Clinical Research Associate - LSS - Nashville, TN
Company Name:
SGS AUTOMOTIVE
#### Primary Responsibilities
SGS is much more than just a place to work. It''s a place where you can put your innovative thinking and business skills into high gear and grow.
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
#### Reporting to
CRA Manager
#### Specific responsibilities
1-Perform Study visits
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.
Ensure compliance of the trial conduct with the protocol and the applicable guidelines and regulations (FDA CFR21 / EU CTD / ICH-GCP).
Report any findings related to the study to the Project Managers responsible for the respective studies
2-Manage Trial Documentation
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.
Ensure creation of the site specific documents such as informed consent and subject information sheet, if applicable
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.
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
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
Ensures that the approval(s) is (are) obtained in due time.
4-Investigator Meetings
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
The CRA may be asked to perform feasibility studies.
6-Perform Trial follow-up and administration
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).
In-house management of the investigational product and the study supplies will be assumed by the CRA.
The CRA is responsible for the archival of the TMF or its return to the Sponsor, if applicable.
7-Assist during Audits
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
The CRA will undertake site visits where he/she is accompanied by a junior CRA in order to pass on monitoring experience to the junior CRA.
#### Profile
Candidate MUST possess at least two years of CRA monitoring experience
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.
Fluent in English (written and spoken). Any other language is an asset
Good computer skills: Word, Excel, PowerPoint, Outlook
Relevant experience or equivalent by internal training, education and experience
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
#### Skills
Strong organizational skills to cope with multi-tasking which result in a goal oriented approach without losing the attention to details
Stress resistant and a strong team player with the ability to work independently with minimal supervision
People management skills: good communicator in writing and verbally with the ability to speak assertively
Presentation skills
Ability to identify problems on site
Willingness to travel internationally
#### Additional information
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skill, and/or ability required.
This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company's rights to assign or reassign duties and responsibilities to this job at any time.
SGS is an EOE AA M/F/Vet/Disability employer.
Qualified applicants will receive consideration for employment without regard to their race, color, religion, national origin, sex, protected veteran status or disability.
If applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call for assistance
Industry or Theme: Life Sciences
Functional Area:
Contract Type:
Reference Number: US04657
Listing Date: 02.07.2014 00
Closing Date: 30.12.2014 00Estimated Salary: $20 to $28 per hour based on qualifications.
SGS AUTOMOTIVE
#### Primary Responsibilities
SGS is much more than just a place to work. It''s a place where you can put your innovative thinking and business skills into high gear and grow.
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
#### Reporting to
CRA Manager
#### Specific responsibilities
1-Perform Study visits
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.
Ensure compliance of the trial conduct with the protocol and the applicable guidelines and regulations (FDA CFR21 / EU CTD / ICH-GCP).
Report any findings related to the study to the Project Managers responsible for the respective studies
2-Manage Trial Documentation
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.
Ensure creation of the site specific documents such as informed consent and subject information sheet, if applicable
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.
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
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
Ensures that the approval(s) is (are) obtained in due time.
4-Investigator Meetings
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
The CRA may be asked to perform feasibility studies.
6-Perform Trial follow-up and administration
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).
In-house management of the investigational product and the study supplies will be assumed by the CRA.
The CRA is responsible for the archival of the TMF or its return to the Sponsor, if applicable.
7-Assist during Audits
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
The CRA will undertake site visits where he/she is accompanied by a junior CRA in order to pass on monitoring experience to the junior CRA.
#### Profile
Candidate MUST possess at least two years of CRA monitoring experience
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.
Fluent in English (written and spoken). Any other language is an asset
Good computer skills: Word, Excel, PowerPoint, Outlook
Relevant experience or equivalent by internal training, education and experience
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
#### Skills
Strong organizational skills to cope with multi-tasking which result in a goal oriented approach without losing the attention to details
Stress resistant and a strong team player with the ability to work independently with minimal supervision
People management skills: good communicator in writing and verbally with the ability to speak assertively
Presentation skills
Ability to identify problems on site
Willingness to travel internationally
#### Additional information
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skill, and/or ability required.
This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company's rights to assign or reassign duties and responsibilities to this job at any time.
SGS is an EOE AA M/F/Vet/Disability employer.
Qualified applicants will receive consideration for employment without regard to their race, color, religion, national origin, sex, protected veteran status or disability.
If applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call for assistance
Industry or Theme: Life Sciences
Functional Area:
Contract Type:
Reference Number: US04657
Listing Date: 02.07.2014 00
Closing Date: 30.12.2014 00Estimated Salary: $20 to $28 per hour based on qualifications.
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