Clinical trials specialist jobs near me

Passionate about precision medicine and advancing the healthcare industry? Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time. Responsibilities: Review patient clinical records and use relevant data to determine clinical trial matches. Independently manage clinical trial workflows, adapting to changing priorities and business needs to ensure efficiency and consistency. Work collaboratively with cross-functional teams at Tempus (including scientists, pathologists, and product development) to create customized clinical reports. Navigate and synthesize information from multiple data sources and systems. Ensure clinical reports are accurate, clear, and aligned with requirements. Support ongoing and future projects within the team. Contribute to a dynamic work environment by maintaining flexibility and responsiveness to shifting workflows. Other duties as assigned. Qualifications: Bachelor's or Master's degree in Genetics, Molecular Genetics, Cancer Biology, or Biological Sciences. Willingness to work flexible hours and adapt to business needs. Strong written and verbal communication skills. Proficient in critical thinking, interpersonal, and problem-solving abilities. Ability to manage complex tasks efficiently under time constraints. Highly detail-oriented with a commitment to accuracy and consistency. Self-motivated and able to thrive independently as well as within a collaborative, high-performing team. Demonstrated passion for making an impact in a fast-paced, mission-driven environment. Preferred Qualifications: Experience reviewing hematology/oncology clinical records. Experience critically evaluating clinical trials. Basic knowledge of generative AI. CHI: $46,000-$50,000 The expected salary range above is applicable if the role is performed from Illinois and may vary for other locations (California, Colorado, New York). Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position. We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases. See Yourself at Telix The Senior Clinical Trial Associate (SCTA) supports clinical studies and the Clinical Operations Department, in managing various administrative tasks such as generation of agenda and minutes, maintaining study tracking, eTMF management, filing and quality reviews of study documents as well as participating in process improvement initiatives across the department. The SCTA will play a key role in working cross functionally to support the clinical teams including close collaboration with study team from vendors/CROs in completing all required tasks to meet departmental and project goals. Strong candidates will bring knowledge and experience in the fundamental aspects of trial and study site management, vendor management, and experience in the full cycle of study from start- up to close out. Key Accountabilities Assists Clinical Project Managers (CPMs) with Sponsor oversight, study-specific documentation review, and QC, including ICF, study plans, study reference manuals, eCRF, etc. Supports Investigator Initiated Trials (IITs) by providing oversight and operational support, including clinical supply forecasting, reoccurring meeting participation and preparation. May be involved in study startup, acting as a startup specialist, and leading or being the point of contact for a CRO regarding site/institutional CDAs, site feasibility questionnaires, and startup documentation. Liaises between internal medical affairs teams/MSLs and CRO/Sites. May be the point of contact for documentation or specific requests (e.g., enrollment updates, missing documentation, meeting arrangements). Supports trial submissions to applicable IRBs and regulatory health authorities, as required. Assists with creating and maintaining study metrics trackers, tools, and reports. Assists in coordinating and tracking Investigator and third-party payments. Ensures required study documents are submitted to the study (electronic) trial master file ((e) TMF). Conducts eTMF reviews for in-house studies in collaboration with the CPM. Creates Investigator Site Files (ISF) for in-house studies. Manages (e) TMF and study documents to meet GCP/ICH and internal guidelines for records retention. Acts as a CLM Super User and facilitates contract execution and management in the system. Assists CPMs with Sponsor oversight of CRO-held eTMFs, periodic audits, and findings resolution. Assists with the customization of CDAs, clinical site contracts, and budgets, when applicable. Assists CPMs and clinical teams with Investigator Meeting coordination and activity preparation. Coordinates document translation, if required. Acts as Veeva Vault owner and owns the training responsibilities to ensure that role-based training and access are granted to each internal and, when required, external stakeholder. May participate in training CRO teams and onboarding new CRO team members. Attends internal and external team meetings/teleconferences and generates meeting agendas and minutes when needed. May assist in or conduct study monitoring, including site qualification visits, site initiation visits, interim monitoring, etc. Other duties as assigned, including study monitoring. Education and Experience Bachelor's degree (BSc, BA or RN equivalent) in a biological or science-related field is essential. 3+ years of experience and knowledge in ICH GCP, eTMF management and DIA TMF Reference Model. Previous CTA experience working with Sponsors, CROs and/or vendors. Experience of working effectively in a fast-paced team environment. Proficiency in office suite notably Microsoft Word, Excel and PowerPoint, Veeva Vault and Smartsheet Ability to develop and/or use existing tools (e.g. tracking tool). Experience of working across functions. Excellent organizational, interpersonal and communication skills Ability to prioritize and manage multiple tasks with competing deadlines. Willingness to travel as needed ( Key Capabilities: Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development. Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics. VIEW OUR PRIVACY POLICY HERE

The remote-based Clinical Trial Associate (CTA) will perform tasks related to supporting operational strategy and and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan. Provide support for essential daily clinical study activities, including regulatory inspection readiness, following established protocols under the general management of the CTA Manager. Work with Clinical Operations Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model. Perform departmental tasks. Perform developmental tasks with oversight of CTA Manager. ACCOUNTABILITIES: For assigned complex, accelerated, and business essential studies, provide support to focus on study startup and site initiation activities, including: Approval of study documentation, including essential document packets, study plans, informed consent forms, etc. Support oversight of risk-based monitoring. Attend important team meetings. Support regulatory inspection readiness (e.g. preparation of materials and participation during regulatory inspections.) Support additional ad-hoc activities, as agreed with CTA Manager. Work with internal departments (Legal, Insurance, R&D functions), CROs, and vendors. Escalate clinical trial insurance issues. Support Health Care Provider Engagement for facilitating contracts and meetings. Support vendor contract administration. Requirements Bachelor's degree or equivalent international degree. 3 or more years' experience in pharmaceutical industry, clinical research organization, or related role. Experience in Phase 2 and 3 studies and global/international studies is advantageous. Experience working across multiple therapeutic areas is advantageous. Knowledge in global regulatory and compliance requirements for clinical research. Excellence in task management and collaboration. Requires availability for 5-10% domestic and international travel, including overnight and international travel on an as-needed basis. Benefits 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contributions Health & Wellness programs including onsite flu shots and health screenings Generous time off for vacation and the option to purchase additional vacation days Community Outreach Programs

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.

Summarized Purpose: Accountable for achieving the final clinical deliverable (usually clean data from evaluable patients as specified in the study protocol) within the time period specified in the contract with the customer. Interprets data on complex issues and makes good business decisions with support from line management. Works to ensure that all clinical deliverables meet the customer's time/quality/cost expectations. Maintains profitability by ensuring clinical activity is conducted within contract scope, through efficient management of the clinical team. Typically works independently on projects of moderate to high complexity, and may assume regional lead or Clinical Study Manager responsibilities. Essential Functions Manages all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Lead CTM responsibilities on regional level, Clinical Study Manager (CSM) responsibilities or take on additional responsibilities; e.g. process improvements, manage complex programs, have wider management or project coordination responsibilities. Develops clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contributes to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensures timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required. Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings. Collaborates with the clinical team and other departments as needed to meet deliverables of the project. Regularly communicates with the team and leads team meetings to ensure that timelines, resources, interactions, and quality are maintained. Responsible for the implementation and training of standardized clinical monitoring processes within the study and according to corporate standard policies. Responsible for the timely archiving of documents and study materials for the department. Ensures achievement of the final clinical deliverable within the contractual time period specified by preparing and monitoring clinical activity timelines and metrics, providing status updates to the project manager, regularly reviewing projects using tracking and management tools, implementing recovery actions, reviewing monitoring visit reports, and managing CRF collection and query resolution. Continuously monitors clinical trials to assess performance and ensure contractual obligations are met. May routinely conduct Accompanied Field Visits (AFVs) and be accountable for project financials. Communicates with study sites regarding issues such as protocol, patient participation, case report form completion and other study-related issues. May coordinate all start-up activities, and ensures that essential document quality meets the expectation of Regulatory Compliance Review. Ensures timely regulatory submissions (if appropriate) are addressed. Reviews and follows up on all questions raised by ethics committees. Responsibilities may vary based on project timelines. Provides input into preparation of forecast estimates for clinical activities. Responsible for clinical resource management, assignment, delegation of clinical responsibilities and identification of additional resource requirements. In North America, where assigned to GPHS (Government & Public Health Studies) projects, may have limited line management responsibilities. Job Complexity: Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors. Job Knowledge: Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways. Some barriers to entry exist at this level (e.g., dept. / peer review). Level at which career may plateau. Supervision Received Determines methods and procedures on new assignments and may coordinate activities of other personnel (i.e., Team Lead). Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Business Relationships: Frequent contacts with internal personnel and outside customer representatives at various management levels concerning operations or scheduling of specific phases of projects or contracts. Creates formal networks with key contacts outside own area of expertise. Qualifications: Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years). In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills and Abilities: Strong leadership skills, effective at mentoring and training, and capable of motivating and integrating teams Strong In Vitro Diagnostic Devices Regulations (IVDR), and ISO20916 Strong planning and organizational skills to enable effective prioritization of workload and workload of team members Strong interpersonal and problem solving skills to enable working in a multicultural matrix organization Solid understanding of change management principles Comprehensive understanding of the practices, processes, and requirements of clinical monitoring Strong judgment, decision making, escalation, and risk management skills Effective oral and written communication skills, including English language proficiency Capable of evaluating own and team members workload against project budget and adjust resources accordingly Strong financial acumen and knowledge of budgeting, forecasting and fiscal management Strong attention to detail In-depth understanding of relevant regulations e.g. ICH/GCP, FDA guidelines, etc. Strong computer skills to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc. Capable of independently managing clinical only studies Management Role: No management responsibility Working Conditions and Environment: · Work is performed in an office environment with exposure to electrical office equipment. · Occasional drives to site locations with occasional travel both domestic and international. Physical Requirements: · Frequently stationary for 6-8 hours per day. · Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. · Frequent mobility required. · Occasional crouching, stooping, bending and twisting of upper body and neck. · Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. · Ability to access and use a variety of computer software developed both in-house and off-the-shelf. · Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. · Frequently interacts with others to obtain or relate information to diverse groups. · Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration. · Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. · Regular and consistent attendance. We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

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 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 $97,600.00-$146,400.00 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

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Title: Clinical Study Manager-Remote Location: Collegeville, PA Duration: 36 months Job Description: This position is needed to assist with Inspection Readiness Prepartion. The candidate will need to assist in leading diverse CRO teams through the Inspection Readiness process. Strong pTMF experience is also desired. A large component of the position will be to search for documents in pTMF and work with 2 different CRO to ensure that all documents are present in pTMF. Strong understanding of clinical trial documents is needed as well as a thorough understanding of a sponsor Inspection. The candidate should be flexible and able to positvely influence CRO staff while meeting the needs of the business. The candidate will also be asked to assist with filing protocol amendments in pTMF, ICD updates, and helping the COSTL and Clinican with tasks on an ad hoc basis. The candidate will lead 2 CROs through Inspection Readiness Activities for a large, high visibility, global oncology protocol that is in submission. The candidate needs to be able to influence and lead the 2 CROs through the Inspection Readiness checklist (~500 items). All items on the checklist will need to be reviewed, the location of the documents will need to be identified and entered onto the checklist. The candidate will need to be able to navigate through pTMF to ensure all documents are in pTMF in the correct cabinet and folder. The candidate will need to be proficient at searching for documents such as Monitoring Visit Reports, Financial Disclosure Documents, SOPs, vendor oversight plans. The candidate will need to compile a listing of relevant SOPs used on the study both past and present and download those SOPs into folders on a sharepoint space. The candidate will need to be comfortable leading 2 CROs in document retrieval and ensuring all Inspection Readiness Documents are up to date with the correct versions. The candidate will need to work with the 2 CROs for any corrections or updates needed. Additional Skills: pTMF, Inspection Readiness activities, Study conduct activities. Qualifications BS Additional Information For More information, Contact Best Regards, Akriti Gupta ************** Morristown, NJ 07960

Piper Companies is seeking Clinical Research Associates to join a highly accredited CRO. This position is fully remote but does require on-site monitoring in Canada. The Clinical Research Associate will take part in assisting the process of creating lifesaving drugs and treatments. Responsibilities of the Clinical Research Associate * Conduct monitoring and close-out visits that align with GCP and ICH guidelines. * Support subject recruitment plans and provide study-specific training to site staff. * Manage regulatory submissions, enrollment, data collection, and documentation in TMF/ISF. * Work with study teams, mentor staff, and generate visit reports and follow-ups. Qualifications of the Clinical Research Associate: * Bachelor's degree in healthcare or science concentration. * Strong experience in onsite oncology monitoring. * Phase 1 oncology required. * Bilingual in French and English. * Skilled in clinical research protocols, technology, and communication. Compensation for the Clinical Research Associate: * Salary Range: $90,000-$120,000 CAD * Comprehensive Benefits: Vacation, PTO, Medical, Dental, Vision, 401k, and sick leave if required by law This job opens for applications on 12/5/2025. Applications for this job will be accepted for at least 30 days from the posting date. Keywords: Clinical Research Associate, CRA, oncology, recruitment, training, communication, quality, documentation, reporting, mentorship, collaboration, GCP, ICH, protocols, submissions, enrollment, CRF, data, TMF, ISF, site-management, initiation, close-out, resolution, scientific, healthcare, experience, Phase1 #LI-HL1 #LI-REMOTE

HistoSonics is a medical device company, founded in 2009, that has developed a non-invasive, sonic beam therapy platform that uses histotripsy, which is capable of destroying targeted liver tumors. Our mission and passion are to advance the novel science of histotripsy and its powerful benefits, bringing meaningful and transformational change to physicians and their patients. Location: Remote position, ideally candidates will live in a major metro area with an international airport in the Northeast, Southeast or West Coast. Travel Expectation: Travel (by automobile or air, day trips and overnight stays) up to 30% of the time. Position Summary: The Clinical Research Associate will play a key role in proactively helping the conduct of pre-market and post-market global clinical studies to ensure compliance with all the regulatory requirements and company strategic initiatives. As a member of the Clinical Affairs team, this role will work with key stakeholders to execute clinical studies. This role will be responsible for study site management, including site qualification, training, activation, and monitoring. Key Responsibilities: * Works on assigned studies to ensure that human subject protection is maintained in accordance with Good Clinical Practice (GCP), SOPs, and applicable regulations * Conducts on-site and remote site qualification, initiation, interim, and close-out monitoring visits * Serve as primary point of contact for site questions relating to study enrollment and conduct; collaborate with appropriate study team members as needed * Assists with the development and execution of clinical study documents including protocols, informed consents, case report forms, and study plans * Communicates through verbal and written communication with site investigator and the project team on the overall site performance, trends, deficiencies, and concerns * Ensures quality and completeness of central and site master files * Oversees site investigational product requirements and device accountability * Supports the planning and coordination of Investigator Meetings * Other duties as assigned Qualifications and Skills: * 2+ years clinical research study monitoring for medical device or related experience * BS degree in relevant area of study * Knowledge of federal and local regulations and policies pertinent to research involving human subjects * Knowledge of ICH, GCP and Declaration of Helsinki * Excellent communication, interpersonal and organizational skills * Ability to collaborate in a team environment and work independently * Self-starter with the ability to manage projects and effectively prioritize tasks in a dynamic, start-up environment * Must be willing and able to travel (by automobile or air, day trips and overnight stays) up to 30% of the time HistoSonics will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Benefits: We offer a comprehensive benefits package for full-time employees. This includes health, dental, and vision insurance, life, short-term and long-term disability insurance, 401(k), paid time off, and more. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. #LI-Remote

Clinical Research Associate ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Clinical Research Associate to join our diverse and dynamic team. As a Clinical Research Associate 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. **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. Are you a current ICON Employee? Please click here (****************************************************** to apply

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs. Position Overview This position is responsible for executing, managing and conducting projects associated with the company clinical study plans. The Contract Clinical Research Associate (CCRA) is responsible for site management deliverables on assigned protocols and may support other CRAs on the team. This position is field based / remote based in the West Coast region (US). Essential Duties Include, but are not limited to, the following: Establish and maintain primary Sponsor communication with clinical sites for in-house and outsourced studies. Conduct oversight visits for outsourced studies to promote study engagement, enrollment and foster sponsor/site relationships. Serve as a point of contact for investigators and site staff. Maintain regular contact with study sites to ensure GCP/ICH/Protocol compliance, assessment of accrual rates. Facilitate communication between the project team and site personnel to ensure that they are appropriately trained, remain current with project requirements, and have a thorough understanding of study milestones and deliverables. Conduct thorough site qualifications visits. Ensure all required information concerning site/staff qualifications is clearly documented and communicated to project teams. Conduct efficient and comprehensive site initiation visits. Ensure all assigned site staff are trained appropriately, have access to the required electronic systems, and are informed of data collection, GCP, protocol and reporting requirements. Ensure monitoring visits are scheduled and performed per the Monitoring Plan and according to the performance of the clinical site and the project team needs. Maintain a flexible monitoring schedule (as appropriate) and assist in co-monitoring or monitoring support of clinical sites/studies. Conduct study specific training for new study coordinators (protocol, ICH/GCP and regulatory guidelines and study specific requirements). Ensure all clinical site staff actively participating in the study are appropriately trained. Identify if any untrained staff are participating in Clinical trial activities, document and communicate the issues and suggested resolutions to the Clinical site and project team. Conduct device/product accountability responsibilities at clinical sites; Identify, clearly communicate and document issues to the clinical site and project team. Assist clinical site in resolving issues, if appropriate. Participate in all aspects of site close-out activities (i.e., evaluation of site readiness for final IMV, preparation for Database lock, etc.). Communicate status of Site management activities on a routine basis to the Clinical Project team and management. Actively participate as an extended team member of the clinical study team including participating in study-specific meetings, teleconferences and investigator meetings, clear and timely communication with cross functional partners and CRA team members. Implement and execute the clinical study Monitoring Plan to ensure compliance with the plan and all assigned tasks throughout the study. Ensure clear and efficient written communication to clinical sites (confirmation letter, site visit report, follow up letter, requests for remediation or action) and project team members. Communicate project specific information to/from trial sites through teleconferences, newsletters, etc. Work with clinical project manager to assure investigator payments are appropriate and paid on a timely basis. Document monitoring activities in monitoring visit reports and follow-up letters. Communicate serious issues to appropriate parties, in a timely manner. Ensure operational and regulatory integrity of assigned studies and participate in FDA or other regulatory authority inspections, as needed. Participate in Investigator Meetings, and other study trainings and meetings as required. Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork. Support and comply with the company's Quality Management System policies and procedures. Maintain regular and reliable attendance. Ability to act with an inclusion mindset and model these behaviors for the organization. Ability to work designated schedule. Ability to work nights and/or weekends, as needed. Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day. Ability to work on a computer and phone simultaneously. Ability to use a telephone through a headset. Ability to travel 50% of working time away from work location may include overnight/weekend travel. Minimum Qualifications Bachelor's Degree in field as outlined in essential duties or Associate degree with a minimum of 6 years of monitoring experience or equivalent experience. Highschool Diploma with a minimum 8 years of monitoring experience or equivalent experience. 4+ years clinical research monitoring experience or equivalent experience. No other results from the Motor Vehicle Report (MVR) check that exposes Exact Sciences to what Exact Sciences deems to be an unacceptable level of liability. Proficiency in data management, including progressive experience in data entry, validation, and cleaning. Familiarity with Electronic Data Capture (EDC) systems. Effective communication skills and ability to collaborate with investigators, site staff, and team members. Demonstrated ability to work well within a team and convey information effectively. Understanding of regulatory compliance to ensure adherence to applicable regulations and requirements. Knowledge and experience in informed consent procedures, adverse event reporting, documentation, and record-keeping practices. Meticulousness with a focus on accuracy and precision in all tasks and activities. Extensive experience in clinical trial monitoring, including site initiation visits, routine monitoring visits, and close-out visits. Proficiency in monitoring plans, protocol adherence, and GCP guidelines. Conducting source data verification, resolving queries, and ensuring site compliance and data accuracy. Demonstrated ability to perform the essential duties of the position with or without accommodation. Authorization to work in the United States without sponsorship. Preferred Qualifications Experience or knowledge in In Vitro Diagnostics (IVD). Certifications related to clinical research. Working knowledge of the FDA submission process including IDE, PMA, and 510(k). Strong on-site monitoring experience in clinical trials, including: Site initiation. Routine monitoring visits. Site closeout. Knowledge of electronic trial master file (eTMF) systems and document management processes. #LI-JH1 We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us. Meet the team: The Director of Clinical Science will lead the pre-commercial and key aspects of post-commercial Global Clinical Science team at Dexcom. As a Director of Clinical Science, you will leverage your scientific, medical device, and therapeutic expertise along with executive management skills to drive the global pre-commercial clinical strategy. Your team will lead the development, design, analysis and reporting of Dexcom's clinical studies to meet the labeling, claims, and global regulatory needs of the business. Your team will be responsible for interactions with regulatory agencies as needed and will use your scientific, engineering and medical knowledge to provide directives to teams and study sites as needed. Where you come in: Provide leadership and long-term vision to the Global Clinical Science team to meet the business objectives. Provide input on best practices in clinical research to develop CGM products in a regulated environment inclusive of gold standard endpoints and outcome measures, scientific/ clinical evaluations, study instruments, questionnaires, and relevant standards for evaluating medical devices Informs clinical evaluation (plans and reports), clinical trial protocols, protocol amendments, and scientific publications. Facilitates communication between Commercial, Marketing, R&D, Clinical Program Management, Regulatory & Scientific Affairs, Medical Writing, Product Development, Quality Assurance/Compliance, Medical Affairs, and external CROs. Conduct team meetings and present regular updates to senior staff. Participates in clinical study or clinical evaluation timelines, and budgets Examine data sets and determine the best end-to-end analysis plan to address key scientific questions Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process. Interprets results in preparation for product applications by evaluating clinical and scientific and risk data and literature and staying abreast of current clinical practice. What makes you successful: You will have a PhD, MD, and/or equivalent in endocrinology, metabolic disease or related field with extensive clinical research experience in medical devices. Excellent communication and interpersonal skills. Ability to simplify complex concepts and communicate these to non-clinical team members Expertise in medical writing, including authoring and leading clinical evidence reports, clinical study reports, and other reports needed for regulatory filings and meetings, in the US and globally Optional but nice to have: Advanced Programming Skills (Python, R, SPSS, SAS, MatLab, Etc) and demonstrated advanced statistical analysis experience Experience in the European market Ability to work in a matrixed organization What you'll get: A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community. A full and comprehensive benefits program. Growth opportunities on a global scale. Access to career development through in-house learning programs and/or qualified tuition reimbursement. An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve. Travel Required: 5-15% Experience and Education Requirements: 15+ years of industry experience Typically requires a Bachelor's degree with 9+ years of successful management experience in relevant industry Remote Workplace: Your location will be a home office; you are not required to live within commuting distance of your assigned Dexcom site (typically 75 miles/120km). If you reside within commuting distance of a Dexcom site (typically 75 miles/120km) a hybrid working environment may be available. Ask about our Flex workplace option. Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. 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, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom's AAP may be viewed upon request by contacting Talent Acquisition at ****************************. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at ****************************. Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: ***************************************************** Code=MERITAIN_I&brand Code=MERITAINOVER/machine-readable-transparency-in-coverage?reporting EntityType=TPA_19874&lock=true To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications. Salary: $199,600.00 - $332,600.00

🔗Are you being referred to one of our roles by a connection in Alira Health? If so, please apply using the referral link emailed to you. Join our global team dedicated to innovation and initiative, where physical walls and different time zones don't limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. Summary The CRA is an important member of the Alira Health Clinical team. The CRA is highly motivated and functions independently to conduct site monitoring responsibilities for clinical trials; as well as providing oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality. The CRA works closely with Lead CRAs, Sr CRAs, in-house CRAs, Associate Director of Clinical Monitoring and Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues. Job Description 2+ years oncology monitoring is a requirement for this position.KEY RESPONSABILITIES Provides guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements. Reviews monitoring visit reports, conducts co-monitoring and evaluation visits as needed. Ensures appropriate and timely investigator site visits. Coordinates with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues. Assists in development of study-specific Monitoring Plans and training presentations as required. Assists in set up/collection of site specific ethics documents and site contract negotiation as required. Provides monthly billing information to finance team as required. For monitoring stand-alone projects, manages study budget and acts as referent for the sponsor. Performs qualification, initiation, interim, and close-out visits both remotely and onsite, ensuring proper documentation of monitoring visits. Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status. Ensures integrity of CRF data through meticulous and thorough source document review and verification. Performs quality control and verification of documents collected at sites for eTMF/TMF. Conducts investigational product accountability. Reviews site regulatory binder for required documents. Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests. Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company/Sponsor SOPs. Participates in internal, client/sponsor, scientific, and other meetings as required. Facilitates adverse event reporting and ensures the reconciliation of SAE reports with source documentation and CRFs. Works closely with in-house CRAs/CTC and data management to resolve queries on discrepant data. Proactively identifies site issues and develops problem-solving strategies for sites. Conducts audit preparation at study sites as needed. Works with other CRAs to maintain consistency and promote a collaborative team atmosphere. Participates in internal, client/sponsor, scientific, and other meetings as required. Assists in CRA new hire training and onboarding. Performs CRA mentoring. Collaborates with development and maintenance of Clinical Trial Management System (CTMS). Manages and resolves conflicting priorities to deliver on commitments. Performs additional duties as assigned. DESIRED QUALIFICATION & EXPERIENCE EU: Graduation in a scientific health field EU (Italy): Certified Monitor in compliance with Italian CRO decree dated 15Nov2011 Ability to establish and maintain positive relationships with Sponsor, Site and Project Team members Ability to autonomously manage monitoring activities TECHNICAL COMPETENCES & SOFT SKILLS Quality focused; Proven ability to be careful, thorough, and detail-oriented Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment Able to manage priorities, organize time and solve problems Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills Ability to travel Ability to manage stress Professional, trustworthy and disciplined Ability to problem-solve unstructured or ambiguous challenges Strong command of Local language, both written and verbal, in the country where monitoring activities are performed Excellent communication and interpersonal skills with customer service orientation Good computer skills, with ability to use clinical trial management systems, clinical trial databases and electronic data capture Self-starter who thrives in a collaborative, yet less structured team environment Knowledge of clinical research, ICH GCP and local regulations Knowledge of Regulatory and Ethical requirements EU: Adequate English Languages English Education Bachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences Contract Type Regular

Peachtree BioResearch Solutions, a Julius Clinical Company, is a global specialized full-service CRO providing highly specialized study operations teams for pharmaceutical, biotech, and medical device companies. Formed over 15 years ago by a pharma leadership team experienced in buying CRO services with the purpose of creating trusting partnerships with sponsor clients - no matter their budget. We do this by investing in people who thrive in an environment where their experience and contributions can be felt throughout the organization. It's an exciting time as we expand our global reach, while still offering a personalized approach to sponsors and delivering incredible value. Peachtree Bioresearch Solutions is a fast growing, full-service Clinical Research Organization with expertise in CNS and other therapeutic areas. We create strong, consultative relationships with sponsor clients and we're looking to add CRAs who are dedicated, want to make an impact, and enjoy having visibility across the entire project beyond their monitoring role. As a small/mid CRO, we focus on building great teams where all ops functions can provide a high level of service. You can see the impact you make, and get recognized for it. It's also fun working with others who are very good at what they do. Responsibilities: Work closely with the Site Management team and sponsor stakeholders so you can plan and manage your work most effectively Perform site selection, initiation, monitoring and close-out visits, plus maintain the appropriate documentation Establish relationships with sites while administering protocol and related study training Work with Peachtree's Data Management team and sites to ensure all queries are resolved Complete all reports and follow up items in a timely manner Work with project leadership to customize solutions that bring value to the sponsor Qualifications: Bachelor's degree 1-5 years of experience working on clinical trials (CRO or Sponsor) with at least a year of site monitoring Experience on CNS or neuro studies highly desirable Willing to travel 65%. Sometimes it's hectic. Sometimes it's not. We do a good job trying to manage it. Highly proficient with business software (MS365) Experience working in a CTMS and EDC system Excellent organizational and critical thinking skills Excellent written and verbal communication and presentation skills Be resourceful and curious - you figure out problems and think about the business beyond the task at hand. A team player who elevates others Leadership traits and attitude In addition to working with great people on high performing teams, full-time employees receive: Medical, Dental, Vision, Life, Disability coverage 20 days PTO + PTO rollover + 13 paid holidays 401(k)

Clinical Research Associate ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Clinical Research Associate to join our diverse and dynamic team. As a Clinical Research Associate 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. 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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Clinical Research Associate ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Clinical Research Associate to join our diverse and dynamic team. As a Clinical Research Associate 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. 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. Are you a current ICON Employee? Please click here to apply

The Senior Clinical Research Coordinator (SCRC) is responsible for the facilitation and coordination of daily clinical trial activities. USRC has a research Partnership with the principal investigator (PI) and their physician practice. The local oversight and direction for activities related to the conduct of the clinical research is directed by the PI. The SCRC will work collaboratively with the principal investigator (PI), the clinical site, sponsor(s), clinical research organization(s) (CROs), institutional review boards (IRBs), and study participants to ensure Execution of the clinical trial in accordance with the Study Protocol, the Food and Drug Administration (FDA), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and applicable state and local regulations. The SCRC will assist the PI in protecting the rights, safety and welfare of all study participants. Essential Duties and Responsibilities include the following. Other duties and tasks may be assigned. Coordinate all aspects of participant care from screening through study completion as defined by the protocol and PI delegation. Ensure and document that the informed consent process has occurred properly according to the Code of Federal Regulations (45 CFR part 46). Maintain and update each study participant's source records, including collection of medical history, assessment of eligibility and documentation of all study related procedures and relevant information. Promptly report adverse events, protocol deviations and unanticipated problems involving risk to human subjects or others to the PI, the Sponsor, the IRB and in accordance with the Federal Code of Regulations (21 CFR 312). Ensure thorough, individualized, protocol-based study subject education on all study processes including but not limited to informed consent, study participation obligations, appropriate use of investigational product(IP), IP side effects and safety, communication with study staff and research rights. Provide timely and accurate exchange of participant information with the PI and research team as it pertains to study conduct and patient safety. Adhere to the Health Insurance Portability and Accountability Act (HIPAA Privacy Rule) and protect participant confidentiality at all times. Dispense, administer and instruct participants on proper use of the investigational product (IP) in accordance with the protocol, coordinator's scope of practice and at the direction of the PI. Engage and collaborate with the USRC clinical team. Provide study specific training, oversee trial implementation, and ensure compliance with the study protocol by our clinical partners. Perform accurate and timely data collection, source documentation, and entry into the USRC databases and sponsor Case Report Forms (CRFs)/ interactive web response systems (IWRS). Address queries and sponsor requests in a timely manner. Coordinate long-term storage of research records in accordance with contractual requirements. Timely preparation for, accommodation of and attendance during site initiation, monitoring visits, audit visits or regulatory authority inspections. Maintains records of all reports as well as the site's response. Responsible for the preparation and ongoing maintenance of Essential Documents (The Trial Master File). This includes those documents that will allow for the evaluation of the clinical trial and demonstrate compliance of the sponsor and PI with the study protocol and GCP. (Including but not limited to: Form FDA 1572, financial disclosures, laboratory certifications, protocol, investigator brochure, institutional review board (IRB) related documents, IND reports delegation of authority (DOA), study specific enrollment logs, monitoring reports. Assists in the coordination of efforts of internal and external resources (industry partners, clinical research organizations) to ensure efficient trial selection, proper patient recruitment, achieving target enrollment goals and trial plan execution. Fosters a patient-care culture that emphasizes patient safety and quality in all aspects. Responsible for the patient stipend automated payment process including registration into the system and processing payments per the USRC policy and ongoing maintenance of payments during the trial. Adheres to the USRC Research quality assurance program guidelines. Travel to Investigator Meetings or similar research related meetings is required. Travel may be required between dialysis facilities or nephrology practices within the community. Maintains a working knowledge of current clinical research practice standards and regulatory requirements. For example, but not limited to; (FDA Federal Code of Regulations Good Clinical Practice (GCP), Health Insurance Portability and Accountability Act (HIPPA), International Air and Transportation Association (IATA) - Shipping of Dangerous Goods. Maintains their industry standard licensures and certifications. May provide training and oversight of Clinical Research Coordinators and/or Research Assistants. Actively promotes GUEST customer service standards; develop effective relationships at all levels of the organization. Participate in team concepts and promote a team effort; perform duties in accordance with company policies and procedures. Participate in staff meetings as required. Regular and reliable attendance is required for the job.

Our clinical activities are growing rapidly, and we are currently seeking full-time, home-based Clinical Research Associates to join our Clinical Operations team in Denmark (candidates can be based anywhere in Denmark). This position will work on a Nordic team to accomplish tasks and projects that are instrumental to the company's success. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you. If you are looking for a stable, consistently, rapidly, developing CRO, Medpace is a great place for you! We are currently seeking full-time, home or office-based Clinical Research Associates to join our energetic Clinical Monitoring team in the Denmark. We offer an exciting career where you can grow further, using your current and and previous expertise. Responsibilities * Conduct feasibility, pre-study, initiation, monitoring, and closeout visits for research sites, mainly phase 1 to 3 and within all available therapeutic areas; * Perform source document verification and case report form review; * Perform regulatory document review; * Conduct study drug inventory; * Perform adverse event and serious adverse event reporting and follow-up; and * Assess patient recruitment and retention. Qualifications * Bachelor of Science in health-related field; * Proven CRA experience of at least 1.5 years independent monitoring experience * Broad knowledge of medical terminology and clinical patient management; * Basic knowledge of drug therapy techniques and clinical research methodologies; * Fluency in local language and excellent English are required. 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 6,000 people across 50+ 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. Medpace Perks * Flexible work environment * Competitive compensation and benefits package * Competitive PTO packages * Structured career paths with opportunities for professional growth * Company-sponsored employee appreciation events * Employee health and wellness initiatives Awards * 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.