Job Description

Aventiv Research, IACT Health, LMC Manna Research, and True North Clinical Research have united to become the largest network of fully-owned and integrated clinical research sites in North America, Centricity Research.

The sites that were formerly known as Aventiv operate in Ohio and Arizona and specialize in phase 1 pharmaceutical, device, and diagnostic clinical trials in a variety of therapeutic areas throughout phases 1-4. The sites that were formerly known as IACT Health brings phase I-IV clinical trials in over 30 therapeutic areas such as oncology, cardiology, pulmonology, endocrinology, infectious disease, and pain with wholly owned and integrated clinical research offices in multiple cities in the United States across the Southeast, including Georgia and Virginia. The sites that were formerly known as LMC Manna bring phase I-IV clinical trial services with specialized focuses on endocrine disorders, real world evidence big data research, vaccine research, and primary care studies within Canada at sites across Alberta, Ontario, and Quebec. The sites that were formerly known as True North Clinical Research are located in Nova Scotia and specialize in research related to Alzheimer's disease and conditions related to aging, and are committed to finding new treatments to maintain an improved quality of life for patients through innovation and passion.

Centricity Research is committed to revolutionize research by creating outstanding clinical trial experiences to improve the health of the community today and tomorrow through clinical research.

Currently, our rapidly expanding team and site network is looking for a Nursing Operations Manager who can work for us on a permanent, full-time basis, supporting our Bayview (Toronto) location.

Responsibilities will include but are not limited to:

Nursing:

• Practice nursing per study protocol(s) and under nursing scope of practice for state/province that study is being conducted.
• Ensure Nurse staff attain required competencies, training, and certifications. Facilitate adherence to safe practice in the conduct of clinical research.
• Impart clinical nursing and research expertise in research-related patient care situations.

Protocol and Safety:

• Ensure the safety and welfare of study participants.
• Conduct the study as per protocol, GCP, and SOPs/WPs including but not limited to screening study participants based on protocol inclusion/exclusion, scheduling visits, and obtaining study specific assessments e.g. vitals and any follow up visit procedures.
• Be knowledgeable of study protocol to ensure all study activities are completed correctly as to limit any deviations.

Recruiting, Screening, and Enrolling Study Participants:

• Assist in local recruiting efforts for clinical trials.
• Ensure operationally ready to achieve recruitment plans and objectives.
• Lead regularly scheduled research meetings w/ focus on recruitment and retention, study, and site updates, and ensuring engagement of CRPs and Investigators.
• Support site level physician engagement ensuring site recruitment and support.

Study Visit Completion:

• Perform delegated research and administrative procedures to assist in conducting clinical studies under the direction of the Investigator.
• Perform ECGs, vital signs, meal distribution, study participant monitoring, and other tasks as required by protocol/site.
• Perform phlebotomy, point of care testing, sample collection, processing & shipping as required by protocol/site.
• Obtain all necessary documentation as required by the protocol.
• Timely and accurate completion of source, data, CRFs, queries and CTMS.

Safety Reporting & Data Integrity:

• Verify input data and timely documentation regularly and accurately.
• Support the review of source docs and other study documents.
• Perform regular quality control (QC) checks and other QC tasks as deemed necessary
• Support audit preparation for any site inspections.

General:

• Abide by GCP, SOPs/WPs, company guidelines, and local healthcare privacy regulations.
• General site level support.
• Support feasibility review and submissions, where required.
• Conduct/support PSV.
• Support study opportunities study planning, and study execution as per the job description for PM, when required.
• Communicate study updates and learnings with applicable staff.
• Communicate effectively both internally and externally.
• Timely phone, TEAMS and email communication and follow-through.
• Develop, coordinate research and administrative procedures for the successful conduct of clinical trials.
• Travel and support applicable sites within the region.
• Ensure confidentiality of study, company, and patient information.
• Serve as a central point of contact for site escalated issues.
• Work independently with little to no supervision.

Management:

• Manage quarterly recruitment targets and support efforts to achieve site/company KPIs.
• Support admin to verify operations metrics are available and accurate.
• Support in recruiting and hiring of CRPs.
• Train employees and model continuous improvement.
• Supervise, train, mentor and develop CRPs.
• Provide ongoing feedback and coaching to all CRPs.
• Conduct reviews/check-ins as outlined by HR.
• Approve time off request and timecards.
• Transparency with the organic growth and future of the company.
• Anticipate issues and needs for the site based on trends seen at the site level
• Actively develop and seek opportunities for regional and site-specific growth.
• Serve as a resource for all teams.
• Fostering cohesiveness at all levels of the company.
• Other supervisory responsibilities as assigned.

Requirements:

• Bachelor's in Nursing/University degree or post-grad diploma
• Registered in good standing as an RN with the College of Nurse's of Ontario
• 5+ years of experience (combination of research and RN experience)
• Experience in progressively responsible positions with experience in research.
• Strong knowledge in clinical research methodology, including regulatory aspects.
• Strong knowledge of medical terminology
• Strong Phlebotomy, IV/IM skills
• Excellent communication skills (verbal and written)
• Excellent computer skills (MS Word, Excel, Outlook, Teams)
• Strong knowledge of ICH GCP, FDA & HC Division 5 guidelines

Centricity Research is committed to meet the accessibility needs of persons with disabilities in a timely manner. These accommodations will be available upon request.

We thank all candidates for their applications, however, only those candidates selected for an interview will be contacted

Centricity Research values the health and well-being of our employees, clients and patients and as such we have instituted a COVID-19 Mandatory Vaccination policy for all employees. All candidates attending interviews in-person or receiving job offers will be required to provide proof of vaccination

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