Clinical Research Coordinator

3 months ago

Mississauga, Canada Cliantha Research Ltd. Full time

_Cliantha Research Inc._ is currently seeking Part-Time Clinical Research Coordinator(s) who can fulfill its business needs and is looking for better learning and growth opportunities.

About Us

Cliantha Research 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, Canada, and Europe.

**General responsibilities**:
Assist in the overall conduct of clinical studies for BE and Phase 1-4 studies including but not limited to:

- Recruitment, screening, and coordination of patient visits as per study protocols
- Execution of all aspects of study visits as experience and training allow
- Perform clinical and study procedures as per study protocols, ensuring mínimal deviations and proper tracking and reporting when deviations occur
- Interact with principal investigator, sponsor, manager and Scientific Director and other study coordinators to ensure all aspects of protocols and study requirements are understood
- Assist in design, implementation and coordination of all aspects of data collection, source documentation and CRF transcription as per protocol, SOPs and ICH/GCP guidelines
- Data entry as required
- Participate in development and execution of Quality Control processes
- Prepare for and support QA audits and sponsor monitoring visits
- Study drug management (for outpatient dosings)
- Lab sample processing, labelling, storage, shipment, documentation and record keeping
- IRBs interactions
- Site Regulator Documentation collection and management
- Archiving
- Work with study managers and other members of the study teams to ensure study performance meets or exceeds client expectations
- Participate in Operational Kick-off meetings and regular study update meetings

**Qualifications**:

- B.Sc., post-secondary diploma in scientific, healthcare or pharmaceutical field, or equivalent experience and/or education
- Minimum 2 years’ experience in a clinical research environment preferably including BE and Ph1-4 studies, EEC is desirable
- Good trouble-shooting and decision making skills, able to escalate response to situations when relevant
- Proven solid project planning/coordination/management skills
- Strong analytical and problem solving skills
- Excellent organizational skills, detail oriented, efficient and able to multi-task and prioritize effectively
- Excellent interpersonal skills
- Strong 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._

**Job Types**: Full-time, Permanent

Schedule:

- 8 hour shift

Ability to commute/relocate:

- Mississauga, ON L4W 1A4: reliably commute or plan to relocate before starting work (preferred)

Application question(s):

- Work Availability: Which Days and What timings are you available for work?
- What is the earliest date you can start?

**Education**:

- Bachelor's Degree (preferred)

**Experience**:

- Clinical Research: 2 years (preferred)

Work Location: In person

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