at Actalent in Chicago, Illinois, United States
Job Description
Must haves:
+ 3 years of Clinical Research Coordinating Experience
+ Regulatory Experience (Full IRB Submittals and submitting amendments)
+ Report writing
+ Query updates
+ Oncology Experience
Description:
Responsibilities
1. Conducts study start-up activities and prepares and maintains all regulatory documents required by sponsor and/or regulatory agencies.
2. Prepares protocols, informed consent documents, modifications, renewals and other necessary documents for review by the IRB and/or sponsor.
3. Coordinates study conduct with other departments to effectively implement clinical research projects; obtains required letters of support and/or approvals as needed (i.e. IBC, SRC, etc.) and protocol is followed.
4. Identifies and recruits eligible study subjects; Assists with informed consent/assent process.
5. Arranges and conducts clinical research visits.
6. Conducts site qualifications, study initiation, monitoring and/or close-out visits.
7. Attends investigator meetings.
8. 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.
9. Creates and/or updates case report forms and/or source document templates.
10. Coordinates reimbursement of subjects.
Skills:
Pre-screening patients, Clinical research, Clinical trial, Oncology, Regulatory, Edc, Project management, Data entry, Chart review, neurology, Redcap, EPIC, IRB, Emr, Recruitment, Clinical study, Data management
Additional Skills & Qualifications:
Nice to have:
+ Completed CRC certification
+ CITI Training
+ Experience of at least 3 years from Hospital/Academic
Will be onsite for the 1st 90 days and then after 90 days will have 2 days WFH based on Clinic Dependency
Please send your resume and 2 professional references to hjaquez@ actalentservices.com to discuss next steps
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 & InclusionAt 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 (%20actalentaccommodation@actalentservices.com) for other accommodation options.
