Job Responsibilities The Clinical Research Associate/Scientist will be responsible for: Scoping Help the team in rapid and accurate feasibility analysis of upcoming projects. Example projects are in the areas of Oncology, Reproductive health, metabolic disorders, neurodegenerative diseases etc often involving some genomics component to the study design, This involves engaging with investigators across the country, and getting reasonably accurate estimates of recruitment rates, often for difficult indications. 2. Planning and Setup Contribute in planning and setting up of new clinical studies including drafting/refining the study related documents and EC dossiers, Identify candidate sites and engage with PIs and site CRCs to assess feasibility for shortlisting sites, negotiate with sites to draft agreements for engagement, Put together necessary documentation for EC submissions and assist site teams as needed to ensure EC approvals are obtained in a timely manner Regular and prompt performing quality control (QC) checks on clinical data received. This involves reviewing the data for accuracy, consistency, and completeness, ensuring that all entries are correctly documented and any discrepancies or errors are identified and addressed in a timely manner. Collaborate with other team members to resolve any issues and ensure compliance with regulatory requirements. Plan the setup of other systems and processes for the smooth running of the trial including where needed setup of systems such as IVRS/IWRS, EDC for electronic CRFs, drafting of study documents, ISF etc. and take care of site initiation activities. Put together the necessary documentation for regulatory compliance submissions like DCGI/CTRI/HMSC etc., Manage vendors, contracts and sourcing and help in budgeting and meticulous planning of projects to ensure smooth implementation and execution of the studies. 3. Implementation & Execution Implement processes for efficient conduct of clinical projects/trials, Take care of necessary activities for training of site staffs and conducting the Site Initiation, Ensure that for each study, each site, each subject the data collection, data validation and monitoring is diligently done, Troubleshoot issues faced in clinical studies in a timely manner like recruitment of subjects using innovative ideas like putting in place systems to rigorously screen patients in OPDs, setting up referral networks with hospitals having substantial patient load, and working with investigators with different ideas for recruitment, Ensure adherence to GCP guidelines to carry out high quality clinical studies following good ethical practices, Ensure smooth handling and reporting of SAEs, payments of medical expenses, compensation, etc keeping record of the same for audit purpose, Track and update status of the studies, identify challenges, record issues with issue resolution matrix and discuss potential solutions in internal meetings, customer meetings etc., Manage the costs and timelines of implementation in line with the original proposal for the project Ensure that SOPs for the clinical studies are up-to-date and work with relevant team members for conducting the study in accordance with the SOP Ensure proper training of new team members, take care of documentation and records for sponsor audits, regulatory inspections and ensure that all the study records are diligently maintained for posterity Candidates Requirements Ph.D. degree in life sciences, fresher or with an experience of 1-2 years in oncology or clinical trials management Ability to successfully manage/work simultaneous trials and meet deadlines Clinical Data Management experience preferably as part of a CRO team in more than one therapeutic area would be an advantage Excellent understanding of clinical trials methodology, GCP (Good Clinical Practice), GDMP (Good clinical data management practice) and medical terminology Have comprehensive knowledge of clinical guidelines like NDCT (New Drugs and Clinical Trials) rules, ICMR guidelines, DCA (Drugs and Cosmetics Act) and procedures involved with relevant Govt regulatory bodies is desirable and will be an added advantage Good organizational skills as the job profile involves lot of documentation and recording of information through computerized processes of clinical trial management systems and electronic data capture High attention to details and a strong analytical mind set Demonstrates comprehensive knowledge of capturing and storing clinical information Excellent proficiency in English language Demonstrated experience of working in multicultural and multidisciplinary environments Dynamic team player with excellent communication and networking skills, flexible mindset and scientifically curious Willing to travel within city and outside as required (job demands 50% or travel and may require extended period of stay at a site location based on project need)
