Senior Clinical Research Associate

New Delhi, India
[Closing date: 7 December 
2018]                                                                 

 

Established in 2003, the Drugs for Neglected Diseases initiative (DNDi) is a not-for-profit research and development (R&D) organization that develops new, improved, and affordable medicines for deadly neglected diseases that afflict millions of the world’s poorest people.

DNDi focuses on discovering and developing treatments for sleeping sickness (human African trypanosomiasis), Chagas disease, leishmaniasis, filarial infections, paediatric HIV, mycetoma, and hepatitis C. In 2016, in collaboration with the World Health Organization, DNDi launched the Global Antibiotic Research & Development Partnership (GARDP), a not-for-profit research and development organization to develop new antibiotic treatments addressing antimicrobial resistance and to promote their responsible use for optimal conservation, while ensuring equitable access for all.

Since its inception, DNDi has developed eight new treatments for neglected patients for malaria, sleeping sickness, visceral leishmaniasis, Chagas disease, and paediatric HIV with several new drug candidates in the R&D pipeline. Our objective is to deliver 16 to 18 new treatments by 2023, ensure equitable access to these treatments, and build a robust pipeline of new drug candidates.

Opened in 2004, the DNDi India office supports the implementation of R&D projects on visceral leishmaniasis, along with activities in hepatitis C, filariasis, and paediatric HIV. The office also works closely on raising awareness and advocating for increased public responsibility and a more enabling environment for neglected disease R&D.

 

Purpose of the position

The Senior Clinical Research Associate is responsible for the set-up and follow-up of a range of clinical trials and observational studies in sites according to applicable regulation and Good Clinical Practice, where applicable, to ensure the safety of the patients participating in clinical trials and get reliable clinical data (clinical trial set-up and clinical trial monitoring).

The Senior CRA will be allocated to projects in the field of DNDi’s visceral leishmaniasis programme, and GARDP’s neonatal sepsis programme.

 

Specific job responsibilities

  • Initiates preliminary contact with the site investigator
  • Sets up and conducts the pre-study visit
  • Writes the pre-study visit report
  • Conducts the site initiation visit at the trial site
  • Ensures that the trial site safely and properly conducts the clinical trials
  • Reviews the ICF (the master and/or local language version as appropriate and any updates)
  • Conducts the Site Monitoring Visits at the trial sites
  • Verifies the validity, accuracy, consistency, and quality of the data in Case Report Forms (CRFs) or data collection forms (e.g. data/forms sent to the DNDi Pharmacovigilance team) against source documentation
  • Checks compliance of the clinical trial conduct according to the protocol, GCP, and the applicable regulations
  • Reviews the investigator Site File (ISF) for completeness
  • Ensures appropriate test article storage, expiry date, dispensing, and accountability, if applicable
  • Verifies proper filing of any safety expedited reporting or safety/clinical periodic reporting to Independent Ethics Committees (IECs), Institutional Review Board (IRB), Regulatory Authorities (RAs), or other institutions (if applicable)
  • Reviews safety reporting requirements and compliance (including tracking)
  • Conducts the site close-out visit in the clinical sites
  • Submits the site close-out visit reports to the clinical trial manager for review and approval
  • Contributes to and reviews the Monitoring Plan
  • Performs activities as per the Monitoring Plan
  • Responsible for the initial set-up of the ISF
  • Regularly reviews the ISF during the monitoring visits to ensure it is up to date and that the essential documents for the centers s/he oversees are appropriately recorded and filled in the investigator site file
  • Provides in a timely manner necessary information to the PV function to develop the SMP. This includes providing necessary information to ensure SMP readiness prior to study initiation in each country, to the CTM and PV function, including on all local regulations and guidances (together if necessary with translation into English and interpretation). This also includes seeking validation of interpretation of implementation modalities with regulatory bodies (RAs/ECs/other bodies), if necessary
  • Provides support to the CTM to track compliance with local safety reporting requirements in their region/country. This includes tracking submission dates and documenting submission (collecting proof of submission/notification) and sharing these documents with PV function and CTM (or delegate) for filing in TMF
  • Ensures the appropriate safety management at trial sites as defined in the protocol, monitoring plan and medical monitoring plan (if any) in compliance with the trial-specify SMP. This includes source data verification, support to sites in completing trial-specify documents sent to PV and CRF data/queries, consistency check between documents sent to PV and CRF and request for correction, as necessary
  • Verifies that any deviations are properly documented
  • Alerts the Clinical Trial Manager in a timely manner in case of any issue and documents any findings in the monitoring reports
  • During monitoring visits: check that equipment is properly used and maintained, check that stock of consumables has not reach the alert threshold, and check that expired consumables are put in quarantine or destroyed according to CTM authorization
  • For IP returns, organizes shipment to the appropriate recipient
  • For IP destroyed on site, requests a certificate of destruction

Additional, specific, and project responsibilities

  • Ensures adequate and timely re-ordering of all study supplies, study medication, etc.
  • Acts as the main line of communication between the sponsor and the Investigator and the site personnel. Provides mentoring and coaching during the regular activities/interaction with the study site personnel
  • Communicates deviations to the Protocol, ICH-GCP, SOP and local regulations to the investigators and sponsor, taking appropriate action designed to prevent recurrence of the detected deviations/issues

 

Job requirements

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
  • Very good communication skills in multicultural, multi-lingual environments
  • Ability to work effectively as part of a multicultural team
  • Well organized and structured
  • Very good analytical skills
  • Ability to contribute to the project delivery under minimum supervision
  • Ability to manage small projects if delegated by upper levels with supervision
  • Ability to supervise an Intern or Apprentice

R&D technical skills

  • Excellent interpersonal skills to deal effectively with clinicians, patients, administrators, auxiliary personnel
  • Very good knowledge of medical terminology, Good Clinical Practice, Schedule Y, and other relevant regulatory requirements

Experience

  • Minimum of 3 years’ experience in similar position in clinical research setting, with graduate degree, at least 2 years of experience with postgraduate degree
  • Experience in monitoring infectious diseases trials would be an advantage
  • 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 or postgraduate degree

Other requirements

  • Fluency in English
  • Proficiency in local languages desirable
  • Good knowledge of Microsoft Suite

 

Reporting line

  • S/he reports to the visceral leishmaniasis team Senior Clinical Manager based in India, and to the Neonatal Sepsis Project Leader based in Geneva

 

Interactions

  • Works with supervisor and with entire DNDi India team as required, on exchange of information, clarification on completion of tasks, or issues requiring attention

 

Other information

  • Status: Full time – 18 months contract        
  • Travel requirement: up to 75% in project locations (India & Bangladesh)

 

To apply

  • Deadline for application: Accepting applications until 7 December 2018
  • Only shortlisted candidates will be contacted