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Job Details

Senior Clinical Research Associate (Quality Reviewer)

Company: CROMSOURCE
Location: United States
Reference: HQ00001337
Closing Date: 20 Jun 18
Type: Permanent
Salary (£): On Application
Benefits: Excellent and Comprehensive Benefits – see below

Job Summary:

Senior Clinical Research Associate (Quality Reviewer) Location: USA TalentSource Life Sciences, a division of CROMSOURCE dedicated to flexible staffing solutions, is currently seeking a number of experienced staff to join our client dedicated team.    This is a truly unique role where we require a high level of quality control over their studies and are dedicating resources to ensure this.

Requirements:

Senior Clinical Research Associate (Quality Reviewer)
Location: USA

TalentSource Life Sciences, a division of CROMSOURCE dedicated to flexible staffing solutions, is currently seeking a number of experienced staff to join our client dedicated team.

This is a truly unique role where we require a high level of quality control over their studies and are dedicating resources to ensure this. The tasks will involve undertaking quality activities including: pre-study site qualification, interim site quality review and post-study site quality review visits. Territories will be regionalized as much as possible and we invite applications from all locations in the US as there will be several positions opened. We also require sites in Canada to be covered through one of the US positions.

Overview:

  • Coordinates and schedules visits with sites as required
  • Review of background details of most current site status and any relevant information, reference eTMF and EDC contents, site QC checklists, and/or other materials supplied by Sponsor
  • On-site activity consists of general and/or targeted (as identified by Sponsor team) review of site organization and performance, not limited to review documents, subject files and EDC as deemed necessary by the Sponsor;
  • General evaluation of site and CRO study management at the site and overall GCP compliance by both parties
  • Verbal and written reports

Responsibilities:

  • Ensuring a good knowledge of the current (and past versions, if applicable) of the protocol and clinical monitoring plan and aware of the recruitment status of the site
  • Knowing the purpose and scope of the review they are to conduct
  • Reviewing monitoring reports (as appropriate) for the trial site and any previous QRV reports to provide a background to the sites compliance status
  • Reviewing all site visit documentation in preparation of the visit
  • Contacting the site to agree suitable dates and times for the review to take place and ensuring that key personnel at the site will be present
  • Conducting the review in accordance with the purpose and scope defined by the Sponsor
  • During the review, report any items of serious concern to the Sponsor in a timely manner, so these can be escalated
  • Providing a daily (informal) written feedback to the Sponsor of any significant findings, if it is an extended review (2+ days)
  • Reporting the quality review findings in a standard report template as per the agreed timelines
  • Ensuring that items identified for action are fed back to the Investigator Site Monitor and other relevant parties to ensure they are acted upon, in collaboration with the Sponsor
  • Assisting in escalation of issues identified during the QRVs

Education/profile

  • University Degree
  • Proven experience in a similar role
  • High level computer literacy; including MS Office, SharePoint, Flowcharting software, Acrobat, etc.
  • Excellent high level oral & written communications skills enabling incumbent to act as a facilitator and/or educator with strong leadership skills.
  • Adaptable and willing to take on multiple new tasks and responsibilities
  • Independent collaborative self-starter with the ability to make appropriate quality-related decisions in real time.
  • Process orientated, Logical, analytical, meticulous, highly organized and able to analyze data & implement solutions.
  • Willingness to travel
  • Knowledge of local and national GCP/GMP regulations and requirements in relation to clinical trial conduct in the country or locality where the review is being conducted

Our benefits when working in the US:

  • Dedicated Line Manager - 1-2-1 support
  • Coaching meetings/Monthly Calls - we care for your wellbeing
  • Employee satisfaction survey - your feedback is important for continuous improvement
  • End year appraisals and development planning
  • Career opportunities within both our CRO departments and our TalentSource Life Sciences Unit, locally and internationally
  • Additional benefits we offer you include:
  • Full health insurance benefits, including health, dental and vision
  • 401k Plan with 5% company match
  • Short term and long term disability insurance
  • Life assurance

Why TalentSource Life Sciences/CROMSOURCE

CROMSOURCE is a family-owned, high quality ISO-certified international provider of outsourced services to the pharmaceutical, biotechnology and medical device industries. Since 1994, we have been supporting our clients with outstanding clinical research and staffing solutions services. TalentSource Life Sciences is a fully dedicated flexible resourcing unit within CROMSOURCE and the successful growth has been achieved by putting high quality and client focus at the heart of everything we do.

Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.

Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are providing expert people. Highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world. Our large management team consists of a people with an extended experience within pharma and a high level of market knowledge. We our open, friendly and approachable and aim to support you through the recruitment process every step of the way.

As this position is client-facing, the successful candidates must be confident and be able to drive the role and themselves and to work autonomously in close liaison with a line manager at TalentSource, who will provide you with mentoring and guidance.

To ensure the success of our clients, our team of international professionals is focused on continuous improvement. We invest in our employees by providing the coaching and training necessary to deliver high quality services for our clients.

Every day we strive to create an environment in which all employees can contribute to their full potential and at the same time allow the company to develop and grow with them. With CROMSOURCE you will be able to participate in exciting projects and achieve your professional goals.

Keywords: Quality Assurance, Quality Management System, FDA, Clinical Research Associate, CRA, Quality Reviewer; Quality Visits, QA, Quality, GCP, Monitor, Contract Research Organization, CRO, Outsourced, Pharmaceutical, Pharma

Senior Clinical Research Associate

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Contact Information:

Address:  UK Office
CROMSOURCE Suite 3 Lomond Court Castle Business Park Stirling United Kingdom
FK9 4TU
Scotland
Tel:  +44 (0) 1786 468990
Website:  Visit Our Web Site

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