Context of the Role
The candidate has the opportunity to join the TGI India’s large program of research in kidney diseases. The ongoing projects includes community studies to ascertain incidence, prevalence and risk factors for kidney disease, their social determinants and health economic consequences, surveillance, investigating the impact of climate change, and running large multicentric cohorts of patients with chronic kidney disease and glomerulonephritis’s and developing kidney disease registries. The intervention projects range from community based interventions through education and behavior change to implementing a technology-based model of healthcare delivery. The kidney disease clinical trial program is wide-ranging, and includes TESTING (steroids in IgA nephropathy), TRACK (rivaroxaban in CKD), RESOLVE (dialysate sodium), and many others. These studies are executed by the TGI core staff as well as through a network of collaborators in India and overseas.
The successful candidate will have access to the learning and development opportunities at TGI and its affiliated organizations such as UNSW Sydney, University of Oxford and Manipal Academy of Higher Education, Manipal.
This position is primarily for a new project in collaboration with the University of Oxford to investigate the long-term outcome of patients admitted to intensive care units who develop acute kidney injury but survive and are discharged from the hospital. We are aiming to understand the clinical as well as laboratory predictors of outcome. Patients will be recruited at a range of hospitals. The successful candidate will be expected to contribute to other projects as appropriate.
The Research Assistant (RA) is required to work with the research team in the tasks associated with running the program/project such as protocol development, ethics approvals, regulatory processes, coordination with collaborators/investigators, site monitoring and data management. The CRA provides regular study updates to the lead researchers and updates clinical study tracking systems as necessary.
This role reports to the Executive Director
Duties and Key Responsibilities
- Assist lead researcher with protocol development, preparing submissions to ethics committee and regulatory agencies as per regulations, database development, organizing study meetings, producing agendas and minutes for study-related meetings, responding to protocol and data collection enquiries, maintaining study documentation, assisting in the preparation of budgetary and administrative documents and other tasks as required.
- Manage effective communication with the key stakeholders (including the Study Management Committee, Principal Investigators, Research Coordinators, etc.).
- Assist in the recruitment of study participants, or study sites, including assisting with site recruitment and engagement strategies
- Conduct Site Feasibility surveys
- Organise site setup (including installation of relevant software(s) and systems) and training with relevant stakeholders and ensure relevant training and site manuals are provided and systems and procedures are in place.
- Educate and train study sites on study technologies and systems, process and procedures (e.g. written informed consent, reporting Serious Adverse Events (SAEs).
- Create, organize and collate documents required by the project team prior to the start of the study (e.g. protocols, questionnaires, feasibility, confidentiality agreements, etc.)
- Assist in the development of appropriate monitoring tools
- Organise and participate in investigator meetings
- Prepare, plan, organise and conduct pre-study (site selection) visits and report on these visits to assist in site selection
- Prepare for, plan, organise and conduct site initiation visits
- Collect and review essential documents from study sites
- Motivate and train investigators.
- Maintain and build relationships with staff at study sites to facilitate participant follow-up in line with the Study protocol
- Ensure accurate and timely data entry and record keeping, including patient recruitment and trial documentation, within the Redcap system and other repositories
- Respect and preserve data confidentiality and security in the maintenance of study administrative files
- Monitor study sites (including site follow-up visits) in accordance with the study’s site
- monitoring procedures and protocols; this may via telephone or face to face.
- Engage in conference calls and meetings to review progress of sites. Ensure that queries generated are documented and responded to in a timely fashion
- Maintain project tracking tools and systems in a timely and accurate manner, including checklists, site start-up and monitoring reports, logs; and all site correspondence
- Setup relevant Site Investigator files and documents on SharePoint and assist with the maintenance of other project documents and manuals to ensure they remain up to date.
- Ensure compliance with study protocols and procedures.
- Regularly update project tracking tools and systems as required
- Perform study monitoring by visit, email and telephone to the participating centres to ensure:
- Data quality, accuracy, completeness and timeliness of data completion
- Complete and efficient resolution of data queries
- Adherence to the study protocol and study procedures manual
- Adherence to ICH/GCP and other guidelines and requirements as relevant to this trial
- Complete monitoring visit reports accurately and within the predetermined timeframe
- Coordinate distribution, tracking, handling and destruction of study supplies per site
- Assist participating centre research staff in the local management of the study where required.
Skills, Knowledge and Experience
- Tertiary qualifications in a related science or health care discipline
- Working knowledge of, and ability to implement project activities in accordance with, ICH/GCP and all applicable regulations and guidelines in the relevant regions.
- Excellent written and spoken communication. Communication training or examples of written work will be a plus
- Knowledge of ICH/ GCP guidelines
- Understanding of confidentiality and privacy laws and all guidelines relevant to medical research
- Excellent skills in MS Office applications including Excel and Word
- Excellent interpersonal skills and the ability to work well and flexibly i.e. autonomously, in small teams and with a wide range of varying stakeholders
- Strong focus on producing the highest quality of work and on ensuring optimum accuracy of outputs
- Ability and willingness to travel (when appropriate and as needed).
- Previous hands on experience of managing clinical trials and monitoring experience working on clinical projects within an academic, CRO or pharmaceutical environment will be valued.
- Candidates interested in expanding their knowledge/skillset and with ambition to acquire higher qualifications (such as PhD) will be preferred.
As a Team Member:
- Be transparent, proactive and solution oriented
- Participate in special projects to improve processes, tools, systems and organisation;
- Take responsibility for personal learning and development and for setting achievable and meaningful work objectives and managing personal targets, meeting obligations of The Institute’s Performance Management and Development Policy;
- Demonstrate commitment to The Institute’s organisational values, including performing to an exceptionally high ethical standard and focus on integrity, collaboration and teamwork in all efforts.
How to apply:
Interested candidates should send their resume with full contact details, clearly mentioning the job title < Research Assistant – Renal Research> in the subject line to firstname.lastname@example.org by the 17th July 2020.
Our big and bold mission to improve the health of millions of people worldwide needs a diverse and innovative team to deliver it. So, we foster a dynamic, inclusive and flexible workplace where each individual can bring their best selves to work.
Everyone is encouraged to apply, including people from culturally and linguistically diverse backgrounds, people with a disability, people of all gender identities and sexual orientations, and mature-aged adults.
Type of career: Jobs
City: New Delhi
Application close date: 17/07/2020