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Cliantha is currently seeking a Nurse Practitioner 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 & Europe.

JOB REQUIREMENTS

The role of the Nurse Practitioner/ Sub-Investigator in clinical research is a refreshing departure from Hospital or Family Practice. It differs from the traditional NP role as it requires a self-motivated individual with a dynamic perspective. It provides an opportunity for autonomy, skill building, decision making, and leadership. This exciting role involves working with clinical teams to manage multiple concurrent clinical trials. The candidate will have the opportunity to study the development of various new and genericized medications and have an impact on the development of pharmaceutical products and medical devices.

The NP/ Sub Investigator role requires performance of duties in keeping with ICH GCP Guidelines and Cliantha Research Standard Operating Procedures (SOP). The candidate will perform the duties of a Nurse Practitioner/ Sub Investigator in various Bioequivalence, Phase 1-4 studies, and company/ departmental initiatives. These include but are not limited to:

• Reviewing the study protocol and informed consent form
• Performs medical procedures as outlined in the protocol (i.e. Physical exams. MMSE, Pap tests)
• Administer any form of Investigational Product as specified in the protocol
• Evaluate subject’s eligibility for a clinical trial by reviewing the medical history, physical examination, laboratory values, ECG and diagnostic findings, spirometry/ PFT and the study inclusion and exclusion criteria
• Monitor and medically manage subject’s health status and progress during the clinical trial according to the protocol, Cliantha Research SOPs, and sound clinical judgment.
• Assist and/or direct the study coordinator, study manager, or other study personnel in the functions of a clinical trial
• Participate in any external or internal audit of a clinical trial
• Policy and Standards of Practice/ Standard Operating Procedure (SOP) creation and revision
• Training of clinical staff
• Be on-call after hours if required

QUALIFICATIONS:

• Current Nurse Practitioner license in the Province of Ontario
• Certification in ACLS preferred
• Demonstrate knowledge of or participation in a course on ICH GCP Guidelines is an asset
• Strong and accurate diagnostic skills
• Be able to work in a fast paced environment as well as maintain productivity during less demanding times.
• Must be able to work and learn independently and maintain strong analytical and problem solving skills.
• Must be detail oriented and self-motivated; and have excellent work ethic, organizational skills, efficiency, and ability to multi-task and prioritize effectively
• Excellent interpersonal and leadership skills
• Strong written and verbal communication skills
• Due to the nature of the research industry, the candidate must be able to accommodate flexible hours and manage changes to work schedule.

• Reviewing the study protocol and informed consent form
• Performs medical procedures as outlined in the protocol (i.e. Physical exams. MMSE, Pap tests)
• Administer any form of Investigational Product as specified in the protocol
• Evaluate subject’s eligibility for a clinical trial by reviewing the medical history, physical examination, laboratory values, ECG and diagnostic findings, spirometry/ PFT and the study inclusion and exclusion criteria
• Monitor and medically manage subject’s health status and progress during the clinical trial according to the protocol, Cliantha Research SOPs, and sound clinical judgment.
• Assist and/or direct the study coordinator, study manager, or other study personnel in the functions of a clinical trial
• Participate in any external or internal audit of a clinical trial
• Policy and Standards of Practice/ Standard Operating Procedure (SOP) creation and revision
• Training of clinical staff
• Be on-call after hours if require