A job vacancy for a S/CRA has arisen at a leading global pharmaceutical company specialising in development of biological therapies. This company is one of the top 10 global pharmaceutical companies that operates in 140 countries worldwide and has market leading products in multiple therapy areas.
Direct point of contact with assigned sites, accountable for quality and delivery during the start-up phase.
- Build relationships with investigators and site staff.
- Conduct, drive and manage country specific feasibility and/or site pre-qualification and qualification activities, which may include:
- Preparation, negotiation, and facilitation of execution of Confidentiality Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.
- Conduct remote Qualification Visits (QVs).
- Generate visit/contact reports, using judgment to identify site issues and problem solving to direct resolution.
- Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site-specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation.
- Customise, review, and negotiate as needed, country/site specific Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customise and negotiate any amendments.
- Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval.
- Submit all pertinent documentation to the trial master file as per project plans/sponsor/company policy.
- Forecast, develop, manage, and revise plans and strategies for:
- IRB/IEC and MoH / RA submission/approval, Site activation, Patient recruitment & retention.
- Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner.
- Promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue, including but not limited to: potential issues or risks with site activation timelines, issues with patient recruitment strategy, deficiencies in training, data quality or integrity, study non-compliance, etc.
- Address/evaluate/resolve issues pending from the previous visit, if any.
- Collect, review, and approve (if applicable) updated/amended site documentation, including regulatory documents as applicable.
- Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements.
- Perform on-site visits; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns.
- Conduct remote visits/contacts as requested/needed.
- Generate visit/contact report
- Evaluate overall compliance and performance of sites and site staff: provide recommendations regarding site-specific actions and use judgment and experience to assess the ability and motivation of site staff.
- Assess & manage test article/study supply including supply, accountability and destruction/return status.
- Update all appropriate Clinical Trial Management Systems (CTMS) on an ongoing basis, including performing regular reviews of site level data in clinical systems (e.g. CTMS, EDC, IVRS, and SIS) and ensure timely and high quality data entry compliance from sites, manage and submit all relevant documents to the Trial Master File (TMF).
- Ensuring first time quality, and distribute study documents to site including configuration of Investigator Site Files if applicable and on-going maintenance for completeness and quality.
Skills and Requirements
- Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience.
- Sound problem solving skills.
- Able to take initiative and work independently, and to proactively seek guidance when necessary.
- Client focused approach to work.
- Willingness to work in a matrix environment and to value the importance of teamwork.
- Strong computer skills including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS).
- Strong interpersonal, verbal, and written communication skills.
- Proficiency with computer skills, such as MS Office.
- Holds a driver's license where required.
- Fluency in English; German and/or French would be beneficial.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Polina Sidorova at +44 0203 854 3535 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.