Description: This position is for a regulatory associate/start up specialist.
The position has the responsibility for IRB submissions for industry, investigator initiated, and cooperative group trials; creating and maintaining professional working relationships with investigators, sponsors, team members, and others.
Previous experience in study activation and IRB submissions is required.
Previous experience with FDA submissions is preferred.
Day to day duties of this position will include but are not limited to:
•IRB submissions to institutional and central IRBs.
•Providing advice to study team colleagues regarding Federal Regulations, IRB policies, and ICH guidelines.
•Shepherding new studies through the site activation process.
•Meeting with internal and external monitors and sponsor representatives.
Proven ability to provide consultation and lead exchange of research information through technical assistance and instruction.
Demonstrated ability to train others, including documenting steps needed to collect information and to independently provide consultation to sites or others related to the specific protocols and regulatory guidance.
Demonstrated ability to write comprehensive reports summarizing results and conveying to supervisory personnel.
Demonstrated ability to plan work to meet objectives and deadlines.
Significant use of information technology is expected for this position.
Experience in clinical research preferred, including familiarity with CFR Parts 50, 54, 56, 312, 314 and ICH Guidelines.
CCRP, CCRC, CIRB or RAC Certification preferred.
Skills: Clinical Research, Regulatory Documents, CRF, IRB submissions, 1572, ICF, Informed Consents Top Skills Details: Clinical Research,Regulatory Documents,CRF,IRB submissions,1572, ICF, Informed Consents Additional Skills & Qualifications: 1-2 years handling and reviewing Regulatory Documents for Clinical trials 4 year degree Preferred:Oncology Experience Experience Level: Entry 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.