Assistant Operations Manager

2 weeks ago

Barrie, Canada Centricity Research Full time

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 an **Assistant Operations Manager** **who can work for us on a** full-time, permanent basis**, supporting our **Barrie** location.

**Responsibilities will include but are not limited to**:

- Staff_
- _ Supervise, train, mentor, develop and retain Clinical Research Professionals (CRPs) (includes Clinical Research Coordinators/Clinical Trial Assistants/Lab Technicians)_
- _ Support in the recruiting and hiring of Clinical Research Professionals (CRPs)_
- _ Train and mentor new CRPs on conducting clinical research studies according to the clinical trial protocol, LMC Manna Research SOPs, Regulatory guidelines and ICH/GCP (also supported by QMS team and experienced CRPs)_
- _ Provide ongoing feedback and coaching to all CRPs_
- _ Conduct quarterly and annual reviews for all CRPs_
- _ Escalate to Senior Research Management / Human Resources as needed_
- Study Operations_
- _ Ensure CRPs conduct the clinical research study according to the study protocol, GCP, and the LMC Manna Research SOPs / WPs_
- _ Ensure all study activities are completed correctly to minimize Major Protocol Deviations (MPDs)_
- _ Liaise with Sponsor / CRO representatives to secure studies, discuss the conduct of studies, and manage any study site escalations and concerns_
- _ Ensure operationally ready to achieve recruitment plans and objectives_
- _ Assist in implementing recruitment and retention strategies of study participants and identifying barriers_
- _ Liaise with QMS department with respect to any quality concerns (current, proactive, and risk-based) and re-training _
- _Support audit preparation for any site inspections_
- Site Operations_
- _ Lead regularly scheduled research meetings, with focus on recruitment and retention, study and site updates, and ensuring engagement of site CRPs and investigators_
- _ Delegate tasks to CRPs based (e.g., chart screening, query review, study lead)_
- _ Support site level physician engagement ensuring site recruitment and support _
- _General site level support (e.g. Uber, running queries, RealTime)_
- _ Approve employee time off requests while ensuring adequate coverage for site, including scheduling of staff, physicians, external vendors, as applicable._
- General_
- _ Travel and support applicable sites within area of responsibility _
- _Attend research management meetings _
- _Support feasibility review and submissions, where required_
- _ Conduct PSV (with support of Centricity Project Manager where applicable)_
- _ Communicate effectively both internally and externally _
- _Assist Senior Research Management and Investigators with any other research tasks as required_
- Back-up functions_
- _ CRP back-up support for designated sites (dependent on Manager’s workload and number of direct reports, could include lead CRC role)_
- _ Support review of source documents, MD letters and summaries, and other study documents to ensure accuracy_
- _ Support outreach to area clinics, physicians, community groups, and/or vendors based on business needs of LMC Manna Research_
- _ Support Study Opportunities, Study Planning, and Study execution as per the job description for Project Manager, when required. _

**Requirements**:

- Bachelors of Science Degree or equivalent, required
- Post secondary education in a clinical research program (preferred)
- ACRP certified Clinical Research

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