/Development

· Good knowledge of Clinical Research/Development

· Good knowledge of Regulatory (GCP)

Experience:

· Over 1 years' relevant experience

· Proven ability to work effectively in a team environment and matrix structure

· Experience of working in public and private sector is highly desirable

Education:

· Graduate university degree, Masters is a plus

· Formal training or certification as required by the function

Other Requirements

· Fluency in English

· Proficiency in local language desirable

· Good knowledge of Microsoft Suite

To Apply

· Please submit your application using the online link

· Deadline for application: accepting applications until 17th April 2022

· Only shortlisted candidates will be contacted

· Application submission for this position may close early if we have enough suitable applicants