Position:  Clinical Research Associate

Organization: DNDI

Location: Delhi

Apply: https://dndi.secure.force.com/hrapp/positionapply?id=a0f0800000oQfzJ&sf=off

Specific job responsibilities:

• Site identification and conducting feasibility as per the approved checklist
• Initiate preliminary contact with the site investigator
• Contribute and provide inputs for drafting the Monitoring Plan.
• Responsible to set-up and coordinate the pre-study visits, draft the pre-study visit notification and report, submit to CPM for review and approval. Responsible to set-up and coordinate the site initiation visit, draft the SIV notification, conducts the site initiation visit, prepare the visit report, submit to CPM for review and approval and ensures compliance with the visit recommendations
• Ensure the site reaching all requirements before site activation
• Ensures that the clinical site conducts the study in compliance with protocol, SOPs and applicable requirements (GCP, and local requirements)
• Reviews the ICF (the master and/or local language version as appropriate and any updates), CRF and study logs/ forms
• Draft monitoring visits notifications, plans and conducts the site monitoring visits at assigned clinical sites as per approved monitoring plan
• Draft monitoring reports and submit to CPM for review and approval
• Closely follow-up on any action or issue identified during the monitoring visit
• 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) through source data verification
• Follow-up on any query generated for data management
• Ongoing coordination with assigned to verify the study conduct as per the protocol, GCP and the applicable regulations.
• Ensures setting up of documentation practices as per study requirement
• Regular review of the ISF 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
• Ensure appropriate article storage, expiry date, dispensing, and accountability, if applicable
• For IP returns, organizes shipment to the appropriate recipient, and for IP destruction on site, ensures documentation in files
• Verifies proper filing of any safety expedited reporting or safety /clinical periodic reporting to independent Ethic+ Committees (IECs)/institutional Review Board (IRB) / Regulatory Authorities (RAs)/other institutions (if applicable)
• 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,
• Reviews safe/ reporting requirements and compliance (including tracking)
• Draft close-out visit notification, conduct the site close-out visits at assigned clinical sites
• Submits the site close out visit reports to the Clinical Project Manager for review and approval
• Escalates to Clinical Project Manager in a timely manner in case of any issue and documents any findings in the monitoring reports

Additional /specific/projects responsibilities:

• Ensures adequate and timely availability of all clinical study supplies, study medication etc. at site
• Acts as the main line of communication between the sponsor, the investigator, and the site personnel
• Provides mentoring and coaching during the regular activities/interaction with the study site personnel and identify need for refresher trainings to respective site staff
• Communicate 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 deviation/issues
• Support respective site for preparation of CAPA its execution as well as reporting or responding to the sponsor/ auditor/ monitoring

Job requirements:

Skills and attributes

• Ability to use initiative, prioritize. multitask, and work well under pressure to meet deadlines
• Clear and systematic working that demonstrates good judgment and problem-solving competencies
• Very good communication skills in multicultural, multilingual environments
• Ability to work effectively as pan 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 additional services to operational line or project team
• Ability to solve non-routine problems on a case by case/project basis
• Has certain autonomy for taking actions and decision
• 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

• Good knowledge of Drug Discovery/ Development
• Good knowledge of Clinical Research/ Development
• Good knowledge of Regulatory requirements and GCP

Experience

• Minimum 4 years of relevant experience in clinical research, including 2 years of clinical monitoring of research projects or public health programmes
• Proven ability to work effectively in a team environment and matrix structure
• Experience of working in public and private sector is highly desirable

Education

• Bachelor in Life sciences/ Pharmacy/ Biotechnology or Allied medical degree
• Master’s degree in Life sciences/ Clinical research will be an added advantage

Other requirements

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