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1+ months

Regional CRA - Ophthalmology

Kelly Services
Anywhere, MD
Kelly Services Outsourcing & Consulting Group is hiring a Regional CRA for a global device company.



**_You MUST have Ophthalmology experience either IOL or refractive lens experience!_**



This is a remarkable opportunity to dedicate yourself to become a vital part of a growing company in a thriving industry!



**The Role**



The Clinical Research Associate will perform all types of site visits including Site Selection, Initiation, Monitoring, and Close-out, as well as drug accountability and other monitor activities to assure adherence to Good Clinical Practices (ICH GCP), SOPs, and study protocols. As the Clinical Research Associate you will ensure selected study sites have adequate qualification resources and facilities/equipment, have provided eligible subjects and qualified investigators.



**Duties Include But Not Limited To**




+ Monitor clinical trials to ensure sponsor and investigator obligations are being met and are compliant with the study specific Monitoring Plan, applicable local regulations, ICH/GCP guidelines, and IRB approvals.

+ Ensure that Regulatory applications have been submitted and approvals received (submissions/notifications to National Health Authorities, Submission to IRB/ Ethics Committees, update submissions, e.g. protocol amendments, safety reports). Deal with Regulatory Branch for timely results.

+ Organize delivery of investigations product, laboratory packs, CRFs and other study specific materials to and from the clinical sites, and ensure that the Investigator receives all study documents and any updates on them.

+ Act as the first-line contact with Clinical Sites and report to the trial Manager on all major site related issues in an expedited manner.

+ AE/SAE expertise; to undertake all efforts the safety and well-being of trial subject are fully protected.

+ Perform review of Site Investigator File, source documents verification, retrieve Case Report Forms (CRFs) and performed query resolution in a timely manner, and follow the appropriate filing of documents in Investigator Site File and In-house Investigator Site File.



**Candidate Profile**




+ Bachelor Degree, preferably in biomedical sciences or related scientific discipline.

+ Prefer a minimum of 2 years monitoring experience

+ Thorough Knowledge of FDA regulations and ICH/GCP guidelines.

+ Ability to travel up to 80% depending on project need.

+ Proficiency in all MS Office programs (Word, Excel, Power point, etc.).

+ Excellent communication skills, both written and verbal.

+ Ability to multi-task, attentiveness to detail, time management.

+ Fluency in written and spoken English.



If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!



**This position comes with enhanced benefits which include:**




+ 50/50 shared healthcare cost (Kelly pays 50% of the monthly premium, employee pays 50%)*

+ Paid holidays

+ Paid sick days and vacation days*



**Perks of being a Kelly employee:**




+ Weekly electronic pay

+ Access to more than 3,000 online training courses though Kelly Learning center

+ Online application system

+ Never an applicant fee



*benefits to be received upon meeting eligibility requirements



**Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume. If you have questions, the recruiter for this position can be reached via email at shari.hulitt@kellyservices.com.**






**Why Kelly** **** **?**




The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG ) is one focus within the full array of Kelly Services workforce solutions.


Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.


The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.


**AboutKelly Services** ****




As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .


Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm

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Posted: 2019-11-25 Expires: 2020-02-13

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Regional CRA - Ophthalmology

Kelly Services
Anywhere, MD

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