Médecins Sans Frontières (MSF)/Doctors Without Borders is an international, independent, medical humanitarian organisation that delivers emergency aid to people affected by armed conflict, epidemics, natural and man-made disasters and exclusion from healthcare in more than 70 countries. MSF offers assistance to people based on need and irrespective of race, religion, gender or political affiliation.
MSF has worked in India since 1999, providing free-of-charge essential healthcare to people in remote areas, and specialist care for people affected by HIV/AIDS, malnutrition, hepatitis C, tuberculosis, kala azar, and sexual and gender-based violence. We also respond to natural disasters and other emergencies, provide mental healthcare and advocate for the development of more effective and affordable medicines to improve access to treatment for people everywhere.
We currently run projects in the states of Andhra Pradesh, Bihar, Chhattisgarh, Delhi, Jammu and Kashmir, Jharkhand, Maharashtra, Manipur, Telangana, and Uttar Pradesh. MSF was awarded the Indira Gandhi Prize for Peace, Disarmament and Development in 1996 and the Nobel Peace Prize in 1999.
Location: Delhi and Mumbai
Last Date of Application: 13th January 2019
Duration: 12 months (Renewable)
Expected Starting Date: 1st February 2019
Monthly Gross Salary: INR 1,13,742 /-
Tasks and Responsibilities
Mission and Responsibilities
The Operational Research Coordinator (ORC) will bring clinical research experience and be responsible for coordinating the endTB clinical trial at the participating site.
During the study conduct, the ORC will support Site Principal Investigator (PI) to facilitate and oversee daily clinical trial activities and play a critical role in the conduct of the study to ensure compliance with the International Conference of Harmonization Good Clinical Practice (ICHGCP), study protocol and all applicable regulatory and Ethics Committee requirements. S/he will work closely with the central research team, the MSF/PIH/IRD program(s), all relevant local institutions (e.g. Ethics Committee and Regulatory Authorities) and supervise activities of departments involved in clinical trial implementation at site level (eg: clinical, laboratory, pharmacy).
The Operational Research Coordinator will:
- Be familiar with and understand the ethical standards and regulatory obligations that govern human subjects’ research; in general and specifically at the site
- Ensure the protection of the rights, safety, and welfare of all study participants and the safety of study staff;
- Assist the Site PI in study start-up activities, including regulatory and ethics committee application, budget development, staff recruitment;
- Provide and maintain education in GCP and other regulations that govern the research activities, as well as in study procedures, to site trial staff;
- Oversee subject recruitment and study enrollment goals;
- Provide assistance to ensure that the study is planned, set up, conducted, documented and reported according to the protocol, effective standard operating procedures (SOPs), GCP, and applicable international and national regulations;
- Ensure that the data (from clinical, laboratory, pharmacy…) are generated, collected and documented with accuracy, consistency and integrity;
- Ensure that site trial staff adheres to the study procedures, verification procedures, audits and inspections procedures
- Be responsible to evaluate site capacity (material and staff) and identify efforts to be deployed to reach site initiation;
- Support the Site PI in preparation of documents to obtain study approval from all local relevant authorities, including drug license importation;
- Review and ensure conformity with local requirements and GCP requirements all trial documents relevant to the site, including the study protocol, the patient information leaflet, informed consent form (ICF) etc.;
- Manage translations, as required;
- Responsible for the budget available at site;
- Work in close collaboration with Medical doctors/ PMR to ensure and improve quality of care being provided to the patients.
- Promote cohesive relationships and clear communication amongst multi-disciplinary team in clinic including nursing, medical and patient support staff.
- Cohesive patient flow and follow-up by DWBI staff.
- Coordinate daily, weekly and monthly clinic meetings as needed to provide a coordinated and multidisciplinary approach.
- Regularly evaluate and provide feedback to clinic staff.
- Provide support to clinical investigators with subject recruitment in accordance with protocol, effective SOP, GCP and applicable regulatory requirements;
- Collaborate with the internal monitor to ensure that site staff is compliant with GCP, applicable regulations, particularly in ethical issues and in agreement with protocol and effective SOPs;
- Monitor study progress and prepare progress reports for EC/RA as required;
- Ensure that any new staff hired after study initiation is been trained in GCP and study protocol and in SOPs, guidelines, processes as required by the role;
- Maintain the Investigator Site File (ISF);
- Support the Site PI for the submission of any amendment to protocol or ICFs for approval to local RA and EC bodies;
- Ensure with the Site PI that notifiable events are reported on time to the MSF Pharmacovigilance unit and to the relevant ethics committee(s) and regulatory authorities;
- Ensure data is recorded, handled, stored and reported accurately and promptly and confidentiality is maintained;
- Provide patient data (collected in eCRF, SAEs and other notifiable events) and pre-screening/screening logs to central research team and external monitor or any audit, when required;
- Ensure study visits are organized within the Clinical trial required timeframe for all study participants;
- Supervise study nurses, treatment supporters, data manager and other site positions essential to the implementation of the endTB clinical trial.
- Be in constant communication with the Site PI, Central Study Coordinator and the central research team for: Study update, Safety issues, Any issue related to protocol deviation(s), Any specific concern related to human specimen analysis, Any request of study related document amendment.
- Interventional Clinical Trial experience as research assistant, study coordinator or study monitor (preferably also in Trial Site set-up and Study implementation). Clinical Research Coordinator Certification (CRCC) is desired, but not required
- Comprehensive knowledge and understanding of clinical research regulations (preferably in India) and GCP
- Thorough understanding of human subjects data confidentiality
- Proficiency in Microsoft Office applications, Internet applications. Experience with electronic medical records and/or data capturing systems is desired
- Must have superior communication, time management and problem-solving skills
- Good knowledge of English and local language(s), Previous experience in Tuberculosis field desirable, Scientific background
- Master Degree in in relevant field.
- Minimum 3 to 5 years work experience in similar profile; preferably in the development sector.
HR and Benefits (Non-negotiable)
- Monthly Gross Salary: INR 113742 /-
- Secondary Benefits as per policies:
- 13th Month Salary/ Festival Bonus
- 18 Annual Leaves
- 12 Casual Leaves
- Other compassionate leaves
- Medical Reimbursement including dependents
To apply please email your CV and motivation letter with the subject Ref: Position To: MSFOCB-Delhi@brussels.msf.org by 13th January 2019, 5:00 pm.
ONLY SHORT-LISTED CANDIDATES WILL BE CONTACTED AND INVITED FOR INTERVIEW.
Delhi and Mumbai