Informed Consent jobs near me - 67 jobs

Job Title: Client Rights Officer We are seeking a highly dedicated and compassionate individual to join our organization as a Client Rights Officer. The Client Rights Officer will be responsible for ensuring the protection and advocacy of our clients' rights, promoting their well-being, and ensuring their voices are heard. The successful candidate will serve as a crucial advocate, providing support, guidance and education to clients and staff to ensure a client-centered approach in all interactions. Responsibilities: - Act as the main point of contact for clients regarding issues and concerns related to their rights, ensuring a timely and professional response. - Develop, implement, and review policies and procedures in conformity with client rights regulations and best practices. - Investigate client complaints and resolve problems promptly, ensuring appropriate and timely actions are taken in compliance with established protocols. - Collaborate with relevant internal departments and external stakeholders to advocate for clients' rights and interests. - Conduct periodic evaluations and audits of programs, policies, and practices to identify potential risks or areas for improvement in client advocacy. - Develop and deliver training programs for staff, volunteers, and clients on client rights, confidentiality, and informed consent. - Stay up to date with relevant laws, regulations, and industry trends pertaining to client rights and services, ensuring compliance and implementing necessary changes. - Coordinate and participate in meetings, committees, and working groups related to client rights and quality improvement efforts. - Document and maintain all relevant records, reports, and documentation related to client rights activities. - Prepare and submit regular reports regarding client rights initiatives, achievements, and challenges to the management team. Qualifications and Skills: - Bachelor's degree in social work, human services, psychology, or a related field. A Master's degree is preferred. - Proven experience (3-5 years) in client advocacy, social work, or a related field. - Strong knowledge of client rights regulations, policies, and best practices. - Excellent communication skills, with the ability to effectively interact and mediate between clients, staff, and external agencies. - Demonstrated ability to resolve conflicts and complaints in a professional and empathetic manner. - Exceptional organizational and time management skills, with the ability to prioritize tasks and work independently. - Proficient in conducting research, analyzing data, and preparing accurate reports. - Strong interpersonal skills and ability to build and maintain positive relationships with diverse populations. - Ability to maintain confidentiality and exercise sound judgment in handling sensitive information. - Knowledge of mental health, substance abuse, and developmental disabilities is an advantage. As a Client Rights Officer, you will play a pivotal role in championing the rights and well-being of our clients. If you are passionate about social justice, have a strong commitment to advocacy, and possess excellent interpersonal skills, we encourage you to apply.

Our mission is to improve health equity by expanding access to cancer precision medicine. About Trial LibraryTrial Library, Inc. is a venture-backed startup founded in 2022 focused on accelerating enrollment and retention to clinical trials with an AI-platform. Trial Library is a mission-driven health technology company dedicated to improving health equity in cancer care by expanding access to precision medicine through clinical trials. We work with community oncology sites, patients, and industry partners to ensure that clinical research is accessible, navigable, and inclusive. As a Customer Success Lead, you will work closely with the Chief Executive Officer, Associate Director of Operations, and Ally Navigation team to support Providers on the Trial Library Platform. This is primarily a remote position. You will own the process of onboarding and getting customers successful on the Trial Library platform. You will build strong relationships with physician practices (our customers) starting with the pre-sales process, managing relationships through sales, onboarding, and post-sales account management to ensure customer delight with Trial Library products. You will be accountable for setting targets and managing milestones in customer use of Trial Library products. Your Responsibilities Tracking customers through the sales cycle, from evolution from leads into opportunities into accounts in the Trial Library CRM system Bridge the gap between sales and customer support Demonstrate Provider empathy to foster trusting relationships between Trial Library and practices Proactively drive provider engagement including contracting and execution of Trial Library platform services to produce fast time to value for customers Demonstrate a solid understanding of product features and how Providers are expected to interact with product Serve as a liaison with physician practice customers to ensure a successful adoption of Trial Library products, resolving issues, addressing concerns, adapting to unique provider workflow requirements Maintain up to date knowledge of Trial Library sponsored opportunities Develop best practice workflows to drive adoption of Trial Library platform across the United States Keep physician practices engaged and regularly using Trial Library products and services Ownership of all Provider inquiry and troubleshooting to support practices when necessary Your Qualifications Minimum 5+ years of professional experience in health care-related customer success Strong metrics-focused customer success experience Open to travel and make on-site visits to practices, attend meetings, if needed General understanding of health care and research topics such as clinical trial informed consent, pre-screening, and study sponsors is desirable Demonstrate a bias towards action and seek to intervene before issues arise Strong communicator and persistent, able to influence behaviors to help drive the desired outcomes Facilitate an analytical approach and use data to drive actions Agile and willing to adapt quickly in order to achieve desired outcomes Demonstrated ability to exercise autonomy in engagement of Providers Demonstrated ability to completely manage a CRM, track Provider engagement and conversion to participation on the Trial Library platform Our Core Values 1. Ally is our favorite moniker2. The most inclusive approach is worth the work3. Celebrate measurable improvements in equity outcomes4. Fearless advocates for belonging5. Incentives matter to stakeholders choosing our products6. Taking initiative is actually giving 7. We are accountable for the experience of patients and providers8. Empathy and humility are the real dynamic duo Trial Library, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sex (including pregnancy), sexual orientation, or any other characteristic protected by applicable laws, regulations, and ordinances.

Department: MED-Impact Institute Salary/Grade: NEX/9 Performs biomedical &/or social-behavioral research by administering tests &/or questionnaires following protocols; collecting, compiling, tabulating &/or processing responses; gathering information; &/or assisting in the preparation of material for inclusion in reports. Completes all activities by strictly following Good Clinical Practices (GCP) & all relevant current local, state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code of Federal Regulations (CFR), & the International Conference on Harmonization (ICH). Job Activities: The Research Study Assistant's primary activities involve completing study visits on the RADAR project. The position's specific activities include: following established protocols for one-on-one sociobehavioral interviews with participants; obtaining informed consent or assent; data collection; conducting study assessments; maintaining accurate, timely and detailed records of participant contact; maintaining and updating databases; managing monthly E-raffles; and other project-related responsibilities. The Research Study Assistant will be responsible for conducting HIV testing and counseling as part of the study procedures. If the candidate does not have an HIV testing and counseling certificate currently, they can obtain the certificate during training. The Research Assistant (RA) is expected to work in-person at study sites without a regular work from home schedule. The position will also require some evening hours (e.g., 11 AM - 7 PM) and weekend shifts to maximize retention efforts for study participants who are unavailable during the regular workday. We are seeking a diverse pool of candidates. Candidates from backgrounds traditionally underrepresented in research are encouraged to apply. Specific Responsibilities: Technical * Recruits study participants. * Reviews & obtains informed consent. * Schedules study visits with participants. * Conducts interviews. * Scores test results. * Collects survey data. * Reviews medical records. * Consults with nurses & physicians to determine pretreatment & eligibility requirements of protocol from completion to registration of participants. * Facilitates communication with key personnel & participants to maintain project study flow. Administration * Maintains detailed records of results which may include collecting, extracting & entering data; &/or preparing basic charts & graphs. * Performs scientific literature searches in support of research. * Completes portions of grant applications &/or documents associated with current local, state, & federal regulatory guidelines, requirements, laws & research protocols. Finance * May process reimbursements for travel expenses. * Monitors & distribute petty cash. * Processes invoices &/or purchase requisitions. * Coordinates fund distribution among multiple sponsors and clinical sites. * Supervision * May train other research staff to interview/test participants. Miscellaneous Performs other duties as assigned. Minimum Qualifications: (Education, experience, and any other certifications or clearances) * Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a major such as social or health science or related; OR appropriate combination of education and experience. * Must complete NU's IRB CITI training before interacting with any participants & must re-certify every 3 years. Minimum Competencies: (Skills, knowledge, and abilities.) * Ability to interact with participants of diverse backgrounds. * Excellent communication skills with effective spoken and written communication. * Strong coordination skills and the ability to prioritize tasks. * Efficient and resourceful in problem-solving. * Effective time management skills. * Demonstrated attention to detail and ability to adhere to instructions/procedures. * Demonstrated ability to take ownership of the work, possessing initiative, and good follow-through. * Knowledge of basic computer skills, familiarity with Windows environment. Preferred Qualifications: (Education and experience) * Previous work experience involving direct interaction with participants or clients. * Previous experience with the LGBTQ (lesbian, gay, bisexual, transgender, and queer/questioning) community and/or LGBTQ youth preferred. * Experience working in public health, psychology, and/or medical research. * Phlebotomy experience (training available if not certified). Preferred Competencies: (Skills, knowledge, and abilities) * Ability to work in a team environment. * Ability to work with minimum supervision and guidance. * Flexibility in adapting to new procedures and environments. * Ability to receive and benefit from feedback; willingness to expand skill set and improve performance. * HIV pre/posttest counseling and training Target hiring range for this position will be between $17.05 - $21.63 per hour. Offered salary will be determined by the applicant's education, experience, knowledge, skills and abilities, as well as internal equity and alignment with market data. Benefits: At Northwestern, we are proud to provide meaningful, competitive, high-quality health care plans, retirement benefits, tuition discounts and more! Visit us at *************************************************** to learn more. Work-Life and Wellness: Northwestern offers comprehensive programs and services to help you and your family navigate life's challenges and opportunities, and adopt and maintain healthy lifestyles. We support flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care. Visit us at ************************************************************* to learn more. Professional Growth & Development: Northwestern supports employee career development in all circumstances whether your workspace is on campus or at home. If you're interested in developing your professional potential or continuing your formal education, we offer a variety of tools and resources. Visit us at *************************************************** to learn more. Northwestern University is an Equal Opportunity Employer and does not discriminate on the basis of protected characteristics, including disability and veteran status. View Northwestern's non-discrimination statement. Job applicants who wish to request an accommodation in the application or hiring process should contact the Office of Civil Rights and Title IX Compliance. View additional information on the accommodations process. #LI-GY1

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future. Summarized Purpose: Accountable for achieving the final clinical deliverable (usually clean data from valuable patients as specified in the study protocol) within the time period specified in the contract with the customer. Interprets data on project issues and makes good business decisions with support from expert team members or line manager. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. Typically works on projects of low to moderate complexity and as part of a team of CTMs. Key responsibilities: Manages all clinical operational and quality aspects of allocated studies, of low to moderate complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Clinical Study Manager (CSM) responsibilities on small and/or less sophisticated projects. Develops clinical tools (e.g. Supervising Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contributes to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensures timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as the need arises. Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings. Collaborates with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicates with the team and leads team meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department. Ensures achievement of the final clinical deliverable within the contractual time period specified by preparing and supervising clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing supervising visit reports, and managing CRF collection and query resolution. Continuously monitors or co-monitors clinical trials to assess performance and ensure contractual obligations are met. In smaller regions, may routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials. May connect with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues. May coordinate all start-up activities and ensures that timely ethics committee and regulatory submissions (if appropriate) are addressed. Ensures that crucial document quality meets the expectation of Regulatory Compliance Review. Reviews and follows up on all questions raised by the ethics committees. May provide input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements. Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years). PREFERRED therapeutic indication experience: Ophthalmology*, Rare Disease, Sleep, and/or Psychiatry (*Ophthalmology specific: General ophthalmology, Diabetic Macular Edema & Geographic Atrophy). PREFERRED experience level: 3+ years of CTM experience (North America) + global gCTM experience +/- biotech experience Knowledge, Skills and Abilities: Good leadership skills, effective at mentoring and training, and capable of motivating and integrating teams Good planning and organizational skills to enable effective prioritization of workload Solid interpersonal and problem solving skills to enable working in a multicultural matrix organization Capable of working effectively in a changing environment with sophisticated/ambiguous situations Familiarity with the practices, processes, and requirements of clinical monitoring Good judgment and decision making skills Effective oral and written communication skills, including English language proficiency Capable of evaluating workload against project budget and adjusting resources accordingly Sound financial acumen and knowledge of budgeting, forecasting and fiscal management Strong attention to detail Solid understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc. Good digital literacy to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc. Working Environment: PPD, a part of Thermo Fisher Scientific, values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role: Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. Able to work upright and stationary for typical working hours. Able to work in non-traditional work environments. Able to use and learn standard office equipment and technology with proficiency. Able to perform successfully under pressure while prioritizing and handling multiple projects or activities. May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments. This role requires independent travel up to 20%, inclusive of traveling in automobiles, airplanes, and trains. Our 4i Values: Integrity - Innovation - Intensity - Involvement If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, submit your application - we'd love to hear from you! Benefits We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Looking to Strengthen your positive impact on patients' lives, your level of excitement at work, and your compensation? We thrive on change. [So can you!] The role of a Medical Professional at Octapharma Plasma is rewarding in every sense of the word. No two days are the same as every situation brings exciting new challenges-ones we meet with genuine empathy, skill, and enthusiasm. Our rapidly expanding organization offers the ability to enhance lives, exhilarating work, and the compensation you deserve. Join us as a: Medical Professional Medical Professional ESSENTIAL JOB FUNCTIONS: Evaluates Donor Eligibility Determines donor eligibility of new and return donors for plasmapheresis procedures and immunizations by conducting evaluations to ensure criteria of plasma donors are met and in accordance with SOPs, Food and Drug Administration (FDA), Clinical Laboratory Improvement Act (CLIA), and cGMP. May not fulfill Licensed Physician's responsibilities for selection of donors for RBC immunization programs. May not evaluate the eligibility for plasmapheresis of donors with abnormal medical/laboratory findings. Reviews informed consent forms for plasmapheresis and immunization. Includes explanation of procedures, potential adverse events, immunization schedules, possible antibody formation, and dose administration. Offering clear opportunity for donor to refuse participation. Performs medical history reviews and health assessments for donors. Maintains accurate and up-to-date Physician Communication Logs, in accordance with SOP. Understands and utilizes donor center's donor management system (NexLynk). Maintains Donor Center Compliance Uses SOPs to facilitate compliance with regulations. Complies with federal, state, local, and company-specific regulations related to quality of product, employee and donor safety, and the proper performance of day-to-day activities. Reviews donor management system (NexLynk) and/or immunization paperwork to ensure accuracy and completeness. Manages Donors Reviews accumulated data in a timely fashion to confirm eligibility and consults with donor center Licensed Physician, as needed. Classifies donors to appropriate program. Monitors donor reactions to plasmapheresis and documents accordingly. Provides appropriate medical care per SOP to donors if complications arise. Interacts with donor center Licensed Physician regarding ordering immunizations. May not order immunizations. Monitors donors for possible adverse reactions to immunization. Medical Professional may not fulfill Licensed Physician's responsibilities in RBC immunization programs. Performs duties for the Hyperimmune Program, if applicable, as described in SOPs. Reviews all normal and abnormal test results in donor management system (Nexlynk) to determine continued donor eligibility. Cannot reinstate donors who have been deferred due to an abnormal Serum Protein Electrophoresis (SPE). May not evaluate high-risk/known infectious donors. May only determine the continued eligibility for plasmapheresis of normal, healthy donors. Ensures confidentiality of employee, donor, and donor center records while performing all duties. Counsels donors with abnormal test results or eligibility concerns and defers them according to the donor deferral matrix. Refers donors to appropriate county/state health department or similar for follow-up and diagnostic testing, when applicable per SOP. Additional Responsibilities Train as a Donor Center Technician I, as outlined in the Donor Center Technician I . Acknowledgment and signature of the job description are required. Note: This requirement does not apply to exempt managers acting as Emergency MP's. Upon completion of initial training in your functional area, and where applicable: Responsible for mentoring and training Medical Professionals, able to drive training efficiencies to ensure timeliness and compliance as a Designated Trainer. Train as a QA Backup and perform related duties as required by business needs. Performs other job-related tasks as assigned. JOB SPECIFICATIONS: Graduate of a recognized healthcare-related educational program, such as Physician, Nurse (Licensed Practical Nurse or Registered Nurse). Certified/licensed as an emergency medical technician (EMT Basic, EMT 2-intermediate, or 3- advanced/paramedic, if allowable). Must work within the scope of the professional license/certification, as defined by the state in which the work is performed. Any specific state licensing requirements must be met per location. Ohio:Must be an EMT-Intermediate, EMT-Paramedic, Licensed Vocational Nurse, Licensed Practical Nurse, or Registered Nurse. Must have at least one (1) RN, LPN, LVN, EMT-P, or EMT-I always present in the Donor Center during plasmapheresis to supervise processes and procedures, but not staff, of the donor floor area, per state regulation. One (1)-year experience in the hospital, field care, or experience in a plasma center preferred. Everyone performing moderate complexity testing must possess a current license issued by the state where the donor center is located, based on any required state regulations. Must successfully complete training program and competency assessments using OPI approved training modules or training curriculum. Must have excellent patient/donor assessment skills. Must be able to manage emergency situations in accordance with standard medical care practices. Maintain current and valid license and pass medical credential evaluation. Must maintain current cardiopulmonary resuscitation (CPR) certification. Must be highly organized and have attention to detail. Possess effective physical and clinical assessment skills customer service, and people management skills. Ability to understand and follow SOPs and protocols. Must possess basic computer knowledge and skills. Basic working knowledge of Microsoft Word and Excel preferred. Must be able to speak, read, write, and understand English. Demonstrate consistency and reliability (good attendance, punctuality, full effort throughout shift, flexibility with assigned schedule). Ability to work shifts consisting of day and evening hours, weekends, holidays and extended shifts on a frequent basis. PHYSICAL REQUIREMENTS: Ability to sit or stand for extended periods. Always utilize all required and appropriate PPE (Personal Protective Equipment). Ability to tug, lift, and pull up to thirty-five pounds. Ability to bend, stoop, or kneel. Ability to perform precise tasks that require repetitive small motor skills, such as drawing blood for screening tests. Occupational exposure to blood-borne pathogens. Ability to view video display terminal less than 18” away from face for extended periods of time, up to four (4) hours at a time. Enter an environment with a temperature of -40C or colder according to Standard Operating Procedures. Occasional exposure to and handling of dry ice. Ability to use assistive devices if needed for mobility or communication. Physical ability to perform CPR and sufficient mobility to immediately assist in treatment of any adverse donor reactions. Do Satisfying Work. Earn Real Rewards and Benefits. We're widely known and respected for our benefits and for leadership that is supportive and hands-on. Managers who truly want you to grow and excel. Formal training Outstanding plans for medical, dental, and vision insurance Health savings account (HSA) Employee assistance program (EAP) Wellness program 401 (k) retirement plan Paid time off Company-paid holidays Personal time More About Octapharma Plasma, Inc. With donation centers and team members throughout the U.S., Octapharma Plasma, Inc. collects plasma to create life-saving medicines for patients worldwide. We are growing at an impressive pace, and so is the positive impact of our work. Our community relies on teamwork, compassion, and expertise to get things done the right way, while making a meaningful difference in the lives we touch. Interested? Learn more online and apply now at: octapharmahiring.com And if you know someone else who'd be a great fit at Octapharma Plasma, Inc., please forward this posting along. INNER SATISFACTION. OUTSTANDING IMPACT.

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases. See Yourself at Telix The Global Clinical Lead will be accountable for the end-to-end clinical development of novel imaging agents within the FAP program, ensuring that clinical strategy is grounded in robust scientific rationale and aligned with commercial objectives. This includes the design and execution of clinical studies that generate high-quality data to support regulatory submissions, market access, and adoption by healthcare professionals, patient advocacy groups, payors, and strategic partners. Working within a highly collaborative, matrixed environment, the Global Clinical Lead will partner closely with Global Program Leads, Clinical Operations, Medical Affairs, Regulatory Affairs, Manufacturing, and Commercial teams. The role requires a deep understanding of the competitive landscape and the ability to translate scientific insights into actionable development plans that accelerate the path to commercialization. Key Accountabilities: Lead Clinical Strategy Development: Define and drive the clinical development plans for Fibroblast Activation Protein (FAP) imaging assets, ensuring alignment with Telix's broader asset strategy and commercial objectives. Cross-Functional Collaboration: Partner closely with Global Program Heads, Regulatory Affairs, Medical Affairs, and Translational Medicine to ensure clinical trial objectives are integrated into the overall development strategy and reflect the needs of diverse stakeholders. Clinical Study Design and Execution: Oversee the development of clinical study plans from concept through to protocol finalization, ensuring scientific rigor and alignment with regulatory expectations, healthcare provider needs, patient advocacy perspectives, and market access requirements. Clinical Documentation Leadership: Lead the creation and review of essential clinical documentation-including informed consent forms, imaging charters, study manuals, and regulatory dossiers-in collaboration with medical writers and cross-functional teams. Regulatory and Scientific Contributions: Provide expert clinical input into key regulatory and scientific documents, including Investigator Brochures, IMPDs, DSURs, PSURs, SUSARs, Clinical Study Reports, and global regulatory submissions (e.g., INDs, BLAs, NDAs, MAAs). Data Integrity and Analysis: Lead the review, interpretation, and quality control of clinical data, including efficacy, safety, and imaging endpoints, to ensure data integrity and support decision-making across the development lifecycle. Stakeholder Communication: Prepare and deliver high-impact presentations, proposals, and reports for senior leadership, external partners, and strategic collaborators to communicate program progress and clinical insights. External Engagement and Thought Leadership: Cultivate relationships with Key Opinion Leaders (KOLs), organize advisory boards, and collaborate with subject matter experts, consultants, and vendors to inform clinical strategy and enhance program visibility. Education and Experience: Medical degree (MD) or doctoral degree (PhD) in a relevant scientific discipline is required. Therapeutic Area Expertise: Demonstrated experience in oncologyor nuclear medicine is required, with a strong understanding of the clinical and scientific landscape. Clinical Development Experience: 5 years of industry experiencein clinical development, with a proven track record of leading clinical programs through early-phase development. Experience in early-stage clinical trial design and execution is strongly preferred. Regulatory Knowledge: Solid understanding of global clinical trial methodology, regulatory frameworks, and submission processes. Experience preparing and submitting regulatory documents (e.g., INDs, CTAs) and engaging with health authorities (e.g., FDA, EMA) is preferred. Leadership and Project Management: Demonstrated success in leading cross-functional teams and managing complex clinical development programs from concept through execution. Strategic and Scientific Acumen: Strong knowledge of clinical trial design, data interpretation, and the ability to translate scientific insights into strategic development plans. Key Capabilities: Willingness to travel domestically and internationally, as needed Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development. Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics. VIEW OUR PRIVACY POLICY HERE

Replies within 24 hours Benefits: Competitive salary Flexible schedule Opportunity for advancement Training & development BCBA Case Management Consultant (Independent Contractor - 1099) Rate: $50-$55 USD per hour Classification: Independent Contractor (1099) Schedule: Part-Time, Hours as Agreed Location: Remote - Providing Services to Ocean Psychological Services, Inc. Position Summary The BCBA Consultant provides assessment-based clinical services on an as-needed basis, including Functional Behavior Assessments (FBA), Initial Assessments (IA), and limited ongoing clinical support when specifically requested and approved. This is a project-based, independent contractor role and does not include employee duties such as staff supervision, case management, ongoing program development, or the provision of employer-directed work schedules. The Consultant may accept or decline individual assignments and retains autonomy over how services are performed, consistent with professional standards and applicable regulations. Scope of Work (1099 - BCBA Case Management Consultant) · Supervises BT's and manages all clinical aspects of the caseload assigned.· Provide clinical consultation, guidance, and recommendations to Mid-levels and BTs to support adherence to ABA best practices.· Consult on the development, implementation, and review of individualized ABA programs, offering clinical insights and suggested adjustments.· Review treatment plans to ensure they align with client needs and current research, and provide recommendations as appropriate.· Offer family consultation to support understanding of ABA strategies and reinforce consistency across home and clinic environments.· Ensure that clinical recommendations align with applicable laws, regulations, and ethical guidelines related to ABA practice.· Maintain client confidentiality and obtain informed consent within the scope of services provided.· Collaborate with other professionals involved in the client's care, providing clinical input when requested.· Support the delivery of clinical services such as ABA programming, parent collaboration, and supervisory guidance as outlined in the agreed-upon service plan.· Provide professional feedback to leadership regarding clinical quality and performance trends, as applicable to the consultant's observations.· Participate in scheduled case review meetings to discuss caseload needs, treatment planning, and quality assurance.· Provide consultation support to Mid-levels related to program development and case management needs.· Attend agreed-upon meetings or trainings relevant to clinical practice and program quality (as scheduled and compensated within the contract).· Will not exceed over 10% of billable hours for non-billable tasks. Qualifications · Active BCBA certification through the Behavior Analyst Certification Board (BACB).· Master's degree in a related field.· Minimum of 1 year of experience practicing as a BCBA.· Knowledge of ABA methodologies including ABA, ESDM, TEACCH, PECS, PRT, etc.· Strong written and verbal communication skills.· Ability to work independently and manage contracted work within agreed timelines.· Must comply with all applicable BACB ethical guidelines.· Ability to pass a criminal background check if required by contract.· Experience conducting assessments preferred.· Cannot exceed over 10% of billable hours for non-billable tasks. Compensation · $50-$55 per hour, based on experience and assignment type.· Contractors are responsible for all taxes, insurance, expenses, tools, and materials necessary to perform services. Contractor Status & Compliance This position is classified as an Independent Contractor (1099). As such: · No employee benefits are provided (including health insurance, PTO, holidays, or retirement benefits).· Contractors determine their own work methods and schedules, except where coordination with clients is required.· Contractors may accept or decline offered assignments.· Contractors are responsible for maintaining their own professional liability insurance unless OPS elects to provide coverage under a separate agreement. About Ocean Psychological Services Ocean Psychological Services is committed to delivering high-quality, equitable ABA services to children and families. We value diversity, inclusion, and culturally responsive practices in all contracted and employed relationships. OPS does not discriminate on the basis of race, color, religion, gender, gender identity, sexual orientation, national origin, disability, age, or veteran status. Background Check Notice If required by law, contract, or payer standards, OPS may request a background check prior to assigning clinical work. Contractors will only be engaged upon satisfactory clearance. This is a remote position. Compensation: $50.00 - $55.00 per hour We are a behavioral and mental health provider that provides assessment, evaluation, and evidence-based treatment for individuals with autism spectrum disorder and other developmental disabilities along with psychotherapy, counseling, and group therapy services. Our team consists of qualified certified and licensed professionals, including but not limited to: licensed psychologists, licensed social workers and counselors, psychological assistants, Board Certified Behavior Analysts (BCBAs), Board Certified Assistant Behavior Analysts (BCaBAs), and Registered Behavior Technicians (RBTs). Our services are provided to individuals across all age ranges. We are actively hiring passionate individuals who to deliver our services to our clients and in supporting their professional development. We are passionate about building a community where equitable care is accessible to all. We also ensure the recruitment of diverse candidates for our organization and aim to increase diversity in representation of race, body types, and age in visual materials on our website, annual reports, and cross-platform communications. At Ocean Psychological Services, you will find a working environment that is ethical, professional, respectful, caring, and fun that works toward supporting your professional development. Our training, programs, services, and dedicated and professional staff continue to create rewarding career opportunities. Our ABA providers deliver services in the home setting, while our social groups, psychotherapy, and counseling services take place in our clinic setting. We ensure the implementation of safety guidelines to ensure that our employees can deliver our services with safety precautions that limit the risk of infection from COVID-19. We offer paid training that includes supervisory hours toward certification (e.g., RBT, BCaBA, BCBA, or equivalent) and educational leave for attaining CEUs toward maintaining licensing requirements for our mental health providers. We also offer ongoing professional development opportunities and didactic training opportunities.

Clinical Trial QC Monitor - (10032952) Description Join the transformative team at City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. City of Hope's growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and treatment facilities in Atlanta, Chicago and Phoenix. Our dedicated and compassionate employees are driven by a common mission: To deliver the cures of tomorrow to the people who need them today. Performs comprehensive quality control (QC) monitoring of source documentation for City of Hope clinical trials. Reviews internal regulatory documents, protocols, amendments, correspondence and serious adverse event reports to maintain current knowledge and requirements of relevant protocols. Performs extensive QC visits to confirm appropriate source documentation in electronic health record (laboratory data, transfusion services records, and any other source used to produce study data) and in other electronic patient records (Florence eBinder) to confirm protocol compliance (including QC review of consent and eligibility criteria). Performs extensive review of case report forms and study data, utilizing medical records, laboratory data, transfusion services records, and any other source used to produce study data. Generates QC report, summarizing the findings of all deviations, discrepancies, and incorrect or missing source documentation. This role ensures the research enterprise maintains high standards of care and adheres to federal, state, and local regulations. As a successful candidate, you will: Ensures timely reporting of Serious Adverse Events (SAEs) to all required regulatory agencies and external sponsors. Reviews protocols and amendments to stay current with eligibility, treatment, and documentation requirements; develops study-specific QC and risk-assessment plans. Identifies clinical trial issues and quality risks, proposes and implements corrective actions, and presents quality, compliance, and risk-management reports to research leadership. Conducts QC monitoring, investigates protocol deviations and documentation discrepancies, generates monitor reports, and provides training to investigators, CRCs, nurses, and sponsors as needed. Serves as a subject matter expert on clinical research documentation and regulatory standards, contributes to enterprise QA initiatives, and may travel to participating sites for monitoring activities. Qualifications Your qualifications should include: Bachelor's degree in biology, chemistry, biochemistry, physiology, nursing, or a related scientific field. Minimum of three years of experience as a Clinical Research Associate or clinical trial monitor, specifically in Oncology and/or Hematology trials. Strong understanding of IND procedures, study protocols, informed consent processes, and applicable regulatory requirements. Knowledgeable in Good Clinical Practice (GCP) guidelines and other relevant clinical research standards. Must obtain certification as a Clinical Research Associate (ACRP) or Clinical Research Professional (SoCRA) within one year of hire. City of Hope is an equal opportunity employer. To learn more about our commitment to diversity, equity, and inclusion, please click here. To learn more about our Comprehensive Benefits, please CLICK HERE. Primary Location: US-Nationwide-USA-RemoteJob: Clinical Trials Auditing & MonitoringWork Force Type: RemoteShift: DaysJob Posting: Dec 2, 2025Minimum Hourly Rate ($): 39. 250700Maximum Hourly Rate ($): 60. 838500

We are currently seeking Experienced Sr. CRAs fluent in Spanish residing in the Mid West US! Also open to hub airports with direct flights to Puerto Rico. This FSP aligned role works with IVD clinical trials. WHAT YOU WILL DO You will utilize your skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards. Responsibilities: Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned - Responsible for all aspects of site management as prescribed in the project plans General On-Site Monitoring Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document Monitor data for missing or implausible data Responsible for all aspects of registry management as prescribed in the project plans - Undertake feasibility work when requested Complete Serious Adverse Event (SAE) reporting, process production of repo11s, narratives and follow up of SAEs Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management Assist with training of new employees, eg. co-monitoring Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assigned Perform other duties as assigned by management Requirements University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure) 4+ years of onsite Clinical Monitoring experience Various therapeutic experience required Open to major hub locations in the Northeast US The important thing for us is you are comfortable working in an environment that is: Fast paced: where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue. Changing priorities constantly asking you to prioritize and adapt on the spot. Teamwork and people skills are essential for the study to run smoothly. Technology based. We collect our data directly into an electronic environment. What do you get? Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to: Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers) 401(K) Paid time off (PTO) - Flex Plan Employee recognition awards Multiple ERG's (employee resource groups) Target Pay Range (based on title): $130-139K #LI - Remote Applications will be accepted on an ongoing basis. Work Environment: Work is performed in an office environment with exposure to electrical office equipment. Frequent travel to clients/ site locations with occasional travel both domestic and international. Physical Requirements: Ability to sit for extended periods and operate a vehicle safely. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Occasional crouching, stooping, with frequent bending and twisting of upper body and neck. Ability to access and use a variety of computer software developed both in-house and off-the-shelf. Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. Regular and consistent attendance. Varied hours may be required. Learn more about our EEO & Accommodations request here.

Job Description ROLE: The PICC Line Nurse will assess and perform an overall evaluation of the patient. Responsible for placement of the line and ensure the line placement is correctly inserted. TASKS AND RESPONSIBILITIES: Ability to work independently. Communicates effectively and appropriately to patient, family and other health care providers. Completes required paperwork. Provides patient education about the PICC (or midline) insertion and the care and maintenance issues post insertion Participates in performance improvement activities by providing information about each PICC (or midline) insertion to the facility staff as requested Demonstrates ability to assess patient past and current medical history including laboratory values, venous and muscle skeletal status that is pertinent in qualifying a patient as a candidate for PICC placement. Assures physicians order on chart for PICC placement. Assures Informed Consent has been obtained. Performs time out; correct patient identifier prior to initiating PICC procedure. Demonstrates ability to perform PICC placement maintaining aseptic technique utilizing measures that prevent patient discomfort and trauma related to procedure. Demonstrates high level skills in critical thinking and assessment related to vascular access devices. Maintains clinical competency by inserting a minimum of six PICCs/year and by performing one observed successful PICC insertion Documents insertion of PICC (or midline), confirmation of placement by radiologist for PICC, and medication administration, in accordance with company policy Provides facility nurses/staff instructions about the patient's PICC (or midline) care and maintenance Assist Territory Managers in meetings for clinical support as needed Assist Director of Vascular Access in facility rounds to meet with and support Directors of Nursing, Administration and Nursing staff Is responsible for the fiscal viability of the PICC program by entering the charges for the insertion, proper usage of equipment, and productive use of time Maintains patient confidentiality. SKILLS|EXPERIENCE: • Undergraduate Degree in Nursing • Current RN (Registered Nursing) license • PICC Certification • Current BLS certification • Must have good knowledge base for caring for central venous catheters. • Strong oral and written communication skills • • 2 years of OR, IR, or PICC insertion experience Pay Rate: Starting at 90k Flexible Schedule No Holiday Required Sign On Bonus Available Benefits: TridentCare offers a competitive wage and robust benefit package to full time employees. Part time employees are eligible for many of the same below, pro-rated. Benefits include: Two weeks of vacation time Health Insurance after 30 days! Sick time 8 paid holidays Same day pay available Medical insurance allowance, giving you the freedom to customize your plan to fit your needs Dental insurance Vision insurance Disability insurance Company paid life insurance 401(k)

Hiring Incentive: $1000* * $250 on first pay and then $750 on first pay following successful completion of 6 months. Must still be employed, full/part-time, and in good standing at the time of each payout. Payments are prorated for part-time hires. COVID-19 vaccination is now optional for all Associates, contractors, volunteers, and vendors at PPGOH. While not required, staying up to date on COVID-19 vaccinations is strongly encouraged as the best way to protect yourself, our team, and the community we serve. For your convenience, COVID-19 vaccinations are available at our clinics. PPGOH remains committed to fostering a safe and healthy environment and will continue to review health and safety policies as needed. For information on additional local COVID-19 vaccine providers, visit COVID-19 Vaccine Provider Locations | COVID-19 (ohio.gov) Planned Parenthood of Greater Ohio is seeking mission-minded Associates to join us as a full-time (37.5 hours per week) Medical Assistant to serve our patients at our North Columbus Health Center. SUMMARY The Medical Assistant performs a variety of client care services in accordance with agency policies and in a courteous and professional manner. Provides general health and contraceptive information to clients, assists with medical procedures and performs clerical functions, while ensuring quality client care and excellent customer service. The Health Care Assistant provides direct services in family planning and, if assigned, abortion care and is responsible for customer service skills in person and on the telephone. Must be pleasant, courteous and helpful. Requires an understanding of and commitment to quality healthcare and excellence in customer service and practice these values in relation with internal and external customers. BENEFITS Signing Bonus Paid Time Off Paid Parental Leave Medical 90% employer-paid base medical plans for single coverage Dental Vision 100% employer paid Life Insurance 100% employer paid Accidental Death & Disability 100% employer paid Long Term/Short Term Disability 100% employer paid 401(k) with matching employer contribution up to 4% Nine (9) paid holidays per year Two (2) Floating holidays per year Financial incentive program for certified bilingual staff Planned Parenthood respects and honors all people. Qualified associates who are fluent in a needed language (Spanish, Nepali, or Somali, depending on geographic service area) will earn a $1.00 per hour differential for two years following successful examination. WHAT YOU CAN EXPECT At Planned Parenthood, we believe that effective onboarding and training is the foundation for a successful and thriving career. New Heath Services Associates will take part in a robust clinical training program with a mix of virtual, instructor led, and hands-on styles. First Week: New Hire Orientation (Virtual with Human Resources), Health Services Orientation (Virtual with Clinical Training Team), Home Health Center Observations (On-Site) Second Week: Training in Electronic Health System, EPIC (Computer Based), Home Health Center Training (On-Site instructor led at Home Site) WHAT YOU WILL DO Provide clients with accurate information regarding PPGOH services, including questions pertaining to contraception options and funding sources. Briefly orients patients on what to expect during their visit. Informs patients about delays. Respond to telephone calls by making appointments, providing information and appropriate referrals. Schedule, cancels and reschedules patient appointments as appropriate. Prepare and maintains patient medical records. Maintain accurate records for patient registration, medical records, lab testing, etc. Competently utilize the computerized client information system for appointment scheduling, entering client visit data, collecting client fees and providing /printing client receipts. Provide client with correct forms and ensures forms are completed. Provide customer focused services. Anticipates needs of the patients and providers and performs necessary duties to ensure patient satisfaction and promote clinic success. Responsible for establishing effective and enduring relationships with patients and other PPGOH constituents as appropriate. Gather and record all pertinent information from patients in order to provide health services. Enters information on patient visits into the medical record and patient data system. Maintains patient data system files with accurate, current patient information. Conduct verbal history and appropriate screening for medical record documentation Screen medical and social history with correct documentation of pertinent information. Can administer medication according to scope of practice or licensure Transfer/document required information in the medical record checking the accuracy of all data per PPGOH protocol Participate in a team approach delivery system of services to patients in accordance with PPGOH policies and procedures and current medical standards. Promotes/maintains communication with patients, peers, health center manager, clinicians and administration Prepare clients for exams and assists in exam room when needed. Understand content of and accurately explains Informed Consent. Provide appropriate and accurate patient education and information as needed. Perform waived laboratory tests and venipuncture. Measure and document client height, weight and blood pressure. Prepare examination room and maintains cleanliness and inventory of all aspects of the health center. Assist in minor surgical procedures. Handle medical waste utilizing universal precautions Communicate with co-workers to keep client visits moving in a timely manner Maintain confidentiality and exercise sensitivity in a nonjudgmental manner when dealing with sexuality and sensitive issues with clients. Participate in risk and quality management processes. Adheres to HIPAA, OSHA and CLIA regulations and workplace safety policies. Attend in-service, workshops, seminars, and staff meetings. WHAT YOU WILL BRING High school diploma or GED Advanced technical training or Certified Medical Assistant required Experience working in a health care setting preferred Knowledge and proficiency in medical assisting techniques and reproductive health preferred Excellent customer service, problem solving, judgment, organizational and communication skills Strong commitment to quality health care PPGOH is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity or expression, sexual orientation, age, disability, national origin, veteran status, or any other basis covered by appropriate law. Research suggests that qualified women, Black, Indigenous, and Persons of Color (BIPOC), may self-select out of opportunities if they don't meet 100% of the job requirements. We encourage individuals who believe they have the skills necessary to thrive to apply for this role

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements. May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets. May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required. For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. Additional responsibilities include:Site support throughout the study lifecycle from site identification through close-out. Knowledge of local requirements for real world late phase study designs.Chart abstraction activities and data collection Collaboration with Sponsor affiliates, medical science liaisons and local country staff. The SMA II may be requested to train junior staff. Identify and communicate out of scope activities to Lead CRA/Project Manager. Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations. Qualifications: Bachelor's degree or RN in a related field or equivalent combination of education, training and experience Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements Must demonstrate good computer skills and be able to embrace new technologies Excellent communication, presentation and interpersonal skills Ability to manage required travel of up to 75% on a regular basis US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: $70,100.00 - $126,100.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. *************************** Additional Information Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

We are currently seeking Healthcare Regulatory and Operations Lawyers to work with Healthcare and Life Sciences corporations. Responsibilities: Manage and ensure compliance with HIPAA, Medicare, Medicaid, and Medi-Cal programs. Oversee licensing and accreditation processes within healthcare operations. Safeguard patient privacy and ensure adherence to informed consent laws. Optimize revenue cycle management and reimbursement strategies. Support physician management by focusing on compliance and regulatory issues. Minimum Qualifications: 5+ years of experience in healthcare or life sciences industries or private practice supporting clients in the healthcare or life science industries. Health care plan experience strongly preferred. Able to negotiate and draft complex contracts and related documents. Transactional healthcare experience handling hospital, health system or physician practice acquisitions, physician contracts, joint ventures, and affiliations. Experience conducting internal corporate investigations of potential violations of legal/regulatory requirements and of corporate requirements/expectations. Familiarity with U.S. privacy law, HIPAA, Anti-Kickback Statute, Stark Law and FDA compliance is required. The ability to thrive in a large, fast-paced environment with a high level of professionalism and outstanding business judgment. Active bar membership in the state in which you intend to practice. Compensation, Benefits & Location: This role offers a range of competitive compensation starting at $140,000 and a highly competitive benefits package in the alternative legal services marketplace that includes health benefits, 401K and more. Axiomites also get access to professional development resources and learning and development programs. Axiomites predominately work remotely, with the exception that some clients require on-site presence. Axiom is the global leader in high-caliber, on-demand legal talent. Covering North America, the UK, Europe, and APAC, we enable legal departments to drive efficiency and growth and meet the demands of today's business landscape with best in breed alterative legal services. Axiom is a leader in diversity, inclusion, and social engagement. Diversity is core to our values and we are proud to be an equal opportunity employer. We are proud to be named a best place to work for LGBTQ+ Equality, earning top marks in the 2021 Corporate Equality Index for the second consecutive year. Axiom's legal department is Mansfield certified and is committed to considering at least 50% diverse candidates for leadership roles and outside counsel representation. Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records. Learn more about working at Axiom. Equal Opportunity Employer: Axiom ensures equal employment opportunity in recruitment and employment, without discrimination or harassment on the basis of race, color, nationality, national or ethnic origin, religious creed or belief, political opinion, sex, gender reassignment, pregnancy or maternity, age, disability, alienage or citizenship status, marital (or civil or other partnership recognized by law) status, genetic predisposition or carrier status, sexual orientation, military service, or any other characteristic protected by applicable law. Axiom prohibits and will not tolerate any such discrimination or harassment. Accommodation for Individuals with Disabilities: Upon request and consistent with applicable laws, Axiom will provide reasonable accommodations for individuals with disabilities who require an accommodation to participate in each stage of the recruitment process. To request an accommodation to complete the application form, please contact us at ********************* and include “Applicant Accommodation” in the subject line. Axiom respects your privacy. For an explanation of the kind of information we collect about you and how it is used, our full privacy notice is available at **************************************** Employment with Axiom may be contingent upon successful completion of a background check, providing proof of identity, and possessing the necessary legal authorization to work. By submitting an application, you acknowledge that all information contained therein, and provided at any part of the application process, is correct and accurate to the best of your knowledge. #LI-LC3

Be Seen and Heard at EyePoint At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach we're taking in business fuels our success for: preventing blindness through vision-saving medications delivering best-in-class proprietary pharmaceutical technologies transforming ocular drug delivery We See You. Your wellbeing Your professional worth Your future at EyePoint EyePoint offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. There's space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected. This position is reporting to the VP, Clinical Development and is remote. Responsibilities Primary responsibilities include, but are not limited to, the following: Individual Responsibilities Contribute in collaboration with a cross-functional team the implementation of Clinical Development Plans and Registrational Strategies for the assigned products within the portfolio. Collaborate within Clinical Development and partnered Clinical Research Organizations (CROs) all clinical trial documents including, Clinical Research Protocol Synopses, Clinical Research Protocols, Investigator Brochures, Informed Consent Templates, Study Case Report Forms/Electronic Data Capture Systems, Procedure Manuals, Clinical Study Reports ensuring high caliber of all documents in compliance with International Conference on Harmonization (ICH)/Good Clinical Practice (GCP) standards/Federal and local regulations and company specific SOPs. Assist in management of the collection, review, and analysis of clinical trial data in compliance with interim analysis and overall statistical analysis plans. Ensure ongoing active review clinical data for trends in safety, effectiveness and adherence to protocol across clinical trials. Assist with the preparation of clinical documents for submission to global health authorities including briefing books/materials supporting EMA Scientific Advice, Pre-IND, IND, End-of-Phase II, NDAs, MAAs and other regulatory meetings and regulatory filings as required. Assist with authorship of meeting abstracts and posters and the publication of clinical trial data in accord with the publication strategy for the clinical program. Assist with all site initiation activities including site initiation visits, investigator meetings, development and implementation of monitoring plans and annotated monitoring visit report templates and completion and submission of all required clinical trial documents prior to site initiation. Actively assist with clinical trial recruitment strategies with evaluation of actual enrollment against assigned targets and working with investigational sites to meet, and whenever feasible, exceed enrollment targets in collaboration with clinical operations. Assist with study milestones and study metrics in collaboration with clinical operations. Ensure proper conduct of global clinical trials in compliance with global regulatory authority, ICH and GCP guidelines. Qualifications Primary skills and knowledge required include, but are not limited to the following: A complete understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP) is required. Experience in ophthalmology and familiarity with drug/device combination products Experience with all phases of clinical drug development including regulatory submissions Ability to survey and interpret scientific literature related to the assigned portfolio of products Strong communication, organizational and interpersonal skills are required. Successful work experience in a matrix team environment with cross functional teams is required. Independent decision-making and analytical skills are required. Level of Education Required: Advanced degree in life science/clinical/medical field, PhD or PharmD Number of Years of Experience in the Function and in the Industry: Minimum of 5+ years of clinical development/research and R&D experience preferred for an Associate Director Level Minimum of 10 years of clinical development/research and R&D experience preferred at Director Level Envision Your Future With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics. The collective power of our values influences everything we do, and everything we do for you. Transformational Innovation We exist to change our patients' lives through the power of sight. We are forward looking, embrace challenges with curiosity, and continuously seek to improve our products and ourselves by learning, problem-solving and pushing the limits of science and technology. Unwavering Integrity We recognize our responsibility to our patients, employees, and our community, and value the trust they put in us. We set a high ethical bar and expect responsible leadership at every level to ensure we serve those who matter most to us. Compassionate Excellence We believe that fun and excellence can coexist. We foster a culture where enjoying the work we do and caring for each other are as important as delivering exceptional outcomes. Inclusive Collaboration We strive to see through the eyes of others and work as one team. We appreciate one another's differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their ideas forward. EyePoint is proud to be an equal opportunity employer. We believe that diversity and inclusion among our colleagues is critical to our success as a company, and we seek to recruit, develop, and retain the most talented people from a diverse candidate pool. All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. EyePoint is committed to fair and equitable compensation practices. The salary offer is commensurate with EyePoint's compensation philosophy and considers factors including but not limited to education, training, experience, market conditions, criticality of the role and internal equity. The target salary range for this position is listed below. #LI-Remote Min USD $154,500.00/Yr. Max USD $249,947.00/Yr.

Responsible for driving study execution and operational excellence in accordance with ICH Good Clinical Practices, FDA regulations, guidance documents, and company SOPs. Provide oversight of site compliance with study protocols, informed consent procedures, and data integrity requirements. Ensure accurate documentation, timely reporting, and consistent implementation of best practices. Job duties: Identify, develop, and maintain investigators and sites capable of delivering start-up goals, enrollment targets, and required data quality. Facilitate and maintain open communication among investigational sites, study and data management teams, and the company. Ensure effective communication with key stakeholders. Ensure clinical studies are conducted in accordance with the protocol, GCP, company SOPs, and all applicable regulations (e.g., FDA). Understand, read, prepare, and deploy study documentation including, informed consents, study forms, and study training documents. Responsible for collecting and reviewing essential documents, facilitating necessary corrections, and filing in assigned system(s). Maintain device accountability records. Review data and source documentation from investigational sites for accuracy and completeness; facilitate resolution of data queries and manage action items to completion. Conduct and perform site initiation visits, site training, interim monitoring visits, and close-out visits. Maintain accurate, detailed, and complete records of monitoring visits and reporting findings according to plans and processes. Collaborate with sites to ensure adherence to compliance requirements and escalates non-compliance when necessary. Draft study-specific Monitoring Plans in collaboration with a Project Manager and Clinical Quality Assurance. Assume Lead Clinical Research Associate responsibilities on assigned studies including reporting of monitoring KPIs. Serve as a mentor to more junior Field Monitors. Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization. Perform additional duties as assigned. Salary Desired $111,149-$138,936 Financial compensation packages may be higher/lower than what is listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. Bachelor's degree in a related field of study, preferably in Life Science, or equivalent combination of education and experience. Minimum six (6) years of medical device monitoring experience. Minimum four (4) years of neurovascular experience. Ability to travel M-F, 4 weeks a month (75%-100%) Strong knowledge of FDA regulations for clinical trials and clinical procedures. Strong collaborative skills with demonstrated ability to work with physicians, site coordinators, and others within the company. Experience using technologies for clinical research (electronic data capture and clinical trial management systems). Excellent written and verbal communication skills, including computer literacy. Strong computer skills including MS Office (e.g., Word, Excel, Access, PowerPoint, Outlook, Teams, etc.). Desired Qualifications Proven clinical research expertise in various therapeutic areas. Experience in a catheter lab environment. EEO We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, veteran status, marital status or any other characteristics protected by law. Fair Chance Ordinance If you are applying to perform work for Terumo Neuro in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Terumo Neuro reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Terumo Neuro will consider for employment qualified job applicants with arrest or conviction records in accordance with the California Fair Chance Act, Los Angeles County Fair Chance Ordinance for Employers, Fair Chance Initiative for Hiring Ordinance, and San Francisco Fair Chance Ordinance.

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. This is an exciting time to join Crinetics as we shape our organization into the world's premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others. Position Summary: The Manager, Regulatory Affairs will be responsible for supporting regulatory strategy implementation for development programs. Works closely with the Executive Director, Regulatory Affairs to prepare regulatory submissions (authoring, timeline planning, etc.), to support regulatory and clinical objectives. Assists in developing and implementing global regulatory strategies. Assists in the establishment and maintenance of department regulatory processes. The individual is expected to develop collaborative and productive partnerships internally, as well as externally with contract research organizations, electronic publishing, and other vendors as required. Essential Job Functions and Responsibilities: These may include but are not limited to: Actively participate as a member of Regulatory Affairs teams and on cross-functional product development teams as needed. Act as a regulatory lead on a Phase 1, 2 or 3 clinical study Contribute to developing and implementing regulatory strategies for global submissions from early research and development (R&D) through commercialization. Support the compilation, review and/or filing of INDs, CTAs, briefing documents and maintenance of development and approved applications. Coordinate and contribute to the authoring of submission documents such as DSURs, annual reports, routine submissions, and amendments as needed. Develop and manage project timelines for regulatory submissions. Maintain effective interactions with all contributors and Regulatory Affairs management, to ensure timely delivery of documents for regulatory submissions. Provide regulatory assistance and review of clinical study documentation, including review of clinical protocols, informed consent documents, clinical study recruitment materials, and essential document packages. Track submissions, correspondence, and commitments with health authorities. Provide guidance to project teams to ensure regulatory documentation is complete, accurate, of high quality and electronically functional. Write and/or maintain standard operating procedures, department working practices, templates and style guides, as appropriate. Conduct regulatory intelligence or research projects as required. Education and Experience: Required: Bachelor's or M.S./Ph.D. degree in scientific area. Minimum of 7 years' experience with a Bachelor's or 5 years' experience with M.S./Ph.D. of relevant Regulatory Affairs experience in a biotech/pharmaceutical setting. Minimum of 2 years supervisory experience. Equivalent combination of relevant education and applicable job experience may be considered. Experience and understanding of International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Good Clinical Practice (GCP) requirements, and FDA regulations. Experience and knowledge in the preparation of regulatory submissions, i.e. US IND and/or NDA sequences. Ability to work both independently with direction and within project teams and see all projects through to their completion. Excellent written and oral communication skills. Strong organizational skills, including the ability to prioritize workload. Strong interpersonal skills and the ability to deal effectively with other people/departments. Ability to meet deadlines and perform multiple tasks in a fast-paced setting Software Knowledge: Windows, MS Office (Outlook, Word, Excel, PowerPoint). Knowledge of other software required: Advanced MS Word and Adobe PDF knowledge required. Preferred: Additional experience with Clinical Trial Authorizations (CTA) and Marketing Authorization Application (MAA) helpful. Experience interpreting and applying local regulations and guidance for drug development from early R&D through commercialization. Software Knowledge: Electronic document management systems use (e.g., Veeva) highly desired. Publishing experience and/or eCTD knowledge is desired (Lorenz, GlobalSubmit, eCTDExpress, etc). Physical Demands and Work Environment: Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities. Travel: You may be required to travel for up to 5% of your time. The Anticipated Base Salary Range: In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process. Equal Opportunity Employer: Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws. Salary Range The salary range for this position is: $126,000 - $158,000. In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.

An MRI Technologist (Magnetic Resonance Imaging Technologist) operates MRI machines to create detailed images of the inside of a patient's body, which are used by doctors to diagnose and treat various medical conditions. MRI Technologists are responsible for positioning patients correctly, ensuring safety protocols are followed, maintaining equipment, and providing high-quality images while delivering compassionate care. Key Responsibilities: Pre-Procedure Preparation: Review the patient's medical history, doctor's orders, and any previous imaging studies to ensure the appropriate MRI procedure is conducted. Explain the MRI procedure to the patient, addressing any questions or concerns to reduce anxiety. Ensure that all necessary documentation, including informed consent forms and patient information, is completed before the procedure. Verify patient identity and screening criteria to ensure safety, such as checking for implanted devices, allergies to contrast agents, or pregnancy. Prepare and position the MRI room by ensuring the machine and equipment are ready for the procedure. Conducting MRI Scans: Operate the MRI machine, adjusting settings (e.g., magnetic field, radiofrequency pulse) to obtain high-quality images as prescribed by the physician. Position patients on the MRI table, ensuring they are comfortable and aligned to capture the correct images while adhering to safety standards. Administer contrast agents as prescribed by the physician to enhance image clarity, ensuring the patient is monitored for adverse reactions. Ensure the patient remains still during the scan to obtain clear, high-resolution images. Monitor the MRI process to confirm quality imaging, making adjustments to the settings or positioning as necessary. Patient Safety and Comfort: Ensure patient safety during the MRI procedure, especially concerning the strong magnetic fields, by verifying that no ferrous or metal objects are present on the patient. Keep patients informed during the scan, providing reassurance and instructions as needed to ensure comfort. Monitor the patient's condition, including vital signs, during the scan to detect any potential issues or discomfort. Ensure proper patient positioning to avoid injuries or discomfort during the imaging process. Post-Procedure Care: Assist the patient off the MRI table after the procedure and ensure they are stable and comfortable. Provide post-procedure instructions, including the use of any follow-up treatments, care for injection sites (if contrast agents were used), and any other aftercare instructions. Ensure that any required post-scan imaging or additional scans are scheduled as necessary. Address any immediate concerns or side effects the patient may experience, especially if contrast agents were administered. Maintenance and Equipment Care: Ensure that the MRI machine is regularly calibrated and functioning correctly, performing basic maintenance and troubleshooting when necessary. Clean and disinfect the MRI suite and equipment between patients to adhere to infection control protocols. Monitor equipment performance, identify malfunctions or issues, and alert the appropriate staff for repairs or servicing. Collaboration with Medical Team: Communicate effectively with physicians, radiologists, and other medical staff to ensure the correct images are obtained and the patient's needs are met. Work with other healthcare professionals to review images, assess the need for follow-up scans, and discuss patient conditions. Collaborate with radiologists to ensure the final images meet diagnostic standards and are transmitted accurately to the appropriate physician for review. Documentation and Record-Keeping: Document all relevant patient information and scan results in the electronic health record (EHR), ensuring that records are complete and accurate. Ensure that imaging data is properly labeled and uploaded into the system, and assist with reports or communications as needed. Maintain logs of equipment usage, maintenance, and any issues encountered during procedures. Radiation Safety and Protocols: While MRI does not use ionizing radiation, ensure safety by following the guidelines for handling contrast agents and any equipment that could pose a risk to patients. Adhere to radiation safety standards for other imaging technologies used in the department, such as when operating in proximity to X-ray or CT equipment. Follow all established safety protocols, including magnetic field safety, to avoid accidents or injuries. Professional Development and Training: Stay current with the latest MRI technology, scanning techniques, and patient care practices. Participate in continuing education programs and obtain necessary certifications to maintain licensure and improve professional skills. Assist in training new MRI technologists or students on the operation of MRI machines and best practices in patient care.

Who We Are Vial is a hyper-scalable biotech company advancing programs into the clinic by leveraging dramatically cheaper trials and computationally designed therapeutics. Our mission is to reimagine drug development in order to cure all human diseases. We have assembled a talented team of clinical operators, chemists, and innovative thinkers to achieve this vision. Vial is fully remote and was founded by Simon Burns in October 2020. Since our founding, we have grown rapidly to a team of 50+ employees with over $100 million in funding from leading investors including General Catalyst, Box Group, and Byers Capital. Vial is rebuilding the infrastructure to advance research. By deploying technology at every step, we are creating a more efficient future for drug discovery. Why You'll Love Working At Vial Innate curiosity. At our core, we embody an insatiable curiosity. Our journey into the realm of clinical trials was ignited by a firsthand understanding of the challenges involved. This innate curiosity drives us to constantly innovate, seek fresh ideas, and bring our vision of reimagining clinical trials to life. Fostering autonomy. Autonomy is our guiding principle. We firmly believe that when team members are entrusted with autonomy, they unleash their true potential. Our culture fosters an environment where each individual takes ownership of their domain, empowering them to make a profound impact. The pursuit of mastery. We are dedicated to cultivating mastery. We understand the value of honing expertise in a craft. The pursuit of mastery, coupled with a deep sense of pride in one's workmanship, fuels our unwavering commitment to tackle intricate challenges. At Vial, we foster a culture of highly autonomous professionals, each an expert in their field, collaborating on an immensely demanding endeavor together. Move fast, stay humble. Our strength lies in agility and humility. We firmly believe that intellectual honesty and a nimble mindset are the pillars of success. By staying adaptable and open-minded to all solutions, we tackle obstacles head-on, remaining humble in the face of adversity. This enables us to surmount the hurdles that confront us at every twist and turn. What You'll Do Support the Clinical Development team in planning and execution of early-stage clinical trials. You'll gain exposure to protocol development, trial operations, and the systems that keep studies running smoothly. Key Responsibilities * Assist with preparation and review of trial documents (protocols, informed consent forms, study reports) * Track study timelines, milestones, and deliverables * Help organize and maintain clinical trial data, regulatory submissions, and correspondence * Support coordination with sites, CROs, and internal stakeholders * Contribute to process improvement projects within clinical operations What You Will Bring * Strong organizational skills and attention to detail * Interest in clinical research, drug development, or healthcare operations * Ability to manage multiple tasks and prioritize effectively * Strong written and verbal communication skills Preferred Skills * Background in life sciences, public health, or related field * Familiarity with clinical trial design or regulatory environment (FDA, ICH/GCP) * Experience with project management tools (Notion, Excel, or similar) * Previous internship or coursework in clinical research a plus

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **************** . This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. **Purpose and Scope:** + Coordination and execution of work within the Site Contract, Budget support function in support of both early and late-stage Clinical Operations and may include support for other functions (Medical Affairs). + This position is responsible for the establishment and maintenance of global best practices as it relates to applying the relevant regulatory, legal requirement and global data privacy requirements in the support of clinical trial execution that adhere to Astellas and GCP/ICH requirements. + This position will collaborate with Astellas Legal/Data Privacy Organizations, Ethics & Compliance and other external stakeholders as required. + This position will contribute to project level timelines and will report on performance timelines both during feasibility and throughout the lifecycle of contract/budget negotiation. + This position is accountable for the efficient delivery of core and country templates for clinical site operational documents that maintain regulatory and corporate compliance, operational and legal standards, while ensuring contracts are delivered to meet study/project timelines. + This position may be responsible for managing direct reports and may additionally include oversight of contractors. **Responsibilities and Accountabilities:** + Responsible for development of final processes, standards and tools for utilization within either both Site Contracts and Site Budget or a specific area of focus (e.g. Site Contract or Site Budget, including global implementation with the project team. + Draft of guidance documentation(s) and training. + Manages the changes of the documents, templates or training under their purview. + Serves as primary liaison to collaborate between business and designated legal partners (as needed) to support development of global templates and processes to help ensure timely, proactive, strategic, best-in-class legal advice and support, taking into account objectives of the organization, and the unique and varying global, regional and local legal and regulatory requirements in a risk-balanced manner in order to effectively minimize and mitigate risk to the business. + Participates in strategic improvement/innovation projects as requested. + Responsible for the preparation and management of functional budgets and resources and oversight of related components of trial budgets and timelines and resources for all clinical studies related to these positions. + Support for Industry Best Practice investigation and implementation. + Support for development of related metrics for functional area, including measurement, and monitoring including recommendations to enhance performance of study start up. + Management of any CRO resources necessary for study delivery. **Required** + Bachelor's Degree or equivalent relevant experience + At least 10 years prior experience handling and executing on functional specific material (e.g. contracts, budgets, payments or informed consent form) matters with at least 5 years directly involved with a company within the pharmaceutical/ biotechnology industry. Global experience preferred. + Good understanding of the regulatory, legal and data privacy issues affecting the pharmaceutical industry, including GDPR as it relates to the core and country templates. + Strong ability to grasp regulatory and legal issues quickly, exhibit strong analytical problem solving and decision-making skills, exercise sound judgment and provide practical and constructive legal advice. + Strong negotiation and communication skills (both oral and written). Ability to communicate legal issues in a clear and understandable manner. + Must have a strong knowledge of clinical development processes and ICH/GCP + Experience in a Manager or equivalent role with responsibility and demonstrated success in execution of strategies for relevant non-project support functions. + Must have excellent interpersonal, written, verbal, and computer skills. + Minimal (10-20%) travel required + Fluent in English + Direct people management experience is preferred **Salary Range** $141,400 - $222,200 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations) **Benefits:** + Medical, Dental and Vision Insurance + Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down + 401(k) match and annual company contribution + Company paid life insurance + Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions + Long Term Incentive Plan for eligible positions + Company fleet vehicle for eligible positions + Referral bonus program \#LI-SS Category Site Activation / Late-Stage Management Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans