Clinical Research Associate
The Clinical Research Associate is responsible for the organization, coordination, administrative management, monitoring and site management of national and international clinical trials (phase I-IV) according to ICH-GCP, EU CTD or FDA CFR21, whichever is applicable. He/she works under direct supervision of the Project Manager for all study related activities.
1-Perform Study visits
o Independently prepare and perform Investigator site visits relevant to the phase of the study (selection and qualification, initiation, regular monitoring or site closure) as specified in the Project Plan and the Monitoring Guidelines.
o Ensure compliance of the trial conduct with the protocol and the applicable guidelines and regulations (FDA CFR21 / EU CTD / ICH-GCP).
o Report any findings related to the study to the Project Managers responsible for the respective studies
2-Manage Trial Documentation
o Write or review patient documents (informed consent, subject information sheet), clinical study protocol, CRF and trial related financial agreements as delegated by the Project Manager.
o Ensure creation of the site specific documents such as informed consent and subject information sheet, if applicable
o The CRA will have to provide the internal study documents such as project plan, monitoring guidelines, protocol manual and CRF completion guidelines which includes the review or writing of a draft and/or follow-up until finalization of these documents.
o Ensure that the appropriate trial related documents are selected for use during the study and that these forms are adequately completed by either the site or the CRA, whichever is applicable.
3-Manage IRB/IEC Submissions
o Whenever applicable the CRA will have to compile the documentation package that needs to be submitted to the IEC/IRB, ensure that the submission is done and that any issues resulting from these submissions are followed-up
o Ensures that the approval(s) is (are) obtained in due time.
4-Investigator Meetings
o In case investigator meetings are required, the CRA may have to assist the Project Manager in the organization of such meeting. In addition the CRA may also be required to present topics at such meeting.
5-Perform Feasibility Studies
o The CRA may be asked to perform feasibility studies.
6-Perform Trial follow-up and administration
o The CRA will have to ensure adequate filing of all study related documents, both hard copy as well as electronic version, if applicable. The CRA also completes the study-specific forms and keeps tracks of the activities at the investigator sites he/she is responsible for. The CRA will also ensure management of all the incoming and outgoing safety information with respect to the timely distribution to sponsor and investigator(s).
o In-house management of the investigational product and the study supplies will be assumed by the CRA.
o The CRA is responsible for the archival of the TMF or its return to the Sponsor, if applicable.
7-Assist during Audits
o In case site audits are to occur, the CRA will need to assist in the site audits and will have to follow up on these audits.
8-Coaching
o The CRA will undertake site visits where he/she is accompanied by a junior CRA in order
Qualifications
o Candidate MUST possess at least two years of CRA monitoring experience
o University degree (equal to 4 years of college) in (para-) medical, pharmaceutical, sciences, life-sciences or biosciences. Equally recognized degree and/or relevant qualifications by experience may also be acceptable and will be evaluated on a case-by-case basis.
o Fluent in English (written and spoken). Any other language is an asset
o Good computer skills:
Word, Excel, PowerPoint, Outlook
o Relevant experience or equivalent by internal training, education and experience
o Excellent command of FDA CFR21 (parts 11, 50, 54, 56, 312, 314 and for devices 812), EU CTD and /or ICH-GCP, whichever is applicable
o Strong organizational skills to cope with multi-tasking which result in a goal oriented approach without losing the attention to details
o Stress resistant and a strong team player with the ability to work independently with minimal supervision
o People management skills:
good communicator in writing and verbally with the ability to speak assertively
o Presentation skills
o Ability to identify problems on site
o Willingness to travel internationally
40-65 dollars an hour depending on experienceEstimated Salary: $20 to $28 per hour based on qualifications.
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