Assistant Operations Manager (Phase I Clinical Trials)

Centricity Research is a clinical research organization with more than 40 sites, access to over 1.6 million patients and participants, and more than 150 active investigators across Canada and the southeastern United States. Our name, Centricity Research, was purposefully chosen to signify the fact that we are customer-centric. Our study participants, sponsors, CROs, and physicians are the cornerstone of our business. We aim to build and nurture strong, trusting relationships with all audiences, and being customer-centric is embedded within our company culture.

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 Centricity Research CPU-Toronto site (ON-CPU) at 1929 Bayview Ave. Toronto, ON in person.

The Assistant Operations Manager is responsible for the coordination and administration of clinical trials under the direction of the Operations Manager and the Investigators. The Assistant Operations Manager will develop, implement, and coordinate research and administrative procedures for the successful management of clinical trials.

Protocol And Safety:

Responsibilities will include but are not limited to:

• Ensure the safety and welfare of study participants.
• Conduct the study as per protocol, GCP, and SOPs including screening study participants based on protocol inclusion/exclusion, scheduling visits, and obtaining study specific assessments e.g. vitals.
• Be knowledgeable of study protocol to ensure all study activities are completed correctly.

Recruiting, Screening, And Enrolling Study Participants:

• Assist in local recruiting efforts for clinical trials.
• Support to ensure operationally ready to achieve recruitment plans and objectives.
• Lead regularly scheduled research meetings with focus on recruitment and retention, study and site updates, and ensuring engagement of CRP 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, as required.
• Support audit preparation for any site inspections.
• Perform regular quality control (QC) checks and other QC tasks as deemed necessary.

General:

• Abide by GCP, SOPs, company guidelines, and local healthcare privacy regulations.
• Communicate study updates and learnings with applicable staff.
• Communicate effectively both internally and externally.
• Timely phone, TEAMS and email communication and follow-through.
• General site level support.
• Travel and support applicable sites within the region.
• Ensure confidentiality.
• Support feasibility review and submissions, where required.
• Conduct/support PSV.
• Work independently with little to no supervision.

Management:

• Support 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.
• Supervise, train, mentor and develop CRPs.
• Serve as a resource for CRPs.
• Train employees and model continuous improvement.
• Provide ongoing feedback and coaching to all CRPs.
• Conduct reviews/check-ins as outlined by HR and/or Operations Manager.
• Approve time off request and timecards.
• Anticipate issues and needs for the site based on trends seen at the site level.
• Fostering cohesiveness at all levels of the company.
• Unify site specific culture and Centricity fundamentals.
• Other supervisory responsibilities as assigned.

Minimum Requirements:

• College/University degree or equivalent in life sciences related field.
• (Internal) At least 1 year of Centricity Research experience OR (External applicants) at least 3 years working in clinical research and 1 year of management experience.

Preferred:

• Post-secondary education in a clinical research program.

Working Conditions:

• Modern medical office environment or home office environment.
• Required to follow OSHA and CCOHS guidelines, in addition to other local healthcare regulations.
• Required to perform duties in relation to HIPAA, PIDEDA, and other local privacy regulations.
• Some positions may require overnight/weekend hours.
• Travel between the USA and Canada as necessary, including multi-day trips.

What We Offer:

• Opportunities to work with internationally renowned physicians.
• Comprehensive health benefits, competitive salary.
• RRSP or 401(k) contribution matching.
• Continued opportunities for growth & development; yearly education allowance.
• Paid holiday closures and employee appreciation days off.

Centricity Research is an equal opportunity employer. We are committed to inclusive, barrier-free recruitment and selection processes and work environments. If you are contacted for a job opportunity, please let us know of any accommodations needed to ensure you have access to a fair and equitable process. Any information received relating to accommodation will be kept confidential.

Centricity Research does not currently utilize Artificial Intelligence for screening or recruitment purposes.

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