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Clinical Trial Regulatory Research Specialist - Full-time, Days

Winfield, Illinois Job REQID 6577 Job Function Research Shift Day Job (1st) Apply Now

At Northwestern Medicine, every patient interaction makes a difference in cultivating a positive workplace. This patient-first approach is what sets us apart as a leader in the healthcare industry. As an integral part of our team, you'll have the opportunity to join our quest for better healthcare, no matter where you work within the Northwestern Medicine system. At Northwestern Medicine, we pride ourselves on providing competitive benefits: from tuition reimbursement and loan forgiveness to 401(k) matching and lifecycle benefits, we take care of our employees. Ready to join our quest for better?

Description

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. Performs all other functions as related to this job and as assigned.

Qualifications

Required:

  • Bachelors Degree in related field.
  • Two years experience in a clinical research regulatory role.
  • Knowledge of Good Clinical Practice and applicable regulations.
  • Ability to adapt to meet multiple and changing deadlines.
  • Intermediate computer and internet knowledge.
  • Meticulous organizational skills and attention to detail.
  • Excellent demonstrated written and verbal communication abilities.
  • Ability to work effectively as a team. Preferred:
  • Three to Five years experience in clinical research trials. ACRP or SOCRA certification.

Equal Opportunity

Northwestern Medicine is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, disability, sexual orientation or any other protected status.

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