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Clinical Research Associate/Monitor II- Field Based

50 Applications Submitted for this Position

Job Description

SUMMARY OF POSITION:

The CRA 2 is an essential member of a Clinical Project Team responsible for the execution of a Clinical Research Project. The degree of responsibility given to a CRA 2 shall reflect his/her experience and the level of contribution, which he/she can make to that project.

 

The CRA 2 is an experienced member of the department and will support the training and development of other CRAs and TCRAs on projects other than those to which they are directly allocated. The CRA2 role involves Clinical Monitoring activities for designated projects and monitoring specified sites to ensure quality and integrity of data, compliance with either Chiltern International or Sponsor’s SOPs, ICH GCP, relevant SOPs and regulatory requirements, ensuring study completion on time and within budget.

 

Job Requirements

 

WORKING CONDITIONS:

Positions can be either office-based or home-based, but work will be required away from Chiltern offices, at Sponsor offices, and may require national or international travel. May also involve travel to meetings or attendance at conferences.  Overnight stays may be required. In addition weekend and evening sessions may be required depending upon the workload and nature of current programmes.

PRINCIPAL ACCOUNTABILITIES AND RESPONSIBILITIES:

 

 

Clinical Monitoring Activities:

 

 

 

  1. To prepare and conduct all site visits including, but not limited to, qualification visits, initiation visits, monitoring visits, motivational visits, audit support visits, and close-out visits according to relevant SOPs.
  2. To identify potential centres for a proposed study in conjunction with the Project Team, and conduct feasibility assessment of sites as required.
  3. To ensure that investigator site files are assembled appropriately and that all required documentation is in place prior to release of clinical supplies
  4. To be proactive in all dealings with study sites. To ensure that all study related communication including e-mail is tracked, printed and filed as required.
  5. To track patient recruitment by contacting investigators as specified for the study, and discuss potential study risks and opportunities with the Project Manager and LCRA.
  6. To deal with local or central laboratories in order to ensure adherence to the protocol.  To ensure that all relevant documentation is current e.g., accreditation certificates, normal ranges, etc.
  7. To provide appropriate support for the preparation, submission/notification of local regulatory approval if required for local country requirements.
  8. To distribute and track clinical trial supplies, e.g. CRFs, study medication, lab kits.  To ensure that sites have sufficient supplies to continue recruitment.
  9. To provide assistance in the production of Case Report Forms and protocol design.
  10. To track CRFs collected during monitoring visits to data management.
  11. To liaise with data management regarding data flow and data query processing.
  12. To ensure that the interim safety reports are provided to EC/IRBs as per country requirements.
  13. An understanding of the purpose of Chiltern's Clinical Project Management System (CPMS), how to use it, and how to navigate within the different sections. The ability to enter weekly details on Chiltern’s Project Management System.
  14. To assist the Project Manager in the production of Status Reports.
  15. To work in a timely manner in accordance with all the activities specified in the agreed study budget, under the supervision and guidance of the LCRA and Project Manager.
  16. To raise invoice requests for investigator payments in accordance with Investigator/Hospital/Pharmacy agreement terms, to maintain the site financial tracking, producing a list for pending investigator payments and producing payment requests for Chiltern International as appropriate for local country requirements.
  17. To facilitate translation and back translation of all necessary documents, as appropriate for local country requirements.
  18. To be accountable for ensuring that all relevant study documentation is present for study sites.
  19. To undertake other project related administrative tasks (i.e. meeting minutes, recruitment tracking, site file preparation) as appropriate, as assigned by the Project Manager and LCRA.
  20. To document all study activities including investigator contacts using relevant forms.
  21. To liaise with all other appropriate departments within Chiltern International to ensure the smooth running of the study.
  22. To assemble files and ensure documents for the sponsor file accurately reflect the progress of the study.
  23. Assist in the organization of meetings (investigator, sponsor, kick-off, face-to-face) and to present at the meetings.
  24. To use all reasonable endeavours to work precisely according to schedules and timelines, established by the Sponsor and Project Manager for the conduct and completion of the study.

 

 

 

 Performance and Quality:

 

 

  1. Conduct all activities according to the defined project-specific quality and performance standards as well as relevant SOPs, ICH/GCP, and local  requirements.
  2. Ensure awareness of project-specific quality and performance standards (within Clinical Monitoring Standards) and ensure that these are adequately documented, communicated and understood.
  3. To be accompanied by Project Manager or Line Manager on selected visits (qualification, initiation, monitoring and close-out visits.)
  4. To attend all relevant training and SOP training sessions.
  5. Actively participate in training sessions and workshops. Provide training support for training sessions and workshops as required
  6. Acknowledgement and acceptance to undergo continued training that may involve a variety of administrative tasks.
  7. Ensure timely completion and documentation of all training requirements.

 

 

General Duties:

 

 

  1. To liaise with other members of the Chiltern International Project Team and clients effectively.
  2. To maintain awareness of current development in the therapeutic areas relevant to his/her project(s), by reading scientific and medical literature.
  3. At all times to promote the image of Chiltern International, acting as an ambassador to the Company.
  4. To undertake non-project related tasks as appropriate as assigned by the Manager
  5. To ensure that all internal systems are routinely updated as appropriate (e.g. CPMS, Timesheets, Expense Claims, Productivity Reports, etc.).
  6. Contribute ideas to the development of the Department, identifying areas for improvement (e.g. SOPs, processes etc) and as appropriate contribute to Department Managers’ meetings.
  7. Ensure timely and accurate completion of expense reports in strict adherence to the Chiltern and/or sponsor travel policy(ies).

 

PREFERRED SKILLS:

 

  • A BSc or BA degree in a biomedical or related life science, or nursing qualification.
  • Previous CRA experience within clinical research of approximately 18 months.
  • Good clinical knowledge with an understanding of medical terminology.
  • An understanding of the basics of physiology and pharmacology.
  • Good computer literacy with working knowledge of PCs, Windows and Microsoft Office applications.
  • Good oral and written communication, organizational skills and personal presentation. The ability to communicate effectively in English.
  • Experience working in a team environment under time and resource pressures.
  • Understanding of the principles of ICH GCP and regulatory requirements.
  • Experience of the clinical research process and terminology.

             

  • Experience using a clinical trial management system.

 

Job Snapshot

Post Date 6/11/2015
Location Nationwide - Home Based, NC
Employment Type Full-Time
Job Type Biotech, Pharmaceutical
Education 4 Year Degree
Experience 2 to 5 years
Manages Others No
Industry Biotechnology, Pharmaceutical
Required Travel Road Warrior
Job ID 5881
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