Clinical Research Regulatory & Quality Specialist

at  Insight

Insight Research Institute is a rapidly growing non profit organization looking to expand its clinical research division at the Insight Hospital and Medical Center in Chicago, IL. We are looking for driven, motivated, and experienced candidates who can spearhead operations in a fast-paced, high-growth environment and who represent our core values.

JOB SUMMARY:

Our autonomous, driven and meticulous Clinical Research Quality & Regulatory Specialist provides support to our Research team at various levels, interacting with Key Stakeholders at the direction of our Research Manager and Director. Our Research Regulatory & Quality Specialist is responsible for the completion and tracking of several regulatory documents, processes, or procedures and serves as a subject matter expert of the Research team. The Research Quality & Regulatory Specialist is able to juggle numerous projects, keeping all parties informed, and is experienced with navigating through data, spreadsheets, and ambiguity to complete work and deadlines in a timely manner. This position is Hybrid with semi regular travel to our Hospital in Chicago.

QUALIFICATIONS:

• Able to provide eligibility for employment for any U.S. employer
• Bachelor’s Degree in Research Science or related field required
• Master’s Degree desired in related field to Clinical Sciences
• Strong working knowledge of FDA CFR 21 Part 11 guidance,GCP and ICH Guidelines.
• Industry monitoring or QA experience (Required)
• Clinical Research Certification (Preferred)
• In-depth knowledge of or willingness to learn about clinical systems, procedures, and corporate standards
• Strong knowledge of medical terminology and regulations
• Broad knowledge of clinical research practice
• Strong knowledge of Microsoft Office, email applications, and G suite applications
• Ability to collect patient medical history and conditions
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Knowledge of FDA regulations and the clinical research regulatory environment as a whole
• Ability to maintain a high level of confidentiality and professionalism at all times
• Detailed oriented, conscientious and committed to precision in work results
• Ability to work independently and to effectively prioritize tasks
• Comfortable with ambiguity, is proactive in solving issues
• Ability to manage multiple projects
• Ability to relate to and work effectively with a wonderfully diverse populace
• Exceptional phone and interpersonal skills
• Proficiency with computers, preferably strong typing and desktop navigational skills
• Ability to multitask and move between responsibilities in fluid manner
• Ability to independently problem solve
• Great data entry skills
• Demonstrated skills in verbal and written English communications for safe and effective patient care and to meet documentation standards.
• Friendly, empathetic & respectful
• Reliable in work results, timeliness & attendance
• Able to work in a fast-paced, and stressful environment while maintaining positive energy
• Able to work under pressure and in situations that benefit from patience, tact, stamina and endurance
• Committed to contributing to a positive environment, even in rapidly changing circumstances.
• Is aware of standards and performs in accordance with them.

• Oversee IRB submission to governing agencies; Provides foundational information for more complex regulatory work.
• Prepares and maintains regulatory files for clinical research studies; reviews for completeness and accuracy.
• Assists start-up and site activation activities according to applicable regulations, SOPs and work instructions.
• Distribute completed documents to the associated sites and internal project team members.
• Ensures the accurate completion and maintenance of internal systems, databases and tracking tools to reflect project specific information.
• Assist staff and physicians with clerical duties and maintain overall organization while following regulations according to standards of Good Clinical Practice, HIPAA and OSHA
• Responsible for compliance regarding regulatory procedures, including study preparation and maintenance which includes interim reviews and study closure reports, SAE reporting and tracking, memo to file reports, maintenance of regulatory, correspondences and visit binders and completion of study closure file
• Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in accordance with project timelines.
• Maintains good communication and follow through when working with IRB’s tracking the regulatory process to assure timely completion of regulatory approvals, changes and reporting.
• Maintains good communication and follow through when working with sponsors and / or CRO’s throughout the conduct of the clinical trial.
• Upkeeps record archiving and destruction records, adhering to regulatory requirements
• Assists in the final close-out storage of clinical trial records.
• Participate in educational training seminars on all topics of clinical research.
• Maintains updated CV’s and GCPs
• Prepares for monitoring visits and assists during the visits with regulatory issues.
• Supports processes and monitors practices to ensure regulatory documentation involving clinical trials complies with Institutional Review Board (IRB) policies, procedures and regulations.
• Responsible for study completion processes including but not limited to data lock, study closeout, reporting and archiving of study files, ensuring completeness and continuity of all study data; performing day-to-day checks of clinical/translational data that has been entered on the case report forms (paper or electronic), source sheets, or in reports and assuring archival of appropriate/required documentation.
• Assists research staff in developing, maintaining, and updating all internal and external protocols, data collection sheets, source sheets, and databases for use in gathering and compiling information specific to each research process.
• Applied knowledge of the safety reporting requirements for the study protocol, FDA and other regulatory bodies.
• Monitors, detects and reports adverse events meeting requirements of regulatory bodies in a timely manner
• Completes and maintains regulatory documents for all study personnel, including curriculum vitae, license, bio-sketches, financial disclosures, Form FDA 1572, confidentiality agreements, and delegation of duties logs.
• Compiles and maintains eRegulatory Binders completed submission applications, along with other required documentation; prepares protocol specific forms for submission to various review committees, including internal scientific review boards, the IRB and sponsoring entities.
• Completes protocol renewal applications, amendment applications and maintains record of all adverse event reports.
• Attends research team meetings to report on regulatory issues.
• Other duties as assigned