- Assists in the development of study documents and study preparation prior to the start of a study.
- Engages with CRCs (Clinical Research Coordinators) and study P.I.s during study preparation to ensure
- documents and procedures are documented in accordance with the protocol GCP and company SOPs.
- Manages the status and required items needed for studies involving the IRB not limited to study
- submissions deviation / SAE reporting and study closeout.
- Engages with clients (when applicable) during study preparation phase to ensure all necessary
- documents (safety letter informed consent etc.) are finalized prior to IRB submission.
- Assists in the review and/or development of new protocols assessments procedures and
- technologies.
- Assist with the development and updating of SOPs WI and training material related to study
- paperwork creation and IRB management.
- Ensure compliance with regulations.
- Provides excellent customer service to clients and maintains positive interaction with peers and
- supervisors
- Adheres to internal standards policies and procedures.
Qualifications :
- Bachelors Degree preferable in science or equivalent degree
- Minimum 1 years of experience in CRC position with SGS Stephens or equivalent from another clinical
- research organization and/or prior project management experience.
- Ability to coordinate multiple projects at once.
- Ability to work independently use time wisely and multi-task.
- Previous IRB experience and / or clinical research regulatory experience.
- CCRC or CCRA Certification preferred
Additional Information :
SGS is an Equal Opportunity Employer and as such we recruit hire train and promote persons in all job classifications without regard to race color religion sex national origin disability age marital status sexual orientation gender identity or expression genetics status as a protected veteran or any other characteristics protected by law.
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 skills and/or abilities 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 companys rights to assign or reassign duties and responsibilities to this job at any time.
If you are 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 and leave a message. You will receive a call back. Please note this phone number is not for general employment information but is only for individuals who are experiencing difficulty applying for a position due to a disability.
Information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Full-time
Assists in the development of study documents and study preparation prior to the start of a study.Engages with CRCs (Clinical Research Coordinators) and study P.I.s during study preparation to ensuredocuments and procedures are documented in accordance with the protocol GCP and company SOPs.Manages ...
- Assists in the development of study documents and study preparation prior to the start of a study.
- Engages with CRCs (Clinical Research Coordinators) and study P.I.s during study preparation to ensure
- documents and procedures are documented in accordance with the protocol GCP and company SOPs.
- Manages the status and required items needed for studies involving the IRB not limited to study
- submissions deviation / SAE reporting and study closeout.
- Engages with clients (when applicable) during study preparation phase to ensure all necessary
- documents (safety letter informed consent etc.) are finalized prior to IRB submission.
- Assists in the review and/or development of new protocols assessments procedures and
- technologies.
- Assist with the development and updating of SOPs WI and training material related to study
- paperwork creation and IRB management.
- Ensure compliance with regulations.
- Provides excellent customer service to clients and maintains positive interaction with peers and
- supervisors
- Adheres to internal standards policies and procedures.
Qualifications :
- Bachelors Degree preferable in science or equivalent degree
- Minimum 1 years of experience in CRC position with SGS Stephens or equivalent from another clinical
- research organization and/or prior project management experience.
- Ability to coordinate multiple projects at once.
- Ability to work independently use time wisely and multi-task.
- Previous IRB experience and / or clinical research regulatory experience.
- CCRC or CCRA Certification preferred
Additional Information :
SGS is an Equal Opportunity Employer and as such we recruit hire train and promote persons in all job classifications without regard to race color religion sex national origin disability age marital status sexual orientation gender identity or expression genetics status as a protected veteran or any other characteristics protected by law.
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 skills and/or abilities 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 companys rights to assign or reassign duties and responsibilities to this job at any time.
If you are 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 and leave a message. You will receive a call back. Please note this phone number is not for general employment information but is only for individuals who are experiencing difficulty applying for a position due to a disability.
Information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Full-time
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