Location: Stockley Park
Closing Date: 30 Dec 16
Salary (£): On Application
• Permanent position with leading Pharma • Office based Stockley Park (may be flexible on 1 day working from home) • Monitoring role but a percentage of it will be involved with CRO Oversight
Manage Investigative Site activities to ensure that subject safety is protected and that timely high quality data are collected in compliance with regulations
Responsibilities include, but are not limited to:
• Investigative Site Monitoring - Demonstrate a commitment to quality in all aspects of monitoring; adhere to study monitoring plans; support site identification by conducting feasibility studies as needed; conduct Pre-study Visits for Investigative Sites; effectively facilitate/negotiate contracts for assigned sites within clinical subject budget as needed; conduct Study Initiation Visits at Investigative Sites; conduct Interim Monitoring Visits at Investigative Sites; review the investigator study file and reconcile versus the Trial Master File in compliance with GCP/ICH ; perform investigational product accountability and verify storage conditions; coordinate/organize the delivery of supplies as required; validate and track payments to assigned sites and patients travel reimbursement as needed; and conduct Close-out Visits at Investigative Sites.
• Data Integrity - Conduct Source Document Verification of CRFs against medical records to ensure CRFs are a valid representation of the subjects during their participation in a study; evaluate data query trends and interact with study team in order to improve data quality; assist investigative sites to achieve timely and accurate data entry and resolution of queries; ensure timely submission and review of CRF data and query resolution according to timelines set forth in the SMP; ensure issues of data quality are escalated and resolved/followed-up with the study team and CQA, as needed.
• Subject Safety - Monitor the informed consent process; perform safety reviews/SAE reconciliations; verify correct dispensing of IP to subjects; manage Investigative Sites’ adherence to GCP, ICH guidelines and local regulations.
• Train and Assist Investigative Sites - Attend Investigator Meetings, contribute and present when
required; train investigative site personnel in GCP/ICH and study-specific requirements and monitor that sites are conducting Company clinical research according to the protocol, local regulatory requirements, and other appropriate regulations; serve as liaison between Company and assigned sites; build effective and positive relationships with site staff at assigned sites.
• Communication - Identify site issues, ensure proper escalation, if necessary, and ensure
• resolution/follow-up; create monitoring reports, confirmation/follow-up correspondence and telephone
• contacts for assigned sites; respond to audit findings if applicable; adhere to proper lines of communication within Company; attend and participate in study team meetings as assigned; keep information in the CTMS current; maintain calendar.
• Regulatory Documentation - Compile ethics submissions dossier in consultation with the investigator; support and ensure that country specific requirements are obtained when applicable, maintain local document files at a country level, as needed, liaise with Regulatory Affairs department for submission and any relevant change to be reported to a Competent Authority; maintain study information in the National Trial Database where appropriate.
• Others - Identify/evaluate potential investigators for future Company studies; participate and contribute to Clinical Research meetings, cross-functional activities and sharing best practices amongst the team as appropriate; contribute to adequate training of monitors in the study requirements; perform field assessments of Company and CRO CRAs, as required; develop study-specific tools for Investigative Sites and CRAs/Field Monitors; CRO monitoring oversight as required; create and review WPs and SOPs if applicable; identify study process improvements.
• Experienced CRA (Requires 5+ yrs monitoring experience would look at a less for a v good candidate, though they may be considered for CRA II not SCRA)
• Monitoring experience within the UK
• Experience in complex therapeutic areas
• Phase I/II experience preferable but not mandatory
• Experience with CRO Oversight a bonus
• Full driving license
• Fluent written and spoken English
• Significant medical and scientific knowledge
• Knowledge of investigational products under study
• Ability to comprehend protocols and supportive information
• Knowledge of Clinical Development Process
• Knowledge of regulatory environment and guidelines (ICH, GCP, CFR, EU CT directive and local laws)
o knowledge of the local health system
• Excellent written and oral communication skills including presentations
• Ability to build excellent working relationship – internally and externally
• Ability to work in a cross-functional team environment
• Ability to work independently
• Working knowledge of SOPs/WPs and policies relevant to position
• Evidence of problem-solving skills
• Ability to resolve routine issues effectively and independently
• Organizational, prioritization and time management skills
• Knowledge of software (EDC, CTMS, MS Office, etc.)
• Ability to travel extensively including overnight stays
• Appropriate local language skills
• Fluent written and spoken English
• Ability to drive a car and have a valid driver’s license – as required
• Ability to coach, mentor site personnel and less experienced or new CRA study process improvements
To apply please send a copy of your CV to firstname.lastname@example.org, 01753 216725.
Please note if your skills/experience do not match the requirements for the role you may not get a response.
171 Bath Road Slough Berkshire
SL1 4AA, UK
|Tel:||+44 (0) 1753 512000|
|Fax:||+44 (0) 1753 511116|
|Website:||Visit Our Web Site|
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