Job Description:
Job title: Clinical Research Specialist
Location: New Delhi
Report to: Country Director, India

Position summary:
IAVI is currently seeking a qualified candidate to engage with the team in design and coordination of clinical research initiatives that are of critical national and regional significance (including Africa and other global collaborations). Briefly, these initiatives are focused on:
• Community engagement and socio-behavioral research to enhance population outreach and linkage to prevention and care services; 

• Epidemiology research to enable establishment of specific cohorts (HIV, TB, HIV and TB, HIV and other co-infections), bio repository and a database for facilitating translational research towards understanding the disease;

• Clinical trials and Implementation research for product evaluation and introduction (HIV and TB vaccine, antibodies, among others) across the testing and care continuum.

The individual will be involved across all stages of planning and implementation of these initiatives including development of study materials, facilitating study site set-up, study initiation, monitoring and close out. The role offers an opportunity to work with a global team combined with opportunity for program management.

Key responsibilities:
Specifically, the candidate would bring in specific expertise towards the following:
• Support study design and drafting of the protocol in accordance with ICH GCP guidelines;

• Enable drafting and development of study materials including the Case Report Forms, Standard Operating Procedures, Manual of Operations, among others in alignment with national guidelines and global best practices;

• Facilitate study site preparedness and its assessment including relevant staff trainings, site set-up, availability of source documents, among others;

• Facilitate effective and smooth implementation of the study through ensuring drafting of study work-plans and specific milestones and their regular management; 

• Help enable study monitoring and close-out and compliance of study procedures as per the protocol and with global best practices — GPP, GCP, GCLP and other national and global regulatory requirements;

• Work with the team to outline capacity and capability building efforts including specific trainings, technology transfer and knowledge sharing activities and setting up linkages for the same;

• Coordinate with the internal and external stakeholder to ensure effective communication channels for study design and implementation;

• Prepare progress reports, archive and manage study documentation and enable drafting of manuscripts for publication.

Experience and skills:
• Evidence of specific training in areas relevant to the above-mentioned responsibilities, ideally PhD in epidemiology/​health sciences/​other allied fields or MD in community medicine from a top institution;

• Experience (1 – 2 years) in design and/​or implementation of clinical research with in-depth technical and operational knowledge, for example in medical writing, development of study materials, study site management, study documents management, study monitoring, among others;

• Sound understanding of good practices, preferably trained in any of the Good Participatory, Good Clinical and/​or Good Clinical Laboratory Practices;

• Excellent communication skills, both written and verbal; 

• Strong interpersonal skills to build effective relationships with relevant stakeholders;

• A detail-oriented individual with outstanding organizational skills, ability to multitask with a flexible and adaptable approach to work;

• Enjoy both working independently and collaboratively in a small collegial team environment with honesty, integrity and intellectual curiosity;

• A self-starter with the ability to deliver under pressure and meet deadlines effectively.

The Organization:
International AIDS Vaccine Initiative (IAVI) is a global not-for-profit organization whose mission is to ensure the development of safe, effective, accessible, preventive HIV vaccines and new tools for biomedical prevention to further global health. Over its 22-year history, IAVI has amassed peerless knowledge and experience in vaccine development from epidemiology and basic biomedical research to clinical trial design, research preparedness, project management and community advocacy. Although IAVI remains focused on advancing promising HIV vaccine candidates, IAVI now supports discovery, translation, and evaluation of global health innovations beyond HIV, using its intellectual capital to illuminate understanding of global health more broadly and seeking answers to unresolved scientific issues in HIV through contributions in other areas. For more information see http://​www​.iavi​.org/IA… in India is focused on facilitating unique partnerships and inter-disciplinary collaborations with key stakeholders with various arms of the Government of India. Over the last 17 years IAVI in India has brought together national and global expertise to define programs that leverage domestic funding for the enhancement of domestic R&D capabilities and solve domestic and global health problems.

IAVI Core Values:
Dedication to the Mission: We are committed to the development of safe, effective, accessible, preventive HIV vaccines for use throughout the world to achieve a world without AIDS
Innovative Evolution: We are committed to solving complex problems in creative and innovative ways, learning from our mistakes and successes and never giving up

Integrity: We are committed to meeting the highest ethical and professional standards in everything we do and to taking responsibility for our actions to earn respect

Collaboration: We are committed to embracing diversity, the power of glocal teamwork and the belief that by working as one we can make a difference

People Management, Leadership and Communication
• Provide direction and oversight to team and support their development. Manage performance expectations to ensure desired results are achieved. 

• Provide leadership and guidance to team ensuring strategic goals are met

• Appropriately share information with direct reports and encourage transparency where possible

• Hold regular meetings and serve as a mentor to team

Ideally PhD in epidemiology/​health sciences/​other allied fields or MD in community medicine from a top institution

Experience (1 – 2 years) in design and/​or implementation of clinical research with in-depth technical and operational knowledge, for example in medical writing, development of study materials, study site management, study documents management, study monitoring, among others.

Kindly share your CV’s along with cover letter to schatrath@​iavi.​org and mpant@​iavi.​org