Clinical research manager work from home jobs

Now Hiring: Research Administrator I (Remote) Salary: $70,000/year | Schedule: Monday-Friday, 8am-5pm Join a high-performing and passionate research administration team! The Research Administrator I plays a key role in supporting clinical and industry research by managing, reviewing, and negotiating a variety of research-related contracts and agreements. This is an excellent opportunity for someone with experience in clinical trial contracting who's looking to grow within a supportive, mission-driven environment. Key Responsibilities Review, process, and negotiate Confidentiality Disclosure Agreements, Master Agreement Work Orders, Clinical Trial Agreements, Industrial Grant Agreements, and Subcontracts. Manage contract receipt, execution, and tracking across multiple systems. Collaborate closely with internal teams and sponsors to finalize terms and implement requested contract language changes. Review budgets, complete required documentation, and coordinate with Post-Award teams for account establishment. Maintain clear communication with sponsors and departments on contract negotiation status. Qualifications Bachelor's Degree required. Previous experience working with clinical trial contracts (industry or academic). Strong organizational skills and attention to detail. Excellent written and verbal communication skills. Proficiency in MS Word, Excel, PeopleSoft, Cayuse, or similar systems preferred. Why Join This Team Collaborative, flexible, and supportive remote work culture. Opportunity to grow in a dynamic research-focused environment. Excellent long-term benefits package upon permanent hire. Be part of a team that values communication, independence, and teamwork.

About the Role The Clinical Research Associate (CRA) is primarily responsible for ensuring the rights and wellbeing of trial participants are protected and the reported trial data are accurate, complete, and verifiable from the source documents. The CRA is the primary contact between the Investigational Sites, Novotech, and Sponsor. Key responsibility of a CRA is as a site relationship manager ensuring that clinical trials are conducted in accordance with ICH GCP guidelines, local and global regulatory requirements, and Novotech/Client SOPs. Responsibilities Prepare, review, and deliver Novotech CRA training program modules and workshops in collaboration with Clinical Services Training team. Act as LCRA on assigned projects according to study-specific, documented delegation. Possible tasks are outlined in the LCRA Role Description. As a PCRA a high degree of delegation from the PM is expected especially regarding mentoring and matrix management of CRA's and championing processes with the team. Serve as a back-up line manager or formal mentor to assigned CRAs and IHCRAs; Conduct co-monitoring visits, solo signoffs, and assessment visits as required. Assume project management responsibilities, i.e., serve as back-up PM, where appropriate, under the supervision of a Novotech Project Manager or Line Manager CRAs primary responsibility is to build relationships with Principal Investigators, study co-ordinators, pharmacists, and all relevant site trial personnel to ensure the efficient, expedited, and smooth management of clinical trials. Foster internal and external customer relationships to ensure focus on efficient, timely and productive project delivery as per study requirements and timelines. In collaboration with the In-house Clinical Research Associate (IHCRA) and Regulatory Start-Up Associate (RSA), prepare site essential documents, and support the ethics and regulatory submission and approval processes as needed. In collaboration with Regulatory Start-up (RSU) Team, understand the requirements of applicable local and international regulatory requirements as relevant to specific clinical trials. Experience and Qualifications Graduate in a clinical or life sciences-related field. Relevant experience/qualifications in allied professions may also be considered. Must have good time management skills, attention to detail, be able to work well in a team, and be computer literate. Preferably experience of working in the research, pharmaceutical industry or a related field per job level as follows: At least 5 years of Clinical Research Associate experience in the Clinical industry. Salary Band - $110,000 - 145,000USD - Salary offered will be based on candidates experience level. Novotech is proud to offer a great workplace. We are committed to being an employer of choice for gender equality and providing an inclusive work environment where everyone is treated fairly and with respect. Our team members are passionate about what we do, but we understand work is only one of the things that is important to them. We support our team members with flexible working options, paid parental leave for both parents, flexible leave entitlements, wellness programs and ongoing development programs. We are looking for people who are passionate about working clinical research and biotech, including people who identify as LGBTIQ+, have a disability or have caring responsibilities. We are a Circle Back Initiative Employer and commit to respond to every application. We look forward to talking to you about working at Novotech.

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 Description • The Study Specialist will augment activities performed by existing study team members whether from client or client's preferred CROs by providing support to CRA activities to ensure adherence to study timelines and deliverables. • This position will provide site level problem solving expertise for complex rare disease clinical studies in early and late phase development. • Position will support all site management activities, which may include operational activities related to site evaluation, initiation, monitoring and close out for assigned clinical study sites to ensure compliance with ICH/Good Clinical Practices (GCP), client SOPs, protocol and patient safety. Organizational Relationships: • Oversight by client Clinical Operations Study Team Lead • Role will lease with client Compliance Oversight Lead for monitoring related activities if they occur • Interfaces with cross-functional study team members in a matrix environment (e.g., CRO Project Lead) Primary Duties: • Removing site obstacles to site start-up, maintenance and close-out while maintaining awareness of site dynamics with ability to motivate and educate site staff • Exhibits ability to independently and proactively identify and interpret problems, recommend creative solutions, drive resolution, and influence appropriate changes • Liaise with site, sponsor and CRO to provide site issue identification and resolution bringing sites to initiation, readiness to enroll and recruitment for assigned clinical research sites • Point of escalation for clinically identified site related issues • Problem solves identified issues (monitoring and/or regulatory) with appropriate escalation to Project Manager and/or designee • Supports the management of multiple academic sites (e.g., clinical research naive requiring in depth coordination and support) • Assures protection of the rights, safety, and wellbeing of subjects, study integrity and data quality • Supports inspection readiness including for example the facilitation of the collection and maintenance of regulatory and site documentation for the Trial Master File and site file • Supports local IRB workflow, submission through approval and reporting of safety information and may prepare answers, as required, to the IRB in conjunction with study team/Client • Completes assigned training as necessary, including general training requirements, SOPs, system and process related training, and protocol specific training. • Complies with all departmental objectives and metrics related to study execution • Attend/lead/facilitate meetings as requested (i.e. investigator, project) to gain and/or share project/site knowledge Secondary Duties • As needed, performs site development and training (supporting and coaching site personnel), site monitoring, and site close-out activities for assigned clinical research sites with designated project SOPs, Client expectations, study specific protocol and GCPs • As needed, supports activities such as but not limited to source data verification, case report form review, AE/SAE review and reconciliation, IP accountability, questionnaire reconciliation, equipment maintenance, supplies tracking and query resolution • Complies with the Clinical Monitoring Plan (CMP) and becomes knowledgeable of the protocol to guide assigned sites in the proper conduct of the study • Potential to complete monitoring reports in compliance with requirements in the Clinical Monitoring Plan Training and Education Preferred: • Bachelor's Degree in Life Science, RN preferred • Minimum 5 years of study management experience with preferred focus in Rare Diseases (for example Sickle Cell Disease and/or other genetic hematological diseases) and experience in on-site monitoring • Expertise in study start up and site management (experience in complex hospital-based Phase 3 clinical trials highly desirable) • Demonstrated ability to problem solve and to prioritize site related activities • Demonstrates solid understanding of drug development and clinical practices • Understands and is able to comprehend study protocols • Has knowledge of FDA regulations • Possesses working knowledge of GCPs and other regulations governing clinical research • Demonstrates technical expertise in computer skills • Demonstrates diligent and self-motivated approach to working in an independent environment • Demonstrates effective oral and written communication skills • Travel anticipated at 25% but could up to 50% at times. Qualifications BS/MS Additional Information For more information, please contact 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 11/28/2025. 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

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** This position is ideally based on the West Coast. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. Purpose and Scope: Support the day-to-day operations of assigned trials and responsibilities to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements Responsible for maintaining accurate and up-to-date trial information within relevant tracking systems and provide regular updates as requested to trial team and other defined stakeholders Participate in the development of core trial documents and trial level plans, as requested Participate in or lead trial related systems set-up including implementation and maintenance of appropriate systems, standards and processes to ensure quality across investigative sites, vendors and data Participate in feasibility assessment and selection of countries and sites for trial conduct Participate in CRO and vendor set-up and management during clinical trial execution, as requested by clinical trial lead and/or clinical team Participate in or facilitates site engagement and communications with investigators and/or staff to support trial milestones and deliverables Participate in CRO and vendor set-up and management during clinical trial execution, as requested by clinical trial lead and/or clinical team Ensure quality and completeness of TMF for assigned clinical trials Participate in trial team meetings and manage associated documentation as requested Participate in data cleaning and data review activities as requested Participate in or lead set-up and implementation of effective investigator and site monitor training Participate in the coordination and implementation of patient-focused strategies for assigned trials, as applicable.

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.

Castle Biosciences Earns a Top Workplaces USA Award for the Fourth Consecutive Year! You won't find a work culture and benefits package like ours every day. Come join our team and a group of colleagues who love working at Castle! Learn more at ************************* Castle Biosciences Inc. is growing, and we are seeking to hire a full-time Clinical Research Associate to work remotely from a home-based office in the USA, preferably located in the greater Chicago area, St. Louis, MO, Ohio, Virginia, Pennsylvania, Nashville, or Atlanta, within close proximity to a major airport. Why Castle Biosciences? * Exceptional Benefits Package: * Excellent Annual Salary + 20% Bonus Potential * 20 Accrued PTO Days Annually * 10 Paid Holidays * 401K with 100% Company Match up to 6% * 3 Health Care Plan Options + Company HSA Contribution * Company Stock Grant Upon Hire Salary Range: $90,000 - $95,000. Salary Range is based on Experience and Education levels. A DAY IN THE LIFE OF A Clinical Research Associate The Clinical Research Associate (CRA) is responsible for managing sites participating in Castle's clinical studies. Daily tasks vary based on study and site needs and may include attending team meetings, training site staff, sending emails, and traveling to U.S. sites to monitor data. The CRA performs all aspects of clinical monitoring and site management in compliance with ICH GCP, FDA guidelines, local regulations, protocols, and Castle's SOPs. This role ensures protocol and regulatory compliance, manages study documentation, and fosters strong relationships with sites. CRAs also play a key role in protecting participant safety, ensuring data quality, and representing Castle in the broader research community. REQUIREMENTS * Bachelor's degree in a science or healthcare-related field or a registered nursing certification, or equivalent certification/licensure from an appropriately accredited institution. * 3 years of CRC experience or previous 1 year experience as a CRA. * Direct patient care or clinical research experience required. * Familiarity with clinical research and study development processes. * Valid Driver's License where applicable. * In some cases, a combination of education, professional training, and demonstrated experience that provides the required knowledge, skills and abilities may be considered. TRAVEL/WORK ENVIRONMENT * Regular overnight travel by car and air, typically 50-60% of the time, with potential peaks up to 80% * Flexibility to accommodate an often changing and unpredictable timeline * Frequent laptop use * When in the office, there is a standard office environment with the use of a desk/phone/computer * Generally, proof of COVID-19 vaccination will be required to access study sites, in accordance with site-specific guidelines and subject to any applicable exceptions as required by Federal, State, and Local laws. SCHEDULE * M-F travel-based position; working remotely from your home based in the USA near a major airport. * Preferred locations include greater Chicago area, St. Louis MO, Ohio, Virginia, Pennsylvania, Nashville or Atlanta within close proximity to a major airport. READY TO JOIN OUR BIOTECH TEAM? We truly appreciate your time. If this feels like the right opportunity for you, we'd love for you to complete our mobile-friendly application. We're excited to learn more about you and look forward to connecting soon! Castle Biosciences Awards and Research Developments! WORK AUTHORIZATION All candidates must be legally authorized to work in the United States. Currently, Castle Biosciences does not sponsor H-1B visas, OPT, or employment-related visas. ABOUT CASTLE BIOSCIENCES INC. At Castle, it all comes down to people. After all, disease doesn't just happen - it happens to people. We believe that disease management and treatment decisions can be better informed through a person's unique biology, which is revealed through the scientific rigor of our innovative, laboratory-developed tests. We are committed to empowering healthcare providers and patients with the goal of improved outcomes. Every employee at Castle has an impact on patient care, and we work to ensure that everyone finds their work to be both challenging and rewarding. We behave with integrity and treat our colleagues with respect and kindness. Our culture fosters an environment of trust, transparency, and collaboration. We prioritize and encourage internal growth and professional development. Castle Biosciences is an equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities. If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please e-mail ReasonableAccommodationsRequest@castlebiosciences.com. This email was created exclusively to assist disabled job seekers whose disability prevents them from being able to apply online. Only messages left for this purpose will be returned. Messages left for other purposes, such as following up on an application or technical issues not related to a disability, will not receive a response. No third-party recruiters, please

SummaryAre you looking to make meaningful impact with your research/technical experience? 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 DescriptionResponsibilities 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 (contributing to letters of support, research proposals, supporting identified grant submissions). 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 R&D teams, explore unmet clinical and technical needs with external collaborators and translate to define and prioritize product development needs. Collect data, clinical & product feedback, technical study endpoints, DICOM images and annotations Support customer satisfaction through communication, observation, and escalation of site inquiries/concerns. Grow technology leadership mindshare through joint scientific presentations and publications. Install/upgrade research equipment and software & prototypes Lead GE Interventional solutions evaluation and optimization for emerging interventional procedures Represent the global modality technical, scientific and product expertise in USCAN 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. Note: No sponsorship available for this role now or in the future to work in the United States.. Qualifications PhD or Master's degree, or foreign degree equivalent, in Medical Imaging, Physics, Computer Science, Biomedical Engineering, or related field. 3+ years of experience in Interventional healthcare industry or research. Knowledge of Interventional procedures, anatomies, clinical practice. Excellent written and verbal communication skills. 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 ( Quality, Compliance, and Continuous Improvement focus 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. #LI-BR3 #LI-Remote 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.Additional Information 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: No

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.***

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

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

🔗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

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

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)

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health * We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. * We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. * We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities * Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. * Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. * Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements. * May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. * Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. * Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. * For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets. * May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements * Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. * Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. * Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required. For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. Additional responsibilities include:Site support throughout the study lifecycle from site identification through close-out. Knowledge of local requirements for real world late phase study designs.Chart abstraction activities and data collection Collaboration with Sponsor affiliates, medical science liaisons and local country staff. The SMA II may be requested to train junior staff. Identify and communicate out of scope activities to Lead CRA/Project Manager. Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations. Qualifications: * Bachelor's degree or RN in a related field or equivalent combination of education, training and experience * Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements * Must demonstrate good computer skills and be able to embrace new technologies * Excellent communication, presentation and interpersonal skills * Ability to manage required travel of up to 75% on a regular basis * US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: 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. Summary Roles within Clinical Monitoring/CRA are responsible for overseeing and ensuring the integrity of clinical research studies by monitoring data and processes from a centralized location. This includes conducting remote monitoring of trial sites to verify compliance with regulatory requirements and clinical protocols. Utilizes data analytics and risk-based monitoring techniques to identify potential issues and trends, ensuring that trials are conducted in accordance with established clinical practices. Collaborates with site teams to develop and implement tools, procedures, and processes that enhance quality monitoring and support the overall success of clinical trials. Impact and Contribution Individual contributors with responsibility in a professional or technical discipline or specialty, but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Established and productive individual contributor. May manage defined components of projects or processes within area of responsibility. Requires practical knowledge of a professional area, typically obtained through education combined with experience.

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

BIOTRONIK is one of the leading manufacturers of cardio- and endovascular implants and catheters for cardiac rhythm management, electrophysiology and vascular intervention. As a globally active company headquartered in Berlin, Germany, we develop, produce and distribute high-quality medical products based on the latest technology and research. Our success is based on the competence and results-oriented cooperation of our employees. BIOTRONIK is looking to add a Regional Clinical Research Associate II to our Clinical Studies team. Responsible for conducting on-site and remote monitoring visits as well as centralized monitoring in compliance with applicable regulatory standards (FDA regulations, ICH/GCP guidelines, BIOTRONIK procedures and IRB/EC policies and procedures) for assigned clinical studies in the field of cardiac rhythm management, vascular intervention or other therapeutic area. Your Responsibilities: Conduct assigned monitoring activities in accordance with BIOTRONIK procedures and applicable regulations to evaluate protocol compliance, data accuracy and subject safety by review of regulatory documents, medical records, reported data and device storage, if applicable. Responsible for all monitoring activities for assigned clinical studies including: Scheduling and conducting monitoring activities within specified timelines and according to the risk-based monitoring plan and BIOTRONIK procedures. Identification of data discrepancies and compliance concerns, present findings to site research staff, provide retraining if needed, provide problem solving strategies and communicate findings to the study team and department management via escalation of issues and/or within the monitoring visit report. Works collaboratively with Research Coordinators and Investigators to conduct monitoring visits, provide retraining and resolve compliance concerns as appropriate. Works cooperatively with the BIOTRONIK Clinical Studies project team members to prepare for monitoring visits, escalates significant findings during monitoring visits and pro-actively provides input on site performance. Presents findings to site staff and provides clear directions for resolution. Reviews data queries with site staff to confirm understanding and resolution. Serves as a resource to site staff between monitoring visits to provide clarification and insights regarding data queries, action items and study visit preparation. Trains and mentors BIOTRONIK personnel on monitoring procedures and practices. Conducts site training and co-monitoring visits as requested by management. Completes monitoring visit reports, action items and monitoring visit follow-up letters per BIOTRONIK procedures. Assists the Manager, RCRA Group with team, department and study related projects as requested including audits, investigator meetings, training, etc. Interfaces with Clinical, Regulatory, Sales and clinical site staff as necessary to accomplish the above responsibilities. Your Profile Bachelor's degree or higher level degree in nursing, life sciences or related medical/scientific field. Must have a valid US driver's license. Minimum of 3 years on-site monitoring research experience for a CRO, Pharma, or Medical Device company. Experience supporting medical device IDE trials is preferred. Strong clinical trial monitoring experience in relevant BIOTRONIK product and/or relevant therapeutic areas (electrophysiology and vascular interventional cardiology) preferred. Experience conducting monitoring activities for first in human, investigational device exemption, post-approval and/or post-market studies. Strong compliance focus and understanding of current GCP/ICH guidelines and FDA regulations specifically, 21 CFR Parts 11, 50, 54, 56, 812, and 820, ISO requirements governing medical device clinical trials. Current certification as a Certified Clinical Research Associate (CCRA) or current Certified Clinical Research Professional (CCRP). Strong knowledge of medical terminology Ability to work independently in a regional area with minimal supervision Excellent organizational and problem-solving skills, including demonstrated ability to evaluate challenging situations and develop alternative solutions creatively and independently. Excellent interpersonal skills, ability to interface and communicate effectively with internal and external collaborators including physicians, site research staff, project teams and management. Ability to interact constructively in communication of adherence to protocol and regulatory requirements. Responsible for adequate and reasonable home office set up including dedicated desk space to accommodate work responsibilities and BIOTRONIK supplied equipment Travel Approximately 60% travel required throughout the United States to investigational centers and BIOTRONIK, Inc. corporate office. The travel percentage may vary based on the study requirements. Travel may be conducted via air travel, driving or train. Location Remote opportunity based on the East Coast, United States Are you interested? Please apply online through our application management system! We are looking forward to welcoming you. Location: East Coast | Working hours: Full-time | Type of contract: Undefined Apply now under: ************************* Job ID: 61606 | BIOTRONIK Inc. | United States (US) We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law. Please note that applications sent by post will only be returned if a sufficiently stamped self-addressed envelope is included.

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.