Senior Clinical Research Associate (SCRA) - UK Part Office/Part Home Based
Company: Pharm-Olam International
Location: Ascot, Berkshire (Home/Office Based)
Closing Date: 17 Nov 16
Type: Full Time
Salary (£): Competitive
Benefits: Competitive Salary & Benefits
Pharm-Olam International are actively looking for a Senior Clinical Research Associate (SCRA) to join our Clinical operations team based in Ascot, Berkshire on a full time permanent basis. This will be a part office/part home based position
Operate as the focus for communication with Clinical Research Associates (CRAs) and the Sponsor. Support the project team, study site personnel and ensure that the clinical trial is conducted in accordance with international Regulatory and Ethical guidelines for Good Clinical Practice and Standard Operating Procedures.
- Provide functional assistance to project team members with logistical and practical activities and tasks including Audit responses
- Review study related documentation for compliance with SOPs and ICH-GCP Guidelines, particularly Regulatory / Ethics Committee review and approval, CVs, drug accountability, translations, SAE reports, etc.
- Alert Medical Adviser / Director and Project Manager immediately on receipt of SAE report from study site, prior to forwarding to the Sponsor (where necessary).
- Follow-up Sponsor’s requests for clarifications; supplementary information; distribution of newsletters and review approval of protocol amendments; financial disclosures (FDA form 1572), Clinical Investigator Brochure revisions; translations etc.
- Supervise Selection, Initiation, Monitoring and Closure at Investigator Sites according to project schedule. Ensure CRA team adheres to project guidelines for monitoring requirements.
- After identifying the minimum requirements for Investigator Site participation, initiate the process for assessing the feasibility of a proposed study.
- If required attend Investigator Selection and Initiation visits. Co-monitor sites and review local site and in-house study files, to ensure consistency in protocol interpretation, monitoring standards and compliance with monitoring responsibilities.
- Govern minimum quality standards for trial monitoring activities, with respect to documentation, punctuality of reporting, compliance with objectives, and co-operation with other project team members. Ensure adequate tracking is in place for all activities and reports formatted as required for submission within agreed timelines
- If required to monitor locally, conduct Site Monitoring visits in accordance with project Monitoring Guidelines, at the frequency specified in the Sponsor contract.
- During Monitoring Visits assess the study progress at the Investigator Site. Check the completion of study data and patient records; by performing Source Data Verification, Accountability for study drug and other trial materials; compliance with study procedures and GCP, and for safety monitoring.
- Review Site Visit Reports for accuracy, legibility and completeness before signing off and forwarding to Sponsor.
- Supervise the Import, Delivery and Return of Trial Medication and other Trial Materials.
- Ensure Study Medications are appropriately stored for the duration of the trial.
- Monitor and record Drug Accountability throughout the study.
- At the end of the study, assist sites in returning Trial Medication(s) to the Sponsor, or with arrangements for the local destruction of remaining supplies.
- Ensure adequate supplies of trial materials (CRFs, study medications, laboratory kits, etc.) are available at trial sites throughout the study and Archiving at study closure has been facilitated as agreed at Initiation
- Liaise with local and/or central laboratories and courier companies, if appropriate, to organise import and distribution of laboratory kits, transportation of biological samples to the laboratory for analysis, and transmission of results to the site/CRA/Sponsor.
- Communicate on a regular basis with Sponsor and Trial Material suppliers e.g. printers, regarding the supply, importation and transportation of Trial Materials to participating countries.
- Collaborate with project team members
- Collaborates with Associate Director of Clinical Operations and Business Development team
- Collaborate with Pharm-Olam Medical Adviser(s), Clinical Trial Administrators, Support Services and QA personnel
- Liaise with Sponsor and sub-contractors (central laboratories, printers, data processors, etc.)
- Deputises for Project Manager as and when required
LEVEL OF RESPONSIBILITY
- Reports to Project Manager for all project related activities and is responsible for the on-going conduct of the study on behalf of the Pharm-Olam in the absence of the Project Manager
- Also reports to the affiliated Clinical Operations Manager for the region
QUALIFICATIONS & SKILLS REQUIRED:
- Relevant life science degree / medical / nursing background
- Good Presentation skills
- Excellent Co-ordination and organisational skills
- Experienced in conducting allocated tasks
- Attention to detail and accuracy
- Ability to work successfully with the Sponsor/Vendors and team members with
- Ability to work independently
- Excellent interpersonal skills