Advanced Group Deerfield , IL 60015
Advanced Clinical is a global clinical development organization that provides CRO, FSP, Quality & Validation, and Strategic Resourcing services for biopharmaceutical and medical device organizations. Our mission is to deliver a better clinical experience for our clients. With global experience in over 50 countries, we are committed to improving all lives touched by clinical research. We understand the complex nature of the clinical research industry and approach each opportunity with compassion. Together, we answer the hopes of patients and healthcare professionals with industry-leading services in global life-sciences. As part of the Advanced Group family of companies, Advanced Clinical employees provide the support, structure, and professional background and experience for better clinical trials and research. They are the foundation of our energetic and collaborative environment, where constant learning and service to others take top priority. We seek dynamic, hard-working team members who are inspired to work amongst diverse backgrounds and perspectives. From our altruistic mission to outstanding career development opportunities, there's no better place to grow your career than Advanced Clinical.
Summary of Responsibilities
The Regulatory Start Up (RS) Manager is responsible for managing and performing the regulatory site start up and maintenance function, including the preparation, review, and overall management of submissions to regulatory authorities and ethics committees. The RS Manager is a contact point for client matters related to study start-up/product approval requirements and must be able to communicate issues effectively to the client, clinical team and Project Manager. The RS Manager supports the Clinical Operations leadership by tracking functional area metrics and reporting key performance indices by site and by study to inform business decisions and maintain compliance during the active trial phase.
Regulatory and Start up:
As Applicable by Geographic / International Region, prepare, review, and manage Regulatory and Ethical submissions as well as any additional regulatory activities to ensure the set up and authorization of clinical trials
Serve as the functional lead on projects with Study Start Up Specialist or other support staff working within the function, providing training on unique aspects and overseeing work for consistency, quality, and compliance with established parameters.
Support and communicate with clinical and project management teams to ensure correct distribution of approved documentation.
Participate and drive the start-up/regulatory strategy pre and post award.
Coordinate and track regulatory and ethical query resolution.
Coordinate and collect essential site regulatory documents including investigator qualifications, local laboratory accreditation certificates and reference ranges, and Ethic Committees submission and approvals and verify the acceptability of such documentation in accordance with applicable specifications, standard operating procedures, ICH/GCP guidelines and other regulatory requirements, in order to activate the site for trial participation.
Maintain current knowledge base of relevant existing and emerging regulations, standards, and guidance documents.
Track regulatory documents in the dedicated databases or systems and maintain regulatory study files to ensure their audit readiness, including proactive tracking of expirations to obtain updates as appropriate.
Prepare study documents and forms such as the Informed Consent template including review for their compliance with ICH/GCP and country-specific requirements as applicable.
Prepare for and participate in internal or external audits/inspections including producing documentation as requested.
Conduct third party vendor oversight, such as printing and translation service providers.
Identify and obtain global regulatory resource needed for specific start-up/regulatory activities.
Communicate and obtain understanding from regulatory resource/vendor ensuring contractual and other expectations
Manage utilization and productivity of resource and communicate these levels within core teams.
Proactively recognize any changes in scope and collaborate with senior management and clinical operations to ensure timely completion of change orders.
Develop and track quality and performance metrics around study start-up activities, including but not limited to Regulatory and Ethics approval turnaround and site activation timelines
Develop and present start-up/regulatory training materials and SOPs to ensure continuous process improvement and compliance with current regulations.
The RS Manager position requires:
Strong, professional communication skills; expected to be client-facing
excellent organizational and time management skills, high level of attention to detail with a proactive approach and commitment to follow through
ability to support multiple programs simultaneously and effectively balance competing priorities within the functional area
knowledge and ability to apply pertinent applicable regulations, guidelines and industry standards, including GCPs, to department services
Education Bachelor's Degree, Associates Degree, RN or LPN is preferred. Relevant clinical trial experience may be considered in place of degree.
Training On the job or professional training in ICH-GCP and regulatory records management required. Proficiency with clinical trial applications including eTMF, Submission portals preferred.
Experience Four (4) years clinical research industry experience with at least three (3) years of experience with site regulatory documentation. Strong ability to manage within a matrixed organization, prioritizing multiple tasks in a timely, budget-conscious manner, and relaying necessary escalations. Must possess a strong computer acumen including advanced proficiency with Microsoft Office Suite and proficiency with clinical trial applications. Must possess knowledge of and demonstrate ability to apply and train others on pertinent applicable regulations and guidelines including GCPs.
Must possess a current passport identity card as applicable, and valid driver's license
This job description is a summary. It is not intended to be comprehensive in detail. Individuals with this job title will be expected to perform according to their individual goals and evaluations in addition to this job description and all applicable standards (SOPs, manuals, code of conduct, laws, regulations, etc.).
What's in it for you? Advanced Group offers competitive compensation, comprehensive benefits packages, and a flexible work environment designed to help our team members and their families stay healthy, meet their financial goals, and generally thrive in and beyond work.
Visit the links below to discover all that Advanced Group has to offer:
Our Culture: https://careers.advancedgroup.com/embrace-our-culture
Career Development Opportunities: https://careers.advancedgroup.com/realize-your-potential
Community Programs: https://careers.advancedgroup.com/unleash-your-passion
For a complete list of all of our job openings, please visit Advanced Group's career site here.
It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.
This practice applies to all terms and conditions of employment including, but not limited to, hiring, training, compensation, benefits, promotions, transfers, layoff, Company-sponsored education, social and recreational programs, and treatment on the job. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.