What are the responsibilities and job description for the Regulatory Assistant position at Actalent?
Description:
The Regulatory Assistant works under the general direction of the Principal Investigator to ensure protocols are conducted in accordance with the principles of Good Clinical Practice. This individual will be responsible for the ongoing monitoring of clinical trial data for various studies. This position will concentrate on data accuracy and completeness, protocol adherence, and regulatory submission and documents management. The person in this role interacts directly with the site staff as issues arise. The primary skills include GCP proficiency, logical thinking, ability to prioritize, a can-do attitude, the ability to adapt quickly to changing business conditions, and strong interpersonal, and team-building skills.
Responsibilities
· This position will concentrate on data accuracy and completeness, protocol adherence.
· Ongoing review includes study data, data submission and protocol compliance, adverse event monitoring, regulatory documents monitoring via our e-reg system.
· Data review - Reviews case report forms submitted for accuracy, protocol compliance and completeness.
· Generates queries and submits them to the coordinator/data manager associated with the protocol.
· Reports data summaries to the study team.
· Perform other duties as assigned by Management.
Additional Skills & Qualifications:
Bachelor's degree in Biology, Chemistry, Health Sciences, etc.
Lab Experience or Clinical Research experience is a plus.
Experience with data completion or familiarity with data form completion guidelines.
Excellent Verbal and written communication skills.
Experience Level:
Entry Level.
If you are interested, please send your resume and 2 professional references to Allison at allcampbell@actalentservices.com.
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.
Salary : $20 - $22
