Clinical Investigator

Job Title Duty Doctor Job Location Semicon Park Electronic city phase II Department HPU About Syngene Syngene is an innovation-led contract research development and manufacturing organization offering integrated scientific services from early discovery to commercial supply At Syngene safety is at the heart of everything we do personally and professionally Syngene has placed safety at par with business performance with shared responsibility and accountability including following safety guidelines procedures and SOPs in letter and spirit Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe practices and procedures of oneself and the teams aligned Contributing to development of procedures practices and systems that ensures safe operations and compliance to company s integrity quality standards Driving a corporate culture that promotes environment health and safety EHS mindset and operational discipline at the workplace at all times Ensuring safety of self teams and lab plant by adhering to safety protocols and following environment health and safety EHS requirements at all times in the workplace Ensure all assigned mandatory trainings related to data integrity health and safety measures are completed on time by all members of the team including self Compliance to Syngene s quality standards at all times Hold self and their teams accountable for the achievement of safety goals Govern and Review safety metrics from time to time Core Purpose of the Role Screening and maintaining complete data of volunteers General physical examination of volunteer is to be performed to ensure that he she is physically fit to participate in the study To review biochemistry hematology serology urine test results ECG Chest X-ray and any other laboratory test values as specified in the study protocol of the volunteers screened for a study Co-ordinate with Central Laboratory for carrying out required laboratory tests on volunteers as specified in the protocol Assisting Investigator for enrolling eligible volunteers as per protocol in the study Monitoring subjects during the study If any of the subject has adverse event Including significant abnormal laboratory test values these subjects should be treated and or followed-up as per protocol requirement Assess the reason for screen failure Classify into permanent volunteers with blood borne sexually transmitted any other major health diseases or temporary screen failure volunteers with temporary abnormal laboratory test results Temporary screen failures are to be followed up with repeat investigations to see if they are fit to participate in the study Permanent screen failures need to be counseled and sent to other health care facilities for treatment Counsel the screen failed volunteers due to medical reasons and guide regarding further management which also includes referral services To perform vitals during the conduct of the study The investigator should follow the study randomization procedures if any and should ensure that the code is broken only in accordance with the protocol Role Accountabilities Maintain the ICU with all necessary equipment and medicines to handle an emergency Communication with tertiary care hospitals regarding study schedule with the possible adverse events description and need for preparedness for handling medical emergencies Responsible for usage maintenance and management of volunteer database software Responsible for obtaining informed consent as per GCP and Schedule Y Co-ordinate with Principal Investigator Clinical Investigator and the staff involved during the study activities To carry out other responsibilities that may be assigned by the Head Human Pharmacology Unit Leadership Capabilities Supervise maintenance of the ambulance Ensure the maintenance of minimum stock amount of life saving emergency medicines in the ICU Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Accountabilities as a Syngene Leader only for Leadership Hires Champion effective Environment Occupational Health Safety and Sustainability EHSS practices for the company and oversee compliance with those practices within Biologics business Play an active leadership role in monitoring and verifying safety performance through Gemba walks and other safety-led activities Foster a corporate culture that promotes an environment occupational health safety and sustainability EHSS mindset as well as the highest standards of quality integrity and compliance Put people at the heart of our success by providing clear active leadership defined by the Syngene leadership framework setting high standards of people management career planning and talent retention as a priority Specific requirements for this role Experience 3-5years Demonstrated Capability Maintenance of ICU obtaining informed consent co-ordination with investigators Education MBBS Equal Opportunity Employer It is the policy of Syngene to provide equal employment opportunity EEO to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by applicable legislation or local law In addition Syngene will provide reasonable accommodations for qualified individuals with disabilities