Senior Clinical Research Associate -Gaithersburg, MD Job
SGS North America - Gaithersburg, MD

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Primary Responsibilities
The Sr. Clinical Research Associate (CRA) 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-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-Trial documentation
- Develop (from concept to final document) the documents independently whenever necessary as delegated by the Project Manager. These documents include “external” documents such as patient documents (informed consent, subject information sheet), clinical study protocol, CRF and financial agreements, whichever is applicable.
- The Sr. CRA will have to develop the internal study documents such as project plan, monitoring guidelines, protocol manual and CRF completion guidelines and follow-up until finalization and implementation of these documents as required.
- The Sr. CRA will 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.
- In case standard forms are insufficient, the Sr. CRA will develop study or project specific forms and documents.
3-IRB/IEC submissions
- Whenever applicable the Sr. CRA compiles the documentation packages for the IEC/IRB, ensures 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 Sr. CRA may have to assist the Project Manager in the organization of the meeting and the presentations. In addition the Sr CRA might also be responsible for presenting at this meeting.
5-Feasibility studies
- The Sr. CRA may be asked to develop, set up and run a feasibility study.
6-Trial follow-up and administration
- Managing the incoming and outgoing safety information with respect to the timely distribution to sponsor and investigator(s) and possible interactions with a DSMB and regulatory authorities on these subjects also fall within the Sr. CRA’s responsibilities.
- The Sr. CRA will organize in-house management of the investigational product and the study supplies.
- The Sr. CRA will keep track of the overall study progress (progress reports) and engage in the management of subcontractors.
- The Sr. CRA will have to ensure adequate filing of all study related documents, both hard copy as well as electronic version, if applicable. The Sr. CRA may have to supervise global filing activities.
- The Sr. CRA also completes the study-specific forms and keeps tracks of the activities at the investigator sites he/she is responsible for.
7-Audits
- In case project audits are to occur, the Sr. CRA will need to assist in project and site audits and will have to follow up on these audits.

Profile
- 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.
- At least 2 years CRA experience
- Thorough understanding of the clinical research process (Phase I-III)
- 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
- Fluent in English (written and spoken). Any other language is an asset
- Good computer skills: Word, Excel, PowerPoint, Outlook
- 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.
- Ability to think ahead with a problem-solving attitude
- People management skills:
- Strong communicator through the spoken and the written word.
- Ability to lead a small group of people by mentoring and coaching.
- Presentation skills
- Willingness to travel internationally

Additional information
- To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. 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 Equal Opportunity Employer.

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