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\xe2\x80\x99s 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 Bayview 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)
• Support admin to verify operations metrics are available, accurate, and delivered to Senior Research Management and Sponsors / CROs in a timely manner (e.g., workload, teamwork, subject status)
• 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\xe2\x80\x99s 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 Coordinator and/or Project Management
• At least 2-3 years of clinical research experience

Centricity seeks dynamic individuals who embrace learning and innovative opportunities and those who contribute to improving the health of society today and tomorrow through clinical research.

Centricity 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 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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Centricity Research