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Clinical Associate remote jobs

- 179 jobs
  • Clinical Trial Specialist (Remote)

    Tandym Group

    Remote job

    A leading organization is currently seeking a skilled Clinical Trial Specialist for a Remote contract opportunity. This role is pivotal in ensuring the successful execution of clinical trials from start-up through closeout. Responsibilities: Actively involved in the performance of study feasibility assessments Develop and review study documents (e.g., site instructions, diaries, lab manual, Pharmacy Binder, Study Management Plan, etc.) and clinical site documents (e.g., site specific informed consent forms) Manage the collection, review and approval of regulatory documents from clinical sites Coordinate investigational product release activities across clinical sites Manage and track study specific payments Create study-specific site budgets Initiate, maintain and reconcile the Trial Master File Assist in the preparation of Investigator and Study Coordinator Meetings Set-up and maintain tracking systems (e.g., CTMS), tools and report study metrics to support the clinical trial programs Coordinate communication of tracking information within the study team and to the clinical sites Develop and review Standard Operating Procedures Perform other duties, as needed Qualifications: Bachelor's Degree Previous experience in Clinical Trial Coordination and/or Site Management Understanding of Study Phases and general knowledge of how they apply to Clinical Development Working knowledge of ICH Good Clinical Practice guidelines Experience using computer applications including spreadsheets, email, word-processing software and web-based systems
    $75k-125k yearly est. 5d ago
  • Clinical Research Associate- Remote

    Icon Plc 4.8company rating

    Remote job

    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
    $48k-70k yearly est. 33d ago
  • Clinical Research Regulatory Coordinator I

    Massachusetts Eye and Ear Infirmary 4.4company rating

    Remote job

    Site: Mass General Brigham Incorporated Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. Job Summary General Summary/Overview Statement: The Clinical Research Regulatory Coordinator I (CRRCI) works under general supervision to ensure the regulatory requirements for clinical trials are met. This position involves working with clinical teams, Institutional Review Boards (IRB), clinical trial sponsors and federal regulatory agencies. The CRRCI will be trained on the institutional and federal regulations governing clinical research. This position does not involve patient contact. Principal Duties and Responsibilities: The following regulatory duties will be performed under general supervision by the Clinical Research Manager: · Maintain and organize study specific regulatory binders · Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB · Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study · Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required · Submit Data and Safety Monitoring Reports · Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process · Collect, complete, and submit essential regulatory documents to various regulatory entities · Participate in monitoring visits and file all monitoring visit correspondence · Ensure appropriate documentation of delegation and training for all study staff members · Maintain screening and enrollment logs Skills/Abilities/Competencies Required · Careful attention to detail · Good organizational skills · Ability to follow directions · Good communication skills · Computer literacy · Working knowledge of clinical research protocols Qualifications Education: Bachelor's Degree Related Field of Study required Can this role accept experience in lieu of a degree? Yes Licenses and Credentials: n/a Experience: Knowledge, Skills and Abilities: - Careful attention to detail. - Good organizational skills. - Ability to follow directions. - Computer literacy. - Working knowledge of clinical research protocols. Additional Job Details (if applicable) Working Conditions: · Duties will be performed remotely Remote Type Remote Work Location 101 Merrimac Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $19.76 - $28.44/Hourly Grade 5 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: Mass General Brigham Incorporated is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.
    $19.8-28.4 hourly Auto-Apply 19d ago
  • Clinical Research Coordinator, Sr - Floater

    U.S. Renal Care, Inc. 4.7company rating

    Remote job

    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.
    $47k-76k yearly est. 36m ago
  • Clinical Research Coordinator (CRC)

    Smarter HR Solutions

    Remote job

    Job description Job Title: Clinical Research Coordinator (CRC) Job Type: Full-Time Job Schedule: M-F 40-hours/week This is an on-site position in Orange, CA, and applicants must reside within a commutable distance of 50 miles or less or be able to independently relocate. THIS IS NOT A REMOTE POSITION. Position Summary The Clinical Research Coordinator will support the planning, execution, and closeout of clinical studies involving human subjects. This includes FDA-regulated drug and device trials, NIH-funded research, and investigator-initiated protocols. The CRC ensures compliance with California-specific regulatory frameworks, institutional policies, and federal guidelines (FDA, ICH-GCP, HIPAA). Experience in CRC in Liver/GI/Obesity studies preferred! Key Responsibilities Study Operations Coordinate Phase I-IV clinical trials across multiple therapeutic areas. Prepare IRB submissions, amendments, and continuing reviews. Develop and maintain study documentation, SOPs, and case report forms. Schedule and conduct study visits, collect data, and ensure protocol adherence. Participant Management Recruit, screen, and consent participants in accordance with CPHS and institutional HRPP standards Educate participants on study procedures, risks, and rights Monitor for adverse events and report per FDA and California Health & Safety Code §24170-24179.5 Regulatory & Compliance Maintain audit-ready records and ensure GCP compliance Handle protected health information (PHI) securely under California law Liaise with sponsors, monitors, and regulatory bodies Data & Budget Oversight Enter and validate data in CTMS and EDC systems Assist with budget development and financial tracking Coordinate biospecimen collection, processing, and shipping Job Type: Full-time Work Location: In person Requirements Qualifications Education Bachelor's degree in health sciences, biology, nursing, or related field (Master's preferred). Formal training in clinical research or regulatory affairs. Experience 1-3 years of clinical research coordination experience, primarily in liver/GI/obesity studies. Familiarity with California IRB systems and CPHS protocols. Experience with FDA-regulated trials and NIH-funded studies. Skills Strong organizational and time management abilities. Excellent verbal and written communication skills. Proficiency in CTMS, EDC, and IRB platforms (e.g., iRIS, OnCore). Ability to work independently and collaboratively across teams Preferably bilingual in English/Spanish
    $49k-72k yearly est. 60d+ ago
  • Clinical Intern - Pharmacy

    Navitus 4.7company rating

    Remote job

    Company Navitus About Us Navitus - Putting People First in Pharmacy - Navitus was founded as an alternative to traditional pharmacy benefit manager (PBM) models. We are committed to removing cost from the drug supply chain to make medications more affordable for the people who need them. At Navitus, our team members work in an environment that celebrates diversity, fosters creativity and encourages growth. We welcome new ideas and share a passion for excellent service to our customers and each other._____________________________________________________________________________________________________________________________________________________________________________________________________________. Current associates must use SSO login option at ************************************ to be considered for internal opportunities. Pay Range USD $17.78 - USD $20.91 /Hr. STAR Bonus % (At Risk Maximum) 0.00 - Ineligible Work Schedule Description (e.g. M-F 8am to 5pm) M-Th between 8:30am to 7pm and F 8:30am-5pm Remote Work Notification ATTENTION: Navitus is unable to offer remote work to residents of Alaska, Hawaii, Maine, Mississippi, New Hampshire, New Mexico, North Dakota, Rhode Island, South Carolina, South Dakota, West Virginia, and Wyoming. Overview Navitus Health Solutions is seeking a Clinical Intern to join our team! The Clinical Intern will be a key contributor to the success of our Clinical Engagement Center focused on improving member's health and wellness via tele-pharmacy and wellness coaching. Under the supervision of a clinician, this individual is responsible for the delivery of the Medication Therapy Management (MTM) services for commercial and Medicare members. In addition, the Clinical Intern will assist in the development and execution of additional clinical outreach programs to exceed client expectations. The MTM program will include telephonic and/or video chat outreach with members to complete an analysis of a member's medication regimen for prescription, OTC, herbal and supplement medications. The assessment will include the development of a personalized Medication Action Plan in partnership with the member as required by CMS. Is this you? Find out more below! Responsibilities How do I make an impact on my team? Conduct medication therapy management (MTM) and expanded clinical programs in accordance with the Centers for Medicare & Medicaid Services (CMS). Develop appropriate clinical algorithms, pathways and call scripts to support pharmacy staff in delivering MTM services. Review and update all algorithms and call scripts with updated clinical guidelines. Develop documentation standards for clinical outreach. Collaborate with other CEC staff to develop and maintain a high quality and consistent MTM product. Assist CEC leadership to develop programs to support STAR ratings outreach. Provide clinical outreach to members, prescribers, and pharmacy providers in order to enhance care coordination. Develop a full understanding of Navitus' Clients' member experience and how the engagement center contributes to improved health and wellness. Adhere to compliance and HIPAA regulations. Participate in, adhere to and support compliance and diversity, equity, and inclusion program objectives. Other duties as assigned Qualifications What our team expects from you? Education: In DPH-2 or DPH-3 year. CPhT Preferred. Experience: Must be 18 years or older. Experience working in Microsoft Office suite, particularly Word, Excel, and PowerPoint preferred. The intern role is considered a learning opportunity and as such, no specific experience is required. Preference may be given to candidates with work experience or education paths determined desirable by the department each intern supports. Participate in, adhere to, and support compliance program objectives. The ability to consistently interact cooperatively and respectfully with other employees. Participate in, adhere to, and support compliance program objectives The ability to consistently interact cooperatively and respectfully with other employees What can you expect from Navitus? Top of the industry benefits for Health, Dental, and Vision insurance 20 days paid time off 4 weeks paid parental leave 9 paid holidays 401K company match of up to 5% - No vesting requirement Adoption Assistance Program Flexible Spending Account Educational Assistance Plan and Professional Membership assistance Referral Bonus Program - up to $750! #LI-Remote Location : Address Remote Location : Country US
    $17.8-20.9 hourly Auto-Apply 2d ago
  • Clinical Research Regulatory Coordinator I

    Brigham and Women's Hospital 4.6company rating

    Remote job

    Site: Mass General Brigham Incorporated Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. Job Summary General Summary/Overview Statement: The Clinical Research Regulatory Coordinator I (CRRCI) works under general supervision to ensure the regulatory requirements for clinical trials are met. This position involves working with clinical teams, Institutional Review Boards (IRB), clinical trial sponsors and federal regulatory agencies. The CRRCI will be trained on the institutional and federal regulations governing clinical research. This position does not involve patient contact. Principal Duties and Responsibilities: The following regulatory duties will be performed under general supervision by the Clinical Research Manager: * Maintain and organize study specific regulatory binders * Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB * Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study * Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required * Submit Data and Safety Monitoring Reports * Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process * Collect, complete, and submit essential regulatory documents to various regulatory entities * Participate in monitoring visits and file all monitoring visit correspondence * Ensure appropriate documentation of delegation and training for all study staff members * Maintain screening and enrollment logs Skills/Abilities/Competencies Required * Careful attention to detail * Good organizational skills * Ability to follow directions * Good communication skills * Computer literacy * Working knowledge of clinical research protocols Qualifications Education: Bachelor's Degree Related Field of Study required Can this role accept experience in lieu of a degree? Yes Licenses and Credentials: n/a Experience: Knowledge, Skills and Abilities: * Careful attention to detail. * Good organizational skills. * Ability to follow directions. * Computer literacy. * Working knowledge of clinical research protocols. Additional Job Details (if applicable) Working Conditions: * Duties will be performed remotely Remote Type Remote Work Location 101 Merrimac Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $19.76 - $28.44/Hourly Grade 5 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: Mass General Brigham Incorporated is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.
    $19.8-28.4 hourly Auto-Apply 19d ago
  • Clinical Trial Intern

    Vial

    Remote job

    Who We Are Vial is a hyper-scalable biotech company advancing programs into the clinic by leveraging dramatically cheaper trials and computationally designed therapeutics. Our mission is to reimagine drug development in order to cure all human diseases. We have assembled a talented team of clinical operators, chemists, and innovative thinkers to achieve this vision. Vial is fully remote and was founded by Simon Burns in October 2020. Since our founding, we have grown rapidly to a team of 50+ employees with over $100 million in funding from leading investors including General Catalyst, Box Group, and Byers Capital. Vial is rebuilding the infrastructure to advance research. By deploying technology at every step, we are creating a more efficient future for drug discovery. Why You'll Love Working At Vial Innate curiosity. At our core, we embody an insatiable curiosity. Our journey into the realm of clinical trials was ignited by a firsthand understanding of the challenges involved. This innate curiosity drives us to constantly innovate, seek fresh ideas, and bring our vision of reimagining clinical trials to life. Fostering autonomy. Autonomy is our guiding principle. We firmly believe that when team members are entrusted with autonomy, they unleash their true potential. Our culture fosters an environment where each individual takes ownership of their domain, empowering them to make a profound impact. The pursuit of mastery. We are dedicated to cultivating mastery. We understand the value of honing expertise in a craft. The pursuit of mastery, coupled with a deep sense of pride in one's workmanship, fuels our unwavering commitment to tackle intricate challenges. At Vial, we foster a culture of highly autonomous professionals, each an expert in their field, collaborating on an immensely demanding endeavor together. Move fast, stay humble. Our strength lies in agility and humility. We firmly believe that intellectual honesty and a nimble mindset are the pillars of success. By staying adaptable and open-minded to all solutions, we tackle obstacles head-on, remaining humble in the face of adversity. This enables us to surmount the hurdles that confront us at every twist and turn. What You'll Do Support the Clinical Development team in planning and execution of early-stage clinical trials. You'll gain exposure to protocol development, trial operations, and the systems that keep studies running smoothly. Key Responsibilities * Assist with preparation and review of trial documents (protocols, informed consent forms, study reports) * Track study timelines, milestones, and deliverables * Help organize and maintain clinical trial data, regulatory submissions, and correspondence * Support coordination with sites, CROs, and internal stakeholders * Contribute to process improvement projects within clinical operations What You Will Bring * Strong organizational skills and attention to detail * Interest in clinical research, drug development, or healthcare operations * Ability to manage multiple tasks and prioritize effectively * Strong written and verbal communication skills Preferred Skills * Background in life sciences, public health, or related field * Familiarity with clinical trial design or regulatory environment (FDA, ICH/GCP) * Experience with project management tools (Notion, Excel, or similar) * Previous internship or coursework in clinical research a plus
    $29k-43k yearly est. 60d+ ago
  • Clinical Practicum Intern (Master's Level)

    Charlie Health

    Remote job

    Why Charlie Health? Millions of people across the country are navigating mental health conditions, substance use disorders, and eating disorders, but too often, they're met with barriers to care. From limited local options and long wait times to treatment that lacks personalization, behavioral healthcare can leave people feeling unseen and unsupported. Charlie Health exists to change that. Our mission is to connect the world to life-saving behavioral health treatment. We deliver personalized, virtual care rooted in connection-between clients and clinicians, care teams, loved ones, and the communities that support them. By focusing on people with complex needs, we're expanding access to meaningful care and driving better outcomes from the comfort of home. As a rapidly growing organization, we're reaching more communities every day and building a team that's redefining what behavioral health treatment can look like. If you're ready to use your skills to drive lasting change and help more people access the care they deserve, we'd love to meet you. About the Role Charlie Health is seeking passionate and driven second-year master's students in mental health programs (such as Social Work, Clinical Mental Health Counseling, Marriage and Family Therapy, or related fields) to join our dynamic virtual care team for their clinical practicum or internship experience. As a clinical practicum student at Charlie Health, you'll gain direct experience working with high-acuity clients in a virtual Intensive Outpatient Program (IOP) setting. Under the close supervision of one of our experienced therapists, you'll develop your clinical skills through a variety of client interactions and treatment modalities. This internship offers a unique opportunity to work across: Group treatment sessions Individual therapy sessions Family therapy sessions Crisis intervention Clinical research Clinical curriculum What You'll Gain Exposure to evidence-based practices used in treating high-acuity teens and adults Experience working within a multidisciplinary team of primary therapists, group facilitators, and care coordinators Training and mentorship from experienced clinicians in the field Skills in virtual care delivery, documentation, and client engagement We're a team of passionate, forward-thinking professionals eager to take on the challenge of the mental health crisis and play a formative role in providing life-saving solutions. If you're inspired by our mission and energized by the opportunity to increase access to mental healthcare and impact millions of lives in a profound way, apply today. Responsibilities Participate in group sessions as well as individual and family therapy sessions under the supervision of an experience clinician Observe and co-facilitate therapeutic interventions using evidence-based modalities Attend clinical supervision meetings and engage in reflective practice to support growth and development Collaborate with members of the interdisciplinary care team to ensure high-quality, coordinated care Maintain confidentiality and adhere to all ethical and professional standards Engage in ongoing learning and training opportunities related to trauma-informed care, telehealth best practices, and working with high-acuity populations #LI-Remote Requirements Enrollment in a master's-level program in Social Work, Clinical Mental Health Counseling, Marriage and Family Therapy, or a related discipline (see list below for examples) Students should be in the second year of their master's program by the time the practicum or internship begins, meeting eligibility requirements to start clinical hours. Interest in working with high-acuity populations and providing trauma-informed care For clinical time, we require a combination of afternoon or evening availability. Non-clinical, administrative, and case management duties can be done outside these hours. A complete schedule will be set individually with the intern to account for clinical time, admin time, and supervision/training meetings. Reliable WIFI connection and familiarity with cloud based communication software (Gmail, Slack, Zoom, Dropbox) Ability to skillfully engage a wide range of ages including children, teens, young adults, and adults over video technology. Strong communication and organizational skills Note: Internship placements are contingent on the availability of clinical supervisors licensed in your state. If you are enrolled in a graduate program we do not currently partner with, additional conversations and a formal agreement with your school will be required before placements are confirmed Example Master's Programs: Master of Science (M.S.) in Mental Health Counseling Master of Social Work (M.S.W.) with a concentration in Mental Health Master of Science (M.S.) in Clinical Mental Health Counseling Master of Arts (M.A.) in Marriage and Family Therapy Other Masters Degree programs that allow pursuit of a Social Work, Marriage & Family, or Counseling license (mental health / therapy focused) Our Values Connection: Care deeply & inspire hope. Congruence: Stay curious & heed the evidence. Commitment: Act with urgency & don't give up. Please do not call our public clinical admissions line in regard to this or any other job posting. Please be cautious of potential recruitment fraud. If you are interested in exploring opportunities at Charlie Health, please go directly to our Careers Page: ******************************************************* Charlie Health will never ask you to pay a fee or download software as part of the interview process with our company. In addition, Charlie Health will not ask for your personal banking information until you have signed an offer of employment and completed onboarding paperwork that is provided by our People Operations team. All communications with Charlie Health Talent and People Operations professionals will only be sent *********************** email addresses. Legitimate emails will never originate from gmail.com, yahoo.com, or other commercial email services. Recruiting agencies, please do not submit unsolicited referrals for this or any open role. We have a roster of agencies with whom we partner, and we will not pay any fee associated with unsolicited referrals. At Charlie Health, we value being an Equal Opportunity Employer. We strive to cultivate an environment where individuals can be their authentic selves. Being an Equal Opportunity Employer means every member of our team feels as though they are supported and belong. We value diverse perspectives to help us provide essential mental health and substance use disorder treatments to all young people. Charlie Health applicants are assessed solely on their qualifications for the role, without regard to disability or need for accommodation. By submitting your application, you agree to receive SMS messages from Charlie Health regarding your application. Message and data rates may apply. Message frequency varies. You can reply STOP to opt out at any time. For help, reply HELP.
    $29k-43k yearly est. Auto-Apply 32d ago
  • Clinical Research Coordinator III - RN

    Invitrogen Holdings

    Remote job

    Work Schedule Standard (Mon-Fri) Environmental Conditions Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future. Discover Impactful Work: We are seeking a Clinical Research Coordinator III (Registered Nurse) to support our government customer on-site in Silver Spring, Maryland . This is a per diem, non benefited position. Availability needed (6:00 am - 10: 00 am). Relocation assistance is NOT provided for this role. Must be a U.S. citizen. Must be able to pass a comprehensive background check, which includes a drug screening and a physical. Required to be a Registered Nurse licensed to practice in the state of Maryland. A day in the Life: Organizes and prioritizes all activities associated with conducting phase 1, 2, and 3 clinical and operational research studies within a military clinic setting. Reviews and understands research protocols, ensuring applicable regulations and guidelines are followed. Organizes research information for clinical projects Selects and observes subjects and assists with data analysis and reporting. Oversees experiment scheduling and collection of data. Participates in source document and study document design, writing SSP, materials planning, visit schedule creation, etc. Enters required data routinely on CRFs and audit records for accuracy, resolve discrepancies, and correct as necessary. Maintains study/test article or investigational product accountability and administration. Monitors study data collection procedures to ensure uniformly high levels of compliance with GCP, GLP, FDA and other government- or locally required guidance. Relies on experience and judgment to plan and accomplish goals. Works under general supervision and performs a variety of tasks. Keys to Success: Required Education Required to be a Registered Nurse licensed to practice in the state of Maryland, who is skilled and qualified in nursing procedures to include, but not limited to the administration of experimental vaccines and other parenteral therapeutics as per specific protocol guidance in accordance with the 21 Code of Federal Regulation (CFR) 11, 50, 54, 56, 312, and 314. Basic Life Support (BLS -CPR/AED) certification. Required Experience and Skills: Five (5) years of experience in clinical research coordination, with expertise in FDA-regulated trials. Experience utilizing clinical trial management systems and databases (e.g., REDcap and Inform). Must be able to work both independently and in a team setting following a brief period of specific technical training. Must have excellent communication, organization, and prioritization skills. Ability to establish and maintain effective working relationships with coworkers, managers and customers. Maintenance of Certification in Clinical Research Coordination by Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SoCRA). Desired Experience and Skills Advanced Cardiac Life Support (ACLS) certification encouraged. Certification in clinical research (e.g., CCRP or CCRA) is preferred. Commission for Case Manager Certification (CCMC) certification preferred. Compensation and Benefits The salary pay range estimated for this position CRA (Level II) based in Maryland is $38.46-$44.23. This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes: A choice of national medical and dental plans, and a national vision plan, including health incentive programs Employee assistance and family support programs, including commuter benefits and tuition reimbursement At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount For more information on our benefits, please visit: *****************************************************
    $44k-62k yearly est. Auto-Apply 60d+ ago
  • Clinical Research Coordinator (Onsite Dallas, TX)

    Syneos Health Clinical Lab

    Remote job

    Illingworth Research Group provides a range of patient focused clinical services to the pharmaceutical, healthcare, biotechnology and medical device industries. These include mobile research nursing, patient concierge, medical photography and clinical research services. Illingworth are experts with experience across all study phases and in a diverse range of therapeutic areas. Illingworth Research Group is a global organization operating in over 45 countries, bringing clinical research directly into the home of the patient, to improve the experience of patients involved in clinical trials and the quality of their lives. Job Responsibilities Clinical Research Project Planning and Preparation Review of assigned protocols and other protocol documentation (ICF, IB) for accuracy, feasibility, timing, and resources. Prepare and maintain the Investigator Site File and/ or Trial Master File (TMF) for the study. Participate in creation and review of timelines and start-up meetings (Investigator Meeting/SIV, Sponsor discussions, or other related meetings). Take the lead and/or overall coordination of all required start-up activities including, but not limited, to the following: o Clinic logistics planning, schedule of clinic activities, and team training. o Preparation, review, and/or finalization of clinic source documents, time and events tables, and other required study materials; review of Case Report Forms (CRFs), laboratory workbooks, staff requirements, and schedules. o In collaboration with the responsible teams, establishes and/or maintains safety assessment requirements, Quality Control (QC) and monitoring plans, pharmacy/dispensing requirements, study supplies/equipment, meal plans, and other elements as applicable to the study. o Confirms all required regulatory and contractual documentation is present prior to study start. Support the Principal Investigator as needed with study related tasks such as, but not limited to: o Delegation of Authority Log. o Management of daily tasks. o Visit calendar development and maintenance. o Scheduling and attending monitor visits. Advertise, recruit, and screen potential participants for the study. Clinical Conduct Perform all study activities following Good Clinical Practices (GCP). Manage multiple clinical trials simultaneously. Protect the safety of human subjects. Monitor appropriate sources for specific clinical study or federal regulation updates. Collect and enter study data into the appropriate system. Coordinate and monitor screening activities; provides support as required. Assist with informed consent of study subjects. Submit data in required timeframe. Monitor appropriate sources for specific clinical study or federal regulation updates. Complete Case Report Forms. Facilitate audits of study data. Develop patient rapport to explain research protocols and minimize protocol violations. Develop rapport with study team to educate team on study procedures and minimize protocol violations. Respond to inquiries by auditors for data clarification or additional data in required timeframe. Take the lead and/or overall coordination of clinic activities including, but not limited to: o Supervises clinic visits (admission, dosing and randomization, discharge, and follow-up) as required and provides on-call support when applicable. o Screens eligibility prior to randomization; oversees, coordinates and/ or performs study drug administration, and other activities as delegated and required. o In collaboration with the responsible teams, monitors that all study-related activities are conducted according to protocol, SOP, and applicable regulations. Review and manage clinic updates, Adverse Event (AE) or Serious Adverse Events (SAEs) reporting, study logs and tracker, quality control, and Monitor findings. Post-Clinic/Close-Out Activities Coordinate resolution and/or address QC, monitor, CRF, or other internal/external findings. Review and/or oversee close-out of study documentation, deviation reporting, CRF completion and sign-off, and other study-related reports/documentation. Review and update TMF documentation. Finalize study and/or volunteer logs. Ensure completion of other close-out activities as required (return of study supplies, IRB reports, archiving, etc.). Responsible for monitoring subjects' compliance throughout the trial and address day-to-day. subject or study issues and escalate as appropriate. Prepare for and participates in sponsor/monitor/QA audits. Provide accurate and timely project status updates to Project Managers and sponsor. Collaborate within and between teams during process improvement exercises, SOP creation. and/or revision, internal and external meetings, and other company-related initiatives and goals. Accommodate flexible schedule (available days, afternoons, nights, and weekends). Perform other work-related duties as assigned. Coordinate and Perform Regulatory Activities Maintain proper protocol, consent, amendment, and yearly renewal submission if requested. Report adverse events relating to the trial. Maintain study files. Travel up to 100% QUALIFICATION REQUIREMENTS Registered Nurse and/ or University Degree such as Bachelor of Science Degree required. Clinical Research certification preferred. A minimum of 1 year experience in clinical research required, preferably in coordination of clinical research projects. 2+ years preferred. Good knowledge of regulations, ICH GCP, privacy, and applicable guidelines. Required skills: problem solving, planning, and evaluation. Possess good time management, detail-oriented, and able to multi-task. Good interpersonal and communication skills with a team focus. Knowledge of SOP writing. Ability to anticipate problems and provide solutions in a timely manner. Ability to coordinate multiple clinical research projects with competing deadlines. Proficiency in computer software programs (e.g. Word, Excel, Power Point). Proficiency in use of various clinical trial EDC software preferred. Disclaimer: 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 . The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available. 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. 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.
    $44k-62k yearly est. Auto-Apply 21d ago
  • Intern I - Clinical Data

    Dexcom 4.7company rating

    Remote job

    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. About Dexcom's Summer Intern Program: Are you passionate about innovative technology and improving lives? Dexcom's 12-week U.S. internship program offers a unique opportunity to work on impactful projects that support people living with diabetes. Designed to develop future leaders, our program provides hands-on experience, professional development, and exposure to real-world challenges in a dynamic, mission-driven environment. With flexible onsite, hybrid, and remote work options, we welcome talented students from across the country. Interns at Dexcom don't just participate-they lead. Join us in summer 2026 and help shape the future of healthcare technology! Internship Department Details: Department Name: Data Management Business Function: Supporting clinical trials through data management, data integrity and ensure the data quality before delivering for final data analysis Team Highlights: You will join the team focusing on ensure high-quality clinical data delivering to support regulatory. submissions and product development. We work closely with cross-functional team including clinical affairs team, biostatistics, data science and R&D. Where you come in: You will assist in reviewing and cleaning clinical trial data to ensure accuracy and completeness and collaborate with team members to identify the resolve data discrepancies. You will help maintain data management documents. You will support database testing and validation and leverage tools such as SAS/Power BI/EDC to support data checking. What makes you successful: You are detail-oriented and have strong communication skills to work with cross-functional team. You have interest in data analysis related skills or life science related knowledge and willing to learn about clinical trials. What you'll get from your Intern Program: A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community. Meaningful work and assignments that impact your early career development. Participation in a targeted Learning Series that encourages professional development topics and provides insight into Dexcom's culture and career opportunities. Engagement in Social Events, Intern Recognition Awards, Paid Holidays, and more! Travel Required: 0-5% 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. Experience and Education Requirements: Requires a high school diploma/certificate or equivalent. Must be a currently enrolled student at an accredited college or university in a STEM discipline with an expected graduation date of December 2026 or later. Non-Exempt Salary Details: The annualized base salary range for this role is $27.00 to $29.00. Annualized values for non-exempt (hourly) positions are estimates, final annualized salary will depend on total hours worked. Final compensation package will ultimately depend on factors including relevant experience, skillset, knowledge, business needs and market demand. 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.
    $27-29 hourly Auto-Apply 60d+ ago
  • Clinical Research Coordinator

    American Oncology Network

    Remote job

    Pay Range: Responsible for the performance of the research study under the medical supervision of the Principal Investigator. Clinical Research Coordinator II (non-RN) performs tasks independently, consistently and accurately, and demonstrate that they have achieved a moderate level of expertise in all of their skills and abilities resulting in high quality work Primary responsibility includes complex types of study designs (phase 1-3, multi-cohort, interventional trial design) and associated study procedures. Administratively and clinically manage an average 10 clinical trials open to accrual annually and/or active (on study treatment) patient volume over 25 annually Demonstrates working knowledge of all facets of role, relevant regulations, and organizational and departmental policies and procedures. Performs other duties and projects as assigned. Performs all duties in accordance with regulatory requirements and organizational policies and procedures. Primary Key Performance Areas: KPA 1 - Protocol Comprehension and Implementation: Coordination of care for patients on clinical research protocols in accordance with GCP, ICH/FDA guidelines and requirements. Demonstrate an understanding of protocol elements / requirements and demonstrate the ability to execute study procedures. Demonstrate the ability to anticipate and mitigate the potential for protocol non-compliance. Conduct protocol feasibility assessments and complete feasibility/site assessment questionnaires Assess subjects on the basis of inclusion/exclusion criteria and demonstrate the ability to evaluate and document subject eligibility independently. Reviews draft informed consent documents in compliance with regulatory requirements and GCPs. Conduct an informed consent discussion in compliance with SOPs Review and interpret diagnostic test results and related documentation required per protocol Follows process for capturing, assessing, determining causal relationship of adverse events to the investigational product, investigator oversight, reporting and following up on adverse events. Recognize, report and follow up on all types of adverse events Maintain accurate records of the receipt, inventory, distribution and destruction of study-related materials / investigational products and research specimens. Ensure that the investigational drug is received, stored, and documented, and that excess materials are returned to the sponsor according to sponsor guidelines and in accordance with Code of Federal Regulations. Assesses and manages investigational products that have been compromised. KPA 2 - Regulatory and Data Integrity Understanding of the IRB/IEC review, key elements of review considerations, approval and reporting requirements for the site. Complete all IRB/IEC-related documents over the course of a clinical study. Maintains site credentials and ensures updated GCP, licenses remain on file Comply with reporting of safety related subject discontinuation and safety concerns (AE, SAE or AE of Interest) to the sponsor and IRB/IEC. Autonomously collect, record and report accurate data and demonstrate per FDA guidelines, and review them against the patient's medical record for completeness and accuracy. Ensure scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials Manage a monitoring visit including appropriate preparations, support, documentation and follow up. Maintain proper (accurate and timely) communication with the monitor and follow up on all monitor requests Implement a CAPA assessment and follow CAPA related issues through to resolution. Escalates issues of protocol non-compliance to study PI and research department leadership KPA 3 - Research Financial Practices: Budget/Contract execution and practices research billing compliance Assess a protocol and study plan to develop a study budget. Understanding of the payment terms of the study budget and the and tract items that need to be invoiced for a clinical study. Position Qualifications/Requirements: Education:. High school education required Some college required, bachelor's degree preferred and/or Licensed Practical Nurse required Certifications/Licenses: Previous Experience: 2-5 years prior oncology research/related medical science experience Core Capabilities: Analysis & Critical Thinking: Critical thinking skills including solid problem solving, analysis, decision-making, planning, time management and organizational skills. Must be detailed oriented with the ability to exercise independent judgment. Interpersonal Effectiveness: Developed interpersonal skills, emotional intelligence, diplomacy, tact, conflict management, delegation skills, and diversity awareness. Ability to work effectively with sensitive and confidential material and sometimes emotionally charged matters. Communication Skills: Good command of the English language. Second language is an asset but not required. Effective communication skills (oral, written, presentation), is an active listener, and effectively provides balanced feedback. Customer Service & Organizational Awareness: Strong customer focus. Ability to build an engaging culture of quality, performance effectiveness and operational excellence through best practices, strong business and political acumen, collaboration and partnerships, as well as a positive employee, physician and community relations. Self-Management: Effectively manages own time, conflicting priorities, self, stress, and professional development. Self-motivated and self-starter with ability work independently with limited supervision. Ability to work remotely effectively as required. Must be able to work effectively in a fast-paced, multi-site environment with demonstrated ability to juggle competing priorities and demands from a variety of stakeholders and sites. Computer Skills: Proficiency in MS Office Word, Excel, Power Point, and Outlook required. Prior experience with electronic medical records (EMR) is preferred Prior experience with clinical trial data entry systems (EDC) preferred Prior Clinical Trial Management Systems (CTMS) preferred. Travel: 0%Standard Core Workdays/Hours: Monday to Friday 8:00 AM - 5:00 PM.
    $38k-57k yearly est. Auto-Apply 57d ago
  • Clinical Research Coordinator to Home-Based CRA (Clinical Research Associate)

    Medpace 4.5company rating

    Remote job

    Clinical Research Coordinators wanted at Medpace! Become a CRA and join our growing team! This is an exciting opportunity for clinical research professionals with at least one year of Clinical Research Coordinator experience to fill Clinical Research Associate (CRA) openings with Medpace. Through our PACE Training Program, you will receive the training needed to become a fully functional CRA with the opportunity to work home-based. You will also have the opportunity to earn a generous travel bonus in addition to a competitive salary. WE OFFER THE FOLLOWING * Competitive travel bonus; * Equity/Stock Option program; * Training completion and retention bonus * Annual merit increases; * 401K matching; * The opportunity to work from home; * Flexible work hours across days within a week; * Retain airline reward miles and hotel reward points; * Home office furniture allowance, laptop, mobile phone with hotspot for internet access anywhere; * In-house travel agents, reimbursement for airline club, and TSA pre-check; * Opportunity for leadership positions - Lead CRA, CRA Manager, Clinical Trial Manager, Training and Development Manager, and many more; * CRA training program (PACE); * Ongoing therapeutic training by our in-house physicians who are medical and regulatory experts; * In-house administrative support for all levels of CRAs; and * Opportunities to work with international team of CRAs. Responsibilities * Conduct qualification, initiation, monitoring, and closeout visits at research sites in compliance with the approved protocol; * Communication with the medical site staff including coordinators, clinical research physicians, and their site staff; * Verify adequate investigator qualifications, training and resources, including facilities, laboratories, equipment, and staff; * Medical record and research source documentation verification against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory requirements; * On-site and virtual/remote monitoring activities with a risk-based monitoring approach (including centralized data review) through our integrated Clinical Trial Management System to identify site deviations/deficiencies and corrective/preventive actions to bring a site back into compliance and mitigate risks moving forward; * Verification that the investigator is enrolling only eligible subjects; * Regulatory document review; * Medical device and/or investigational product/drug accountability and inventory; * Verification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol; * Assess the clinical research site's patient recruitment and retention success and offering suggestions for improvement; and * Completion of monitoring reports and follow-up letters, which includes providing summaries of the significant findings, deviations, deficiencies, and recommended actions to secure compliance. Qualifications * Must have a minimum of a Bachelor's degree in a health or science related field; * Experience as a Clinical Research Coordinator (minimum 1 year); * Ability to travel 60-70% to locations nationwide is required; some visits may be conducted remotely; * Must maintain a valid driver's license and the ability to drive to monitoring sites; * Proficient knowledge of Microsoft Office; * Strong communication and presentation skills; and * Must be detail-oriented and efficient in time management. #LI-Remote Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks * Flexible work environment * Competitive PTO packages - starting at 20+ days * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Competitive compensation and benefits package * Structured career paths with opportunities for professional growth * Discounts for local businesses Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.
    $42k-62k yearly est. Auto-Apply 60d+ ago
  • Clinical Coordinator (Hybrid)

    Samuel Merritt University 4.6company rating

    Remote job

    The Clinical Coordinator coordinates the clinical and/or community placement activities of the pre-licensure or graduate nursing programs within the College of Nursing for an assigned campus. Assists the team to develop, coordinate, assigns, and maintain clinical and/or community site relationships. Collects and/or maintains documentation required by the clinical and/or community sites to be compliant with policies and standards. Collaborates with the specific placement director for program-specific needs. Duties and Responsibilities: I. Coordinate Clinical Placements 1. Work with CCT leadership and Clinical Directors of pre-licensure to ensure adequate clinical/community placements (sites, preceptors, and required hours) are available. 2. Communicate effectively with the relevant individuals and groups (internally and externally) reporting any concerns to the Director(s) of Clinical Affairs for follow-up. 3. Provide guidance and support for students to prepare for onboarding and progression through the entire clinical/community placement process. 4. Maintain ongoing communication with the Clinical Coordinators and Placement Directors regarding updates (e.g., new policies, new trainings) from clinical partners that may have an impact on student placement. 5. Participate in meetings with clinical partners locally and/or regionally as requested by CCT leadership. 6. Maintain, or have immediate access to, the documents required by clinical partners to demonstrate student and faculty compliance during audits. 7. Develop and maintain proficiency in multiple applications for all clinical placement activities. II. Procurement and Management of Clinical Sites 1. Maintain relationships with existing sites/preceptors to ensure a positive relationship. 2. Represent the Samuel Merritt University School of Nursing in a positive and professional manner. 3. Prepare, and review for accuracy, the clinical contract request forms and submit to the SMU Contract Specialist for processing. 4. Monitor contract status of all clinical sites (new and existing contracts) and notify Directors when contracts expire or need renewal. 5. Maintains an accurate database to document status of student displacements and the resolution. III. Compliance A. CLINICAL SITES 1. Maintain a current repository of all SMU required preceptor documents and manage the distribution of these documents to clinical sites as necessary. 2. Submit required clinical/community documents to the sites in a timely and complete manner. 3. Submit course syllabi and objectives to clinical/community partners/preceptors prior to the start of the course at their requests. 4. Communicate with the hospital partners regarding Preceptorship and provide necessary paperwork/documentation for the student rotation. 5. Submit to the clinical/community sites student rosters, contact information and other required information prior to clinical rotations. B. STUDENTS 1. Ensure students have submitted all required documents for their specific clinical site assignments in a timely manner. 2. Assist AA to confirm all student compliance requirements are complete and uploaded into the SMU system as required by Samuel Merritt University programs and various clinical sites. 3. Ensure students are aware of required documents and/or logs they need to maintain during their clinical/community rotations. This includes providing students with instructions on how to access, complete and submit. 4. Maintain access to My Clinical Exchange and other similar systems (i.e., accounts) are up to date; monitor for account expirations 5. Confirm access for students to site specific systems, i.e., OAR (Sutter) and UC Davis. Identity; monitor for expiration dates and need for renewal. C. FACULTY 1. Ensure clinical faculty have submitted all required documents for their specific clinical site assignments in a timely manner. 2. Assist AA to ensure all faculty compliance requirements are met and uploaded into the SMU system as required by Samuel Merritt University programs and various clinical sites. 3. Ensure access to My Clinical Exchange and other similar systems (i.e., accounts) are up to date; monitor for account expirations 4. Confirm access for faculty to site specific systems, i.e., OAR (Sutter,) UC Davis and NUIDs Identity; monitor for expiration dates and need for renewal. IV. General Administrative Support 1. Receive and direct inquiries from clinical/community sites, preceptors, and students to appropriate administrators, faculty, and staff, as needed 2. Assist AA with scheduling on campus electronic health record training for faculty (PL) and students prior to start of clinical/community rotation 3. Participate in new student orientation, as appropriate for each program, to provide clinical/community overview and unique requirements 4. Assist AA to schedule/arrange new faculty orientation at the clinical/community site; maintain documentation of completion date. 5. Collaborate with Program Chair/Course Managers to ensure clinical/community faculty are appropriate for each clinical setting. MINIMUM QUALIFICATIONS Self-starter that takes initiative and independently develops solutions. Strong leadership and evaluation skills. Excellent communication, written, oral and negotiation skills. Excellent interpersonal skills that would support optimal public relations for CCT and the SoN. Good judgement and creative critical thinking to solve problems and to develop alternative solutions. Handle privileged information in a confident manner. Ability to organize and prioritize workload. Effective project planning and implementation skills. Excellent organizational and operational skills. Excellent concentration and attention to details required for an extended period of time Extensive computer experience and the ability to use the Microsoft Office Suite (Word, Excel, PowerPoint). Ability to speak effectively with public, co-workers, faculty and student populations. Ability to receive and interpret detailed information through written and verbal communication. Ability to read and write clear documents PHYSICAL REQUIREMENTS Considerable time is spent at a desk using a computer. Physical ability to lift, bend and flex the upper body. Ability to lift up to 20-30 pounds; Ability to push and pull carts. May be required to attend conference and training sessions within Bay Area. May be required to travel occasionally to offsite campuses and agency locations. EDUCATION, QUALIFICATIONS AND/OR EXPERIENCE Bachelor's Degree Required SUPERVISORY RESPONSIBILITIES Assist with supervising/managing student employees and work-study projects Employee Status:RegularExemption Status:United States of America (Non-Exempt) Time Type:Full time Job Shift: Pay Range: $29/hr to $35/hr ( non exempt/hourly) Samuel Merritt University currently provides base salary ranges for all positions-on job advertisements-in the United States based on local requirements. Individual compensation will ultimately be determined based on a variety of relevant factors including but-not limited to qualifications, geographic location, and other relevant skills.
    $29 hourly Auto-Apply 53d ago
  • Clinical Research Coordinator I

    St. Charles Health System 4.6company rating

    Remote job

    This position may be filled at the coordinator level 1 or level 2, based on experience/qualifications and requires the incumbent to reside in Central Oregon: Level 1 Pay range: $25.18 - $37.77 per hour. Level 2 Pay range: $27.20 - $40.79 per hour. St. Charles Health System is a leading healthcare provider in Central Oregon, offering a comprehensive range of services to meet the needs of our community. We are committed to providing high-quality, compassionate care to all patients, regardless of their ability to pay. Our values of compassion, excellence, integrity, teamwork, and stewardship guide our work and shape our culture. What We Offer: Competitive Salary Comprehensive benefits including Medical, Dental, Vision for you and your immediate family 403b with up to 6% match on Retirement Contributions Generous Earned Time Off Growth Opportunities within Healthcare ST. CHARLES HEALTH SYSTEM JOB DESCRIPTION TITLE: Clinical Research Coordinator I REPORTS TO POSITION: Research Manager DEPARTMENT: Research DATE LAST REVIEWED: November 15, 2024 OUR VISION: Creating America's healthiest community, together OUR MISSION: In the spirit of love and compassion, better health, better care, better value OUR VALUES: Accountability, Caring and Teamwork DEPARTMENTAL SUMMARY: St. Charles Research Department conducts clinical trials for promising new treatments and therapies in a wide variety of medical fields, including cancer treatment and prevention, cardiovascular disease and supportive care. POSITION OVERVIEW: The Clinical Research Coordinator I is responsible for conducting clinical trials in compliance with FDA regulation, ICH Guidelines and applicable industry standards. The Clinical Research Coordinator 1 will oversee up to ten clinical trials as the main research coordinator. This position does not directly manage other caregivers, however may be asked to review and provide feedback on the work of other caregivers. ESSENTIAL FUNCTIONS AND DUTIES: Maintains surveillance system to identify potential subjects for study eligibility, prescreen patients, and assists physicians in determining eligibility. Obtains informed consent according to GCP and ICH guidelines. Performs study procedures and assessments following protocol specific guidelines. Assures research is conducted in an ethical and safe manner according to FDA, ICH and St. Charles Health System guidelines. Adheres to St. Charles Health System's compliance plan. Attends IRB meetings as requested by the IRB. Supports the processing of study alerts, protocol revisions, amendments, accrual suspension notices, informed consent modifications, product information and advertisement, and related memoranda. Supports the modification of template informed consent forms for local application in compliance with federal guidelines for patients in lay language at appropriate reading level Prepares for and participates in required sponsor and regulatory audits. Attend Investigator meetings as required to assure seamless study start-up. Assists with subject education and informed consent process, including tissue and genetics consent when indicated. Surveys for re-consent and obtains from eligible subjects. Educates patients regarding protocol diagnostic tests and assists with appointments. Process tissue/blood specimens and prepare it for shipment. Manages treatment and follow-up schedules to assure protocol compliance. Attends subject clinic visits and interacts with subjects and staff as appropriate to assist in protocol adherence. Track study drug usage per protocol and oversee study drug supply. Maintains subject research records including long-term follow up and reporting. Participates in institutional research activities (committee meetings, Tumor Boards, Grand Rounds, other conferences, etc.) that are relevant to the Position. Keeps current with new developments in research methodologies. Participates in quality assurance program for St. Charles Health System and affiliated research partners. Supports the vision, mission and values of the organization in all respects. Supports Value Improvement Practice (VIP- Lean) principles of continuous improvement with energy and enthusiasm, functioning as a champion of change. Provides and maintains a safe environment for caregivers, patients and guests. Conducts all activities with the highest standards of professionalism and confidentiality. Complies with all applicable laws, regulations, policies and procedures, supporting the organization's corporate integrity efforts by acting in an ethical and appropriate manner, reporting known or suspected violation of applicable rules, and cooperating fully with all organizational investigations and proceedings. Delivers customer service and/or patient care in a manner that promotes goodwill, is timely, efficient and accurate May perform additional duties of similar complexity within the organization, as required or assigned. EDUCATION: Required: Bachelor of Science degree, or combination of college level education and Research experience to perform the full scope of position duties. Preferred: Bachelor of Science degree in related field. LICENSURE/CERTIFICATION/REGISTRATION Required: Association of Clinical Research Professional (ACRP) or Society of Clinical research Associates (SOCRA) certification or must obtain within 2 years of full time employment. Current American Heart Association (AHA) Basic Life Support for Healthcare Provider certification. Preferred: N/A EXPERIENCE: Required: None Required. Preferred: Experience as a Clinical Research Coordinator. Experience dealing with multidisciplinary teams. Basic Clinical task knowledge. ADDITIONAL POSITION INFORMATION: N/A Schedule Weekly Hours: 40 Caregiver Type: Regular Shift: First Shift (United States of America) Is Exempt Position? No Job Family: COORDINATOR CLERICAL Scheduled Days of the Week: Monday-Friday Shift Start & End Time: Variable
    $25.2-37.8 hourly Auto-Apply 11d ago
  • Clinical Research Recruitment Coordinator

    Irvine Clinical Research

    Remote job

    Job DescriptionIrvine Clinical Research is the largest independent memory research center on the West Coast. Alzheimer's Disease is a serious cognitive illness that affects millions of people each year. Every research trial brings us closer to finding a treatment or cure for Alzheimer's Disease. A recent study conducted at Irvine Clinical Research was successful in slowing cognitive decline by as much as 27%. Irvine Clinical Research is looking for a friendly, outgoing person to join our team as a Clinical Research Recruitment Coordinator. You will be speaking with potential study participants about their health concerns, especially around memory loss, and when appropriate, presenting research as a care option.In this role, expect to Recruit study participants via short telephone interviews; make outbound phone calls to achieve appointment scheduling goal Build rapport with potential participants to ensure engagement and retention Promote Irvine Clinical Research's services and the opportunity to advance the fight against Alzheimer's Disease via study participation Work independently while still being accountable to recruitment goals Input data into electronic systems in a consistently timely and accurate manner Assist with other recruitment, marketing, and outreach efforts as needed To succeed in this role, you have A welcoming, friendly, and professional attitude and demeanor that you bring with you every day Ability to consistently build trust and rapport with persons concerned about memory High attention to detail for all of your work responsibilities Time management skills to coordinate and manage recruitment calls efficiently Nice to have, but not essential Experience speaking with people with cognitive issues or older adults Call center or clinical research experience Salesforce/CRM/CTMS experience Hours and CompensationThis is a full-time employment position based in-person at our clinic in the Alzheimer's Orange County building in Irvine. There is an opportunity to transition to hybrid or remote work after 6 consecutive months of meeting performance standards. The starting salary for this position is $25 per hour (approximately $52k per year). The company pays for 100% of health/dental/vision individual insurance costs for eligible full-time employees. Vacation (PTO) is earned at a rate of 3 weeks per year.Equal Employment OpportunityIrvine Clinical Research is committed to diversity within our organization and building an equitable and inclusive environment for people of all backgrounds and experiences. Irvine Clinical Research provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Irvine Clinical Research complies with all state and local laws governing nondiscrimination in employment in any location. We especially encourage members of traditionally underrepresented communities to apply, including women, people of color, LGBTQ people, veterans, and people with disabilities.
    $52k yearly 29d ago
  • Clinical Research Systems Coordinator - (Clinical Conductor experience required)

    Alcanza Clinical Research

    Remote job

    Department Clinical Systems Employment Type Full Time Location Alcanza Corporate Workplace type Fully remote Reporting To Tina White Key Responsibilities Skills, Knowledge and Expertise Benefits About Alcanza Clinical Research Alcanza Clinical Research (“Alcanza”) is a national, collaborative network of clinical research sites, founded on the mission to accelerate the development of new therapies by reducing barriers to clinical research participation for all. We conduct research on dozens of conditions in several therapeutic areas including psychiatry, neurology, dermatology, and infectious disease. Our work is important to the patients who participate, the scientists who develop these new therapies, and the entire medical community. Because all approved medications require clinical trials, the impact of your work is exponential, reaching many thousands of future patients and improving their quality of life. Alcanza is a culturally competent organization. We treat each other with dignity, creating an environment where all individuals feel welcome, heard, and respected for their unique perspectives and aspirations. We put considerable effort into finding exceptional employees who mirror the values most important to us: Inclusive, Impactful, Compassionate, and Determined. Alcanza Clinical Research is an Equal Opportunity Employer that values and respects the importance of a diverse and inclusive workforce. It is the policy of the company to recruit, hire, train and promote persons in all job titles without regard to race, color, religion, sex, age, national origin, marital status, veteran status, disability, sexual orientation, gender identity or expression, genetic information, or any other category protected by law. We recognize that diversity and inclusion is a driving force in the success of our company.
    $39k-57k yearly est. 6d ago
  • Neonatal Intensive Care Clinical Research Coordinator

    Uwmsn University of Wisconsin Madison

    Remote job

    Current Employees: If you are currently employed at any of the Universities of Wisconsin, log in to Workday to apply through the internal application process. Want to join a fun, hard-working, collaborative team? Come join the Clinical Research team within the Department of Pediatrics at UW-Madison! The Clinical Research team supports clinical research across multiple divisions in the Department of Pediatrics. Working within the Neonatal Intensive Care Unit at both American Family Children's Hospital and UnityPoint-Meriter, this position is a unique opportunity to contribute to research aimed at prevention, detection, and treatment of disease in critically ill infants. This position will assist with coordinating a variety of clinical research studies by performing various tasks and activities. These tasks include, but are not limited to, recruitment, screening, and enrolling study participants and families, as well as ensuring study participants and families follow the research study protocol. Our team of clinical research coordinators and research nurses apply expertise, knowledge, and skills to a broad range of clinical studies, navigate resources, identify issues requiring escalation, and contribute to the development of new team and unit processes, procedures, and tools. The Clinical Research Coordinator will work in collaboration with pediatric faculty, nurses and staff to coordinate clinical research studies for the Department of Pediatrics, ranging from industry partnered to investigator initiated clinical trials. This position is full or part time, 90-100% Some work may need to be performed outside of standard business hours. However, most work is expected to occur during standard business hours. This position may require some work to be performed in-person, onsite, at a designated campus work location. Some work may be performed remotely, at an offsite, non-campus work location. This position has been identified as a position of trust with access to vulnerable populations. The selected candidate will be required to pass an initial caregiver check to be eligible for employment under the Wisconsin Caregiver Law and every four years. Applicants for this position will be considered for the following titles: Clinical Research Coordinator I, Clinical Research Coordinator II. The title is determined by the experience and qualifications of the finalist. The responsibilities in this job posting are for the Clinical Research Coordinator I title. A Clinical Research Coordinator II will perform tasks more independently, collect more complex information, perform quality checks, identify resource needs, develop clinical research documents, contribute to the development of protocols, and may assist with training of staff. Key Job Responsibilities: Serves as an initial point of contact for clinical research participants and clinical staff, providing information regarding research procedures, expectations, and informational inquiries. Ensures participants follow the research protocol and alerts Principal Investigator of issues Schedules logistics, determines workflows, and secures resources for a defined clinical research trial(s) Identifies work unit resources needs and manages supply and equipment inventory levels Manages research workflow components, collects, prepares, processes, and submits participant data and samples to appropriate entities, adhering to research protocols Recruits, screens, selects, determines eligibility and enrolls trial participants, collects information, and answers questions under supervision of a medically licensed professional. May perform basic medical assessments after completion of required training/certification, such as collecting vital signs, obtaining weight, and performing phlebotomy Department: School of Medicine and Public Health, Department of Pediatrics, Administration - Clinical Research The Department of Pediatrics at the University of Wisconsin School of Medicine and Public Health is a vibrant academic department comprising more than 200 faculty in 16 subspecialty divisions. The department promotes and enhances the health of children through outstanding clinical care, exemplary education of pediatric trainees, performance of cutting-edge research, and vigorous advocacy. To learn more about the department's work and accomplishments, please visit: ********************************* Compensation: The starting salary for a Clinical Research Coordinator I is $41,244. The starting salary for a Clinical Research Coordinator II is $44,543. Salary is negotiable based on experience and qualifications. Employees in this position can expect to receive benefits such as generous vacation, holidays, and sick leave; competitive insurances and savings accounts; retirement benefits. For more information, refer to the campus benefits webpage. SMPH Faculty /Academic Staff Benefits Flyer 2026 Effective July 1, 2024, the U.S. Department of Labor Fair Labor Standards Act (FLSA) requires that positions earning less than $43,888 annually be considered non-exempt under FLSA provisions for overtime. Based on these rules, if the person selected for this recruitment will earn less than the new salary threshold at July 1, 2024 ($43,888 annually), they will be an academic staff non-exempt employee, will be paid hourly and will receive overtime compensation for any hours worked over 40 in a workweek. Preferred Qualifications: Minimum 2 years of experience working in a clinical research role Experience working with the pediatric population Experience working in a healthcare setting Experience working with research data collection and/or sample processing Experience utilizing a variety of platforms including Health Link or other electronic medical record, Microsoft Office Suite, REDCap, OnCore, and Google Drive Clinical Research Certification Experience with quality checks, and/or study monitoring (for Clinical Research Coordinator II) Additional knowledge, skills, and abilities include effective oral and written communication skills, ability to manage multiple projects at the same time, excellent attention to detail and organization skills, excellent time management and prioritization, ability to independently and creatively problem solve Education: Bachelor's Degree preferred How to Apply: For the best experience completing your application, we recommend using Chrome or Firefox as your web browser. To apply for this position, select either “I am a current employee” or “I am not a current employee” under Apply Now. You will then be prompted to upload your application materials. Important: The application has only one attachment field. Upload all required documents in that field, either as a single combined file or as multiple files in the same upload area. Upload required documents: Cover Letter Resume Your cover letter should address how your training and experience align with the qualifications listed above. Application reviewers will rely on these written materials to determine which applicants move forward in the process. References will be requested from final candidates. All applicants will be notified once the search concludes and a candidate is selected. University sponsorship is not available for this position, including transfers of sponsorship and TN visas. The selected applicant will be responsible for ensuring their continuous eligibility to work in the United States (i.e. a citizen or national of the United States, a lawful permanent resident, a foreign national authorized to work in the United States without the need of an employer sponsorship) on or before the effective date of appointment. This position is an ongoing position that will require continuous work eligibility. If you are selected for this position you must provide proof of work authorization and eligibility to work. The department will not be able to support a request for a J-1 waiver. If you choose to pursue a waiver and apply for our position, neither the UW nor UWMF will reimburse you for your legal or waiver fees. Contact Information: Hope Jende, *******************, ************ Relay Access (WTRS): 7-1-1. See RELAY_SERVICE for further information. Institutional Statement on Diversity: Diversity is a source of strength, creativity, and innovation for UW-Madison. We value the contributions of each person and respect the profound ways their identity, culture, background, experience, status, abilities, and opinion enrich the university community. We commit ourselves to the pursuit of excellence in teaching, research, outreach, and diversity as inextricably linked goals. The University of Wisconsin-Madison fulfills its public mission by creating a welcoming and inclusive community for people from every background - people who as students, faculty, and staff serve Wisconsin and the world. The University of Wisconsin-Madison is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to, including but not limited to, race, color, religion, sex, sexual orientation, national origin, age, pregnancy, disability, or status as a protected veteran and other bases as defined by federal regulations and UW System policies. We promote excellence by acknowledging skills and expertise from all backgrounds and encourage all qualified individuals to apply. For more information regarding applicant and employee rights and to view federal and state required postings, visit the Human Resources Workplace Poster website. To request a disability or pregnancy-related accommodation for any step in the hiring process (e.g., application, interview, pre-employment testing, etc.), please contact the Divisional Disability Representative (DDR) in the division you are applying to. Please make your request as soon as possible to help the university respond most effectively to you. Employment may require a criminal background check. It may also require your references to answer questions regarding misconduct, including sexual violence and sexual harassment. The University of Wisconsin System will not reveal the identities of applicants who request confidentiality in writing, except that the identity of the successful candidate will be released. See Wis. Stat. sec. 19.36(7). The Annual Security and Fire Safety Report contains current campus safety and disciplinary policies, crime statistics for the previous 3 calendar years, and on-campus student housing fire safety policies and fire statistics for the previous 3 calendar years. UW-Madison will provide a paper copy upon request; please contact the University of Wisconsin Police Department.
    $41.2k-44.5k yearly Auto-Apply 6d ago
  • Clinical Research Coordinator Associate (Hybrid Opportunity) (1 Year Fixed - Term)

    Stanford University 4.5company rating

    Remote job

    Dr. Emmanuel Mignot's laboratory within the Division of Sleep Medicine in the Department of Psychiatry & Behavioral Sciences is seeking a Clinical Research Coordinator Associate to perform duties related to the collection of clinical data and the coordination of clinical studies. The Mignot laboratory in connection with the Center for Narcolepsy combines basic molecular research with translational and clinical research. This position will work under the supervision of the senior clinical research coordinator and will collaborate with a team of clinical research coordinators while taking the lead role and coordinating moderately complex aspects of an ongoing study. This position will be located at the Stanford Redwood City campus and is hybrid-eligible. . Duties include: * Serve as primary contact with research participants, sponsors, and regulatory agencies. Coordinate studies from startup through close-out. * Determine eligibility of and gather consent from study participants according to protocol. Assist in developing recruitment strategies. * Coordinate collection of study specimens and processing. * Collect and manage patient and laboratory data for clinical research projects. Manage research project databases, develop flow sheets and other study related documents, and complete study documents/case report forms. * Ensure compliance with research protocols, and review and audit case report forms for completion and accuracy with source documents. Prepare regulatory submissions, and ensure institutional Review Board renewals are completed. * Assemble study kits for study visits, monitor scheduling of procedures and charges, coordinate documents, and attend monitoring meetings with sponsors, acting as primary contact. * Monitor expenditures and adherence to study budgets and resolve billing issues in collaboration with finance and/or management staff. * Interact with the principal investigator regularly, ensuring patient safety and adherence to proper study conduct. * Ensure essential documentation and recording of patient and research data in appropriate files per institutional and regulatory requirements. * Participate in monitor visits and regulatory audits. * - Other duties may also be assigned . DESIRED QUALIFICATIONS: * Bachelor's degree * 2 years of related experience in clinical trials EDUCATION & EXPERIENCE (REQUIRED): Two year college degree and two years related work experience or a Bachelor's degree in a related field or an equivalent combination of related education and relevant experience. . KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED): * Strong interpersonal skills. * Proficiency with Microsoft Office. * Knowledge of medical terminology. CERTIFICATIONS & LICENSES: Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred. PHYSICAL REQUIREMENTS*: * Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping. * Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds. * Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more. * - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job. . WORKING CONDITIONS: Occasional evening and weekend hours. . The expected pay range for this position is $34.56-$40.30 per hour. Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs. . * Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Additional Information * Schedule: Full-time * Job Code: 1013 * Employee Status: Fixed-Term * Grade: F * Requisition ID: 106349 * Work Arrangement : Hybrid Eligible
    $34.6-40.3 hourly 5d ago

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