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.
1. Summary of Responsibilities
The Study Start-Up Specialist (SSU Spec) is responsible for the coordination, preparation and review of clinical regulatory documents including tracking and reporting of key performance indices by site and by study. The SSU Spec will prepare, handle, distribute, file, and archive clinical documentation and reports including maintaining Clinical Trial Master Files (TMFs); and review of study files periodically for accuracy and completeness. The SSU Spec will accurately update and maintain clinical systems related to site activation and re-supply of test article.
2. Essential Functions
2.1 Coordinate efforts associated with the compilation of site level regulatory document submissions
2.2 Prepare, review, and manage ethics committee submissions for domestic or international projects, including protocol,
informed consent template, financial disclosure, privacy protection, site staff qualification, and all other related forms or
information as required
2.3 Prepare or contribute to technical reports and files as necessary to obtain and sustain regulatory, ethics, or product
2.4 Communicate with central and local/academic Institutional Review Boards (IRBs) and Independent Ethics Committees
(IECs) regarding pre-submission strategies or clarification and follow-up of submissions under review
2.5 Update and maintain clinical systems related to site activation and re-supply of test article.
2.6 Maintain current knowledge base of relevant existing and emerging regulations, standards, and guidance documents
2.7 Track regulatory documents in the dedicated databases or systems and maintain regulatory study files to ensure their
2.8 Establish and maintain the Trial Master File (TMF). Under the supervision of the PM or designee, review the Trial Master
File (TMF) for compliance for given clinical studies.
2.9 Coordinate preparation of study documents and forms such as the Informed Consent template including review for their
compliance with ICH/GCP and country-specific requirements and translation services as applicable
2.10 Assist with third party vendor oversight, such as printing, courier, and translation service providers
2.11 Participate in internal or external audits
2.12 Develop or track quality metrics around study start-up activities, including but not limited to ethics approval and drug
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.).
Education - The ideal candidate should have Bachelor’s Degree, Associates Degree, RN or LPN with 2 years industry experience or an equivalent combination of education, training and experience.
Training - On the job or professional training in regulatory document processing preferred.
Certification – If RN or LPN, state licensure.
Experience - The ideal candidate has excellent organizational and time management skills and attention to detail. Strong written and verbal communication skills, and computer competence with Microsoft Word, Excel and PowerPoint. Advanced knowledge of and ability to apply pertinent applicable regulations and guidelines including ICH/GCP.
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:
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.