Site Compliance Specialist - Fixed term contract 3 months
Panthera BioPartners
Location - Rochdale
At Panthera Biopartners, we put the patient at the heart of everything we do, to ensure the best experience and environment for volunteers, participants and employees. We want people who are swift to action, confident to lead, willing to collaborate and curious about what science can do.
If this sounds like you, then you're our kind of person!
As a professional in Clinical Research, you will be at the forefront of our growth. As we look to accelerate our clinical breakthroughs for our patients, customers and future generations, we are looking for a forward-thinking individual with excellent communication skills. This candidate should be proactive and striving to grow and succeed with the organisation.
The Site Compliance Specialist will be responsible for providing oversight, mentoring and guidance to staff and ensuring compliance with all appropriate guidelines for legal, regulatory, and site compliance, as well as company policies and procedures.
Role and responsibilities:
* Building key relationships with stakeholders, colleagues, clients, monitors and CRAs
* Responsible for complex data collection, transcribing information into case report forms in accordance with Good Clinical Practice
* Ensuring accuracy and high quality of data input in to Panthera systems
* Ensuring patient notes are always complete and up to date
* Responsibility for safeguarding and ensuring the quality of information for patients, clients and vendors
* Prepares individual/site operational compliance plans and performs quarterly operational compliance check activities.
* Prepares associated reports and follows up on quality issues from all sources and related CAPAs.
* Performs regular quality control and oversees that quality of data is accurate, on time and adheres to latest approved SOPs, COPs standards, GCPs, Local Regulatory and protocol.
* Validates and checks quality of essential documents, participant files and site study data, ensuring accuracy of data entered and source documents and reports discrepancies.
* Develops, maintains and produces a dashboard for tracking patients, flow of CRFs, and queries, ensuring that this is provided in a timely manner.
* Conducts, hosts, and produces meeting minutes and actions for departmental and other relevant meetings, ensuring that issues impacting on business are highlighted to senior leaders as needed.
* Monitors quality and training processes to ensure appropriate timelines are met
* Completes the preparation for monitoring visit duties and audits and clarifies concerns related to CRF completions; resolves queries as well as CAPA reporting and basic root cause analyses.
* Identifies trends in data queries and escalates appropriately.
* Supports QA regarding notifications, preparations and facilitation of client audit and regulatory inspections, investigations of quality issues and tracking and follow up of local CAPA status.
* Ensures that quality and patient safety are at the forefront of all activities through review and interpretations of audit reports, quality statistics and operating procedure robustness, and follows up on quality issues.
* Ensures robust application and compliance with Good Clinical Practice and Data Protection Act or SOPs, QA and applicable regulatory guidelines
Skills and capabilities for this role:
* Degree level or equivalent experience
* Strong interpersonal, leadership and consultative skills
* Experience with the preparation of and collation of regulatory documents for ethics submissions
* Ability to take detailed and accurate notes, transposing and recording information
* Proactive mind set, motivated and keen to learn new skills
* Committed to improving quality through research
* Able to demonstrate commercial awareness
* Comprehensive industry knowledge of quality compliance, GCP
Benefits:
* A very competitive salary
* 25 days holiday a year + bank holidays
* Enhanced Employer Pension Contributions
* Annual bonus (based part on individual and part based on company performance)
* Car leasing scheme - Salary sacrifice scheme for electric car options.
* Medicash plan - Reclaim doctor, dentist & optician expenses.
* Enhanced Family Policies (Paternity, Maternity, Shared Parental & Adoption Leave).
Join us on our journey of building a new kind of organisation. This means we're opening new ways to work, ground-breaking methods and bringing unexpected teams together.
Interested? Come and join our journey!
Panthera Biopartners is an equal opportunity employer. Panthera will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. Panthera only employs individuals with the right to work in the country where the role is advertised.
Job Types: Full-time, Part-time, Fixed term contract
Contract length: 3 months
Pay: £15.00-£20.00 per hour
Expected hours: 40 per week
Schedule:
* Monday to Friday
Work Location: In person
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