Hybrid Regulatory Coordinator

Qualifications

Bachelor’s Degree

MUST have a minimum of 2 years of Regulatory experience (Full IRB Submittals and submitting amendments)

Experience with report writing

Experience with query updates

MUST have Oncology experience ;  Neurooncological preferred

 

Duties

Conducts study start-up activities and prepares and maintains all regulatory documents required by sponsor and/or regulatory agencies

Prepares protocols, informed consent documents, modifications, renewals and other necessary documents for review by the IRB and/or sponsor

Handle IRB submittals and submit amendments

Handle report writing and query updates

Partner with PIs and attends investigator meetings

Abstracts data from medical records and enters medical information/data onto protocol specific case report forms, study flow sheets, and other required study forms;

prepares abstracted/coded data for processing/analysis

Creates and/or updates case report forms and/or source document templates

Adheres to research protocol in compliance with applicable institutional, local and federal regulations (OHRP, FDA, GCP, etc.)

Assists in the training of personnel for role in study conduct; maintains delegation of authority and training logs

QA/QC checks for database validity and data monitoring

Ability to take on project management duties

Additional duties as assigned

 

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

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

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.