Lakeshore Talent is partnered with a leading Hospital network in their search for a Clinical Trial Regulatory Specialist to support the Oncology team. This role will be based in Warrenville but the Clinical Trial Regulatory Specialist may need to visit patients in Geneva and DeKalb as well.
Contract: 3 months to start
Pay: $35 – $36 per hour
- Serves as the primary point of contact for the research team in regard to coordination of the regulatory aspects of the clinical studies/trials in accordance with the Code of Federal Regulations, Good Clinical Practice, and Standard Operating Procedures and Policies.
- Completes and submits all sponsor documents to adhere to regulatory requirements and requirements of sponsors. Ensures all necessary forms are submitted to Sponsor to activate protocols.
- Prepares regulatory documentation packets and creates all FDA 1572 Forms for initial submissions. Proactively monitors the research regulatory environment for proposed changes that impact research activities and practices and then disseminates to affected parties. Prepares submissions to the IRB including but not limited to study protocol applications, amendments, continuing reviews, and safety reporting.
- Notifies administration and study team including Principal Investigator (PI) upon receipt and submission of regulatory documents Notifies administration and study team of IRB correspondence and approval letters in a timely fashion. Sets up and maintains document retention, security, and destruction activities.
- Creates and maintains regulatory files for each study and updates them as needed.
- Maintains certifications of laboratory and other pertinent ancillary departments as they relate to research. Maintains Investigator and research staff CVs, medical licenses as applicable, and appropriate training and certifications and communicates with staff to obtain current documents as needed.
- Maintains an accurate and expanding knowledge regarding standard operating procedures, research compliance, ethical foundations, federal regulations, and Good Clinical Practice standards. Has a working understanding of all study protocols assigned in order to appropriately maintain the regulatory files. Prepares the informed consent document for the study and communicates with Sponsor, CRO, study coordinator, and Office of Research for approvals prior to submission.
- Performs internal audits on regulatory aspects of clinical studies/trials; reports findings and delivers corrective action plan to the Office of Research and the study team. Works closely with the clinical research coordinator, PI, and other study staff to ensure that all regulatory needs of each study are addressed and completed and to ensure issues are resolved timely after a monitors visit. Notifies study staff to train team on protocols and amendments as needed and ensure training documents are completed and filed in the regulatory files.
- Ensures documents are filed in a timely fashion. Attends Study Initiation Visits and Close Out Visits. Prepares for and participates in routine monitoring visits and audits.
- Reports, monitors, distributes and maintains files for all safety information including Investigational Drug Brochures, IND safety reports, and Serious Adverse Events reports.
- Responsible for completing all necessary training for the position, including study protocol specific training and Health System policies and procedures. Provides documentation that is timely, accurate, current, complete, and legible.
- Ensures documentation meets current standards and policies. Manages work schedule efficiently, completing tasks and assignments on time. Displays professional conduct in the presence of research subjects, research staff, sponsors, study monitors, and auditors.
Requirements & Preferences:
- B.S. degree required
- Prefer ACRP or SOCRA certification
- 3+ years experience as a clinical research coordinator preferably in GU oncology
- Knowledge of oncology
- Because this position is in a healthcare setting, all vaccinations must be up to date (including Covid-19, 2022 flu, MMR, Varicella, and TDaP)
Job ID: 43902