Clinical research coordinator jobs in Burlington, NC

Clinical Trial Coordination Coordinate and manage all aspects of assigned clinical trials from site initiation to close-out. Conduct study visits, including obtaining informed consent, performing protocol-required procedures, and collecting source data using eSource systems. Ensure timely and accurate entry of study data into electronic case report forms (eCRFs). Technology & Documentation Utilize eSource, eConsent, eISF, and other clinical trial software platforms to maintain complete, accurate, and regulatory-compliant study records. Support site readiness and compliance Regulatory Compliance Maintain up-to-date regulatory documents and study binders (electronic and/or paper as required). Assist with preparation for sponsor, CRO, or regulatory audits. Patient Engagement & Safety Recruit, screen, and enroll study participants according to protocol inclusion/exclusion criteria. Ensure ongoing patient safety by monitoring for adverse events and reporting per protocol. Execute phlebotomy Collaboration & Support Serve as the primary point of contact for sponsors, CROs, monitors, and other site staff. Support training and mentoring of new CRC staff as assigned.

Title: Study USA Coordinator Position Type: Staff Full-Time Days Per Week: M-F Hours Per Week: 40 VP Area: Office of the Provost and Academic Affairs Department: Global Engagement Reporting to the Director of Study USA within the Isabella Cannon Global Education Center (GEC), this 12-month, full-time position manages a portfolio of Elon's University's signature Study USA programs and serves as a general advisor for students considering study away options. Benefits of Working at Elon As an Elon University employee, you'll join an internationally acclaimed university with a commitment to fostering a thriving community. Ranked among the most innovative, creative and best-run universities in the nation, Elon's personal approach to education extends to employees, whose growth, professional development and success is a hallmark of our training and advancement opportunities. Elon University's home is the charming town of Elon, North Carolina, a small, friendly community located a short distance from the beach and the mountains, and among the vibrant cities of Greensboro, Raleigh and Durham. In addition to the beautiful canopy of historic oak trees iconic to our campus, you'll find boundless opportunities for family-friendly recreation, cultural events and outdoor activities. Hiking, water sports, fine dining and entertainment are just a few of the many happenings in the Elon area, making the region one of the nation's premier travel destinations. Employees at Elon enjoy a generous and comprehensive benefits package that includes: 28 annual days off, including holidays and vacation. Immediate tuition remission for undergraduate courses Tuition remission for approved graduate-level courses after 12 months of employment. Retirement plan with an 8 percent contribution from the university. Immediate eligibility for health, dental and vision insurance, along with free acute care and lab services at our onsite Health & Wellness Clinic. Free use of campus fitness facilities. Free admission to musical and theater performances, guest speakers, religious and ethnic observances, recitals, art exhibitions, entertainment and our Division I Phoenix athletics. Eligibility for tuition remission at Elon for spouses, qualifying domestic partners and dependents begins at two years of service. After two years of employment, eligibility begins for participation in the Tuition Exchange, a national scholarship exchange program that enables dependents to enroll in nationally recognized partner colleges and universities. Elon values and celebrates the diverse backgrounds, cultures, experiences and perspectives of our community members. As an equal opportunity employer, Elon's principles of diversity extend to race and gender identity, age, disability status, veteran status, sexual orientation, religion, and other aspects of one's identity. At Elon, our employees respect human differences, passion for lifelong learning, emphasis on personal integrity and an ethic of service. Minimum Required Education and Experience Bachelor's degree with minimum 1 year of experience with the following relevant work experience: Preference for prior professional experience in a unit related to experiential learning (service, internship, research, leadership) at a four-year college/university, or the equivalent. Commitment to diversity, equity, and inclusion. Preferred Education and Experience Bachelor's degree in in relevant field of study Job Duties * Program Management * Manage logistical aspects of Study USA programs including Study USA in NYC, DC, Charlotte, and other assigned programs, in coordination with the Director of Study USA and other key stakeholders. * Support data collection and analysis to monitor program growth and identify areas for improvement. * Organize and maintain excel spreadsheets of internships, alumni, and student support resources to ensure accurate and accessible information. * Create and maintain records of internships, alumni, and student resources. * Provide support to faculty and staff within assigned programs. * Support on-campus student recruitment in Study USA through programming and campus partners. * Student Support and Advising * Advise students on program selection for Study USA program centers and select short-term programs including tabling at Quick Questions. * In coordination with the Assistant Director of Career Services for Study USA and International Students and Director of Study USA, mentor and prepare students for internships. * Conduct series of predeparture workshops and a reentry experience for participants. * Provide crisis management support and counseling for students participating in assigned programs. * Liaise with other offices on main campus to support students during pre-departure, on-program and during re-entry as necessary. * Communications and Relationships * In coordination with the Communications Manager, assist with updates to Study USA webpages and brochures. * In coordination with the Director of Study USA, assist in development and implementation of outreach and communications plan. * Maintain connections and relationships with Elon alumni who live within New York City and DC through planned events, social media, and regular interaction, in coordination with the SPDC, Alumni Office, and Student Affairs. * Additional Experiential & Non-GEC Programs * Serve as the GEC point person for experiential learning including overseas research, internships, and service-learning. * Serve as liaison and support person for study away Athletics programs, Periclean Scholars, Honors, and the Truitt Center. * Serve as the GEC point person for graduate-level study away programs, providing resources and assistance, as needed. * Inclusive Community Building Community is foundational to Elon and a shared responsibility within our residential campus. All who work at Elon should demonstrate an understanding of and engagement with Elon's foundational commitment to relationships, mentoring and collaboration in a close-knit residential community. We embrace the shared responsibility to foster inclusive excellence within a strong residential community. Accordingly, employees are expected to join together and build connections in activities that foster an active and engaged campus environment and engage in professional development to support the shared responsibility of enriching diversity, equity, and inclusion through meaningful relationships and mentoring at Elon. Employees are encouraged to, for example, attend or participate in campus activities such as College Coffee, Numen Lumen, campus cultural events, athletic events, continuing education, professional development opportunities and trainings, employee resource groups and other university-sponsored activities to demonstrate an active commitment to the Elon community. Special Instructions to Applicants: Applicants are asked to submit both a resume and cover letter for full consideration.

Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions: * Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice. * Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability. * Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. * Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate. * Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase. * Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. * Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. * Collaborate and liaise with study team members for project execution support as appropriate. * If applicable, may be accountable for supporting development of project subject recruitment plan on a per site basis. * If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. Qualifications: * Bachelor's Degree Degree in scientific discipline or health care preferred. Req * Requires at least 1.5 years of year of on-site monitoring experience. Req * Equivalent combination of education, training and experience may be accepted in lieu of degree. Req * Good knowledge of, and skill in applying, applicable clinical research regulatory requirements. * i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. * Good therapeutic and protocol knowledge as provided in company training. * Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable). * Written and verbal communication skills including good command of English language. * Organizational and problem-solving skills. * Effective time and financial management skills. * Ability to establish and maintain effective working relationships with coworkers, managers, and clients. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at ********************** IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe The potential base pay range for this role, when annualized, is $57,500.00 - $226,800.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.

School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations. Be You. The Oncology Clinical Research Unit (CRU) at the Duke Cancer Institute (DCI) is seeking a Senior Clinical Research Coordinator (CRC Sr.) to join to join our Thoracic, Sarcoma, Head & Neck, and Genitourinary (GU) Clinical Research Program. In this role, you will lead a dynamic team coordinating multiple complex oncology clinical trials across Thoracic, Sarcoma, Head & Neck, and Genitourinary (GU) clinical research programs, including those involving investigational products. You'll play a critical role in advancing cancer research and improving patient outcomes. You'll work closely with principal investigators, sponsors, and research participants to ensure studies are conducted with excellence and integrity. From managing recruitment strategies to overseeing data quality and compliance, your leadership will be key to the success of our research efforts. Minimum Requirements: * Associate's degree required. * Minimum of six years of research experience. A Bachelor's degree may substitute for 2 years of required experience. * Proficiency in computing software and web-based applications (e.g., Microsoft Office, internet browsers). * Basic Life Saving (BLS) certification from the American Heart Association or Duke-approved equivalent. Preferred Qualifications: * Oncology or clinical research experience. * Experience coordinating clinical trials. * Prior supervisory or management experience. Other Requirements: * This position is onsite at Duke University. * Must maintain Duke and project-specific training and certification requirements. * Must comply with all SOPs, regulations, and protocol requirements governing clinical research. Be Bold. As a Senior Clinical Research Coordinator, you will: * Lead the coordination and implementation of multiple oncology clinical trials. * Manage study compliance, documentation, and regulatory requirements. * Supervise and mentor research staff, fostering a collaborative and high-performing team culture. * Implement data capture systems and ensure data integrity and security. * Serve as the primary liaison with sponsors, investigators, and study personnel. Choose Duke. At Duke, we believe in "Cancer Care as It Should Be." The DCI is nationally recognized for its cutting-edge research and compassionate care. Our GU Clinical Research Program is at the forefront of innovation in oncology, offering a collaborative environment where your contributions truly matter. Anticipated Pay Range: Duke University provides an annual base salary range for this position as USD $69,362.00 to USD $110,658.00. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer. Your total compensation goes beyond the dollars on your paycheck. Duke provides comprehensive and competitive medical and dental care programs, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members. Learn more at ***************************** Job Code: 00001202 CLINICAL RESEARCH COORDINATOR, SR Job Level: 53 Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex (including pregnancy and pregnancy related conditions), sexual orientation or military status. Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values. Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department. Nearest Major Market: Durham Nearest Secondary Market: Raleigh

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

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

Piper Companies is currently seeking a Senior Clinical Research Associate (CRA) for an opportunity in North Carolina. The Senior Clinical Research Associate (CRA) will participate in ongoing Clinical Trials throughout the Country for a leading Clinical Research Organization. Responsibilities for the Senior Clinical Research Associate: * Conduct site and study visits and perform all site monitoring activities across multiple study * Responsible for both remote and on-site monitoring and study activation * Participate in the development of study tools, protocols, and clinical trial documentation * Some travel required once travel bands are lifted Qualifications for the Senior Clinical Research Associate: * 3-5 years performing on-site monitoring and hands on experience with EDC Systems * Experience with Oncology is highly advantageous * Organization to perform monitoring duties across multiple sites is a must Compensation for the Senior Clinical Research Associate: * Salary Range: $115,000-125,000 * Comprehensive Benefits: Medical, Dental, Vision, 401K, PTO, Sick Leave as required by law, and Holidays #LI-SR1

Department: 38923 Wake Forest University Health Sciences - Gerontology Status: Part time Benefits Eligible: Yes Hours Per Week: 20 Schedule Details/Additional Information: Part-time Pay Range $26.10 - $39.15 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.

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 $26.10 - $39.15 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.

Flexible work arrangements, including virtual/hybrid work locations, are an integral part of the School of Medicine's Working Forward initiative. As such, this position's work location is designated as hybrid. Please note that the designated work location is subject to change based on the unit's business needs. This position will serve as a Senior Clinical Research Coordinator within the Department of Urology. The Senior Clinical Research Coordinator is responsible for the planning, organization, conduct, and evaluation of multi-faceted clinical research protocols, including study execution, developing strategies and solutions to improve study processes and execution, providing reviews of other team members' work product, and serving as mentor and subject matter expert. Required Qualifications, Competencies, And Experience Strong written and verbal communication skills. Must be able to work and communicate with diverse populations effectively and professionally. Ability to work independently as well as function as part of a team. Proficient with Microsoft Outlook, Excel, and Word. Basic working knowledge of research in the area of assignment, retrieval of data/information, working within established deadlines, and working with a project of limited scope and complexity. Preferred Qualifications, Competencies, And Experience Experience with methods and Good Clinical Practice used in data collection, patient facing enrollment and consent, intervention dissemination, data entry in sponsor EDC platforms, screening for patient enrollment in EPIC , and database storage and management. Manage all regulatory study tasks within IRBIS , the Protocol Review Committee ( PRC ), including initial submission, renewals, and modifications. Collaborate with department finance director and OnCore affiliates to ensure timely sponsor invoicing and payments, along with trial patient compensation. Training in CITI's Human Subject Research curriculum. Optimal experience would include experience in OnCore, REDCap, EPIC , IRBIS , as well as past collaboration with OCT , PRC , and other related UNC clinical trials regulatory offices.

A global higher education leader in innovative teaching, research and public service, the University of North Carolina at Chapel Hill consistently ranks as one of the nation's top public universities. Known for its beautiful campus, world-class medical care, commitment to the arts and top athletic programs, Carolina is an ideal place to teach, work and learn. One of the best college towns and best places to live in the United States, Chapel Hill has diverse social, cultural, recreation and professional opportunities that span the campus and community. University employees can choose from a wide range of professional training opportunities for career growth, skill development and lifelong learning and enjoy exclusive perks for numerous retail, restaurant and performing arts discounts, savings on local child care centers and special rates on select campus events. UNC-Chapel Hill offers full-time employees a comprehensive benefits package, paid leave, and a variety of health, life and retirement plans and additional programs that support a healthy work/life balance. Primary Purpose of Organizational Unit Our mission is to improve the health and well-being of North Carolinians and others whom we serve. We accomplish this by providing leadership and excellence in the interrelated areas of patient care, education and research. Patient care: We promote health and provide superb clinical care while maintaining our strong tradition of reaching underserved populations and reducing health disparities across North Carolina and beyond. Education: We prepare tomorrow`s healthcare professionals and biomedical researchers from all backgrounds by facilitating learning within innovative and integrated curricula and team-oriented interprofessional education to ensure a highly skilled workforce. Research: We develop and support a rich array of outstanding health sciences research programs, centers and resources. We provide infrastructure and opportunities for collaboration among disciplines throughout and beyond our university to support outstanding research. We foster programs in the areas of basic, translational, mechanistic and population research. Position Summary 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. Minimum Education and Experience Requirements Bachelor's degree in a discipline related to the field assigned and one year of related training or experience; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions. 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 Required Licenses/Certifications Special Physical/Mental Requirements Campus Security Authority Responsibilities Not Applicable. Position/Schedule Requirements Clinic - UNCH or ACC, Evening work occasionally, Exposure to Bloodborne Pathogens, Exposure to Hazardous Materials, Laboratory, Overtime occasionally, Patient care involved, Weekend work occasionally Special Instructions Quick Link *******************************************

Back to Search Results Clinical Studies Coordinator I, Internal Medicine Winston Salem, NC, United States Shift: 1st Job Type: Regular Share: mail

About Kriya Kriya is a biopharmaceutical company whose mission is to develop life-changing gene therapies for diseases affecting millions of patients around the world. We leverage our proprietary computational engine, in-house manufacturing infrastructure, and integrated design platform to engineer technologies and therapeutics with the potential to transform the treatment of a broad universe of diseases of high unmet need, with a focus on metabolic disorders, neurology, and ophthalmology. We are proud to have been named Triangle Business Journal's Life Sciences 2024 “Best Private Company to Work For,” recognized by Forbes as one of “America's Best Startup Employers of 2024,” and honored as one of BioSpace's “2025 Best Places to Work.” Role Overview We are looking for an Associate Director/Director, Clinical Trial Manger for programs within our exciting pipeline. The Associate Director/Director, Clinical Trial Manger will be responsible for the day-to-day management of clinical trials, vendors, and clinical trial sites. This position will report to the Senior Vice President of Clinical Operations and work closely with cross-functional teams to ensure that clinical trials are conducted in a manner compliant with SOPs, ICH/GCP Country specific regulatory guidelines, company goals, timelines, and budgets. Key Responsibilities Acts as the primary clinical operational oversight to ensure assigned project/studies are conducted in accordance with internal SOPs and ICH GCP requirements. Participate in the preparation of study budgets; negotiation of contracts and vendors; supports invoice review through payment. Lead operational activities as they relate to study-level start-up, conduct and close-out. Assist with the development of clinical protocols as they relate to the operational aspects of the trial. Manage and serve as the main point of contact CRO and other clinical vendors on a study. Lead the creation and amending of informed consent forms, source documents, and other documents, manuals and plans related to a clinical trial. Participate in the development, maintenance and reporting of clinical project milestones and timelines. Participate in the selection of CROs, clinical vendors, and other consultants. Create a partnership with CRO and other key vendors. Establish relationships with PIs and clinical site staff and, in conjunction with the CRO, ensure they are compliant with protocols and overall clinical objectives and deliverables. Participate in the creation of the eCRF and data cleaning activities, as necessary. Additional Essential Responsibilities: Lead cross-functional internal study team meetings. Work with project management to keep the project plan current and managed to critical path. Provide regular study status updates including critical issues to Program level management as needed. Escalates performance issues with CRO and other key vendors in a timely fashion to program level management. Collaborate with the Quality Assurance (QA) team to stay abreast of new and/or evolving local regulations, guidelines, and policies. Perform other related duties as required to support the Clinical Operations Team and company goals. Assist with the development of operational SOPs and processes and contributes to the design of operational excellence activities including study and trial metrics, communication platforms, and other process improvement initiatives pertinent to the execution of clinical trials. Experience & Skills BS or equivalent A minimum 10+ years experience in the pharma/biotech industry with a minimum of at least 8 years direct clinical trials management experience. Experience managing external suppliers and/or working in a virtual environment (e.g., CROs and independent contractors). Previous clinical trial management or project management experience with demonstrated leadership ability. Experience with Electronic Data Capture (EDC), CTMS, IRT systems; UAT experience desirable. Excellent communication; interpersonal skills and influencing skills. Ability to determine the resources and support to meet project goals and timelines. Previous budget and contract negotiation experience. Knowledge of ICH/Good Clinical Practices (GCP) Ability to leverage own expertise and input from others to identify issues and make recommendations that address overall corporate and program needs. Able to work in a fast-paced environment and effectively multi-task. Able to work independently. Excellent time management skills (timelines, schedules, task prioritization). Willing and able to travel, including within the U.S. and internationally. Proficiency using Microsoft Outlook, Word, PowerPoint, and Excel. Experience with gene therapy, metabolic is preferred, but not required. Work Environment Primarily desk-based, generally in an office or home office setting. Involves extended periods of sitting and computer use. Travel requirements: Occasional Possibility of working outside of normal scheduled hours. Discover True Collaborative Teamwork We have an ambitious set of goals, but our confidence - and our inspiration - stems from our people. From California to North Carolina, our teammates bring a spirit of Collaboration, Leadership, and Innovation to their work every day. We're always looking for teammates with the drive and energy to help us grow. If you want to be a part of a company with an entrepreneurial culture, a bold vision, and a meaningful purpose, join us. Rewards & Benefits Medical, Dental and Vision ∙ 401(k) with Company Match ∙ Short and Long-term Disability Benefits ∙ Company Paid Holidays ∙ Flexible Time Off ∙ Cyber Safety protection ∙ EAP ∙ Life Insurance ∙ Equity ∙ and more! Kriya is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All job requirements in the provided indicate the minimum level of knowledge, skills, and/or abilities deemed necessary to perform the job competently. Job descriptions are an overview of the duties, responsibilities, and requirements of the position. Employees may be required to perform other job-related assignments as requested.

'The Clinical Research Coordinator works closely with study subjects and other research staff and is responsible for the day-to-day clinical research process to collect, compile, document, and analyze clinical research data. Working under direct supervision, the position assists the investigator with subject follow-up visits, completes clinical tasks, prepares research documentation, reports, and graphs while keeping appropriate logs, tracking participants, and preparing study materials. Assesses patients for protocol eligibility, ensuring the appropriate selection of participants for clinical trials, thereby enhancing the accuracy and validity of research outcomes. Confers with study participants to explain the purpose of the study and obtains informed consent, fostering transparency and trust with patients and their families throughout the research process. Collects data from various sources, including patient charts, medical records, interviews, and diagnostic tests, and prepares comprehensive documentation, ensuring the accurate and reliable analysis of research data. When applicable, completes documentation in the electronic health/medical record (EMR) system to securely maintain patient health records. Coordinates multiple, less complex clinical trials simultaneously, managing and organizing various research activities efficiently, and ensuring optimal use of resources and timely execution of research protocols. Serves as study coordinator for pharmaceutical and/or device trials, successfully coordinating site initiation visits, monitoring visits, and close-out visits, and ensuring adherence to protocol guidelines and regulatory requirements. Supports the regulatory process in the submission of study protocols, consent forms, and recruiting materials to the Institutional Review Board and the department for approval, facilitating the regulatory compliance necessary for research projects in the hospital. Completes clinical tasks (i.e., electrocardiogram (ECG), pulmonary function tests (PFT), phlebotomy, drug administration, etc.) when not prohibited by state or licensing board requirements under the supervision of the principal investigator. Performs other duties as assigned. EDUCATION:Required: Bachelor's degree OR Associate's Degree (with 2 yrs experience) OR Healthcare/Health-related certification, e.g., EMT, Pharm Tech, Rad Tech, etc. (with 4 yrs experience) EXPERIENCE:Required: 4 Years (education and/or experience) LICENSURE/CERTIFICATION/REGISTRY/LISTING:Preferred: Clinical Research Coordinator (CCRC) and/or Clinical Research Associate (CCRA) certification Equal Opportunity Employer At Cone Health, we strive to create a welcoming atmosphere that celebrates a diverse and unique workforce. We believe in offering equal opportunities for employment to all applicants and employees, regardless of their race, religion, age, sex, sexual orientation, gender identity, veteran's status, ethnicity, national origin, disability, color, or any other characteristic protected by law. Our hiring and employment choices are based on each individual's qualifications, skills and performance. We believe that by embracing the diversity of our team, we can better serve our patients, communities and each other.

Kind Behavioral Health is seeking a Clinic Director in our Research Triangle Park clinic who would like to join us in a state of the art facility, growing a top tier clinical team. As a Clinic Director, you will coach and mentor clinicians and steward the daily operations of the clinic. The ideal Clinic Director will have a passion for improving the lives of children with Autism and their families. They are committed to a “gold standard” implementation of the science of ABA and evidence and data-based analyses and are looking to do their life's work in an environment where exceptional people can Think Big, Have Fun, Do Good, and Be KIND. How you'll contribute: Manage own caseload, driving high quality care and strong outcomes for clients Conduct behavior assessments and facilitate behavior programs based on the principles of Applied Behavior Analysis (ABA) Provide quality leadership, clinical supervision, and direction to BCBAs and RBTs Partner with other senior leaders to develop, replicate and continually improve new clinical programming Facilitate parent training and support the stewardship of families Partner with the Intake & Scheduling departments to promote broad access to services with our clinicians and ensure a smooth onboarding process for new clients Actively participate in the hiring and onboarding/training process of new clinicians Verify that high quality supervision, program management and professional development is occurring for all clinicians Provide continuing education to employees, families, and our communities Promote KBH's professional, ethical and people values and holds others accountable to live up to those standards Manage the day-to-day operations of your Clinic, including but not limited to supervising office admin, ensuring adequate supplies inventory, resolving any maintenance/sanitation/security issues, and proactive management of potential personnel or client issues Oversee the growth of your Clinic as well as the home, school, and community-based services that extend from it Serve as a liaison between the organization, staff, families, community, health care providers, etc. What we're looking for: Board Certified Behavior Analyst (BCBA) credential with at least 3 years of experience as a BCBA, Experience supervising other BCBAs strongly preferred. Highly skilled as a clinician with diverse skillset and strong understanding of how to approach challenging cases Proven experience as an inspirational team leader (positive, motivating) that has created a following of talented individuals Highly skilled in training, development and apprenticeship of other clinicians Exceptional communication, writing, and interpersonal skills Self-starter that adapts well to change in a fast-paced, unstructured workplace Adept to problem-solving, conflict resolution, disciplinary processes and workplace investigations Diligent and firm with high ethical standards Physically able to work on the floor with children, while providing therapy (sit, stand, kneel, lift up to 50 lbs.) Able to use computers and tablets for extended periods of time Has access to reliable transportation, holds a valid driver's license, and is able to pass a background check The exemplar BCBA is constantly seeking knowledge and pursuing excellence in Applied Behavior Analysis. They are motivated, coachable, eager and kind. They are solution focused, take responsibility for their work, they celebrate the success of others and are always seeking to improve As part of our team, you will be eligible for: Competitive compensation Quarterly incentive bonuses Annual continued education stipends Relocation assistance and sign on bonuses available Paid time off, paid holidays, paid sick time and paid birthday! Medical, dental, vision insurance Short-term disability and life/ADD insurance 401K with company match, or company contribution to student loan payments High level of collaboration with a strong emphasis towards growth and development Ability to partner with other high-level clinicians and senior leadership team across our organization About Us: Kind Behavioral Health is committed to providing the highest quality of care by utilizing the empirical science of behavior in order to make data-based decisions to deliver remarkable outcomes and exceed client expectations. We have a strong focus on teaching functional communication and the life skills necessary to lead autonomous, fulfilling lives. Our love of science and our passion for serving special needs populations keeps us motivated for constant improvement and the pursuit of excellence. We recognize that our investment in our clinical team drives our client outcomes and we have created a culture of learning, collaboration, and continued growth. Our team is committed to creating a diverse environment and we are proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Diversity is more than a commitment - it is the foundation of what we do, adhering to the highest professional standards while creating an environment in which exceptional people (like you!) can think big, have fun, do good, and be kind.

CRC Level 1 - 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 1 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-SB4 #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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

CRC Level 1 - 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 1 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-SB4 #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, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity. Oversees site interactions post activation through site closeout. This may include patient recruitment, investigator payments or other related activities. May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT). Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/CeMs) is aware of the contractual obligations and parameters. Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables. Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope. Employs strategic thinking and problem-solving skills to propose and implement risk mitigations. Participates and presents in key meetings such as Kick Off Meeting. Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members. This may include accompanying CRA team members to sites for observation or conflict resolution. Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines. Reviews and provides feedback on other functional plans (e.g. Data Management Plan, Communication Plan) as they relate to the clinical trial management activities. Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan. Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as needed. Ensures access and audit trail reviews are conducted as required. Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study. Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality. Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools. Reviews the project oversight dashboards and other clinical trial systems (e.g. Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs), Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to oversee site and patient activities, study team conduct and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency) according to plan. Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan. Is accountable for their assigned clinical team members' understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans. Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports and pertinent correspondence), to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity. Document requested revisions and approvals in CTMS. Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines. Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables. Provides status updates on the clinical deliverables and risks to clients, project management and leadership as per departmental or study agreements. Provides solutions for obstacles in protocol execution and site management. Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations This may include data management, study start up, patient recruitment, medical monitoring, pharmacovigilance and Quality Assurance (QA). Supports Inspection Readiness for clinical trial management scope. Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance, CMP compliance, and identifies emerging risks. Develop and support execution of corrective action plans at site and study level. Supports and completes activities to achieve data cut and lock deadlines. Provides feedback to line managers on staff performance including strengths as well as areas for development. May be assigned to larger, more complex trials or may coordinate clinical activities for a team of CTMs across a portfolio of projects May coach and mentor CTMs regarding functional clinical delivery, evaluation of project risks, and action implementation. Qualifications: Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience Demonstrated ability to lead and align teams in the achievement of project milestones Demonstrated capability of working in an international environment. Demonstrated expertise in site management and monitoring (clinical or central) Preferred experience with risk-based monitoring Demonstrates understanding of clinical trial management financial principles and budget management Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements Must demonstrate good computer skills Strong conflict resolution skills Demonstrated ability to apply problem solving techniques to resolve complex issues and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project. Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues Moderate travel may be required, approximately 20% 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. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. *************************** Additional Information Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Clinical Research Coordinator - Join Our Growing Team! The CRC is responsible for managing and conducting clinical research projects by leading overall trial operations, collecting data, informing study participants about study objectives, administering questionnaires, ensuring US Foot and Ankle Specialists Standard Operating Procedures (SOPs) are followed and working closely with the sponsor/Clinical Research Organization (CRO). Clinical Research Coordinator Essential Functions/Responsibilities (other duties may be assigned): Oversee daily clinical trial operations and ensure compliance with study protocols Screen and enroll participants, obtain informed consent, and collect study data Coordinate with investigators, sponsors, and research staff Maintain accurate study records and regulatory documentation Manage inventory, lab work, and study supplies Be a point of contact for participants throughout the trial . Clinical Research Coordinator Required Education, Skills and Experience: 2+ years of clinical research coordination experience preferred Associate's degree in health sciences, biology, or related field (or equivalent experience) Excellent organizational skills, attention to detail, and ability to multitask Strong communication skills - you'll be working with patients, providers, and sponsors Willingness to travel between Louisville, Shepherdsville & Shelbyville Why You'll Love Working Here: Health, life, and disability insurance 401(k) with company match PTO + paid holidays Employee discounts A supportive and collaborative work environment Physical Requirements: Ability to sit, stand, and perform clinical tasks as needed Lift up to 50 lbs occasionally