Clinical quality assurance associate jobs near me - 150 jobs

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain's biggest problems so patients and their loved ones can flourish. For more information, please visit us at ************** and follow us on LinkedIn and X. About This Role Axsome Therapeutics is seeking a Clinical Trial Associate (CTA) that is responsible for supporting the organization to successfully develop and implement clinical trials across its product portfolio and development pipeline. This role provides support to the Clinical Trial Manager (CTM), field based Clinical Research Associates (CRAs), and clinical study sites. This role will be a key study team member responsible for contributing to the life cycle of a clinical trial (all phases) and assure compliance with SOPs, FDA regulations, and ICH/GCP guidelines. This role is based at Axsome's HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles. Job Responsibilities and Duties include, but are not limited to, the following: Create and maintain study trackers (e.g., contact lists, study status trackers, study specific checklists.) Ensure accurate and up to date information in clinical trial management system (CTMS) Review and maintain documents in the Electronic Trial Master File (eTMF) Assist clinical study team during all phases of clinical trial activities (e.g., feasibility, start-up, maintenance, and close-out) Collect and review clinical study site essential regulatory documents prior to site initiation/study drug release Submission and tracking of documents to central/local Institutional Review Board (IRB) Distribute study materials to clinical study sites, as directed Participate in meetings with internal and external stakeholders, draft meeting agendas and minutes, as needed Assist the clinical study team in preparation and distribution of study documents and materials (e.g., informed consent form, regulatory binder, patient recruitment materials, and newsletters) Support field-based CRAs Assist data management with review of clinical data as needed Assist clinical study team with the final reconciliation of the eTMF during study close-out Requirements / Qualifications Bachelor's degree required. Preference to candidates with a life science degree Minimum 6 months - 1 year of relevant experience Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles. Experience and Knowledge Must have good organizational skills, be a team player, function independently, and be able to interact comfortably with colleagues and external stakeholders (e.g., study vendors, clinical study sites). Basic understanding of ICH/GCP and clinical research terminology preferred Comfortable multi-tasking in a fast-paced small company environment and able to adjust priorities as needed Excellent team player; willingness and ability to fill functional gaps in a small but growing organization Additional skills/qualifications for the role, including any that are preferred but not required Salary & Benefits The anticipated salary range for this role is $60,000 - $66,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package. Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law. Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.

At Headlands Research, we are dedicated to enhancing clinical trial delivery within our communities. As a leading network of advanced clinical trial sites, we leverage cutting-edge technology and exceptional support services to broaden outreach and participation. Founded in 2018, our rapidly growing company currently operates 20+ sites across the US and Canada, with plans for further expansion. The Company At Headlands Research, we are building a best-in-class site network to improve the delivery of clinical trial options in the communities we serve. We're an exceptional family of next-generation clinical trial sites, integrating cutting edge technology and high-quality support services, and significantly expanding outreach and participation with a focus on participant diversity. Founded in 2018, our company is in high growth mode; we operate 21 clinical trial sites in the US and Canada and have rapid expansion plans. The Role The Director of Quality is tasked with ensuring that Headlands delivers consistent, high-quality data to our pharma partners as well as ensuring patient safety during the trial process. This individual will oversee quality and training functions for the organization including, but not limited to, the development and maintenance of quality assurance and training programs and policies, oversight of inspections and audits, quality diligence for acquired sites, and management of SOP's and quality documents to ensure GCP and all regulatory guidelines are adhered to. In addition to strategic oversight, the Director will also serve as the Quality Leader for a group of sites. This includes hands-on support in quality reviews, audit/inspection preparation, and CAPA resolution, ensuring that sites are inspection-ready and quality standards are consistently met. Direct Reports- 3-4 This individual should bring a strong background in the clinical trial industry with specific experience supporting and leading multi-site or large research organization quality development programs. Candidates should appreciate the atmosphere of a growing company and the need to impact process development while supporting sites. Success in this position requires agility, collaboration and exceptional critical thinking and problem-solving abilities. Duties Oversee and direct the Quality Department, ensuring its alignment with the broader business strategy and adherence to industry standards, while establishing clear goals and promoting a culture of quality, compliance, and ongoing improvement. Communicate, train, and author (when applicable) Standard Operating Procedures (SOPs) including periodic review/revisions of procedures and policies to ensure compliance with regulations and guidelines in both the US and Canada. Develop and maintain key performance indicators (KPIs) to evaluate the effectiveness of quality assurance activities and initiatives. Conduct and/or oversee annual and monthly quality reviews. Support the corporate development team through quality review of potential acquisition candidates. Developing and monitoring employee training as applicable to quality, including GCP, IATA, PHI, KnowB4, etc. Develop, implement, and maintain an internal review monitoring system and schedule. Report out on quality trends and metrics to aide in effective process improvement and risk management. Works with Regional Director of Operations, Quality Managers and Site Directors to ensure quality incidents are investigated, root cause analysis is performed, and a CAPA has been implemented and monitored for effectiveness. Partners with regional leaders and site teams to identify potential changes and opportunities for process improvement. Provide guidance, support, training and interpretation of regulations, guidelines, and policies Supports coordination of sponsor audits, regulatory inspections, and mock audits. Oversee documentation, reporting and closure of significant compliance and/or site review findings. Acts as backup Quality Manager for all sites within the network. Serve as the Quality Leader for assigned sites, providing direct hands-on support with quality reviews, audits/inspections, and CAPA resolution to reinforce site-level compliance and readiness. Facilitates New Hire Orientation and on boarding in collaboration with HR for clinical operations to specific functions related to quality. Develops and implements a mentorship program for new site employees to foster quality across the enterprise. Facilitates CTMS training in collaboration with ESource team. Requirements: Education - bachelors-degree in business or a health-related field required; master's degree preferred 5 years' + experience in clinical trials industry (sponsor or site) with experience in managing quality 3+ years' experience leading a team Experience with Quality oversight in Canada preferred but not required Prior experience authoring site SOP's preferred but not required Fundamental knowledge of US regulatory standards and guidelines for the conduct of clinical trials (ICH GCP, FDA; EMA; ANZ regulations) Ability to work in a remote setting with travel required sometimes with short notice Demonstrates strong analytical and proactive problem-solving skills Strong written and verbal communication skills Exceptional organizational skills, ability to multi-task and be detail oriented Experience developing and implementing training materials Accomplishes work in accordance with scheduled objectives and effectively meets deadlines Ability to maintain high degree of professionalism and integrity

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Clinical Research Associate II/ Sr. Clinical Research Associate to join our diverse and dynamic team. As a Clinical Research Associate II at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. CRA's must have Oncology experience, GVHD would be nice but not required. They should be willing to do dermatology if requested. What you will be doing * Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. * Ensuring protocol compliance, data integrity, and patient safety throughout the trial process. * Collaborating with investigators and site staff to facilitate smooth study conduct. * Performing data review and resolution of queries to maintain high-quality clinical data. * Contributing to the preparation and review of study documentation, including protocols and clinical study reports Your profile * Bachelor's degree in a scientific or healthcare-related field. * Minimum of 2 years of experience as a Clinical Research Associate. * In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines. * Strong organizational and communication skills, with attention to detail. * Ability to work independently and collaboratively in a fast-paced environment. * Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: * Various annual leave entitlements * A range of health insurance offerings to suit you and your family's needs. * Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. * Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. * Life assurance * Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Salary range: $110,520.00-$138,150.00 Bonus, Com, Stock, Benefits & Disclaimer verbiage: Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level. You may be eligible for a bonus, stock compensation and commissions in some cases depending on your role and performance. Are you a current ICON Employee? Please click here to apply

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: R&D Operations Job Sub Function: Clinical Trial Project Management Job Category: Professional All Job Posting Locations: Santa Clara, California, United States of America Job Description: Johnson & Johnson is hiring for a Clinical Research Associate II- Shockwave Medical to join our team. The position is FULLY REMOTE and can sit anywhere in the US. At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************/. Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque. Position Overview The Clinical Research Associate II (CRA II) is responsible for facilitating in-house set up, activation, maintenance and closure of global clinical trials while gaining experience in clinical trial management processes. The CRA II will work closely with Investigators, Site Personnel and Vendors to ensure compliance with protocol and overall clinical objectives. In collaboration with the Clinical Research Manager, the CRA II maintains consistent CRF data quality and discrepancy interpretation across sites. The CRA II will develop a basic understanding of the disease and indication. Essential Job Functions May participate in study design and study set up activities May conduct site visits (pre-study, initiation, interim and close-out visits) to ensure protocol compliance, accurate and thorough data collection, and appropriate study conduct Participate in the review of monitoring visit reports for completeness Supports development of study training and may provide study site training to site personnel Provides study training to internal employees as applicable Assists in development of CRF design, CRF guidelines and supports database development when applicable Develop study tools and guidelines to be utilized by study sites Develops basic knowledge of the process used to evaluate and select potential investigators and sites Develops basic knowledge of the process used to evaluate and select potential vendors as applicable Interacts with field monitors/CRO CRAs, investigators and study coordinators through frequent communication (written and verbal) and maintains effective management of study issues Drafts informed consents as applicable Reviews site's informed consent forms against the consent template for presence of all GCP requirements and protocol specific information and revisions as needed. Also reviews the consent for accuracy and ensures that the consent is written in language that subjects will understand Coordinates and reviews regulatory documents from study sites; ensures completeness and accuracy, facilitates translation as needed Ensure study records are auditable in-house Responsible for authoring internal documents, and may author portions of clinical study reports or clinical evaluation reports Develops basic knowledge of the investigator contract, budget, and payment process including legal language and document structure as it impacts assigned studies May be responsible for initiating and tracking quarterly site payments and reconciling study invoices Communicates status of trial to manager and team May be responsible for development or revision of SOPs or work instructions Appropriately represents functional area Other duties as assigned Qualifications Bachelor's degree in science or healthcare with a minimum of 2 years of medical device industry experience directly supporting clinical research in a Sponsor role Must have excellent verbal and written communication skills High attention to detail and organizational skills are necessary Basic understanding of peripheral and coronary artery disease and therapies preferred Working knowledge of GCP, FDA, ISO and other applicable regulations Ability to travel 10-20% domestically and internationally Experience with EDC Data Management Systems Ability to work in a fast-paced environment while managing multiple priorities ACRP or SOCRA clinical research certification preferred Operate as a team and/or independently while demonstrating flexibility to changing requirements Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (********************************) or contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: Analytical Reasoning, Analytics Dashboards, Business Behavior, Clinical Data Management, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trials, Execution Focus, Laboratory Operations, Medical Knowledge, Process Oriented, Professional Ethics, Project Integration Management, Project Management, Research and Development, Research Ethics, Training Administration The anticipated base pay range for this position is : $87,000.00 - $140,300.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave - 80 hours in a 52-week rolling period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year For additional general information on Company benefits, please go to: - *********************************************

Avalyn is a biopharmaceutical company developing inhaled therapies for the treatment of rare respiratory diseases including pulmonary fibrosis and other interstitial lung diseases (ILD). Pulmonary fibrosis is characterized by scarring of lung tissue, decline in lung function, reduced exercise capacity and quality of life, and is associated with increased mortality. Currently approved therapeutic options slow pulmonary fibrosis progression but are associated with significant toxicities that restrict their use and dosing. Avalyn is developing a pipeline of new inhaled formulations of approved medicines designed to reduce systemic exposure and deliver medication directly to the site of disease. Avalyn's lead program, AP01, is an optimized inhaled formulation of pirfenidone, currently being studied in the ongoing MIST Phase 2b Study in progressive pulmonary fibrosis (PPF). Avalyn has initiated a Phase 2 study for its second program, AP02, inhaled nintedanib, that is being developed for the treatment of idiopathic pulmonary fibrosis (IPF). For more information, please visit avalynpharma.com and follow us on LinkedIn. Position Overview: The Clinical Trial Assistant will provide general administrative and project support for clinical research studies. He/she will provide day-to-day operational support to the Clinical Operations and Study Management teams across Avalyn's clinical trials spanning PH 1-2b and beyond. This role will support study start-up, ongoing study conduct, and close-out activities in close collaboration with CRO partners, external vendors, and internal cross-functional teams. The Clinical Trial Assistant will help coordinate global clinical trial activities by tracking key study milestones, deliverables, and timelines across investigational sites, and will assist in the preparation and organization of study materials for Investigator Meetings, Site Initiation Visits (SIVs), and other study-related meetings and communications. Responsibilities: · Support TMF related activities (sending / tracking Avalyn vendor documents to CRO TMF, TMF QC and reconciliation (through life of the trial and final reconciliation) Including conducting TMF audits based on the timing outlined in the applicable study plans communicating issues identified to the CRO and tracking resolution of the identified issues. · Create and maintain a SharePoint study file organization structure; build a file folder format consistent with TMF reference model to use consistently across all trials. · Assist with study start-up, maintenance, and close-out activities in collaboration with CROs, vendors, and internal cross-functional teams. · Responsible for coordination of meetings and generate meeting minutes · Will assist in building Smartsheet or similar workspaces to house various study specific trackers allowing for a central location · Responsible for supporting Data Review, identifying gaps/missing data, outliers, etc) to ensure accuracy of data. Track and report status of issues to resolution, escalating when appropriate. · Support GCP compliance and inspection readiness activities by ensuring study documentation is complete, accurate, and well organized. · Assist with internal audits, inspection preparation activities, and responses to audit findings as needed. Required Qualifications: · Minimum of Bachelor's degree in Life Sciences, Health Sciences, Nursing, Public Health, or a related field (or equivalent relevant experience) · 2+ years of experience in Clinical Operations, Clinical Research, or a related clinical trial support role (industry or CRO) · Working knowledge of clinical trial documentation and Trial Master File (TMF) requirements including the CDISC TMF reference model · Experience supporting TMF activities, including document collection, filing, tracking, and basic QC · Familiarity with electronic TMF (eTMF) systems and document management best practices · Experience with TMF related activities (sending / tracking Avalyn vendor documents to CRO TMF, TMF QC (set a frequency through life of the trial and final recon) · Ability to build, maintain, and update study trackers (e.g., Excel, Smartsheet, or similar tools) · Strong attention to detail with the ability to identify missing, inconsistent, or incomplete information · Excellent organizational, time management, and prioritization skills · Strong written and verbal communication skills, including the ability to document meeting minutes clearly and concisely · Ability to work collaboratively, as well as independently. with cross-functional teams, CROs, and external vendors · Must be familiar with ICH GCP and appropriate regulations · Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook) Proposed pay range$90,000-$125,000 USD

Piper Companies is seeking a well-rounded Clinical Research Associate with direct oncology monitoring experience to work with a Global CRO. The Clinical Research Associate will be working remote with some travel included. Requirements for the Clinical Research Associate include: * Conducting site monitoring visits in line with GCP and ICH guidelines * Ensure project needs are met by collaborating with local sites * Oversee regulatory submissions, CRF completion, and data query resolutions * Ensure documentation is properly formatted and filed; TMF and ISF * Mentor clinical staff during visits Qualifications for the Clinical Research Associate include: * 3+ years of Oncology monitoring experience * 3+ years of onsite monitoring experience * Able to travel locally for work * Proficient in GCP and ICH guidelines * Understand Microsoft Office and mobiles devices * Strong understanding of Phase 1 oncology trials (phase 2 and 3 are welcomed) * Bachelor's degree in a related field Compensation for the Clinical Research Associate includes: * Salary range: $100,000 - $130,000 * Comprehensive benefit package: Medical, Dental, Vision, 401k match plus PTO, Sick leave as required by law, and Paid Holidays Keywords: Clinical research associate, CRA, hospital, travel, oncology, documentation, trials, trial sites, cancer, cancer research, GCP, ICH, recruitment plans, projects, project, protocol adherence, regulatory submissions, enrollment, CRF completion, data, data query, start-up phase, phase 1, trial master file, TMF, Investigators site file, ISF, mentorship, Microsoft office, mobile devices #LI-BH1 #LI-REMOTE This job opens for applications on 1/23/2025. Applications for this job will be accepted for at least 30 days from the posting date.

We are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,800 driven, dedicated and passionate individuals. We work on the front-line of medical science, changing lives, and bringing new medicines to those who need them. If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you. Job Description As a Senior Clinical Research Associate you will work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research projects in a variety of therapeutic indications. You will build and maintain relationships with clinical sites and investigators. You will focus on subjects' rights, safety and well-being and quality of data compliance. Office-Based or Home-based You will: Conduct and report all types of onsite monitoring visits Be involved in study startup (if applicable) Perform CRF review, source document verification and query resolution Be responsible for site communication and management Supervise study activities, timelines, and schedules on the country level Be a point of contact for in-house support services and vendors Be involved in quality control, such as compliance monitoring and reports review Participate in feasibility research Support regulatory team in preparing documents for study submissions Qualifications College/University degree in Life Sciences or an equivalent combination of education, training & experience Independent on-site monitoring experience in the USA (5 years minimum) Experience in all types of monitoring visits in Phase I-III Participation in clinical projects as a Senior Monitor Experience monitoring complex Oncology trials required; experience with radiopharmaceuticals and/or breast cancer preferred Experience monitoring GI studies (IBD, Chron's, UC) is preferred. Full working proficiency in English Proficiency in MS Office applications Ability to plan, multitask and work in a dynamic team environment Communication, collaboration, and problem-solving skills Ability to travel up to 80% Valid driver's license (if applicable) Additional Information Advance your career in clinical research and lead challenging full-service projects on the country/regional level while growing with a rapid company, that puts its people first! You will get hands-on involvement in every aspect of the study. For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.

At Praxis, we turn neuroscience discoveries into treatments that improve patients' lives. The Clinical Research Associate (CRA) plays a key role in monitoring clinical trials and ensuring they are conducted to the highest quality and compliance standards. This position involves direct site management, monitoring visits, and close collaboration with site staff and cross-functional teams to support the successful execution of studies. Key Responsibilities Conduct site qualification, initiation, monitoring, and close-out visits in accordance with study protocols, ICH-GCP, and regulatory requirements. Verify source data and ensure accuracy, completeness, and consistency with case report forms (CRFs) and study databases. Review monitoring reports and follow-up letters to ensure timely resolution of issues. Assist CTMs in site activation activities and provide ongoing site management support. Collaborate with cross-functional teams (Data Management, Medical, Regulatory, Quality) to maintain high-quality trial conduct. Identify and escalate protocol deviations, data integrity issues, and safety concerns. Maintain study files and documentation, ensuring compliance with SOPs and trial master file (TMF) requirements. Support investigators and site staff with training and guidance on study procedures. Qualifications Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related field (advanced degree a plus). 3+ years of clinical research experience, including site monitoring responsibilities. Strong knowledge of ICH-GCP, FDA regulations, and international trial standards. Excellent organizational, communication, and problem-solving skills. Ability to manage multiple priorities and work independently as well as in a team. Willingness to travel as needed for monitoring visits (up to 50-75%). Preferred Experience Previous experience in CNS or rare disease clinical trials. Strong understanding of GCP, FDA, and global trial regulations. Familiarity with registrational trial requirements. Praxis Values Patients First Scientific Rigor Integrity Collaboration Urgency with Purpose Accountability The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You'll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions. Compensation & Benefits At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive. This includes 99% of the premium paid for medical, dental and vision plans. We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future? We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP. We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns. Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring. We aim high, collaborate hard, and produce results. Let's achieve the impossible together! To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below. Final salary range may be modified commensurate with job level, education, and experience. Annualized Base Salary$103,000-$122,000 USD Company Overview Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members. Diversity, Equity & Inclusion Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws. Attention: Job Scam Alert Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to ***************************. Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency.

At SpyGlass Pharma, we are focused on improving and preserving the vision of patients suffering from chronic eye conditions, while minimizing the impact on their daily lives. We aim to achieve this by developing cutting-edge long-term drug delivery products to address common causes of blindness and getting these products to the patients that need them. We have built a team of driven professionals with diverse expertise in ophthalmic products and drug delivery. Our accomplished scientists and engineers work alongside a seasoned leadership team with extensive experience in ophthalmology and a history of commercial success. Our unifying mantra, “We create for patients” doesn't just live on our walls but drives our decision making as we build the company, creating the products, processes and culture that make it happen. This team has delivered a solid foundation of development and clinical data, enabling over $200 million in funding to date with several top-tier venture partners. We are building confidence in the performance of our lead product going into Phase 3 clinical trials. Summary: The Clinical Research Associate (CRA) will join our Clinical Operations team in a hands-on role supporting the planning, execution, and monitoring of clinical trials. We are hiring across a range of experience levels, and the title and scope of responsibilities may be adjusted based on background and expertise. This role is integral to the successful execution of our clinical trials, serving as a primary point of contact for clinical sites and supporting patient-centered study conduct. The CRA will conduct monitoring visits, build strong relationships with investigators and site staff, and help ensure studies are executed with quality, consistency, and regulatory compliance across all phases of the trial. Please note: This is a U.S. based, remote position that requires regular travel to clinical trial sites across the country (up to 70%). Applicants must be currently authorized to work in the United States and comfortable with a travel-based schedule. Essential Duties and Responsibilities: Conduct site monitoring visits (initiation, routine, and close-out) to ensure compliance with the clinical protocol, GCP, and regulatory requirements. Assist in the preparation and review of essential trial documents, such as informed consent forms, case report forms, and investigator brochures. Collaborate with site staff to ensure proper documentation, timely data entry, and resolution of data queries. Assist in the identification, selection, and training of investigative sites. Maintain accurate and complete study files and records in accordance with GCP and company SOPs. Monitor study progress to ensure timelines and quality standards are met. Report site activities and findings to the Clinical Study Manager and escalate issues as necessary. Support regulatory submissions by preparing clinical trial applications and maintaining relevant documentation. Work collaboratively with cross-functional teams, including Regulatory Affairs, Quality Assurance, and Project Management, to achieve study objectives. Qualifications Required for Position: Bachelor's degree in life sciences, nursing, or a related field. Minimum of 4 years of experience in clinical affairs within the pharmaceutical or medical device industry, with a preference on drug and drug/device combination products. Knowledge of GCP, FDA/ICH guidelines, and clinical trial monitoring practices. Strong organizational and problem-solving skills. Excellent communication and interpersonal skills, with the ability to build strong relationships with investigative sites and internal teams. Proficiency in Microsoft Office and electronic data capture (EDC) systems. Ability to travel up to 50-75% domestically, as required. Why SpyGlass Pharma? We are offering a range of $90,000 - $110,000, based on experience and qualifications, along with an Annual Bonus opportunity. Share in our success with stock options, giving you a stake in the company's future. Comprehensive health, dental, and vision insurance plans to keep you and your family healthy and happy, with a variety of plan and coverage options. Generous paid time off, including holidays, vacation days, and personal leave. SpyGlass Pharma is an Equal Opportunity Employer and participates in E-Verify. SpyGlass Pharma takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status. SpyGlass Pharma is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to *********************** and let us know the nature of your request and your contact information.

How will you make an impact? Responsible for assessing the study capabilities of potential study sites, training, on-site monitoring, closure, and management of sites participating in clinical research studies sponsored by Glaukos. The SR. Clinical Research Associate (CRA) is responsible for maintaining data integrity and monitoring study conduct in accordance with regulations and the study protocol at the site level. What will you do? CLINICAL SITE MONITORING Travel to investigative sites to conduct site qualification, initiation, interim monitoring, and close-out visits Assist with selection of potential investigators Conduct initial and ongoing site training throughout the course of the study Verify informed consent process is properly followed Evaluate investigator compliance with the study protocol and applicable regulations Verify sites are collecting all required source data per protocol, accurately completing Case Report Forms, and resolving all data queries Review the regulatory binder and essential documents at the site and verify all documents are appropriately filed Verify and reconcile site's essential documents against the trial master file as required Oversee and conduct monitoring activities, including remote monitoring when applicable Verify investigational product is properly stored, dispensed, returned, and that accountability of the product and masking requirements are maintained throughout the study CLINICAL SITE MANAGEMENT Lead/manage assigned sites through regular contact with investigators and site staff to monitor progress, answer questions, and provide guidance during the course of the clinical study Critically review and analyze site activities through frequent visits and contacts to monitor study sites and performance Build relationships with the Investigators and site staff to enhance productivity, as well as collaborate with study management on protocol discrepancies, improving efficiency, and monitoring data integrity Manage the progress of assigned studies by tracking subject enrollment, data collection, CRF completion, source data verification, data query generation and resolution, and investigational product accountability Monitor subject safety and address protocol deviations, data quality issues, drug accountability, and identify process improvements for assigned sites. Create and maintain appropriate documentation (e.g., visit reports/letters) Works independently with seldom supervision Mentor/train new CRAs Conduct peer to peer review visits Provide FDA inspection support Maintain strong productive relationships with study investigators, site staff, and study management personnel, including assessment and resolution of existing relationship issues Participate in the development of source document templates, CRFs, CRF completion guidelines, monitoring plans, etc. Executes department projects How will you get here? Minimum of 4 years' work experience as a CRA; 8 years direct clinical research experience Bachelor's degree in biological science, nursing, or other related discipline preferred, or direct work experience as detailed below. Experience in the medical device and pharmaceutical industry is preferred, and ophthalmology experience is strongly preferred for all levels Knowledge and understanding of Good Clinical Practices (ICH E6 R2) Knowledge and understanding of FDA's Code of Federal Regulations applicable to conducting clinical research studies Must have proficient computer skills and experience with Microsoft Office Must be willing and able to travel approximately 75-80%, including overnight, domestic and international Must have Self-directed behavior Ideally will be located in Western US #GKOSUS Minimum of 4 years' work experience as a CRA; 8 years direct clinical research experience Bachelor's degree in biological science, nursing, or other related discipline preferred, or direct work experience as detailed below. Experience in the medical device and pharmaceutical industry is preferred, and ophthalmology experience is strongly preferred for all levels Knowledge and understanding of Good Clinical Practices (ICH E6 R2) Knowledge and understanding of FDA's Code of Federal Regulations applicable to conducting clinical research studies Must have proficient computer skills and experience with Microsoft Office Must be willing and able to travel approximately 75-80%, including overnight, domestic and international Must have Self-directed behavior

As an innovative research institute, Alcedis provides clinical research services supported by a modern information technology infrastructure. Our flat hierarchies and collaborative culture foster a flexible, dynamic, and team-oriented working environment. We are seeking a Clinical Research Associate / Clinical Monitor / Site Manager (home-based) to join our Clinical Operations team. In this role, you will play a key part in site monitoring activities and in ensuring protocol compliance and overall study quality at investigational sites. You will independently monitor U.S. study sites and may also support Canadian sites as needed, working in close and regular contact with the responsible Project Manager or Lead Clinical Research Associate at Alcedis in Germany or the United States. We are looking for candidates based in the Eastern United States, ideally in or near major metropolitan areas such as Boston, New York City, Philadelphia, Pittsburgh, Columbus, Detroit, Atlanta, or Raleigh-Durham. Candidates located in other parts of the Eastern U.S. will also be considered. Provide on-site and remote support in the organization and conduct of the study and supervision of the investigators Prepare, conduct and follow-up of site initiation, monitoring and close-out visits (remote or on-site) Assess study progress at assigned sites according to predefined guidelines and ensure complete, accurate documentation Validate study data collected by investigators (source data verification) Prepare monitoring visit reports and related documentation Evaluate study sites for compliance with applicable regulations, guidelines, and study protocols Collaborate closely with data manager and project manager Generate, track, and resolve queries Train investigators and study coordinators in the use of EDC systems Conduct feasibility assessments for new study sites and upcoming projects Support and coordinate study sites, including assistance with documentation and escalation of site-level issues Prepare documents for submission to regulatory authorities and ethics committees From day one, we expect you to bring: Bachelor's degree in natural or life sciences or a comparable qualification (e.g., Study Nurse certification) At least 3 years of hands-on monitoring experience in GCP-regulated interventional clinical trials Working knowledge of data privacy and protection regulations relevant to clinical trials, including HIPAA (U.S.) and FDA 21 CFR Part 11, familiarity with GDPR (EU) is a plus Ability to work independently, plan proactively, and execute tasks with foresight and attention to detail Strong communication and organizational skills Collaborative, team-oriented mindset Excellent written and spoken English Willingness to travel and flexibility to support study needs Annual salary: $75,000 - $95,000 DOE 15 days of paid vacation per year 6 paid sick days per year Health, dental and vision insurance for you and your dependents Employee life insurance Health Savings Account (HSA) 401(K) You'll work in a future-oriented and secure working environment A forward-looking, growth-oriented work environment Exciting and challenging projects that make an impact Flat organizational structure with an open and collaborative culture A dedicated, successful, and supportive team environment Varied work with the autonomy to take ownership of your projects Flexible working hours to support work-life balance We welcome applicants of all backgrounds and do not discriminate based on race, ethnicity, gender, sexual orientation, disability, age, religion, or any other protected characteristic. Come join us! Take the next step and apply today - we can't wait to meet you! To apply, submit your resume, a short cover letter, and a Clinical Trial Experience Table detailing your study experience (type, phase, sites, role) directly through the link or alternatively via our careers page: Career | Alcedis For more information about our company, please visit our website at Alcedis | Digital Clinical Trials

Where You'll Work Hello humankindness Located conveniently in the heart of Phoenix, Arizona,St. Joseph's Hospital and Medical Center is a 571-bed, not-for-profit hospital that provides a wide range of health, social and support services. Founded in 1895 by the Sisters of Mercy, St. Joseph's was the first hospital in the Phoenix area. More than 125 years later, St. Joseph's remains dedicated to its mission of caring for the poor and underserved. We are extremely proud to be a nationally recognized center for quality quaternary care, medical education and research. St. Joseph's includes the internationally renowned Barrow Neurological Institute, Norton Thoracic Institute, Cancer Center at St. Joseph's, Ivy Brain Tumor Center, and St. Joseph's Level I Trauma Center (which is verified by the American College of Surgeons). The hospital is also a respected center for high-risk obstetrics, neuro-rehabilitation, orthopedics, and other medical services. St. Joseph's is considered a sought-after destination hospital for treating the most complex cases from throughout the world. Every day, approximately 20 percent of the hospital's patients have traveled from outside of Arizona and the United States to seek treatment at St. Joseph's. U.S News & World Report routinely ranks St. Joseph's among the top hospitals in the United States for neurology and neurosurgery. In addition, St. Joseph's boasts the Creighton University School of Medicine at St. Joseph's, and a strategic alliance with Phoenix Children's Hospital. St. Joseph's is consistently named an outstanding place to work and one of Arizona's healthiest employers. Come grow your career with one of Arizona's Most Admired Companies. Look for us on Facebookand follow us on Twitter. For the health of our community ... we are proud to be a tobacco-free campus. Job Summary and Responsibilities Join BNI CRO as a Clinical Research Associate (CRA) and collaborate with dedicated research sites contributing to rare neurological disease research. Make a significant impact in the scientific community alongside a dedicated team of CRAs. This remote position involves up to 75% travel across the US primarily focusing on regional site assignments. Your role will encompass important site monitoring and management activities including SIVs Interim and Remote Monitoring Visits as well as Final Onsite and Closeout Visits. Advance your career and acquire valuable skills at Barrow Neurological Institute all while contributing to groundbreaking clinical research! Experienced and entry level positions available! To be successful in this role, you will bring relevant clinical research experience and a strong understanding of regulatory guidelines. Your exceptional organizational skills, attention to detail, and ability to communicate effectively will be crucial in this dynamic field. Responsible for all aspects of clinical monitoring, site management, and trial administration as prescribed in the monitoring plan and as instructed by program leadership. Employee is responsible for working with sites during study start up, including assessing site feasibility as required, provide ongoing training and site initiation visits, conducting remote monitoring, and approx. 25-30 interim onsite and closeout field monitoring visits located throughout the US and Canada. During each monitoring visit the CRA is responsible for the evaluation of clinical data documentation, regulatory document review, monitor safety and conduct of study to ensure investigator and site compliance with study protocol, overall clinical objectives, FDA regulations, ICH/GCP guidelines, institutional/ CRO SOPs, and HIPAA guidelines. The CRA is expected to work cooperatively with study team and operations management to proactively drive project success. Completes preparation and submission of accurate and timely monitoring reports, and other requested deliverables, as outlined in the Study Monitoring Plan or as requested by program leadership. Effective long-term planning/scheduling of remote and on-site monitoring visits in accordance with the Study Monitoring Plan or as requested by program leadership. Perform Lead Study Monitoring activities as assigned, including acting as the primary liaison between BNI CRO and the Clinical Study Sponsor to ensure BNI CRO provides quality monitoring and site management customer services. The Lead Study Monitor will be responsible for the timely review of all monitoring deliverables, conduct co-monitoring visits and mentorship of CRA team members. Participates in the quality control process for assigned monitoring activities, and makes contributions to improve and adapt quality control procedures, including the development of internal corrective and preventative action plans if needed, and align service goals with internal and external client expectations Proactively participate in program development. This includes making contributions to the overall quality improvement of clinical monitoring services, as well as actively collaborating with program leadership to expand and grow the CRO's professional portfolio. Job Requirements Bachelors Other or equivalent combination of education and experience or its international equivalent in clinical, science, or health related field from an accredited institution 2-3 years of clinical research experience required or a combination of equivalent experience and education Experience with Microsoft Office Suite Systems Preferred Registered Nurse: AZ, or Physical Therapist: AZ, or Occupational Therapist: AZ, or Clinical Research Associate, or Certified Clinical Research Professional

Job Summary and Responsibilities Join BNI CRO as a Clinical Research Associate (CRA) and collaborate with dedicated research sites contributing to rare neurological disease research. Make a significant impact in the scientific community alongside a dedicated team of CRAs. This remote position involves up to 75% travel across the US primarily focusing on regional site assignments. Your role will encompass important site monitoring and management activities including SIVs Interim and Remote Monitoring Visits as well as Final Onsite and Closeout Visits. Advance your career and acquire valuable skills at Barrow Neurological Institute all while contributing to groundbreaking clinical research! Experienced and entry level positions available! To be successful in this role, you will bring relevant clinical research experience and a strong understanding of regulatory guidelines. Your exceptional organizational skills, attention to detail, and ability to communicate effectively will be crucial in this dynamic field. * Responsible for all aspects of clinical monitoring, site management, and trial administration as prescribed in the monitoring plan and as instructed by program leadership. Employee is responsible for working with sites during study start up, including assessing site feasibility as required, provide ongoing training and site initiation visits, conducting remote monitoring, and approx. 25-30 interim onsite and closeout field monitoring visits located throughout the US and Canada. During each monitoring visit the CRA is responsible for the evaluation of clinical data documentation, regulatory document review, monitor safety and conduct of study to ensure investigator and site compliance with study protocol, overall clinical objectives, FDA regulations, ICH/GCP guidelines, institutional/ CRO SOPs, and HIPAA guidelines. The CRA is expected to work cooperatively with study team and operations management to proactively drive project success. * Completes preparation and submission of accurate and timely monitoring reports, and other requested deliverables, as outlined in the Study Monitoring Plan or as requested by program leadership. * Effective long-term planning/scheduling of remote and on-site monitoring visits in accordance with the Study Monitoring Plan or as requested by program leadership. * Perform Lead Study Monitoring activities as assigned, including acting as the primary liaison between BNI CRO and the Clinical Study Sponsor to ensure BNI CRO provides quality monitoring and site management customer services. The Lead Study Monitor will be responsible for the timely review of all monitoring deliverables, conduct co-monitoring visits and mentorship of CRA team members. * Participates in the quality control process for assigned monitoring activities, and makes contributions to improve and adapt quality control procedures, including the development of internal corrective and preventative action plans if needed, and align service goals with internal and external client expectations * Proactively participate in program development. This includes making contributions to the overall quality improvement of clinical monitoring services, as well as actively collaborating with program leadership to expand and grow the CRO's professional portfolio. Job Requirements Required * Bachelors Other or equivalent combination of education and experience or its international equivalent in clinical, science, or health related field from an accredited institution * 2-3 years of clinical research experience required or a combination of equivalent experience and education * Experience with Microsoft Office Suite Systems Preferred * Registered Nurse: AZ, or * Physical Therapist: AZ, or * Occupational Therapist: AZ, or * Clinical Research Associate, or * Certified Clinical Research Professional Where You'll Work Hello humankindness Located conveniently in the heart of Phoenix, Arizona,St. Joseph's Hospital and Medical Center is a 571-bed, not-for-profit hospital that provides a wide range of health, social and support services. Founded in 1895 by the Sisters of Mercy, St. Joseph's was the first hospital in the Phoenix area. More than 125 years later, St. Joseph's remains dedicated to its mission of caring for the poor and underserved. We are extremely proud to be a nationally recognized center for quality quaternary care, medical education and research. St. Joseph's includes the internationally renowned Barrow Neurological Institute, Norton Thoracic Institute, Cancer Center at St. Joseph's, Ivy Brain Tumor Center, and St. Joseph's Level I Trauma Center (which is verified by the American College of Surgeons). The hospital is also a respected center for high-risk obstetrics, neuro-rehabilitation, orthopedics, and other medical services. St. Joseph's is considered a sought-after destination hospital for treating the most complex cases from throughout the world. Every day, approximately 20 percent of the hospital's patients have traveled from outside of Arizona and the United States to seek treatment at St. Joseph's. U.S News & World Report routinely ranks St. Joseph's among the top hospitals in the United States for neurology and neurosurgery. In addition, St. Joseph's boasts the Creighton University School of Medicine at St. Joseph's, and a strategic alliance with Phoenix Children's Hospital. St. Joseph's is consistently named an outstanding place to work and one of Arizona's healthiest employers. Come grow your career with one of Arizona's Most Admired Companies. Look for us on Facebookand follow us on Twitter. For the health of our community ... we are proud to be a tobacco-free campus.

Remote Clinical Research Associate III needs 2 years of site management and field monitoring experience Remote Clinical Research Associate III requires: Work Schedule: M-F 7:00 am -3:30 pm or 8:00 am to 4:30 pm EST Qualifications: BS/BA Minimum of 2 years of site management and field monitoring experience Knowledge of applicable standards and regulations for clinical trials Proven oral and written communication skills Proven planning skills; ability to create and track detailed project plans Proven interpersonal, leadership, organizational and effective time management skills Demonstrated experience in computer skills to include Microsoft Word, Excel and basic templates Ability to work independently and within a cross-functional team environment to identify and escalate site/monitoring related activities issues to the management team in a timely fashion Preferred: Experience in womens fertility VD Study Experience Medidata RAVE system Remote Clinical Research Associate III duties: Performs Site initiation, interim & close out monitoring visits Verifies required clinical data entered in the electronic case report form (eCRF) is accurate and complete Manages site communication and escalates to leadership in a timely fashion when needed Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines 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 Site support throughout the study lifecycle from site identification through close-out Attends and participates in internal meetings

ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases. • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California. • Work with a collaborative team with the ability to work across different areas of the company. • Ability to join a growing company with professional development opportunities. Position Summary Responsible for clinical trials administration to ensure the most effective and efficient conduct of clinical research studies. Essential Functions Support the Clinical Operations teams in the completion of all required tasks to meet trial, departmental and project goals. Maintain, share and champion a thorough knowledge ICH GCP, appropriate regulations, relevant SOPs and internal tracking systems. Collaborate with Clinical Trials Manager (CTM) and Clinical Research Associates (CRAs) to resolve clinical trial documentation issues. Establish, organize and maintain clinical study documentation (e.g. Trial Master File, study level and site level documents, etc.) including preparation for internal/external audits, final reconciliation and archival. Review clinical trial documents to determine compliance with Good Documentation Practices (GDocP), file and track study documents. Determine materials and other resources needed to conduct the clinical trial and manage their acquisition and distribution. Audit Investigator/Site invoices for accuracy, and reconcile invoices against the case report forms (CRFs) and budget for payment submission. Gather central IRB report information, submit the report to the central IRB portal and track the IRB submissions from beginning through approval. Facilitate the collection and review of required study documents during site start-up Contact clinical sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements, etc.) Route study documents to the appropriate personnel for validated digital signatures Submit purchase requisitions to Enterprise Resource Planning (ERP) System for Clinical Operations functional groups as needed. Request invoice approval from internal supplier designee. Participate in clinical operations safety reporting activities; distribute, file and track safety reports and IRB submissions. Facilitate clinical operations team meeting coordination, agenda preparation and meeting minutes preparation Performs ad-hoc and cross-functional duties and/or projects as assigned to support business needs and provide developmental opportunities. Education & Experience Bachelor's degree with 0-2 years of clinical research experience required; or High school diploma with 5+ years of clinical research experience required Knowledge, Skills, & Abilities Proficiency in MS Word, Excel, PowerPoint, Outlook, Adobe Excellent written/oral communication skills as well as strong organizational and multi-tasking skills Maintain corporate confidentiality at all times. Strong oral and written communication skills Detail oriented, with solid organization and time management skills Working knowledge of good documentation practices (GDP) Working Environment / Physical Environment This position works on site in El Segundo, CA or remotely depending on the candidate's geographic location Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval. This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. National Market (all markets unless identified as Premium) $70,000 (entry-level qualifications) to $77,000 (highly experienced) annually Premium Market (Premium markets include Los Angeles, San Diego, San Francisco, New York City, Chicago, & Boston) $73,800 (entry-level qualifications) to $81,000 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options • Health and Financial Wellness Programs • Employer Assistance Program (EAP) • Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability • Healthcare and Dependent Care Flexible Spending Accounts • 401(k) Retirement Plan with Company Match • 529 Education Savings Program • Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks • Paid Time Off (PTO) includes: 11 Holidays • Exempt Employees are eligible for Unlimited PTO • Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day • We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

BrainChild Bio, Inc. is seeking a motivated and detail driven Clinical Research Associate (CRA) to support the execution and monitoring of our CAR T clinical trials. This role will contribute directly to the quality, integrity, and success of our clinical programs as we advance our autologous cell therapy candidates. The CRA will be a member of the Clinical Operations team and collaborate closely with our internal Patient Operations team, Contract Research Organization (CRO) partners, vendors, and clinical trial sites to ensure study conduct is compliant with Good Clinical Practice (GCP), applicable regulations, and internal procedures. This is an exciting opportunity to join a growing early-stage biotech where you will have meaningful impact, broad exposure, and the ability to help build scalable clinical processes from the ground up. PLease see the Key Responsibilities for this role below.Site Management and Monitoring Conduct remote and on-site monitoring visits in accordance with the monitoring plan, including site qualification, site initiation, routine monitoring, and close out activities Perform source data review (SDR) and verification (SDV) to ensure data accuracy, completeness, and alignment with our clinical trial protocols Ensure sites enter clinical data into applicable study systems within required timelines and support ongoing data cleaning activities, including query resolution, interim data reviews, and database lock readiness. Assess site compliance with GCP, protocol requirements, institutional policies, and regulatory expectations Identify, document, and track protocol deviations, safety events/trends (AEs, SAEs, SUSARs, etc.), and data quality issues, escalating concerns as needed Evaluate site performance, enrollment progress, and readiness for key study milestones Support site training on protocol requirements, investigational product handling, and study procedures Complete monitoring visit reports within required timelines, issue timely follow up correspondence to clinical sites, and ensure resolution of outstanding action items and findings Study Conduct Support Assist Clinical Operations team with study level oversight of assigned sites Support study conduct across multiple site functions, including inpatient/outpatient care teams, apheresis centers, cell processing laboratories, local laboratories, and radiology departments, to ensure coordinated execution of protocol requirements. As needed, support development, revision, and execution of study tools, checklists, training materials, and tracking documents Provide ongoing feedback on opportunities to streamline monitoring processes, reduce redundancy, and improve operational efficiency at the site level. Collaborate with Clinical Operations and Patient Operations teams to resolve operational issues that impact site performance, data integrity, and patient safety Review essential documents for completeness and assist with TMF quality and inspection readiness Contribute to risk identification and mitigation activities related to site operations Cross Functional Collaboration Partner effectively with internal and external teams including Clinical Operations, Patient Operations, Clinical Development, Safety, Data Management, and Quality Engage with external stakeholders including CRO partners, vendors, and site staff to ensure smooth trial execution Provide timely updates on site status, risks, and action item resolution Required Qualifications: Bachelor's degree in a scientific or health-related field Minimum 3 years of independent clinical trial monitoring experience within a CRO or sponsor environment, including experience monitoring Phase 2-3 clinical trials Current Good Clinical Practice (GCP) certification Strong understanding of ICH E6, FDA regulations, and clinical trial conduct Familiarity with common clinical trial systems including Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), and vendor portals Excellent communication, organizational, and time management skills Willingness and ability to travel up to 75% for on-site monitoring visits (domestic travel; occasional short notice travel may be required) Must be eligible to work in the United States Preferred Qualifications: Prior oncology monitoring experience; pediatric or neuro-oncology exposure is a plus Experience in rare disease studies or high acuity patient populations Background in cell therapy or gene therapy trials, especially autologous programs Experience with risk-based monitoring (RBM) and targeted SDV models Familiarity with complex studies that include central imaging, chain of custody workflows, and/or time sensitive procedures Experience working in a fast-paced environment Key Behaviors and Skills: Attention to Detail: Delivers high quality work with careful review of data, documentation, and site level activities Independent and Adaptive: Ability to work independently, collaborate effectively across functions, and remain comfortable navigating ambiguity as priorities or processes evolve Proactive Problem-Solving: Identifies risks early and takes ownership and thoughtful action to resolve site or operational challenges Relationship Building: Demonstrates strong interpersonal skills with the ability to build trust, communicate clearly, and work effectively with site teams, internal partners, and external collaborators

We are hiring PhD candidates at Medpace! The Clinical Research Associate position at Medpace offers the unique opportunity to have an exciting career in the research of drug and medical device development while making a difference in the lives of those around them. For those with a Life Science background who want to explore the research field, travel the US, and be part of a team bringing pharmaceutical and medical devices to market - this could be the right opportunity for you! Positions are office based in our Irving, TX. MEDPACE CRA TRAINING PROGRAM (PACE) No research experience is needed as Medpace provides comprehensive initial and ongoing training, unmatched by other CROs. Through our PACE. Training Program, you will join other Professionals Achieving CRA Excellence: PACE provides the platform to effectively and confidently carry out your duties, enhance your current abilities and ultimately help you become a high-functioning independent Medpace CRA. PACE will prepare you by developing your CRA skills through interactive discussions and hands on job-related exercises and practicums. To supplement your in-house and field-based training you may also participate in other clinical research departmental core rotations, learning other aspects of the drug/device development and approval process. WHY BECOME A CRA This role takes you on a journey through travel and excitement which will allow you to make a difference on a large scale through the enhancement of pharmaceuticals and medical devices. The CRA position provides many other distinctive advantages including: * Dynamic working environment, with varying responsibilities day-to-day * Expansive experience in multiple therapeutic areas * Work within a team of therapeutic and regulatory experts * Defined CRA promotion and growth ladder with potential for mentoring and management advancements * Competitive pay and many additional perks unmatched by other CROs (SEE BELOW). WE OFFER THE FOLLOWING Competitive travel bonus; Equity/Stock Option program; Training completion and retention bonus; Annual merit increases; 401K matching; The opportunity to work from home; Flexible work hours across days within a week; Retain airline reward miles and hotel reward points; Home office furniture allowance, laptop, mobile phone with hotspot for internet access anywhere; In-house travel agents, reimbursement for airline club, TSA pre-check; Opportunity for leadership positions - Lead CRA, CRA Manager, Clinical Trial Manager, Training and Development Manager, and many more; CRA training program (PACE); Ongoing therapeutic training by our in-house physicians who are medical and regulatory experts; In-house administrative support for all levels of CRAs; and Opportunities to work with international team of CRAs. Responsibilities * Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol; * Communication with the medical site staff including coordinators, clinical research physicians, and their site staff; * Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff; * Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements; * Verification that the investigator is enrolling only eligible subjects; * Regulatory document review; * Medical device and/or investigational product/drug accountability and inventory; * Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol; * Assess the clinical research site's patient recruitment and retention success and offering suggestions for improvement; and * Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance. Qualifications * Must have a minimum of a Bachelor's degree in a health or science related field; PhD preferred * Ability to travel 60-70% to locations nationwide is required, or less if remote/virtual visits required; * Must maintain a valid driver's license and the ability to drive to monitoring sites; * Minimum 1 year healthcare-related work experience preferred; * Proficient knowledge of Microsoft Office; * Strong communication and presentation skills; and * Must be detail-oriented and efficient in time management. Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Dallas Perks * Dallas Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with nonprofit organizations * Structured career paths with opportunities for professional growth * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Free on-site parking * Outdoor seating and workspace Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Clinical Trials Contracts Associate I (Remote) Rate: $25-$30/hour | Fully Remote We are seeking a Clinical Trials Contracts Associate I to join our team and support the contracting process for clinical trials. This role is fully remote and involves both frontline and backend administrative duties to ensure smooth and compliant contract operations. Key Responsibilities * Contract Administration: Review, process, and maintain clinical trial contracts and related documentation. * Collaboration: Work closely with clinical research teams, sponsors, and site staff to facilitate negotiations. * Communication: Serve as a point of contact for stakeholders, providing updates on contract status. * Process Improvement: Identify opportunities to streamline workflows and enhance efficiency. * Contract Reconciliation: Research discrepancies, track pending agreements, and support execution steps. Qualifications * Education: Bachelor's degree in business, healthcare, or life sciences. * Experience: 1-3 years in contract administration, clinical trials, or related field preferred. * Skills: Strong attention to detail, organizational ability, and excellent verbal/written communication. * Problem-Solving: Ability to identify issues and propose solutions in a fast-paced environment. Why Join Us This role offers the opportunity to contribute to the success of clinical research initiatives while working remotely. You'll play a vital part in ensuring contractual obligations are met and supporting teams that advance healthcare innovation. Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico. Apex uses a virtual recruiter as part of the application process. Click here for more details. Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Apex team member can provide. Employee Type: Contract Remote: Yes Location: Memphis, TN, US Job Type: Scientific and Clinical Date Posted: December 11, 2025 Pay Range: $25 - $30 per hour Similar Jobs * Sr. Clinical Study Associate III * Contracts Manager * Associate Instock Manager - Associate Instock Manager I * Director of Clinical Solutions * Development Associate

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. **What will you be doing?** + Works on multiple trials within the Cross Therapeutic areas - Start up focus + Collaborate with country operations teams to identify, select, and activate clinical trial sites in accordance with project timelines and requirements. + Perform Site Qualification Visits (SQVs) to assess the eligibility of sites for participation in specific clinical studies. + Build strong relationships with site personnel to facilitate a smooth onboarding process. + Ensure that all activities adhere to ICH-GCP guidelines, local regulatory standards, and internal Standard Operating Procedures (SOPs). + Coordinate with the country operations team to collect essential documents (such as regulatory approvals and contracts) to enable timely site activation. + Act as the main point of contact for sites, study teams, and external stakeholders throughout the start-up process. + Work closely with the country operations team to manage investigator contracts, regulatory documents, and site-specific start-up activities. + Provide regular status updates to both internal and external stakeholders, ensuring alignment with important project milestones. + Monitor, report on, and analyze key performance indicators (KPIs) related to site selection and start-up timelines. + Proactively identify and address any issues that may delay study initiation or affect trial deliverables. + Maintain precise documentation to ensure readiness for inspections. + Support sites during the activation phase until they achieve "Green Light" status for site opening. + Facilitate coordination with site staff to ensure all pre-study requirements, including contracts, budgets, and essential documentation, are met. + Possibly assist in audit and inspection preparations to guarantee compliance with regulatory and ethical standards. **What do you need to have?** + Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences + Must be located in Columbus, OH area; near a major airport. + Must have 2 -3 years' experience in monitoring pharmaceutical industry clinical trials + Have a minimum of 1-3 years' experience monitoring cross therapeutic area clinical trials + Knowledge of several therapeutic areas + Analytical/risk-based monitoring experience is an asset + Ability to actively drive patient recruitment strategies at assigned sites + Ability to partner closely with investigator and site staff to meet all of our study timelines + Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting). + Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently. + Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements. + To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status. **What ICON can offer you:** Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: + Various annual leave entitlements + A range of health insurance offerings to suit you and your family's needs. + Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. + Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. + Life assurance + Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site (************************************* to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (****************************************************** Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here (****************************************************** to apply