Clinical biochemist jobs near me - 61 jobs

Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting α4β7, TL1A, and IL-23. Role Summary: As a Director, Clinical Scientist at Spyre Therapeutics, you will play a key role in designing, executing, and interpreting clinical trials that support development of our novel antibody-based therapies. You will collaborate across functions (clinical operations, regulatory, translational science, biomarker teams) to ensure robust study designs, high-quality data generation and efficient progression of programs. You will bring scientific and operational expertise and act as a bridge between internal teams, external investigators and CRO partners. Key Responsibilities: Lead/Contribute to study design and amendments in collaboration with internal and external stakeholders. Collaborate with Clinical Development, regulatory and other internal partners/stakeholders with authoring and submission of protocols, protocol amendments, regulatory filings, and other regulatory documentation. Collaborate with clinical operations, data management and CRO to develop and implement the overall data quality plan and lead internal medical data review and safety trend analysis on one or more studies/programs. Work closely with translational science to integrate mechanistic biomarkers, PK/PD modelling, patient stratification, and exploratory endpoints. Provide scientific oversight and decision-making support during trial execution: site selection, study start-up, monitoring of key trial metrics, risk-based quality oversight and study close-out. Interpret clinical data (safety, efficacy, biomarker, PK/PD) and present findings internally and externally (investigators, scientific meetings, publications). Write and/or review abstracts, posters, content for scientific meetings, conferences, other events and presentations, and other publicly distributed materials and coordinate further reviews with internal partners and stakeholders. Write clinical science sections of meeting packages and assist in the development and review of other clinical documentation required for regulatory submissions and other regulatory processes Collaborate with regulatory affairs to ensure study designs meet regulatory standards (e.g., FDA/ICH, GCP) and support regulatory submissions and interactions. Develop and maintain clinical trial documentation (protocols, clinical study reports, investigator brochures, informed-consent forms, etc.). Monitor the competitive and scientific landscape in therapeutics space and contribute to strategic positioning of Spyre's pipeline programs. Additional duties as assigned. Ideal Candidate: PhD, MD, PharmD or equivalent in life sciences, clinical pharmacology, immunology or related discipline is preferred; alternatively, MSc plus significant industry experience. 5+ years of clinical development experience in the biotech/pharma industry, ideally with at least 2 years in immunology, gastroenterology/IBD or immune-mediated disease area. Demonstrated experience designing and executing clinical trials IBD or other I&I therapeutic area. Strong understanding of clinical biomarkers, PK/PD modelling, patient stratification and immunologic endpoints. Familiarity with regulatory requirements (FDA/ICH guidelines, GCP) and Good Clinical Practice. Proven ability to work cross-functionally in a matrix organization (clinical operations, translational science, regulatory, QA). Excellent written and verbal communication skills, presentation and interpersonal skills; ability to influence diverse stakeholders. Comfortable working in a fast-paced, dynamic environment with ambiguity, and willing to wear multiple hats. What We Offer: Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly. Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits. Unlimited PTO Two, one-week company-wide shutdowns each Commitment to provide professional development opportunities. Remote working environment with frequent in-person meetings to address complex problems and build relationships. The expected salary range offer for this role is $215,000 to $230,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location. As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients. Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain “@spyre.com.” We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email. Please also be aware that all job postings will be listed on our website at spyre.com/careers/.

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

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities Contributes to draft protocol review, scale selection, and may contribute to full protocol design and development, offering clinical expertise and partnering with customers on design and specific text Participates in the development of eligibility review, endpoint review, rater qualification, training, and certification plans, documents, reports, etc. Contributes to scales management and translations deliverables Reviews case report forms and electronic clinical outcome assessment (eCOA) pages to ensure consistency between the database and original scale, and provides feedback to team Works with vendors and/or Company staff involved in training regarding the use of clinical scales, diagnostic instruments, or provision of (eCOA) technology Provides internal Syneos Health and site staff training on therapeutic indications, scale administration, and scale scoring Performs clinical and statistical analysis of rating scale, and/or endpoint data 8. Works with Investigators and their staff in order to ensure that they understand the specifics of the protocol, particularly surrounding entry criteria, diagnostic scales, and clinical scales In collaboration with Medical Directors, reviews screening data and leads case reviews to determine whether subjects are appropriate for entry into a trial Provides professional, collaborative, and scientific feedback to investigators Continuously improves clinical and scientific expertise through research and publication. Maintains familiarity with current relevant literature Provides scientific and clinical expertise to Sponsors, study teams, and the Company. May serve as indication subject matter expert May support business development activities by providing scientific proposal text, protocol considerations and/or slides. May participate in bid defense meetings At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: $97,300.00 - $170,300.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. *************************** Additional Information Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

SummaryAs the Clinical Scientist - Interventional, you will be responsible for working daily in close partnership with Interventional key clinical partners as well as global and local GE HealthCare colleagues. You will be responsible for locally driving the technical and scientific design and execution of collaborative projects, evaluating early developments and generating evidence on new products while providing insights to the global modality on unaddressed clinical needs and growing trends. GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.Job DescriptionEssential Responsibilities: Support collaboration with top Interventional clinical partners, planning and executing pre- and post-market evidence generation research projects per Interventional research priorities Assist in maturing evidence portfolio (writing journal publications/summary articles, technical documents, clinical marketing/training collaterals) and identifying unique opportunities for partnership Support adoption of new technology or clinical applications through advocacy and evidence Participate in customer presentations regarding use of Interventional products for institution research purposes Closely connected with GEHC global modality clinical and research and development teams, explore unmet clinical and technical needs with external collaborators and translate to define and prioritize product development needs Support customer satisfaction through communication, observation, and escalation of site inquiries/concerns Grow technology leadership mindshare through joint scientific presentations and publications Lead and represent the global modality technical, scientific and product expertise in the US and Canada to support local clinical teams and best-in-class customer experience on new products Study new technology concepts and leverage expertise to move initiatives forward Qualifications/Requirements: PhD or Master's degree, or foreign degree equivalent, in Medical Imaging, Physics, Computer Science, Biomedical Engineering, or related field Preferred 1+ year(s) of experience in Interventional healthcare industry or clinical research Experience with imaging modalities and dose analysis Knowledge of Interventional procedures, anatomies, clinical practice Knowledge of Interventional products including IGS product line and Advantage Windows applications Excellent customer relationship management and collaboration skills Demonstrated clear thinking and problem-solving abilities, a creative mindset, and the ability to quickly grasp new ideas Self-starter, able to work independently and collaboratively with partners clinical staff, GE global engineering team and GE regional clinical teams, results oriented, able to multi-task Flexible, intellectually curious, and able to work under remote supervision with cross-functional, global teams. Able to individually lead complex projects with autonomy, rigor, drive & competence Ability to travel ( Desired Characteristics: 5 + years experience in an engineering or science field such as Biomedical Engineering, Medical Imaging, Computer Science, Applied Math or Physics Experience in a clinical environment working with clinicians/radiologists/specialists (e.g. interventional radiology or cardiology department) Demonstrated record of innovation and development. History of publications, clinical/non-clinical experiments, knowledge in statistics Programming / Image processing experience Experience with academic and/or clinical research collaborations We expect all employees to live and breathe our behaviors: to act with humility and build trust, lead with transparency, deliver with focus, and drive ownership - always with unyielding integrity. Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration, and support. While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees. We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $100,000.00-$150,000.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement. GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable). While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees. Relocation Assistance Provided: Yes

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 Management, 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 May prepare and/or review monitoring reports per SOPs 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 Develops 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 May perform data in clinical database for completeness, accuracy and performs data trending as needed May analyze and evaluate clinical data gathered during research 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 revises 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 Ensures audit preparedness May be responsible for tracking Safety Reports for assigned sites Responsible for authoring internal documents, and may author portions of clinical study reports or clinical evaluation reports May initiate device shipments to ensure that study supplies are adequate for assigned studies and accurately accounted throughout study 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 a scientific field of study, with a minimum of 2 years directly supporting clinical research 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: - *********************************************

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: - *********************************************

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 Management, 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 May prepare and/or review monitoring reports per SOPs 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 Develops 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 May perform data in clinical database for completeness, accuracy and performs data trending as needed May analyze and evaluate clinical data gathered during research 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 revises 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 Ensures audit preparedness May be responsible for tracking Safety Reports for assigned sites Responsible for authoring internal documents, and may author portions of clinical study reports or clinical evaluation reports May initiate device shipments to ensure that study supplies are adequate for assigned studies and accurately accounted throughout study 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 a scientific field of study, with a minimum of 2 years directly supporting clinical research 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: - *********************************************

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.

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.

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 The Clinical Research Associate I will participate in clinical research teams to ensure the most effective and efficient conduct of clinical research studies by providing training, protocol interpretation, document collection and review and overall clinical trial support. Essential Functions Develop, review, and update study-related training materials and documents including site initiation training slides, informed consent form templates, procedures manuals, laboratory and pharmacy manuals Interpret medical and scientific intent of assigned study protocols and study procedures, logistics, risks to research subjects and safety, data evaluation methods etc. Communicate scientific rationale for assigned studies to team members and clinical sites Serve as Subject Matter Expert for clinical sites including providing guidance on protocol interpretation and eligibility requirements Create/edit, distribute and collect site feasibility questionnaires Oversee and support collection of essential documents during study start-up Determine materials and other resources needed to conduct the clinical trial and manage their acquisition and distribution. Collect study and site metrics and maintain study trackers, as needed Conduct case report form (CRF) data review and review of source documents, work with sites to resolve data queries Communicate regularly with field Clinical Research Associates (CRAs) to provide information before and after site visits Partner with field CRAs and CTAs to resolve issues identified during site visits Work with Supply Chain to ensure sites maintain sufficient investigational product (IP) to properly conduct the trial as well as resolve IP temperature monitoring excursions and train or assist sites with corrective actions Train vendors, investigators, and study coordinators on study requirements and provide guidance on site issues Conduct clinical specimen log review, and coordinate shipment of specimens to the sponsor or contracted vendor Train sites on specimen and shipment requirements for central laboratory and serve as liaison with contracted vendors Conduct remote monitoring tasks including reconciliation of site investigational product accountability Provide data listings and compile clinical study report documents to support medical writing activities Create and/or review of slides, overheads, etc., for a project, departmental, sponsor and/or business development presentations Provide support and escalate issues to the Clinical Trial Manager (CTM) as appropriate. 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 in a clinical research, science, or health-related field with 2 years of experience in a clinical research setting; or a high school diploma with 3 years of experience in a clinical research setting required 2 years of experience as a Clinical Research Coordinator, Clinical Trial Associate or In-House Clinical Research Associate strongly preferred Knowledge, Skills, & Abilities Proficiency in MS Word, Excel, PowerPoint, Outlook, Adobe Excellent written/oral communication skills Strong organizational and multi-tasking skills Maintain corporate confidentiality at all times Ability to set priorities and independent decision making Ability to work independently as well as in teams Strong oral and written communication skills Outgoing and confident demeanor Independent thinker and persuasive communicator Detail oriented, with solid organization and time management skills Completes projects with reliability and minimal guidance Knowledge of drug development process Computer literacy: EDC, eTMF, CTMS, etc. Working knowledge of ICH E6, and the Code of Federal Regulations Working Environment / Physical Environment This position works remotely with ability to work flexible hours for various time zones Must be able to travel up to 75% of the time based on study requirement. 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. $103,900 (entry-level qualifications) to $114,300 (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.

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

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

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 medical and/or health/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! Our successful Clinical Research Associates possess various backgrounds in medical and other science-related healthcare fields. Backgrounds of individuals who have succeeded in the CRA role include: * Nursing * Dietetics * Nutrition Science * Pharmacist * Pharmaceutical/Device Sales Representative * Physical and Occupational Therapists * Biomedical/Chemical Engineer * PhD/Post-Doc * Pharm.D * Health and Wellness Education Coordinators * Public Health * Clinical Research Coordinators * Research Assistants 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; * On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward; * 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; Advanced degrees or prior clinical research experience is a plus; In-House CRA position available for those with no or minimal clinical research experience with rapid advancement; Ability to travel 60-70% to locations nationwide is required; some visits may be conducted remotely; Must maintain a valid driver's license and the ability to drive to monitoring sites; 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.

Join us in person for our clinical hiring event - where purpose meets opportunity! Meet our team, learn about open roles (clinical and hospital setting), and discover how you can make a difference in the lives of patients and our community. Whether you're experienced or just starting out, we'd love to connect. Location: 272 Hospital Road, Chillicothe, OH 45601 - Board Room Date: Thursday, March 5th, 2026 Time: 1pm-5pm