Research Writing & Regulatory Specialist
University of Colorado | CU Anschutz Medical Campus
- Independently contribute to the development of scientific and regulatory documents in collaboration with the CTOP team, clinical teams, and other collaborators. This includes but is not limited to clinical study reports, protocols, amendments, informed consent forms, as well as regulatory application materials such as clinical and non-clinical sections of the electronic Common Technical Document (eCTD) and other regulatory applications. Participate in the development of timelines for regulatory documents and lead preparation of assigned deliverables. Responsible for the development of the non-scientific and technical portions of required documents, including the regulatory and compliance sections.Closely collaborate with relevant stakeholders in to convert scientific data into clear, scientifically sound, well-structured documents, ensuring consistency across scientific and regulatory documents. Assist in the development of pre-clinical basic science and animal research documents needed to support an Investigational New Drug application to the FDA, including electronic Investigational New Drug (IND) format (eCTD).Serve as the primary point of contact for internal and external contributors regarding protocol development. This includes managing direct communications and meetings about the clinical trial with regulatory compliance, scientific review committees, the manufacturing sites, the hospital-based research administration, and other entities on campus. Maintain protocol and other associated document version control as updates and edits are made during the IND application process and throughout the protocol life cycle. Directly develop and obtain regulatory and PI approval of study support materials including lab manual, protocol-related procedure forms, data collection forms, needed appendices, investigator’s brochures, etc. required to open and operationalize the study.Monitor and support the development of the overall IND application development and track its progress. Elevate any significant barriers delaying the IND application and operationalizing of the protocol to CTOP leadership. Work with the disease specific clinical research teams to develop study flows consistent with the protocol and clinic – level practices. Ensure the protocol procedures are feasible in the local clinical environment.Develop complete and accurate clinical research applications to all required regulatory bodies for the conduct of clinical research, including but not limited to the Institutional Review Boards (IRBs), Protocol Review and Monitoring System (PRMS), and the Institutional Biosafety Committee (IBC). This role will also support regulatory tasks, including IRB, IBC and other submissions.Review all source documents, perform literature searches, and interact with internal team members and external clients to develop a thorough understanding of project background, timelines, and goals.Advise on appropriate document preparation and the regulatory requirements of various types of documents.Review and edit documents for other team members.This position will also support other duties as assigned by CTOP leadership and provide cross-coverage for CTOP team members when necessary.
- The salary range (or hiring range) for this position has been established at $61,877 - $90,000The salary of the finalist(s) selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialty and training.The above salary range (or hiring range) represents the University’s good faith and reasonable estimate of the range of possible compensation at the time of posting.This position is not eligible for overtime compensation.Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.Here is a link to an overview of the benefits packageHere is a link to a Total Compensation Calculator
- The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at [email protected]The University of Colorado Denver | Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities and all veterans. The University of Colorado is committed to diversity and equality in education and employment.The University of Colorado Denver | Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.
- A bachelor’s degree in a business, business administration, finance, accounting, education, social sciences, physical/biological sciences, engineering, healthcare administration, public administration, communications, information systems, or a directly related field from an accredited institution
- At least two (2) years of relevant scientific/research writing experience or the equivalent combination of education, training and experience from which similar skills can be acquired.
- At least three (3) years clinical research experience including experience in operationalizing investigator-initiated trials
- Experience with clinical trial regulations and regulatory submissions Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year for year basis.Applicants must meet minimum qualifications at the time of hire.
- Advanced degree, (MA, MS, PhD) or the equivalent combination of education, training and experience from which comparable skills can be acquired, preferably in life sciences or health-related field
- Experience synthesizing laboratory and animal research data
- Experience writing and/or developing clinical protocols and associated documents
- Experience preparing IND/IDE applications and working on FDA regulated studies
- Experience submitting research documents to an IRB, IBC and other review organizations
- Ability to communicate effectively, both in writing and orallyAbility to establish and maintain effective working relationships with employees at all levels throughout the institutionOutstanding customer service skillsDemonstrated commitment and leadership ability to advance diversity and inclusionAble to adapt to ambiguous and/or changing situations and produce results
- Ability to work on multiple projects and with multiple project teams at one time
- Able to interpret clinical and non-clinical data as needed to prepare documents
- Strong knowledge and experience with Common Technical Document content templates as well as content expectations for IND and other regulatory documentation
- Exceptional attention to detail
- Effective collaboration and facilitation skills
- Self-motivated, willing to take action with demonstrated ability to establish relationships
- Independent judgment, strong organization and communication skills, and a superior customer service focus
- Ability to critically assess a program solicitation
- Ability to work with minimal supervision and also as part of a team
- Strong interpersonal skills (written and verbal) and high degree of professionalism
- Ability to prioritize and manage multiple projects and tasks
- Proficiency in Microsoft Suite
- PLEASE NOTE: Due to COVID-19, this position will begin working 100% remotely. When we return to campus, the individual in this position will have the option to continue working remotely, begin reporting to campus, or an appropriate combination. Details will be discussed and agreed to with management.
Job Category: Research Services
Primary Location: Aurora
Posting Date: Mar 31, 2021
Unposting Date: Apr 29, 2021, 12:59:00 AM