The Clinical Compliance Specialist will act as an advisor on ICH GCP and other
regulations/standards governing clinical research activities and will support
study teams by driving and overseeing quality and compliance for clinical
studies. This role will partner with study delivery teams focusing on first-time
quality, issue management and maintaining an inspection-ready state. The
Clinical Compliance Specialist will provide expertise to support clinical study
delivery, clinical compliance leadership and customers.
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Quality Issue Management (40%)
- Facilitate the identification of quality issues, collaborate with study teams
to address quality issues and ensure timely resolution of quality issues.
- Facilitate quality issue investigations, including root cause analysis CAPA
plan creation
- Ensure on time completion of quality issues and CAPA per procedural timelines
- Monitor implementation of corrective and preventative actions
- Support study teams to identify and assess risks arising from quality issues
including protocol deviations and privacy incidents.
- Provide oversight, transparency and tracking of quality issues for assigned
studies
- Monitor quality metrics and key indicators and report trends to senior
Quality and Compliance leadership
- Escalate critical study issues to senior Quality and Compliance leadership
Audits and Inspections (20%)
- Perform site audits as defined in sponsor contract
- Support site and study audit/inspection readiness activities including
conducting routine/periodic assessments to measure and ensure adherence of
study processes and procedures by internal personnel and external vendors.
- Act as Alimentiv lead for site audit/inspections including preparation,
review, and provision of relevant documents, assigning roles and
responsibilities for each audit/inspection Primary point of contact between
study team and auditor/inspector to respond to questions and attend all audit
interviews and meetings
- Debrief study teams on site audit/inspection findings
- Maintain an inspection-ready state by ensuring the study project management
team has submitted all study documentation for uploading to the study Trial
Master File (TMF).
Training Oversight (15%)
- Oversee study level training compliance of study teams by conducting
compliance reviews of study training assigned to the study team to ensure on
time completion.
Compliance and Continuous Improvement (25 %)
- Support inquiries from sponsors/customers, corporate and study teams with
global quality, regulation, ethics, and privacy inquiries.
- Develop and cultivate transparent relationships, while managing expectations
with customer/sponsor representatives
- Provide study level compliance advice and mentorship, using ICH-GCP,
Alimentiv processes, regulatory requirements, applicable country requirements
and input of appropriate subject-matter experts.
- Identify areas for continuous improvement of the Quality Management System by
submitting feedback on processes and participating in process improvement
initiatives
- Develop and monitor key performance indicators related to study quality and
compliance to track and report on performance.
- Maintain compliance with Alimentiv policies, standard operating procedures,
work instructions and other regulatory requirements
- Remain current with evolving regulatory requirements and industry best
practices to ensure compliance with requirements governing clinical research
activities.
- All employees are expected to complete training on time and maintain a
minimum level of 90% training compliance at all times.
Additional Qualifications
- Expertise in root cause methodologies (5-whys, fishbone diagram, etc.) and
CAPA development
- Expertise with ICH-GCP principles, ISO 20916 and ISO 14155
- Strong interpersonal, verbal and written communication skills including
effective listening, facilitating group discussions, influencing without
authority and providing appropriate feedback.
- Superior analytical skills focusing on identifying potential compliance
issues, investigating root causes, brainstorming and identifying alternatives
and assessing the effectiveness of actions.
- Strong skills in interpreting, synthesizing, inferring, evaluating and
extracting pertinent data to identify areas of risk, trends and aggregated
issues.
- Adaptable to changing environments, able to think quickly, able to deal with
ambiguity and learn new tasks applying routine knowledge.
- Ability to plan, organize, prioritize and manage workload independently,
keeping the patient and customer at the focus.
- Superior critical thinking skills
- Knowledge of Quality by Design principles
- 7+ years of related experience
- Bachelors Degree
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$76,000 - $127,000 a year
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