Senior Clinical Research Associate at Drugs for Neglected Diseases initiative (DNDi)

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 DNDi’s SOPs, 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). The incumbent acts as lead CRA, managing a team of CRAs who are monitoring the studies.

Specific Job Responsibilities

• Initiate preliminary contact with the site investigator
• Responsible to 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
• 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 DNDi Pharmacovigilance) 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)/other institutions (if applicable),
• Reviews safety reporting requirements and compliance (including tracking)
• Conduct the site close-out visit in the clinical sites
• Submits 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
• Regularly reviews the ISF during the monitoring visits to ensure it is up to date and that the essential documents for the centers overseed are appropriately recorded and filled in the investigator site file
• Provides support to the Head Diseases/TS with regards to local/regional safety regulatory intelligence,
• 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 CPM and PV function, including on all local regulations and guidance’s (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.
• Provides 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.
• 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 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
• Verifies that any deviations are properly documented,
• Alerts 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, check that stock of consumables has not reach the alert threshold, check that expired consumables are put in quarantine or destroyed according to CPM authorization
• For IP returns, organizes shipment to the appropriate recipient,
• For IP destroyed on site, requests a certificate of destruction

Reporting line

• Senior Clinical Research Associate reports to Senior Project Manager

Job Requirements

Skills and Attributes

• Very good knowledge of Drug Discovery/Development.
• Very good knowledge of Clinical Research/Development.
• Very good knowledge of Regulatory (GCP, GLP and GMP).
• Very good knowledge of Disease/academia knowledge.
• 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.

Experience

• Minimum 6 years’ relevant experience in which at least 3 years at Officer level or equivalent
• 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 post graduate degree in relevant field.