About this role
_Cliantha Research Inc._ is currently seeking a *Respiratory Therapist* who can fulfill its business needs and is looking for better learning and growth opportunities.
About Us
Cliantha Research Inc. is a full service Clinical Research Organization (CRO) that provides comprehensive and integrated offerings in Early Phase, Late Phase, Respiratory, Tobacco Research, Dermatology, Consumer Research, Research Lab, IVRT, Biometrics, Pharmacovigilance & Medical Services, and Environmental Exposure Chambers (EECs).
With several advanced clinical sites and bio-analytical laboratories in North America and India, Cliantha now has presence in 4 countries along with a strong team of 1000+ professionals. Some of the key regulators, such as the USFDA, EMA, AGES, ANSM, AMPS, MCC South Africa, Health Canada, DCGI, CAP, NABL, Turkey MOH, Thailand MoPH and others have successfully inspected Cliantha across the globe.
Cliantha Research is headquartered in Ahmedabad and has expanded its domestic presence with 5 regional offices & international presence with offices in USA (Florida), Canada (Mississauga & Scarborough).
*Job Description / Roles and Responsibilities for Job Title:*
*1) *Independently supervise and Lead the overall coordination and management of clinical studies/Clinical study staff for BE and Phase 1-4 studies including but not limited to:
*i. *Recruitment, screening, and coordination of patient visits as per study protocols
*ii. *Execution of all aspects of study visits as experience and training allow
*iii. *Perform clinical and study procedures as per study protocols, ensuring minimal deviations and proper tracking and reporting when deviations occur
*iv. *Interact with Principal Investigator, sponsor, manager and Scientific Director and other study coordinators to ensure all aspects of protocols and study requirements are understood
*v. *Design, implementation and coordination of all aspects of data collection, source documentation and CRF transcription as per protocol, SOPs and ICH/GCP guidelines
*vi. *Data entry
*vii. *Participate in development and execution of Quality Control processes
*viii. *Prepare for and support QA audits and sponsor monitoring visits
*ix. *Study drug management
*x. *Lab Sample processing, labelling, storage, shipment, documentation and record keeping
*xi. *IRBs interactions
*xii. *Site Regulatory Documentation collection and management
*xiii. *Archiving
*xiv. *Work with study managers and other members of the study teams to ensure study performance meets or exceeds client expectations
*xv. *Participate in Operational kick-off meetings and regular study update meetings
*xvi. *Ensure study subjects are having the best possible experience while participating in studies
*2) *Participate in development of department SOPs, Equipment Binders, templates
*3) *Procurement of equipment and supplies as required
*4) *Calibration and maintenance of equipment per SOPs; Maintain appropriate logbooks
*5) *Participate in training of staff as experience and qualifications permit
*6) *Participate in Environmental Chamber validations and maintenance; write validation protocols and reports, conduct validation experiments, maintain appropriate logbooks
*7) *Assist in all aspects of company start up activities as required
*8) *Uphold the company mission statement and conduct yourself at all times in a respectful and business-like manner. Be a positive role model for all staff and interact with colleagues in a collaborative way
*9) *Assist in set up and maintenance of laboratory and EMS system
*10) *Identifies any discrepancies with respiratory therapy medications to study investigator. Contributes to a safe working environment by participating in safety activities by cleaning and maintaining equipment as required
*11) *Maintains and updates professional and technical knowledge by participating in professional societies and complying with applicable certification requirements
*12) *Contributes t