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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.
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Protocol and Safety:
- 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
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