Clinical Research Associate (Oncology)
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POST DATE 8/31/2016
END DATE 10/18/2016
JOB DESCRIPTIONCLINICAL RESEARCH ASSOCIATE (ONCOLOGY)
The SCRA is a high-profile role within the Department; using their experience as a knowledge resource to help other CRAs develop their skills. The SCRA will provide expert advice, guidance and general supervision to Clinical Monitoring team activities for designated projects, and to monitor specified sites to ensure quality and integrity of data, compliance with Chiltern International or Client s SOPs, ICH GCP, regulatory requirements, ensuring study completion on time and within budget. They may be called upon to interact independently with Clients not directly involved in their projects, and to assist in some relevant departmental tasks.
The SCRA 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 SCRA shall reflect his/her experience and the level of contribution, which he/she can make to that project.
DUTIES & RESPONSIBILITIES
1. To assist in the protocol writing and review process
2. 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.
3. To identify potential centres for a proposed study in conjunction with the Project Team, and conduct feasibility assessment of sites as required.
4. To ensure that investigator site files are assembled appropriately and that all required documentation is in place prior to release of clinical supplies
5. 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.
6. 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.
7. 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.
8. To prepare, or facilitate the preparation of Multicentre and/or Local Ethics Committee / IRB submission documentation as defined by local requirements. To ensure that EC/IRBs are updated regarding protocol amendments, SAEs etc.
9. To distribute and track clinical trial supplies, e.g. CRFs, study medication, lab kits. To ensure that sites have sufficient supplies to continue recruitment.
10. To assist in the CRF writing and review process. This also includes production of Diary Cards, eCRF page formats, and other patient related data capture tools.
11. To track CRFs collected during monitoring visits to data management.
12. To liaise with data management regarding data flow and data query processing.
13. To ensure that the interim safety reports are provided to EC/IRBs as per country requirements.
14. 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.
15. To assist the Project Manager/LCRA in the production of Status Reports.
16. 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.
17. 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.
18. To facilitate translation and back translation of all necessary documents, as appropriate for local country requirements.
19. To be accountable for ensuring that all relevant study documentation is present for study sites.
20. To undertake other project related tasks, as assigned by the Project Manager and LCRA.
21. To document all study activities including investigator contacts using relevant forms.
22. To liaise with all other appropriate departments within Chiltern International to ensure the smooth running of the study.
23. To assemble files and ensure documents for the Sponsor File accurately reflect the progress of the study.
24. Assist in the organization of meetings (investigator, sponsor, kick-off, face-to-face) and to present at the meetings.
25. To support the clinical lead in ensuring that members of the Clinical Monitoring project team maintain effective and productive working relationships across locations and with staff in other functions. Work with the relevant managers to address any problems promptly.
26. To use all reasonable endeavors to work precisely according to schedules and timelines, established by the Sponsor and Project Manager for the conduct and completion of the study.
27. Take on critical project responsibilities (on behalf of the Project Manager/LCRA where appropriate), acting independently to achieve objectives and manage other team members
28. To act on behalf of the Project Manager or LCRA in their absence, and manage the progress of different CI functions
29. Assist where required in developing contacts with Sponsors
30. Developing relationships with 3rd parties and reviewing quality of services
Chiltern is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities and candidates with military service.
* A BSc or BA degree in a biomedical or related life science, or nursing qualification.
* Previous CRA experience within clinical research, approximately 3 years
* Demonstrated ability to conduct the majority of clinical monitoring activities effectively, efficiently and with the minimum of supervision
* 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
* Preferable experience using a clinical trial management system (CPMS)
Chiltern is an EEO / AA Employer and is committed to providing opportunities to minorities, women, individuals with disabilities and veterans.
Salary based on experience
Email Cheri Shedeck