Clinical Investigator

Job Title: Duty Doctor

Job Location: Semicon Park, Electronic city phase II

Department: HPU

About Syngene:  Syngene (www.syngeneintl.com) 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

1. Experience: 3-5years
2. Demonstrated Capability: Maintenance of ICU, obtaining informed consent, co-ordination with investigators.
3. 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.