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 to team effort by working with other team members to achieve optimal client & patient service and on other teams as required
13) Seeks to continuously improve the operation of the clinic by evaluating processes and workflow and participating in other quality improvement activities and training.
14) Train staff on Pulmonary Function Testing.
15) Write SOPs relating to Pulmonary Function testing.
16) Perform Pulmonary Function Tests such as Spirometry, Peak Flows, Reversibility Testing, Methacholine Challenge and other assessments as required by a study protocol.
17) Perform other functions as required by study protocol or business needs such as 6 minute walk tests
18) Perform specialized asthma tests including bronchial provocation and FENO testing
19) Execute other duties as may be required
Any Additional responsibility given by Head of the Department / Management
Qualifications:
· B.SC., post-secondary diploma in a scientific, healthcare or pharmaceutical field or equivalent
· Graduation from an accredited institution of Respiratory Therapy and licensed to practice with the provincial governing body
· >4 years of experience in performing Pulmonary Function Tests such as Spirometry, Methacholine Challenges, Exercise induced Bronchoconstriction
· Solid understanding and broad knowledge of the pathophysiology of the cardiopulmonary system
· Minimum 3 years’ experience in a clinical research environment preferably including BE and Ph 1 – IV studies, EEC is desirable
· BCLS preferred, ACLS an asset
· SOCRA/ACRP certificate is an asset
· Demonstrates effective time-management skills and able to quickly make decisions in order to solve problems as required; ability to work independently
· Working knowledge of ICH/GCP and GDP
· Strong analytical and problem solving skills
· Demonstrated superior leadership skills
· Good trouble-shooting and decision making skills, able to escalate response to situations when relevant
· Proven solid project planning/coordination/management skills
· Excellent organizational skills, detail oriented, efficient and able to multi-task and prioritize effectively
· Excellent interpersonal skills
· Strong English written and verbal communication skills
Cliantha Research is committed to creating and maintaining a diverse, inclusive, and accessible environment for all its employees and clients. We value diversity at workplace and believe in fostering a spirit of excellence brought in by all our employees and clients. If you require accommodation before, during, or after the interview/recruitment process do not hesitate to let us know when we contact you and we will work with you and do our level best to meet your needs.
We thank all our candidates for taking interest and the time to apply for stated job vacancy; however only those selected will be contacted for next steps.
Pay: From $60.00 per hour
Experience:
- Respiratory Therapist: 1 year (preferred)
Work Location: In person
