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Clinical research associate jobs in North Carolina - 205 jobs

  • Clinical Trial Manager

    Advanced Recruiting Partners

    Clinical research associate job in Raleigh, NC

    Key Responsibilities: Lead and manage operational aspects of global clinical trials from study start-up through close-out Oversee study timelines, deliverables, and budgets to ensure milestones are met Coordinate with cross-functional teams, external vendors, and CROs to ensure high-quality study conduct Oversee site activation, clinical monitoring, data integrity, and adherence to protocol Conduct study-level risk assessments and ensure inspection readiness Manage safety and pharmacovigilance activities in collaboration with internal and external teams Lead internal and external study meetings; provide training to relevant stakeholders Contribute to the development of study-related documents and clinical study reports Perform other duties as needed to support successful trial execution Qualifications: Bachelor's degree in life sciences or a related (advanced degree preferred) Minimum of 8 years of clinical trial management experience, particularly in respiratory trials or pediatric studies Demonstrated success in leading global trials and working with cross-functional and vendor teams Deep understanding of GCP, ICH guidelines, and global regulatory requirements Specific therapeutic experience in respiratory diseases, strongly preferred Strong project management, problem-solving, and communication skills Proficiency in using clinical trial systems (e.g., eTMF, EDC), Microsoft Office, and Excel
    $67k-108k yearly est. 1d ago
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  • Clinical Research Coordinator 247616

    Medix™ 4.5company rating

    Clinical research associate job in Greenville, NC

    Participant Management: Screens potential participants, explains study details, obtains informed consent, schedules visits, and acts as a primary contact for subjects. Administrative Oversight: Organizes study files, prepares and submits regulatory documents (like IRB submissions), manages study budgets, and maintains trial-specific logs. Protocol Adherence: Ensures the trial follows the specific scientific protocol, protecting data integrity and participant safety. Data & Documentation: Collects, organizes, and manages research data, including case reports and drug accountability records, often working with data management teams. Staff & Resource Coordination: Trains research staff, arranges study equipment, and communicates with laboratories and investigators. Ethical Compliance: Upholds ethical standards, ensuring patient rights and well-being are prioritized throughout the study.
    $45k-64k yearly est. 5d ago
  • Clinical Research Coordinator

    Actalent

    Clinical research associate job in Winston-Salem, NC

    The Research Coordinator will assist with implementing research study tasks. This involves recruitment, data collection, data management, and reporting of results, supporting a seamless research process. Responsibilities + Recruit and consent research participants. + Conduct telephone or in-person interviews with participants, including eligibility screening. + Perform follow-up with study participants via telephone, email, and mail. + Prepare, mail, and process questionnaires and other study correspondence. + Assist in tracking study participants using MS Excel. + Maintain accurate and detailed records and files of work. + Review, edit, clean, and enter participant data into a database. + Assist with literature reviews for proposal submissions and manuscript preparation. + Handle bookkeeping related to study budgets, including ordering supplies and requesting checks for payment and participant incentives. + Perform miscellaneous administrative tasks such as typing labels, copying, faxing, meeting preparation, note-taking, and transcribing audio files. Essential Skills + High school diploma or General Education Development (GED). + 6+ months of clinical research experience. + Experience in the medical field, including phlebotomy and vaccines. Additional Skills & Qualifications + Tech savvy. + Interest in growing in clinical research. + Proficiency in data entry. Job Type & Location This is a Contract position based out of Winston-Salem, NC. Pay and Benefits The pay range for this position is $25.00 - $30.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Winston-Salem,NC. Application Deadline This position is anticipated to close on Jan 26, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.
    $25-30 hourly 7d ago
  • Clinical Research Coordinator

    Medasource 4.2company rating

    Clinical research associate job in Asheville, NC

    Clinical Research Coordinator I Client: Large Healthcare Organization Duration: 1-year contract - possibility of FTE conversion MUST RESIDE IN ASHEVILLE, NC OR NEARBY Position Summary: The Research Coordinator position is responsible for Coordinating multiple research protocols and serving as a liaison with local investigators and Sponsors. Under direct supervision, this individual will mature in their understanding of research operations and regulations in order to achieve a fundamental understanding of human subject research. Major Responsibilities: Practice and adhere to the “Code of Conduct” philosophy and “Mission and Value Statement” During your employment you will be routinely assigned training requirements. You are expected to complete any training assignments by the due date. Performs routine operational activities for multiple research protocols Liaise between site research personnel, industry sponsors, and Supervisor Collaborates closely with various site departments/teams, including finance, relevant hospital administrative representatives, and the local IRB, if applicable Coordinates schedule of assessments from initial submission of feasibility until study closeout Reviews the study design and inclusion/exclusion criteria with physician and patient Ensures the protection of study patients by verifying informed consent procedures and adhering to protocol requirements Ensures the integrity of the data submitted on Case Report Forms or other data collection tools by careful source document review; monitors data for missing or implausible data Creates study specific tools for source documentation when not provided by sponsor Collects, completes, and enters data into study specific case report forms or electronic data capture systems Generates and tracks drug shipments, device shipments, and supplies as needed Ensures timely and accurate data completion Tracks and reports adverse events, serious adverse events, protocol waivers, deviations, and violations Communicates all protocol-related issues to appropriate study personnel or manager Attends study specific on-site meetings, investigator meetings, conference calls and monthly CRC meetings, as required Reviews and responds to any monitoring and auditing findings Qualifications: Bachelor's degree - Required 1+ years of relevant experience - Required Phlebotomy - Required Certified Clinical Research Coordinator - Preferred
    $43k-62k yearly est. 1d ago
  • Clinical Research Associate (Spanish Speaking)

    Propharma Group

    Clinical research associate job in Raleigh, NC

    For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs. Position Overview This position is responsible for executing, managing and conducting projects associated with the company clinical study plans. The Contract Clinical Research Associate (CCRA) is responsible for site management deliverables on assigned protocols and may support other CRAs on the team. Essential Duties Include, but are not limited to, the following: Establish and maintain primary Sponsor communication with clinical sites for in-house and outsourced studies. Conduct oversight visits for outsourced studies to promote study engagement, enrollment and foster sponsor/site relationships. Serve as a point of contact for investigators and site staff. Maintain regular contact with study sites to ensure GCP/ICH/Protocol compliance, assessment of accrual rates. Facilitate communication between the project team and site personnel to ensure that they are appropriately trained, remain current with project requirements, and have a thorough understanding of study milestones and deliverables. Conduct thorough site qualifications visits. Ensure all required information concerning site/staff qualifications is clearly documented and communicated to project teams. Conduct efficient and comprehensive site initiation visits. Ensure all assigned site staff are trained appropriately, have access to the required electronic systems, and are informed of data collection, GCP, protocol and reporting requirements. Ensure monitoring visits are scheduled and performed per the Monitoring Plan and according to the performance of the clinical site and the project team needs. Maintain a flexible monitoring schedule (as appropriate) and assist in co-monitoring or monitoring support of clinical sites/studies. Conduct study specific training for new study coordinators (protocol, ICH/GCP and regulatory guidelines and study specific requirements). Ensure all clinical site staff actively participating in the study are appropriately trained. Identify if any untrained staff are participating in Clinical trial activities, document and communicate the issues and suggested resolutions to the Clinical site and project team. Conduct device/product accountability responsibilities at clinical sites; Identify, clearly communicate and document issues to the clinical site and project team. Assist clinical site in resolving issues, if appropriate. Participate in all aspects of site close-out activities (i.e., evaluation of site readiness for final IMV, preparation for Database lock, etc.). Communicate status of Site management activities on a routine basis to the Clinical Project team and management. Actively participate as an extended team member of the clinical study team including participating in study-specific meetings, teleconferences and investigator meetings, clear and timely communication with cross functional partners and CRA team members. Implement and execute the clinical study Monitoring Plan to ensure compliance with the plan and all assigned tasks throughout the study. Ensure clear and efficient written communication to clinical sites (confirmation letter, site visit report, follow up letter, requests for remediation or action) and project team members. Communicate project specific information to/from trial sites through teleconferences, newsletters, etc. Work with clinical project manager to assure investigator payments are appropriate and paid on a timely basis. Document monitoring activities in monitoring visit reports and follow-up letters. Communicate serious issues to appropriate parties, in a timely manner. Ensure operational and regulatory integrity of assigned studies and participate in FDA or other regulatory authority inspections, as needed. Participate in Investigator Meetings, and other study trainings and meetings as required. Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork. Support and comply with the company's Quality Management System policies and procedures. Maintain regular and reliable attendance. Ability to act with an inclusion mindset and model these behaviors for the organization. Ability to work designated schedule. Ability to work nights and/or weekends, as needed. Ability to work on a mobile device, tablet, or in front of a computer screen and/or perform typing for approximately 90% of a typical working day. Ability to work on a computer and phone simultaneously. Ability to use a telephone through a headset. Ability to travel 50% of working time away from work location may include overnight/weekend travel. Minimum Qualifications Bachelor's Degree in field as outlined in essential duties or Associate degree with a minimum of 6 years of monitoring experience or equivalent experience. Highschool Diploma with a minimum 8 years of monitoring experience or equivalent experience. 4+ years clinical research monitoring experience or equivalent experience. No other results from the Motor Vehicle Report (MVR) check that exposes Exact Sciences to what Exact Sciences deems to be an unacceptable level of liability. Proficiency in data management, including progressive experience in data entry, validation, and cleaning. Familiarity with Electronic Data Capture (EDC) systems. Effective communication skills and ability to collaborate with investigators, site staff, and team members. Demonstrated ability to work well within a team and convey information effectively. Understanding of regulatory compliance to ensure adherence to applicable regulations and requirements. Knowledge and experience in informed consent procedures, adverse event reporting, documentation, and record-keeping practices. Meticulousness with a focus on accuracy and precision in all tasks and activities. Extensive experience in clinical trial monitoring, including site initiation visits, routine monitoring visits, and close-out visits. Proficiency in monitoring plans, protocol adherence, and GCP guidelines. Conducting source data verification, resolving queries, and ensuring site compliance and data accuracy. Demonstrated ability to perform the essential duties of the position with or without accommodation. Authorization to work in the United States without sponsorship. Preferred Qualifications Experience or knowledge in In Vitro Diagnostics (IVD). Certifications related to clinical research. Working knowledge of the FDA submission process including IDE, PMA, and 510(k). Strong on-site monitoring experience in clinical trials, including: Site initiation. Routine monitoring visits. Site closeout. Knowledge of electronic trial master file (eTMF) systems and document management processes. This position requires the CRA to be based in either Chicago, IL or Dallas, TX and be fluent in Spanish. #LI-JH1 #LI-REMOTE We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not. Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
    $54k-85k yearly est. Auto-Apply 60d+ ago
  • Clinical Research Associate

    Icon Clinical Research

    Clinical research associate job in Cary, NC

    Clinical Research Associate (CRA) - East Coast 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 12 months onsite monitoring experience as a Clinical Research Associate; level (CRA I, CRA II, or Senior CRA) determined by total years of experience. 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
    $54k-85k yearly est. 60d+ ago
  • Clinical Research Associate

    Nutramaxlabs Laboratories

    Clinical research associate job in Charlotte, NC

    Nutramax desires to provide a drug-free, healthful, and safe workplace. We hold a zero-tolerance policy for drug use. Employment is contingent upon successfully passing a preemployment background check and drug screen (subject to applicable law). This position is 100% on site in our Lancaster, SC Headquarters (roughly 45 min - 1 hour south of Charlotte, NC). Summary of the Position: The Clinical Research Associate is responsible for assisting in clinical trials from initiation to completion through participating in the development of study protocols, case report forms and clinical reports, as well as performing site monitoring visits and interfacing with site staff, Clinical Research Organizations (CRO), and other company representatives. This position is also responsible for supporting clinical trials as required. Roles and Responsibilities: * Facilitate the development of study protocols, reports, SOPs, NDAs and research agreements by coordinating input from various sources including literature, experts, and internal team members. * Coordinates and conducts study protocol training at study sites and appropriate documentation. * Select and manage investigational sites and clinical trial vendors such as CROs and external laboratories. * Facilitate the development of study documentation including case report forms, informed consent forms, source documentation and study-specific plans for sound and thorough data to support the approval process or study objective. * Serve as a resource to site coordinators, investigators, and other staff members regarding investigational products and protocols. * Assure procedures are in adherence with the assigned study protocol and in accordance with good clinical research principals. * Monitors clinical studies and provides reports throughout study execution. * Perform quality checks on data, analytical results, study procedures and materials. * Obtain and coordinate results of information from blood samples and laboratory analysis as described in study protocol. * Prepare data for statistical analysis. * Assist in preparation of final study reports, scientific abstracts and manuscripts for publication. * Represent company at veterinary conferences and trade shows. * Communicate effectively with other departments within the organization and function within a team environment. * Review journals, abstracts and scientific literature to keep abreast of new developments. * Perform other Clinical Operations duties, as requested Requirements Minimum Requirements: Basic knowledge of scientific principles and practices. Excellent writing, interpersonal, communication, and organization skills required. Must be detail oriented and work collaboratively with internal and external teams. Must be proficient in computer usage, such as word processing, spreadsheets, and/or databases. Knowledge of MS Access desired. Experience with Good Laboratory Practices (GLPs), Good Clinical Practices (GCPs) regulations, and Standard Operating Procedures (SOPs), a PLUS. Some travel required for monitoring clinical studies, attending conferences and trade shows (20% travel required). Education and Experience: Master's degree or bachelor's degree with equivalent experience required, preferably in animal science, biology, veterinary, or related life sciences. Certifications such as CVT, LVT, RVT, or CVPM. Supervisory Responsibilities: None
    $52k-82k yearly est. 14d ago
  • Clinical Research Assistant (human subject research / TBI)

    GDIT

    Clinical research associate job in North Carolina

    Type of Requisition: Regular Clearance Level Must Currently Possess: None Clearance Level Must Be Able to Obtain: None Public Trust/Other Required: NACLC (T3) Job Family: SCA Job Qualifications: Skills: Clinical Investigations, Clinical Research, Recruiting Certifications: None Experience: 1 + years of related experience US Citizenship Required: No Job Description: GDIT's Military Health Team is hiring a Clinical Research Assistant to support clinical investigations for the TBI Center of Excellence (TBICoE) located at Ft. Liberty in Fayetteville, North Carolina. As the TBI Pathway of Care manager within the MHS, the Traumatic Brain Injury Center of Excellence promotes state-of-the-science care from point-of-injury to reintegration for service members, veterans, and their families to prevent and mitigate consequences of mild to severe TBI. The Clinical Research Assistant is responsible for assisting with the performance of clinical research projects in a clinical or field based operational setting, including recruitment of potential study subjects, collection of data using psychometric and neuropsychometric tools, data scoring and entry, and scheduling participants for follow up appointments HOW YOU WILL MAKE AN IMPACT: Recruits, screens, and consents research participants. Performs data collection, organization, and entry for clinical investigation projects. Performs data collection and entry quality checks and quality assurance. Maintains study related documents and supplies; secures, organizes and documents following all federal/ state regulations. Creates, collects, disseminates, maintains appropriate files of study data, and assists with review and completion of study manuals and SOPs. Schedules potential research participants for testing or evaluation. Completes protocol-specific testing and evaluation requirements. Facilitates follow-up assessment reminders and scheduling. Extracts data from patient medical records; transcribes and resolves data queries in case report forms (hardcopy or electronic); prepares documents, under direction of project leaders; reports statistical analyses and descriptive data from patient's study books to be used in research/clinical investigations/studies reports. Maintains awareness and compliance of research regulatory issues. Provides written and verbal updates to senior staff. Communicates regularly with study team, under direction of project leaders, via email and conference calling as needed. May assist with TBI program/project improvement initiatives at the site Assists with literature searches and/or obtaining and collating materials for reports, manuscripts, and meetings. Other duties consistent with the above responsibilities. WHAT YOU'LL NEED (REQUIRED): Bachelor's Degree required. 1+ year of experience in research/clinical investigations/studies required. Human Subjects training required. Current certification in Basic Life Support (BLS). Ability to pass a T3 security investigation. WHAT WOULD BE EVEN BETTER (PREFERRED): Prior experience within the DoD/VA systems of care strongly preferred. Experience using psychometric and neuropsychometric assessment tools, data scoring and entry. SKILLS AND ATTRIBUTES FOR SUCCESS: Ability to follow detailed instructions required. Excellent communication and analytical skills required. S/he must adhere to legal, professional and ethical codes with respect to confidentiality and privacy. GDIT IS YOUR PLACE: 401K with company match Comprehensive health and wellness packages Internal mobility team dedicated to helping you own your career Professional growth opportunities including paid education and certifications Cutting-edge technology you can learn from Rest and recharge with paid vacation and holidays #militaryhealthgditjobs #GDITHealth #gidtpriority The likely hourly rate for this position is between $20.98 - $26.77. This is not, however, a guarantee of compensation or salary. Rather, salary will be set based on experience, geographic location and possibly contractual requirements and could fall outside of this range. Scheduled Weekly Hours: 40 Travel Required: None Telecommuting Options: Onsite Work Location: USA NC Fort Bragg Additional Work Locations: Total Rewards at GDIT: Our benefits package for all US-based employees includes a variety of medical plan options, some with Health Savings Accounts, dental plan options, a vision plan, and a 401(k) plan offering the ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match. To encourage work/life balance, GDIT offers employees full flex work weeks where possible and a variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave. To ensure our employees are able to protect their income, other offerings such as short and long-term disability benefits, life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance are provided or available. We regularly review our Total Rewards package to ensure our offerings are competitive and reflect what our employees have told us they value most.We are GDIT. A global technology and professional services company that delivers consulting, technology and mission services to every major agency across the U.S. government, defense and intelligence community. Our 30,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation. We operate across 50 countries worldwide, offering leading capabilities in digital modernization, AI/ML, Cloud, Cyber and application development. Together with our clients, we strive to create a safer, smarter world by harnessing the power of deep expertise and advanced technology.Join our Talent Community to stay up to date on our career opportunities and events at gdit.com/tc. Equal Opportunity Employer / Individuals with Disabilities / Protected Veterans
    $21-26.8 hourly Auto-Apply 12d ago
  • Study Coordinator

    UNC-Chapel Hill

    Clinical research associate job in Chapel Hill, NC

    This position plays a pivotal role in advancing cancer research and improving patient outcomes by facilitating the conduct of oncology clinical trials in compliance with federal regulations, Good Clinical Practice, and institutional policies. This position independently manages multiple complex trials throughout their life cycle, including activation, implementation, and closure, under the direction of a Clinical Operations Manager. Key responsibilities include: * Recruitment, consent, and enrollment of study participants * Coordination of study visits across various clinic settings * Documentation of procedures and visits, facilitation of sample collection, and data entry * Collaboration with research teams to ensure regulatory compliance and patient safety This position is integral to the mission of the UNC / LCCC Clinical Trials Office, maintaining research quality and safeguarding institutional integrity, and driving discoveries that shape the future of cancer care. Required Qualifications, Competencies, And Experience * Knowledge of ICH GCP , Federal Regulations and Guidelines and ability to follow established regulations, procedures, and protocols * Strong computer skills * Ability to gather data and document procedures High level of accuracy and attention to detail, * Ability to plan work and coordinate multiple projects * Possess strong decision making and problem-solving skills * Customer oriented and ability to work in a team environment * Ability to communicate effectively and professionally verbally and in writing. * Requires study coordinator experience or experience in oncology clinical trials Ability to work on site at UNC Medical Center, UNC Chapel Hill Campus, and any satellite clinic site where trials are conducted. Ability to work on evenings, weekends and/or holidays occasionally required. Preferred Qualifications, Competencies, And Experience Previous experience with therapeutic clinical research involving drugs and/or devices Experience with direct patient contact in the hospital/clinic setting SOCRA / ACRP Certification Experience in Phase I, II, and III clinical research. Experience or familiarity with medical terminology, navigation of medical records and data abstraction Prior experience with translational science research projects Demonstrated ability to operate at a high degree of independence Demonstrated ability to coordinate studies of high complexity Work Schedule Monday - Friday, 8:30AM - 5PM
    $39k-56k yearly est. 1d ago
  • Clinical Studies Coordinator II, Nephrology

    Advocate Health and Hospitals Corporation 4.6company rating

    Clinical research associate job in Wake Forest, NC

    Department: 38922 Wake Forest University Health Sciences - Nephrology Status: Full time Benefits Eligible: Yes Hours Per Week: 40 Schedule Details/Additional Information: Monday- to Friday 8am - 5pm Pay Range $26.55 - $39.85 JOB SUMMARY Under departmental direction, coordinates activities to support multiple research studies of all phases. Serves as the principal administrative liaison for assigned studies with the ability to manage a workload that includes studies of increased complexity. Develops and maintains recordkeeping systems and procedures to ensure compliance with study protocols and all appropriate regulations. Attends clinic as needed to perform activities including, but not limited to: assist the research team with recruitment activities, administer questionnaires and answer any questions about future appointments. Responsible for the compilation, registration and submission of data, as required by the Sponsor. EDUCATION/EXPERIENCE Bachelor's degree with two years; experience in clinical research; or an equivalent combination of experience and education. LICENSURE, CERTIFICATION, and/or REGISTRATION SOCRA or ACRP Certification preferred. Must complete the CITI certification for Human Subject Research if not already completed. All additional required WakeOne training for research coordinators. ESSENTIAL FUNCTIONS 1. Works under the direction of the Study Investigators or Clinical Research Nurse Manager with minimal supervision. 2. Plays an active role in recruitment of patients to study. 3. Performs protocol specific duties required per the research protocol. 4. Obtains or assists the Principal Investigator in obtaining informed consent from subjects and reinforces the information that has been provided to subjects and families. 5. Fulfills sponsor requirements related to reportable information including adverse events, unanticipated problems, and other information required by the sponsor protocol. 6. Abstracts data from the medical record and completes paper and electronic case report forms, including responding to any requests for data clarification, and maintains all necessary source documents. 7. Identifies and communicates important protocol and data management issues or problems to the supervisor in a timely manner. 8. Provides staff relief as required to meet the needs of the department. Participates in scheduled team/department meetings. Participates in quality improvement projects on an on-going basis. 9. May mentor new and less experienced staff. 10. Follows established Wake Forest Baptist and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality. 11. Performs other related duties as assigned or requested. SKILLS/QUALIFICATIONS Excellent interpersonal, oral, and written communication skills Excellent reading comprehension Strong organizational skills EPIC/WakeOne proficiency to include appropriate documentation of research notes Proficient in the use of OnCore/WISER Clinical Trial Management System Basic computer skills Fosters/promotes a positive image and professional appearance Sensitivity to intercultural relations Sensitivity to the maintenance of confidentiality Knowledge of Microsoft Products WORK ENVIRONMENT Clean, comfortable, office environment Our Commitment to You: Advocate Health offers a comprehensive suite of Total Rewards: benefits and well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more - so you can live fully at and away from work, including: Compensation Base compensation listed within the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training Premium pay such as shift, on call, and more based on a teammate's job Incentive pay for select positions Opportunity for annual increases based on performance Benefits and more Paid Time Off programs Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability Flexible Spending Accounts for eligible health care and dependent care expenses Family benefits such as adoption assistance and paid parental leave Defined contribution retirement plans with employer match and other financial wellness programs Educational Assistance Program About Advocate Health Advocate Health is the third-largest nonprofit, integrated health system in the United States, created from the combination of Advocate Aurora Health and Atrium Health. Providing care under the names Advocate Health Care in Illinois; Atrium Health in the Carolinas, Georgia and Alabama; and Aurora Health Care in Wisconsin, Advocate Health is a national leader in clinical innovation, health outcomes, consumer experience and value-based care. Headquartered in Charlotte, North Carolina, Advocate Health services nearly 6 million patients and is engaged in hundreds of clinical trials and research studies, with Wake Forest University School of Medicine serving as the academic core of the enterprise. It is nationally recognized for its expertise in cardiology, neurosciences, oncology, pediatrics and rehabilitation, as well as organ transplants, burn treatments and specialized musculoskeletal programs. Advocate Health employs 155,000 teammates across 69 hospitals and over 1,000 care locations, and offers one of the nation's largest graduate medical education programs with over 2,000 residents and fellows across more than 200 programs. Committed to providing equitable care for all, Advocate Health provides more than $6 billion in annual community benefits.
    $26.6-39.9 hourly Auto-Apply 60d+ ago
  • Study Coordinator I,Technical Operation

    Crown Bio

    Clinical research associate job in Kannapolis, NC

    The purpose of the Study Coordinator I position is to support the execution of in vitro and in vivo pharmacology studies by coordinating the technical execution of projects. This includes scheduling, creating and distributing study-related documents, as well as providing hands-on assistance. The Study Coordinator will provide operational input to Study Directors (Scientists) on study protocol design, and they will serve as a team leader for a group of Research Associates whose primary responsibility is executing the hands-on portion of any given study. Responsibilities: - Coordinate the successful execution of client studies with various internal departments - Create and distribute study-related documentation and other materials for required for execution - Support Study Directors (Scientists) in scientific protocol development - Schedule studies with operational flexibility while maintaining competitive timelines - Maintain a daily schedule of all tasks that must be executed by Research Associates - Monitor and assure quality of data collection - Provide hands-on In-vivo support for study milestones - Provide drug formulation, if needed - Ordering study-related materials - Conduct work activities in compliance with all relevant regulations including ethics, environmental health and safety, financial, human resources, SOPs, and general business policies, requirements and objectives Minimum Requirements: - Bachelor's degree in a scientific discipline and 1+ years of experience in oncology related animal studies. - Demonstrated experience leading teams, strong communication skills, maintaining organization, and driving results - Willing and able to work under the pressure of deadlines and find solutions to meet timelines. - Able to work under pressure to meet deadlines - Ability to work across teams by being a flexible team player with strong communication and interpersonal skills. - Willing and able to work within a Quality System with oversight by QA and other regulatory bodies. - Exceptional organizational and time-management skills. - Ability to multi-task with a high degree of professionalism and diplomacy. - Ability to work independently and collaboratively in a fast-paced, team-oriented environment. Preferred Requirements: - CRO industry experience and ability to manage a high volume of customer projects - Preferred experience and knowledge with translational research in oncology - Preferred Animal handling/ In-vivo experience in a laboratory setting - Preferred Animal welfare/ IACUC knowledge - Preferred experience with SmartSheet, Study Director, Outlook, and Microsoft teams Crown Bioscience is committed to a diverse and inclusive workplace. Crown Bioscience is an equal opportunity employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.
    $38k-56k yearly est. Auto-Apply 60d+ ago
  • Clinical Research Assistant

    Care Access 4.3company rating

    Clinical research associate job in Charlotte, NC

    Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine , which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers , which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit ******************* How This Role Makes a Difference The Clinical Research Assistant is an entry level clinical position and is designed to fully integrate the individual in the Care Access Research process while learning the skills necessary to be a Clinical Research Coordinator. This position has potential growth and advancement within the Care Access Research organization. How You'll Make An Impact Ability to understand and follow institutional SOPs Participate in recruitment and pre-screening events (may be at another location) Assist with preparation of outreach materials Identify potential participants by reviewing medical records, study charts and subject database Assist with recruitment of new participants by conducting phone screenings Request medical records of potential and current research participants Schedule visits with participants, contact with reminders Obtain informed consent per Care Access Research SOP, under the direction of the CRC Complete visit procedures as required by protocol, under the direction of the CRC Collect, process and ship specimens as directed by protocol, under the direction of the CRC Record data legibly and enter in real time on paper or e-source documents Request study participant payments Update all applicable internal trackers and online recruitment systems Assist with query resolution Assist with administrative tasks such as copying, scanning, filing, mailing, emailing, etc. Assist with maintaining all site logs Assist with inventory and ordering equipment and supplies Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials. Maintain effective relationships with study participants and other care Access Research personnel. Interact in a positive, professional manner with patients/participants, sponsor representatives, Investigators and Care Access Research personnel and management. Communicate clearly verbally and in writing. Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. The Expertise Required Ability and willingness to work independently with minimal supervision Ability to learn to work in a fast-paced environment Excellent communication skills and a high degree of professionalism with all types of people Excellent organizational skills with strong attention to detail A working knowledge of medical and research terminology A working knowledge of federal regulations, Good Clinical Practices (GCP) Critical thinker and problem solver Friendly, outgoing personality with the ability to maintain a positive attitude under pressure Contribute to team and site goals Proficiency in Microsoft Office Suite High level of self-motivation and energy An optimistic, “can do” attitude Certifications/Licenses, Education, and Experience A minimum of 1-year recent working experience as a Medical Assistant, EMT, LPN, Clinical Research Assistant or Phlebotomist. Phlebotomy Experience and Proficiency Required Some Clinical Research experience preferred California based roles require National phlebotomy certification by an organization approved by the California Department of Public Health Louisiana based roles require National phlebotomy certification by an organization approved by the Louisiana State Board of Medical Examiners Washington based roles require National phlebotomy certification by an organization approved by the Washington State Department of Health Nevada based roles require Laboratory Assistant certification by the Division of Public and Behavioral Health How We Work Together Location: This is an on-site position with regional commute requirements, located in Charlotte, NC Travel: Regularly planned travel within the region will be required as part of the role. Overnight travel will be minimal ( Physical demands associated with this position Include: The ability to use keyboards and other computer equipment. The expected salary range for this role is $19.00 - $33.00 USD per hour for full time team members. Benefits & Perks (US Full Time Employees) Paid Time Off (PTO) and Company Paid Holidays 100% Employer paid medical, dental, and vision insurance plan options Health Savings Account and Flexible Spending Accounts Bi-weekly HSA employer contribution Company paid Short-Term Disability and Long-Term Disability 401(k) Retirement Plan, with Company Match Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************
    $19-33 hourly Auto-Apply 13d ago
  • Clinical Research Assistant

    Eastern Nephrology Associates

    Clinical research associate job in New Bern, NC

    You're not just applying for a job - you're stepping into a role that matters and where YOU matter. Ready to lead with purpose and make a lasting impact? Eastern Nephrology Associates is looking for a dedicated professional to join our team and help drive excellence across our organization. In this role, you'll play a key part in supporting operations, collaborating with teams, and ensuring the highest standards of service and care. If you're a motivated, organized individual with strong leadership skills and a passion for making a difference-this could be your next big move! Full Job Description Below Summary: To serve as a clinical research assistant during the conduct of clinical research at the investigative site. Provides administrative and clinical support for the implementation and conduct of clinical trials under the direct supervision of the Principal Investigator and other site personnel as applicable. Responsible for the collection and submission of regulatory documents, performance of study specific procedures, regulatory reporting requirements as instructed by the Principal Investigator and governed by Good Clinical Practice and International Council for Harmonization and assisting with ongoing study activity. In-office presence is an essential function due to the need for real-time collaboration with providers, direct interaction with patients and caregivers, and secure handling of health data in compliance with HIPAA. Qualification Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. High School Diploma or equivalent Healthcare and/or Research experience preferred. Skilled in the use of personal computers and related software applications to include Microsoft Office Applications and email. Valid drivers' license and reliable transportation to allow individuals to provide support to offsite locations, as necessary. The ability to provide a minimum of a 4 week notice in the event resignation is tendered. Minimum Qualifications Excellent record maintenance skills. Ability to communicate effectively both orally and written. Proactive individuals with the ability to be a self-starter with strong independent decision-making skills and attention to detail. Knowledge, Skills and Abilities Demonstrated human relations and effective communication skills are required. Ability to understand the ethics of confidentiality and the ability to maintain confidentiality of sensitive information. The ability to function independently and enjoy a fast paced, challenging, changing environment; possesses the energy and commitment to help the organization move forward. Maintain a positive and professional attitude in all aspects of work from patient care to interaction with co-workers and physicians. Maintains confidentiality of patients and their medical information. Maintains confidentiality of research activities as required by study sponsor confidentiality agreements and mandates. Must be able to meet deadlines for multiple concurrent projects. Ability to understand and follow policies, procedures and direction. Ability to foster a cooperative work environment. Possess a willingness to accept orders and to perform repetitive tasks. Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community. Ability to function well while involved in multiple task assignments. Ability to concentrate on details and deal with constant interruption. Skill in organizing resources and establishing priorities. Ability to travel to attend off-site meetings as necessary and as directed. Ability to accept delegated tasks from Clinical Research Coordinators as applicable. Supervisory Responsibilities: None Essential Functions % Essential Functions: All essential functions listed below are expected to be performed on-site. ENA has determined that these duties cannot be effectively or securely executed in a remote environment without compromising patient care, data privacy, or operational standards. ENA has determined that these duties cannot be effectively or securely executed in a remote environment without compromising patient care, data privacy, or operational standards. Provides administrative and clinical support to help coordinate and facilitate day-to-day operations of the Clinical Research department- 90% Other duties as assigned -10% Physical Demands The employee may be required to assist in patient transfer and should use appropriate techniques and equipment to safely transfer patients. Hearing, visual acuity, depth perception, balancing, handling, and talking and requires full range of body motion. Reaching, grabbing, holding - fine motor skills with dexterity and eye-hand coordination Extended periods in a stationary or standing position Repetitive motion such as entering data into computer-based programs Lift or move up to 30 pounds. Employees are expected to use appropriate ergonomics and tools such as hand carts for heavier loads. Work Environment Work is normally performed in a typical interior/office work environment. The noise level is usually moderate. This position requires visual acuity eyesight (corrected or uncorrected). Moderate risk of exposure to blood borne pathogens and OPIM. The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties and skills required for the position. All employees may have other duties assigned at any time. This position falls under a 180-day evaluation review period.
    $29k-42k yearly est. 8d ago
  • Clinical Research Assistant 247615

    Medix™ 4.5company rating

    Clinical research associate job in Greenville, NC

    Participant Management: Screening, enrolling, scheduling, and caring for trial participants, often taking vital signs or samples. Data & Documentation: Collecting, organizing, entering data into electronic systems (like EDCs), managing Trial Master Files (TMF), and preparing reports. Study Execution: Setting up labs, preparing study materials, ensuring adherence to the trial's protocol, and cleaning work areas. Compliance & Ethics: Upholding Good Clinical Practice (GCP) and regulatory standards to safeguard participants and data integrity. Communication: Serving as a liaison between participants, medical staff, sponsors, and regulatory bodies.
    $31k-42k yearly est. 5d ago
  • Clinical Research Coordinator Level 2

    Icon Clinical Research

    Clinical research associate job in Winston-Salem, NC

    CRC Level 2 - Winston Salem, NC (Onsite) 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 have an incredible opportunity for a Clinical Research Coordinator 2 to join ICON's Accellacare team. The CRC ensures the safety of our volunteers, promotes the mission of Accellacare, and strives to meet and exceed study priorities. This individual is responsible for recruiting and promoting our service to suitable participants and sponsor representatives. Additionally, the CRC will perform tasks required to coordinate and complete a study according to the protocol. This role is with Accellacare (********************************** , part of ICON's clinical research network, where you'll play a key role in transforming the clinical trial experience for patients and sponsors alike. Our global site network is designed with one goal in mind: to deliver better access, greater efficiency, and improved outcomes in clinical research. **Location:** Onsite (1901 S. Hawthorne Road, Suite 306, Winston-Salem, NC) **What you will be doing:** + Performing technical and clinical requirements of study protocols, i.e., venipuncture, specimen processing, vital signs, electrocardiograms, IV infusions, IV pump operations, Holtor monitoring, pulmonary function testing, allergy testing, urine/serum pregnancy testing, strep throat screening, injections (IM or SQ) or any procedure necessary for the protocol as ordered by the investigator. + Attending investigator meetings, site initiation visits, and coordinator meetings to obtain training on drug preparation and administration and general knowledge about a protocol with a focus on clinical procedures. + Obtaining knowledge about the study drugs with an emphasis on injection or intravenous infusion medications. + Monitoring for possible complications with the administration of study drugs with an emphasis on injections or intravenous infusions. + Maintaining accurate dispensing logs, separate from those of the coordinator, to include such information as lot number, drug vs. placebo, and information about the third party mixer or un-blinded mixer/preparer of medication. + Documenting laboratory data and adverse reactions, and immediately notifying investigators, sponsors and the Institutional Review Board, if indicated, of any unexpected or serious events. + Assisting other staff members as determined by the needs and priorities of the research organization and as time and abilities permit. + Actively recruiting and effectively selling our service to suitable patient participants for clinical trials with set time allotted each week for recruitment efforts. + Proactively promoting the site with monitors and in-house contacts for future trials. + Responding to queries in a timely manner, prompt data entry and working with the monitor during on-site visits are examples of pro-active behaviors. + Preparing study documentation in the event of a sponsor or FDA audit and assisting the auditor for the duration of the audit. + Ordering clinical supplies, as well as ordering, storing and monitoring of protocol specific rescue drugs and maintaining scheduled assessment of the code/crash cart and AED including maintaining proper documentation for both. + Monitoring and maintaining refrigerators, freezer units and investigational product storage temperatures for safety and stability. + Obtaining and maintaining knowledge in regards to temperature monitoring devices and procedures for lab specimens and investigational products and providing detailed information to all staff and sponsors in regards to how temperatures are monitored and maintained. + Maintaining certification for packaging and shipping specimens on dry ice, as well as maintaining and updating knowledge of lab procedures to assist with work flow. + Acting as the OSHA Representative for the site which would include but not be limited to; maintaining employee immunization records, obtaining vaccines when necessary for site or PMG and administering vaccines to staff. + Performing equipment calibration when needed, if not performed by the lab coordinator or outside service and maintaining equipment calibration records. + Supporting training and additional development of clinical skills for site staff as needed **Your Profile:** + 1+ years of work experience in a clinical research or pharmaceutical environment, with prior CRC experience + Experience with Neurology or Psychiatric clinical trials + Strong attention to detail + Motivated about a career in clinical research + Excellent time management and planning skills with an organized approach to work + Bachelor's degree in life sciences or other related field \#LI-Office \#LI-TP1 \#LI-Accellacare **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
    $46k-71k yearly est. 9d ago
  • Research Study Coordinator

    UNC-Chapel Hill

    Clinical research associate job in Chapel Hill, NC

    The primary purpose for this position is to work directly with investigators and other research personnel to initiate and execute imaging research studies at the BRIC . This position will be the primary contact for oncology-related research endeavors at the BRIC , and will work directly with physicians, investigators, and regulatory bodies for study start up, and then directly with physicians and patients in a clinical setting for recruitment and data collection. In addition, this position will work directly with mothers, newborn babies, families, and a variety of clinical populations to collect research data for various studies at the BRIC . Major responsibilities include: recruitment and coordination of study subjects, attendance of tumor board meetings, and communication across study teams to implement study protocols, management of study information, and data collection/entry. Required Qualifications, Competencies, And Experience The employee must have knowledge and experience in the use of data, preferable medical information. Work environment will include the Magnetic Resonance Imaging ( MRI ) and Positron Emission Tomography ( PET ) scanner room. Employee will undergo safety screening and will need to complete required safety training (including radiation worker training) to work in this environment. This position's work requires excellent customer service, decision-making and time management skills. Employee will need excellent judgement, concentration and focus to detail. Excellent written and verbal communication skills are required. Preferred Qualifications, Competencies, And Experience The individual should be self-directed and able to work with minimal supervision. Being bilingual in Spanish is preferred. Experience in administering oncology-related protocols. Experience with working with oncology patients and clinical teams. Previous experience with OnCore, EPIC , CRMS , and IRB . Work Schedule Monday - Friday, 8am-5pm. Occasional evenings/weekends.
    $39k-56k yearly est. 1d ago
  • Central Study Coordinator - Mexico

    Propharma Group

    Clinical research associate job in Raleigh, NC

    For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs. The Central Study Coordinator position is responsible for the coordination and support of remote site activities for assigned projects and must reside in Mexico. Essential Functions: Serve as point of contact for day-to-day Site communications, document submissions and activity coordination. Support pre-screening, screening and recruitment activities, as assigned. Responsible for subject re-consenting, acquiring medical records, conducting protocol activities, as directed by the Principal Investigator. Perform data-entry, evaluate and respond to system queries and monitor clinical databases as assigned. Establish and maintain timely Site communication as assigned. Maintain documentation which complies with IRB/FDA policies. Assist with study closeout. Assist site with other study-related activities as directed. Other duties as assigned. Necessary Skills and Abilities: Ability to manage technology and web-based research platforms on PC (Microsoft OS) laptop in the remote workspace. Study Tearn experience is ideal. Critical thinking skills. Strong communication Skills (verbal and written). Ability to work independently, and collaboratively with other CSCs to delegate tasks as needed. Working location that has the ability to maintain privacy. Current knowledge of and the ability to apply ICH / GCP and applicable regulations and guidelines. Competent in the application of standard business procedures including but not limited to SOPs, global regulations. Well organized and able to multitask. Able to work independently and as a team member. Able to take initiative while following directives. Educational Requirements: Bachelor's degree or equivalent experience defined as a minimum of 2 years related, combined experience in education, knowledge and skills that will allow one to perform the tasks of the role proficiently. #LI Remote We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
    $39k-56k yearly est. Auto-Apply 46d ago
  • Clinical Studies Coordinator I, Pulmonology

    Advocate Health and Hospitals Corporation 4.6company rating

    Clinical research associate job in Wake Forest, NC

    Department: 36412 Wake Forest University Health Sciences - Pulmonology Clinic Status: Full time Benefits Eligible: Yes Hours Per Week: 40 Schedule Details/Additional Information: Position will support Pulmonary Critical Care Research Program at Atrium Health Wake Forest Baptist Medical Center. Pay Range $24.10 - $36.15 JOB SUMMARY Under general supervision, responsible for the compilation and collection of data, recruitment of subjects, and general coordination of clinical studies. EDUCATION/EXPERIENCE Bachelor's degree in a related field of study or an equivalent combination of experience and education. Experience in a medical and/or research setting. Paramedical or other clinical experience. LICENSURE, CERTIFICATION, and/or REGISTRATION Registered Record Administrator preferred. ESSENTIAL FUNCTIONS 1. Assists principal investigator and other health professionals in troubleshooting various problems related to the management of the clinical study. Assists in all aspects of the data collection process. 2. Performs technical procedures on clinical subjects under the direction of the principal investigator or his/her designee. 3. Assists with recruitment of patients for the clinical study including tracking the sources of patient referrals. Follow-up with sources of patient referrals including referring doctors, various Medical Center labs, and other sources. 4. Maintains appropriate patient records as necessary. This includes charting the condition of the patient and determining their continued eligibility in the study. 5. Obtains and interprets pertinent data from medical records as needed to understand past and present condition of the patients. 6. Performs day-to-day administrative and clerical duties such as designing brochures, stationary and data forms. Creates reports and graphs pertinent to the study including presentation of the results of the study. 7. May supervise other personnel including volunteers as assigned. 8. Assists in development of suitable codes and data collection forms for computerization. 9. Consults and cooperates with all faculty, coordination centers, sponsors, and health professionals involved in the clinical study. 10. Performs other related duties incidental to the work described herein. SKILLS/QUALIFICATIONS Understanding of medical and/or scientific terminology Strong oral, written, and interpersonal communication skills WORK ENVIRONMENT Clean, well-lit, office environment, clinic Our Commitment to You: Advocate Health offers a comprehensive suite of Total Rewards: benefits and well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more - so you can live fully at and away from work, including: Compensation Base compensation listed within the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training Premium pay such as shift, on call, and more based on a teammate's job Incentive pay for select positions Opportunity for annual increases based on performance Benefits and more Paid Time Off programs Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability Flexible Spending Accounts for eligible health care and dependent care expenses Family benefits such as adoption assistance and paid parental leave Defined contribution retirement plans with employer match and other financial wellness programs Educational Assistance Program About Advocate Health Advocate Health is the third-largest nonprofit, integrated health system in the United States, created from the combination of Advocate Aurora Health and Atrium Health. Providing care under the names Advocate Health Care in Illinois; Atrium Health in the Carolinas, Georgia and Alabama; and Aurora Health Care in Wisconsin, Advocate Health is a national leader in clinical innovation, health outcomes, consumer experience and value-based care. Headquartered in Charlotte, North Carolina, Advocate Health services nearly 6 million patients and is engaged in hundreds of clinical trials and research studies, with Wake Forest University School of Medicine serving as the academic core of the enterprise. It is nationally recognized for its expertise in cardiology, neurosciences, oncology, pediatrics and rehabilitation, as well as organ transplants, burn treatments and specialized musculoskeletal programs. Advocate Health employs 155,000 teammates across 69 hospitals and over 1,000 care locations, and offers one of the nation's largest graduate medical education programs with over 2,000 residents and fellows across more than 200 programs. Committed to providing equitable care for all, Advocate Health provides more than $6 billion in annual community benefits.
    $24.1-36.2 hourly Auto-Apply 60d+ ago
  • Clinical Research Assistant

    Care Access 4.3company rating

    Clinical research associate job in Raleigh, NC

    Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine , which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers , which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit ******************* How This Role Makes a Difference The Clinical Research Assistant is an entry level clinical position and is designed to fully integrate the individual in the Care Access Research process while learning the skills necessary to be a Clinical Research Coordinator. This position has potential growth and advancement within the Care Access Research organization. How You'll Make An Impact Ability to understand and follow institutional SOPs Participate in recruitment and pre-screening events (may be at another location) Assist with preparation of outreach materials Identify potential participants by reviewing medical records, study charts and subject database Assist with recruitment of new participants by conducting phone screenings Request medical records of potential and current research participants Schedule visits with participants, contact with reminders Obtain informed consent per Care Access Research SOP, under the direction of the CRC Complete visit procedures as required by protocol, under the direction of the CRC Collect, process and ship specimens as directed by protocol, under the direction of the CRC Record data legibly and enter in real time on paper or e-source documents Request study participant payments Update all applicable internal trackers and online recruitment systems Assist with query resolution Assist with administrative tasks such as copying, scanning, filing, mailing, emailing, etc. Assist with maintaining all site logs Assist with inventory and ordering equipment and supplies Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials. Maintain effective relationships with study participants and other care Access Research personnel. Interact in a positive, professional manner with patients/participants, sponsor representatives, Investigators and Care Access Research personnel and management. Communicate clearly verbally and in writing. Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. The Expertise Required Ability and willingness to work independently with minimal supervision Ability to learn to work in a fast-paced environment Excellent communication skills and a high degree of professionalism with all types of people Excellent organizational skills with strong attention to detail A working knowledge of medical and research terminology A working knowledge of federal regulations, Good Clinical Practices (GCP) Critical thinker and problem solver Friendly, outgoing personality with the ability to maintain a positive attitude under pressure Contribute to team and site goals Proficiency in Microsoft Office Suite High level of self-motivation and energy An optimistic, “can do” attitude Certifications/Licenses, Education, and Experience: A minimum of 1-year recent working experience as a Medical Assistant, EMT, LPN, Clinical Research Assistant or Phlebotomist. Phlebotomy Experience and Proficiency Required Some Clinical Research experience preferred California based roles require National phlebotomy certification by an organization approved by the California Department of Public Health Louisiana based roles require National phlebotomy certification by an organization approved by the Louisiana State Board of Medical Examiners Washington based roles require National phlebotomy certification by an organization approved by the Washington State Department of Health Nevada based roles require Laboratory Assistant certification by the Division of Public and Behavioral Health How We Work Together Location: This is an on-site position with regional commute requirements. Regularly planned travel within the region will be required as part of the role. Overnight travel will be minimal ( Physical demands associated with this position Include: The ability to use keyboards and other computer equipment. The expected salary range for this role is $19.00 - $33.00 USD per hour for full time team members. Benefits & Perks (US Full Time Employees) Paid Time Off (PTO) and Company Paid Holidays 100% Employer paid medical, dental, and vision insurance plan options Health Savings Account and Flexible Spending Accounts Bi-weekly HSA employer contribution Company paid Short-Term Disability and Long-Term Disability 401(k) Retirement Plan, with Company Match Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************
    $19-33 hourly Auto-Apply 10d ago
  • Clinical Research Assistant

    UNC-Chapel Hill

    Clinical research associate job in Chapel Hill, NC

    The Clinical Research Assistant is responsible for oversight of archival laboratory samples for TPF business partners and clinical research trials; including knowledge of trial-specific requirements, interactions with vendors, sample acquisition, processing and shipping, and maintaining supplies. The Clinical Research Assistant is also responsible for support of live tissue acquisition and specimen distributions. These responsibilities relate to the mission of the UNC LCCC in providing support for our translational research partners, and support of the translational research pipeline. Work Schedule Monday - Friday 8:00 am - 5:00 pm
    $29k-42k yearly est. 49d ago

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