Senior Clinical Research Associate

Colombia
[Closing date: 31 August
2019]

 

Drugs for Neglected Diseases initiative (DNDi) is a collaborative, patients’ needs-driven, non-profit drug research and development (R&D) organization that is developing new treatments for Neglected Diseases (www.dndi.org)

After 15 years of sustained growth, DNDi has built a team of approximately 200 full-time employees working across nine offices (Geneva, Rio de Janeiro, Kinshasa, Nairobi, New Delhi, Kuala Lumpur, New York, Tokyo, and Cape Town).

The DNDi Latin America office was opened in 2004. With the primary aim to support regional R&D activities for Chagas disease and leishmaniasis, along with activities in hepatitis C, the Latin American office also undertakes advocacy and communications activities to increase neglected diseases awareness in the region. It also leads capacity building projects through multi-country research platforms.

DNDi‘s neglected tropical disease (NTD) initiative is dedicated to clinical development and access for the following NTD areas: human African trypanosomiasis, leishmaniasis, Chagas disease, filarial diseases, and mycetoma. The NTD initiative is responsible for developing overall and disease-specific strategy, conducting and reporting on research, supporting fundraising efforts, and managing budgets – from phase 1b/proof of concept studies right through registration, policy change, and product introduction. 

The team is based in DNDi’s headquarters office in Geneva and in our regional offices located in Africa, Asia, and South America.

 

Purpose of the position

The Senior Clinical Research Associate is responsible for the set-up and follow-up of a range of clinical trials/observational studies in sites according to applicable regulation and Good Clinical Practice, other ICH Guidelines and in compliance with overall local, regional, and international regulatory obligations associated with the study/ies conducted. 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). S/he acts as lead CRA, managing a team of CRAs.

 

Specific job responsibilities

  • Initiate preliminary contact with the site investigator
  • Set-up and coordinate the pre-study visits, write the pre-study visit report and conduct the site initiation visit at the trial site with the support of the CRAs
  • Write the pre-study visit report
  • Conduct the site initiation visit at the trial site
  • Ensure that the trial site safely and properly conducts the clinical trials
  • Review the ICF (the master and/or local language version as appropriate and any updates)
  • Conduct the site monitoring visits at the trial sites
  • Verify the validity, accuracy, consistency, and quality of the data in Case Report Forms (CRFs) or data collection forms (e.g. data/forms sent to DNDi Pharmacovigilance) against source documentation
  • Check compliance of the clinical trial conduct according to the protocol, GCP, and the applicable regulations
  • Review the investigator site file (ISF) for completeness
  • Ensure appropriate test article storage, expiry date, dispensing, and accountability, if applicable
  • Verify proper filing of any safety expedited reporting or safety/clinical periodic reporting to Independent Ethics Committees (IECs)/Institutional Review Board (IRB)/Regulatory Authorities (RAs)/other institutions (if applicable)
  • Review safety reporting requirements and compliance (including tracking)
  • Conduct the site close-out visit in the clinical sites
  • Submit the site close-out visit reports to the Clinical Project Manager for review and approval
  • Contribute to and review the Monitoring Plan
  • Perform activities as per the Monitoring Plan
  • Responsible for the initial set-up of the ISF
  • Review regularly 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
  • Provide support to the HDCP/Head TS with regards to local/regional safety regulatory intelligence
  • Provide 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 CPM and PV function, including on all local regulations and guidances (together if necessary with translation into English and interpretation). This includes seeking validation of interpretation of implementation modalities with regulatory bodies (RAs/ECs/other bodies), if necessary.
  • Provide support to the CPM 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 CPM (or delegate) for filing in TMF
  • Ensure 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 Safety Management Plan. 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
  • Verify that any deviations are properly documented
  • Alert the Clinical Project 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, that stock of consumables has not reach the alert threshold, that expired consumables are put in quarantine or destroyed according to CPM authorization
  • For IP returns, organize shipment to the appropriate recipient
  • For IP destroyed on site, request a certificate of destruction

Additional/specific/projects responsibilities

  • Represent DNDi Regional Office in Colombia, contributing to complementary dimensions of DNDi social mission, to enhance the regional footprint
  • Contribution to the Chagas Platform and Chagas Access projects, if needed.

 

Reporting line

  • S/he reports to the Clinical Project Manager
  • The Senior Clinical Project Manager can act as a contributing manager

 

Interactions

  • Works with Chagas team in the R&D department
  • Collaborators, counterparts, and service providers are mainly in the functional area in and outside DNDi to get information, guidance, and feedback or to enlist cooperation. Work on the organization of representation of DNDi at smaller events and with external stakeholders of same equivalent level

 

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 middle sized projects with budget management under supervision
  • Provide specialist services to operational line or project team
  • Ability solve non-routine problems on a case by case/project basis
  • Has certain autonomy for taking actions and decisions
  • Ability to interact with external stakeholders
  • Ability to be the focal point/manager for consultants
  • Ability to supervise at a smaller level

R&D technical skills

  • Strong knowledge of Drug Discovery/Development
  • Strong knowledge of Clinical Research/Development
  • Strong knowledge of Regulatory (GCP, GLP and GMP)
  • Strong knowledge of disease/academia knowledge

Experience

  • Minimum 6 years’ relevant experience in which at least 3 years as CRA
  • Proven ability to work effectively in a team environment and matrix structure
  • Experience of working in public and private sector is highly desirable
  • Previous experience with clinical research in resource-limited settings is highly desired

Education

  • Bachelor’s degree in science or related fields
  • An advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA is highly desired

Other requirements

  • Native proficiency in Portuguese or Spanish
  • Fluency in the other (Spanish or Portuguese) desirable.
  • Ability to communicate in English
  • Good knowledge of Microsoft office

 

Other information

  • Status: full time – permanent role – core consultancy

 

To apply

  • Please submit your application using the online form
  • Deadline for application: Accepting applications until 31 August 2019
  • Only shortlisted candidates will be contacted 
  • Application submission for this position may close early if we have enough suitable applicants