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Job Details

Senior Clinical Research Associate - SCRA

Company: Chiltern
Location: Stockley Park
Reference: JT-899205
Closing Date: 30 Dec 16
Type: Permanent
Salary (£): On Application
Benefits:

Job Summary:

• 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

Requirements:

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.
 
Qualifications

• 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 julia.thomson@chiltern.com, 01753 216725.
Please note if your skills/experience do not match the requirements for the role you may not get a response.

Apply for this job: Senior Clinical Research Associate - SCRA

Contact Information:

Address:  London, UK
171 Bath Road Slough Berkshire
SL1 4AA, UK
England
Tel:  +44 (0) 1753 512000
Fax:  +44 (0) 1753 511116
Website:  Visit Our Web Site

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