The Business Analyst will be working on a variety of interesting projects, and work closely with our clients as well as internal teams (including, but not limited to, Project Managers, Development, QA, Sales, and Executive Leadership), in a fast paced and dynamic environment. We are looking for a Business Analyst that is detail oriented, flexible when faced with change, able to manage multiple tasks and projects, skilled at building relationships with clients and internal team members, thrives in a fast paced work environment, and has a solid understanding of the software development lifecycle. This candidate will have many opportunities to impact business process and company success. This is a highly technical position with accountability for product quality that requires the ability to motivate and mentor project team members. Tasks/Responsibilities: - Effectively manage client communications and expectations. - Able to function as subject matter expert in order to collect complete and accurate business requirements from clients. - Work as a team player and leader in order to effectively coordinate across functional teams. - Collaborate with Product Management to balance product vision and voice of customer in order to recommend and deliver best-in-class solutions. - Develop documentation that accurately reflects client needs and is clearly defined for Development and QA teams (i.e. business requirements, user stories, wireframes, functional specifications, test plans, etc). - Create clear and easy to follow user guides for clients and end-users. - Share knowledge and organize training for team members. Key Competencies: - Leadership and entrepreneurial spirit - Advanced decision making and problem solving skills - Analytical mindset - Written and verbal communication and presentation skills to both technical and non-technical teams - Solid business requirements gathering skills - Wireframes, specifications, and technical documentation - Understanding of user experience design principals - Team building/collaboration - Positive attitude, enthusiasm, and flexibility Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The START Center for Cancer Research (“START”) is the world’s largest early phase site network, fully dedicated to oncology clinical research. Throughout our history, START has provided hope to cancer patients in global community practices by offering "Hope Through Access” to cutting edge trials throughout the United States and Europe.    We are seeking a Lead, Regulatory Operations (Remote) who will serve as the regulatory subject-matter expert (SME) and provides guidance, training, and operational oversight to the Regulatory Operations team. This role oversees complex regulatory submissions, supports process improvement initiatives, delegates and prioritizes work as needed, performs quality reviews to ensure compliance and accuracy.  The Lead will prepare and submit regulatory documents for new and ongoing clinical studies to the Institutional Review Board (IRB), US Food and Drug Administration (FDA), and Institutional Biosafety Committee (IBC). This role requires strong problem‑solving ability, sound judgment, and a high degree of independence.  As team lead, ensure turnaround times are met, collect and review key metrics and continually improve processes to help achieve goals.  This is a remote role. The annual base salary for this role is $80,000 - $105,000. However, base pay may vary depending on multiple individualized factors including market location, job-related knowledge, skills, and experience. A 10% annual performance bonus is offered as well. Essential Responsibilities:  -  Ensure turnaround times are met and actively seek ways to enhances processes to ensure departmental goals are consistently achieved.   - Prepare and submit new study applications and amendments to the IRB, including drafting and negotiating informed consent forms (ICFs) with Sponsors/CROs.  - Serve as the primary point of contact for assigned studies with the IRB, IBC, and FDA.  - Prepare and submit regulatory documents including revised protocols, investigator brochures, safety reports, deviations, clarifications, continuing review reports, and closure documents.  - Prepare and submit Expanded Access and other complex or high‑risk study submissions to the FDA.  - Track all submissions in FileMaker or applicable systems and maintain accurate status updates.  - Maintain complete, accurate, and audit‑ready Investigator Site Files (ISF), both paper and electronic.  - Lead and manage regulatory close‑out responsibilities for assigned studies.  - Train, mentor, and support Regulatory Operations team members, ensuring accurate submissions and proper regulatory filing.  - Perform quality control (QC) reviews of submissions and regulatory documents prepared by staff.  - Assist in work prioritization, workflow management, and cross‑functional coordination.  - Serve as the escalation point for complex regulatory questions or study challenges.  - Attend and represent Regulatory Operations in weekly Phase I meetings, Protocol Review, and Site Initiation Visits.  - Collaborate with other departments to resolve regulatory issues and ensure timely submission of deliverables.  - Develop, revise, and implement Work Instructions and SOPs.  - Assist with regulatory file preparation for audits and inspections; participate in CAPA development.  - Partner with leadership to improve regulatory processes, systems, and standardization across START USA sites.  Education & Experience:  - Bachelor’s degree or equivalent experience.    - Minimum 5–7 years of regulatory experience in clinical research, including new study submissions  - Advanced knowledge of IRB, IBC, and FDA submission requirements.  - Proficiency with Microsoft Word and FileMaker Pro (or similar regulatory tracking systems).  - Exceptional organizational skills with attention to detail, accuracy, and completeness.  - Ability to independently manage multiple priorities, deadlines, and complex tasks.  Best-in-Class Benefits and Perks   We value the time, talent, and dedication our employees bring to START. Our commitment to your well-being and growth is reflected in a competitive compensation package—based on experience—along with comprehensive benefits designed to support you both personally and professionally:   - 401(k) retirement savings plan with employer match   - Eligibility for an annual performance bonus, based on role and company results   - Generous paid time off and paid holidays   - Comprehensive medical, dental, and vision coverage and optional insurance options   - Company paid life and disability insurance for added financial protection   - Employee Assistance Program (EAP) providing confidential, no cost support for you and your family from day one   - Flexible FSA and HSA plans to support your financial wellness   - Commitment to a supportive environment that values balance, wellbeing, and flexibility   - We’re committed to fostering a collaborative, creative workplace where every team member is encouraged to contribute. At START, you’ll join a team that values continuous learning, professional growth, shared ideas, and a culture built on inclusivity and innovation.   More About START   START clinical trial sites have conducted more than 1,000 early-phase clinical trials, including dozens of therapies that were approved by the FDA or EMA. START represents the world’s largest roster of early-phase principal investigators across its Network of clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world via our mission of “Hope Through Access”. As an example, in San Antonio, where START was founded, START treated the first patient ever with Keytruda – one of the most effective cancer drugs in medical history.   Learn more at STARTresearch.com.    Ready to be part of a team changing the future of cancer treatment?   Join us in our mission to conquer cancer, one clinical trial at a time. Your expertise and dedication can help us bring hope and healing to patients worldwide. Please submit your application online.   We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

- Effectively manage client communications and expectations. - Able to function as subject matter expert in order to collect complete and accurate business requirements from clients. - Work as a team player and leader in order to effectively coordinate across functional teams. - Collaborate with Product Management to balance product vision and voice of customer in order to recommend and deliver best-in-class solutions. - Develop documentation that accurately reflects client needs and is clearly defined for Development and QA teams (i.e. business requirements, user stories, wireframes, functional specifications, test plans, etc). - Create clear and easy to follow user guides for clients and end-users. - Share knowledge and organize training for team members.

Overview Allied Consultants, Inc is a proudly Austin based firm with over 34 years of experience delivering top-tier technical and business professionals within Texas State Agencies. We are currently seeking an experience Senior Business Analyst to play a key role within a high-impact technical services team. At Allied Consultants, we value our consultants and are committed to providing an exceptional experience including: - Highly competitive pay rates - Local support staff for responsive, personal service - Comprehensive benefits package, including: - Medical insurance (with employer cost sharing) - Life insurance - A 401(K) plan with company match - Flexible spending through a cafeteria plan Candidates selected for interviews will be subject to a criminal background check and may be required to pass a drug screening, in compliance with federal and state regulations. All offers of employment are contingent upon successful completion of these checks. Allied Consultants is a proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Responsibilities This position is for a Senior Business Analyst within a Public Pension organization, where the selected candidate will play a pivotal role in bridging the gap between business stakeholders and technical teams. The core responsibilities include leading requirements elicitation and documentation efforts, crafting comprehensive test plans, and facilitating effective communication across departments. Candidates must possess at least (5) five years of experience in business analysis, specifically in requirements gathering, documentation, and quality assurance or testing. Expertise in the Public Pension System domain is essential, as the role demands familiarity with its unique functionalities and processes. Additionally, the Senior Business Analyst will be expected to conduct Joint Application Development (JAD) sessions with product owners and business users to address complex business needs. Collaboration with the development team will be crucial for designing tailored solutions, developing and executing business function test cases, and assisting in the triage and testing of defects during User Acceptance Testing (UAT). **Location of job: 100% Remote** Qualifications Minimum (Required): Years Skills/Experience 5 Experience as a Business Analysis 5 Public Pension Systems experience 5 Experience in conducting Joint Application Development (JAD) Experience in requirement gathering, documentation, quality assurance or testing Experience in Team development Strong Communication skills