ABOUT EMVENIO RESEARCH:
EmVenio Research delivers localized trial access to diverse and underserved communities. We empower patients and embrace communities on their terms. Our research solutions cultivate a sustainable local ecosystem that benefits all stakeholders. Removing barriers and unlocking doors to innovation reduces risk and time associated with clinical research, while improving ROI.
EmVenio Research offers competitive pay, a comprehensive benefits program and opportunities for learning and career development. We promote a diverse and inclusive workplace, and our team members have a voice in their work through surveys and town halls.
POSITION SUMMARY:
The Manager of Site Standards and Research Coordination will have direct oversight and leadership of the both the virtual and on-site Clinical Research Coordinators. This has the unique opportunity to build and maintain a high functioning workforce, adequately resourced and equipped to deliver clinical trials in all site types within the network. Providing cover during periods of team absence will be required, across multiple US time zones. By combining the leadership of CRC’s and site standards, the role is positioned to standardize operating practice across the network and thus creating a culture of high quality when delivering trial critical data and patient safety. Integral to this role is experience and understanding of the standards required by CRC’s during trial setup, operation and closeout from both the site and sponsor / CRO viewpoints, ensuring company compliance with applicable regulations and external expectation.
ESSENTIAL FUNCTIONS
Reasonable Accommodations Statement
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.
Essential Functions:
Coordinator Leadership & Management
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Direct line management of Clinical Research Coordinators (CRCs) and matrix management of CRCs within sites large enough to command a different structure, including performance management
- Recruiting, mentoring, training and retaining Clinical Research Coordinators in line with demand planning requirements
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Coordinate and manage study assignment, demand planning, and allocation of coordinator team
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Oversees caseload management for CRCs
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Implementing and developing a training and career growth structure for the CRC team
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Maintains CTMS, eISF, participant scheduling management, QC, and review
- Set EmVenio study management standards across coordinator team
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Oversight of EDC entry timelines
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Ensure the CRC team are adequately resolving action items before, during, after monitoring visits, both on-site and remote
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Monitoring report review and ensuring all follow ups are completed in a timely manner by the CRC team
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Maintain compliance with OSHA, HIPAA, ICH-GCP and other applicable regulations and guidance
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Follows and monitors team’s compliance with ALCOA+C for good documentation practice
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Ensures adherence to clinical trial protocols and supports the clinical trials team in ensuring that trials are conducted and comply with all regulatory, state, national and internationally accepted guidelines for Good Clinical Practice (ICH GCP)
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Trending of non-compliances
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Coordinates routine review of coordinator team activity with regulatory and quality supervisors
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Creates and/or implements corrective action plans if non-compliance discovered
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Reviews new protocols and other materials provided by study sponsors and gives input to the Principal Investigators (PIs), site leadership, and site staff, as applicable, regarding study conduct and research issues in order to resolve financial and clinical feasibility
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Provide subject matter expertise to cross functional teams pertaining to new solutions, issue resolution and commercial opportunities
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Ensures their team has set clear personal and business goals; conducting monthly reviews to foster a culture of collaboration, continuous improvement, and personal development
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Capacity management of CRCs, collaborating cross functionally with sales and trial optimization to include recommendations of when expand the team, whilst managing financial expenditure and risk
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Set regular cadence of cross functional team briefings to share experience, lessons learnt and update on targets / feedback
Site Standards
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Implement, develop, and review study processes that standardize the ways sites operate throughout the duration of study conduct via the CRC role, through all stages of a study
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Standardize the interaction and review of study data between the CRC, site staff and Principal Investigators
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Development, implementation, and management of ‘Lead Coordinator’ role per study
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Manage the process of allocating and reviewing critical trial documentation and system setup / revision, including the setup of CTMS and eSource
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KPI implementation and oversight for key parameters, such as EDC entry timelines, protocol deviations and monitoring visit findings
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Collaborate with the training and education group to ensure a curriculum fit to develop junior staff members and train in processes / therapeutic areas that may be new
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Act as a primary point of contact for Project Managers, Site Management, Quality and Regulatory for matters pertaining to assigned studies
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Ensure CAPAs are addressed in an open and expedited manner with systematic follow-up to ensure adherence
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Address escalations on CRA performance and collaboration with Project Management as appropriate
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Stay current with constantly changing clinical research technology and embrace innovation
POSITION QUALIFICATIONS
SKILLS AND ABILITIES
Education & Experience: A bachelor’s degree in health research, public health, social work, social science or a related field. 3 years’ supervisory experience is required. Experience as a CRA / Monitor / Trial Manager in either Sponsor or CRO preferred.
Other Requirements:
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Excellent communication skills, demonstrated effective spoken and written communication, including willingness to ask questions when clarification or amplification is required
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Demonstrated attention to detail and ability to adhere to instructions/procedures
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Good time management skills; efficient and resourceful in problem-solving
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Demonstrated ability to take ownership of the work, possessing initiative, good follow-through; ability to work without supervision
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Ability to receive and benefit from feedback; willingness to expand skill set and improve
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Flexibility in adapting to new procedures and environments
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Ability to work in a team environment
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Familiarity with research/data collection software and client processes
WORK ENVIRONMENT
Work is performed primarily remotely. The noise level in the work environment is usually quiet in office settings and moderate in other situations.
The preceding functions may not be comprehensive in scope regarding work performed by an employee assigned to this position classification. Management reserves the right to add, modify, change or rescind the work assignments of this position. Management also reserves the right to make reasonable accommodations so that a qualified employee(s) can perform the essential functions of the position.
Location: Remote (preferred EST or CST time zone)
Amount of Travel Required: 25%
Schedule: Monday – Friday, remote
Compensation: $85,000 - $105,000. The actual salary offered will carefully consider a wide range of factors, including your skills, qualifications, experience, and location.
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