Regulatory Specialist - Richmond, Virginia | CareerCircle
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Regulatory Specialist

Actalent

02/22/2022

Posting ID: JP-002662762

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Richmond, Virginia
Full Time
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Description:

In this role the individual would be required to provide regulatory expertise across multicenter consortium studies. This individual would be responsible for clinical regulatory document submission and maintenance across the program. The program serves as a multinational coordinating center for multiple muscular dystrophy networks. In this role, the individual would work closely with the network coordinator to facilitate local, US, and EU regulatory document submissions. Under the direction of the Principal Investigator (PI), collaborate with all members of the clinical research team to ensure all federal, state, university, and protocol requirements are followed, institutional research objectives are met, and that ethical obligations are kept.

Key responsibilities include:

Prepare IRB submissions, informed consent form documents, continuing review documents.

Maintain the clinical research regulatory documents in compliance with federal regulations, ICH, and GCP guidelines

Contribute to policy and procedure development, review, training, and evaluation

Provide regulatory assistance to network sites to ensure regulatory reporting is conducted.

Skills:

Regulatory, EDC, Submissions, QA, Quality Assurance, IRB, Sponsor, Biotech, Pharma, Site, RedCap, Veeva, Sponsor background

Top Skills Details:

Regulatory,EDC,Submissions,QA,Quality Assurance,IRB,Sponsor,Biotech,Pharma,Site,RedCap,Veeva

Additional Skills & Qualifications:

Candidate must have 3+ years of regulatory experience in biomedical research.

Must have extensive experience working on sponsor funded, federally-funded, investigator-initiated, and investigator-held studies.

Must have experience conducting clinical research while working within IRB, Federal, and State regulatory guidelines.

The candidate must have demonstrated knowledge of and experience performing study monitoring services and must possess extensive knowledge of study monitoring guidelines and general practices.

Must be able to delegate tasks in a timely fashion to generate highest performance outcomes.

Must be highly competent with computer software, including database, spreadsheet, and word processing applications.

Ability to work independently is essential and ideally seeking candidates who have worked remotely in the past.

Bachelor’s degree or equivalent training/experience required.

Experience in human subjects research with participants with neurological disorders preferred

Experience developing and maintaining research affiliations, relations and agreements preferred.

Familiarity with Veeva site vault, RedCap, and RedCap Cloud preferred.

Experience Level:

Intermediate Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Contact Information

Recruiter: Jean Chambers

Phone: (410) 579-3072

Email: jchambers@careercircle.com

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