We are seeking a highly skilled and experienced Nurse Practitioner, Clinical Trials and oversee clinical trials for our client, in the pharmaceutical industry. The Nurse Practitioner will ensure the successful execution, oversight, and compliance of clinical studies in alignment with regulatory guidelines, ethical standards, and the scientific objectives of the research. This role requires expertise in clinical trial methodologies, patient safety, data integrity, and regulatory requirements, along with the ability to lead a multidisciplinary team and engage effectively with stakeholders at all levels.

Roles and Responsibilities

Leadership and Oversight:

• Lead and manage sponsors’ implementation and execution of clinical trials from protocol development to study completion.

• Ensure all clinical trial activities comply with Good Clinical Practice (GCP), institutional guidelines, and regulatory requirements.

• Provide medical and scientific leadership to maintain scientific rigor and adherence to research objectives.

Protocol Development and Study Design:

• Collaborate with stakeholders, including research teams, sponsors, and regulatory bodies, to develop study protocols, case report forms (CRFs), and essential study documents.

• Educate staff on protocol inclusion/exclusion criteria, endpoints, and other key components of clinical trial design.

Patient Safety and Welfare:

• Oversee the safety and well-being of study participants, ensuring appropriate monitoring and timely reporting of adverse events (AEs) and serious adverse events (SAEs).

• Ensure informed consent is obtained and participants' rights and confidentiality are protected.

Regulatory Compliance and Documentation:

• Ensure all necessary regulatory submissions are completed and approved in a timely manner, such as IRB/ethics committee approvals and IND/NDA submissions.

• Oversee accurate and complete data collection, source documentation, and timely reporting of study results to regulatory agencies (Health Canada, FDA, EMA, etc.).

Collaboration and Communication:

• Serve as the primary point of contact for external stakeholders, including sponsors, regulatory agencies, and monitoring teams.

• Communicate regularly with the clinical trial team, including research coordinators, data managers, and research assistants, to ensure smooth trial operations.

Training and Mentorship:

• Provide ongoing education and guidance to clinical research staff, including clinical research associates (CRAs), coordinators, and other personnel.

• Mentor junior investigators and staff to foster professional development, ethical standards, and high-quality research.

Data Integrity and Reporting:

• Ensure that clinical data is accurately recorded and monitored in accordance with study protocols.

• Contribute to the preparation of clinical trial reports, manuscripts, and publications based on study findings.

Continuous Improvement:

• Monitor and evaluate trial progress, addressing issues or obstacles promptly.

• Identify opportunities for process improvements and contribute to the development of best practices in the clinical trial research environment.

Qualifications and Skills

• Minimum of 5-10 years of clinical research experience, including experience as a PI in clinical trials.
• Expertise in clinical trial design, GCP, and regulatory guidelines.
• Strong knowledge of clinical trial design, GCP, FDA, ICH, and other applicable regulatory guidelines.
• Exceptional leadership, project management, and organizational skills.
• Ability to lead and manage multidisciplinary teams, prioritize tasks, and resolve conflicts.
• Excellent written and verbal communication skills, with the ability to effectively present data and findings.
• Proficiency with clinical trial management systems (CTMS), electronic data capture (EDC) systems (experience with CRIO is an asset).

Education

• NP or equivalent in a relevant scientific or medical discipline.

Nice-to-Haves

• Experience in CNS-specific therapeutic areas.

Benefits

• 3 weeks' vacation + holiday closure.
• Personal days, 10 stat holidays off and sick days. 
• Comprehensive benefits plan (health, dental & vision) 
• RRSP Matching up to 3% after 3 months.