Clinical research coordinator jobs in Wilmington, 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, especially COPD, strongly preferred Strong project management, problem-solving, and communication skills Proficiency in using clinical trial systems (e.g., eTMF, EDC), Microsoft Office, and Excel

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: Clinical Engineering Project Manager Duration: 3-4 months (High Likelihood of extension) Hybrid: (Will coverany bi-weekly/monthly travel costs- few days a month onsite preferred) Role Overview Precise. Reliable. Powerful. Join a team as innovative as the technology we manage. Due to expansion, our healthcare client is expanding the HTM Projects Management team. This opportunity will work on capital and large projects. Their HTM division is looking for a Project Manager to oversee capital planning of medical devices and acquisitions along with service contract review. A Clinical Engineer degree is not required, but preferred. Project Management in a healthcare setting preferred. Are you a Clinical Engineer or lead biomedical/imaging equipment technology professional who has strong project management experience/training? Here's your opportunity to use analytic skills to manage and make recommendations for equipment replacement planning and forecasting. What You'll Do Coordinate the implementation of a defined, short-term project or sub-set of projects (less than one year) within set organizational procedures and standards. Responsible for meeting sub-set objectives within quality, time, and budget targets, and for managing associated risks. Typical knowledge and experience of the technical area being managed and an awareness of the business issues. What We Offer Compensation is fair and equitable, partially determined by a candidate's education level or years of relevant experience. Salary offers are based on a candidate's specific criteria, like experience, skills, education, and training. Sodexo offers a comprehensive benefits package that may include: Medical, Dental, Vision Care and Wellness Programs 401(k) Plan with Matching Contributions Paid Time Off and Company Holidays Career Growth Opportunities and Tuition Reimbursement More extensive information is provided to new employees upon hire. What You Bring Background in clinical engineering with medical devices and project management, specific to equipment replacement planning & forecasting and contracts analysis; Clinical Engineering degree or equivalent experience, 3-5 years in a healthcare setting. This position will manage the capital process of medical equipment from start to finish. Experience providing analysis, consultation, and research to establish project timelines and deliverables; Participated in cross functional project teams to determine the most appropriate equipment service, purchases, and agreements; Experience in managing projects, being well organized, self-motivated, and have excellent communication skills.

Additional skills: Experience with data entry/query resolution using Medidata RAVE, has previous exp as a study coordinator in a clinic setting with direct interaction with patients and supporting clinic staff. Has experience managing all aspects of the study including performing study visits (collecting patient vitals, collecting AEs/SAEs) Part-Time hours are flexible the site only requires 24 hours per week and worker's schedule will be 3 (8 hour) days onsite each week. Responsibilities: Perform clinical research support to investigators to prepare for and execute assigned research studies. Review study protocols, Case Report Forms (CRFs), other study-specific documents, and electronic data capture systems used to record clinical research data. Attend all relevant study meetings. Collect and submit regulatory/ethics documentation as required by the FDA and other regulatory bodies governing the conduct of clinical research. Recruit and screen patients for clinical trials and maintain subject screening logs. Orient research subjects to the study, including the purpose of the study, procedures, and protocol issues such as timelines for visits. Design and maintain source documentation based on protocol requirements. Schedule and execute study visits and perform study procedures. Collect, record, and maintain research subject study data according to study protocol and SOPs, preserving quality control for content, accuracy, and completeness. Handle lab testing and analysis, including preparation of specimen collection tubes and lab logistics. Monitor subject safety and report adverse reactions to appropriate medical personnel. Correspond with research subjects and troubleshoot study-related questions or issues. Participate in huddles to confirm daily study tasks are assigned to team members and are executed to the expected standards. Assist with study data quality checking and query resolution. Perform complex clinical research procedures including ECG, sample collection, spirometry, vital signs, dose verification, cannulation, and cardiac telemetry monitoring. Record, report, and interpret study findings appropriately to develop a study-specific database. Assist investigator in verifying that research study objectives are met on time, within budget, and according to applicable protocol requirements, clinical research regulations, and quality standards. Provide training to new investigator site staff members on study-specific topics and requirements. Assist in maintaining adherence to investigator site staff training requirements by auditing and maintaining training records. Prepare for and attend study monitoring visits, study audits, and regulatory inspections with clinical research regulatory agencies. Assist research site with coverage planning related to staffing and scheduling for research projects. Required Knowledge, Skills and Abilities: Knowledge of clinical trials. In-depth knowledge of departmental, protocol, and study-specific operating procedures, consent forms, and study schedules. Knowledge of medical terminology. Skilled in using MS Windows and Office applications such as Access, Outlook, Excel, and Word. Excellent interpersonal skills. Ability to pay close attention to detail. Ability to establish and maintain effective working relationships with coworkers, managers, and clients. Minimum Required Education and Experience: High school diploma or educational equivalent and relevant work experience in a clinical environment or medical setting; or equivalent combination of education, training, and experience. Applicable certifications and licenses as required by the company, country, state, and/or other regulatory bodies.

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.

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

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

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, 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

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, 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

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

Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team. Essential Duties And Responsibilities Participate and assist in design and preparation of protocols and case report forms. Generate clinical SOPs, policies, charters, and plans according to US and international guidelines. Participate in the evaluation of potential clinical sites according to established criteria of acceptability. Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials. Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow -up actions for assigned study sites. Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. Assist with the maintenance of clinical archive and electronic files. Other tasks as assigned. 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 accommodations may be made to enable individuals with disabilities to perform the essential functions. BA, BS, RN, BSN or equivalent Basic knowledge and adherence to GCPs 1 -2 years of clinical research experience or equivalent experience or training Strong attention to detail Ability to multi -task Unquestionable integrity and highest ethical standards Excellent written and verbal communication skills Self -motivated, assertive, and driven BenefitsDental, Medical, Vision, PTO and 401K

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 The UNC Adams School of Dentistry Division of Pediatric and Public Health provides oral health care for individuals from infancy through adolescence, and promotes the prevention of oral disease. The Pediatric Dentistry discipline is committed to the treatment of children, adolescents and special needs patients while balancing teaching, scholarship, patient care, research and professional service activities. Position Summary The Research Study Coordinator will support the clinical and translational research program led by Dr. Caroline Sawicki in the Department of Pediatric Dentistry and Dental Public Health at the UNC Adams School of Dentistry. This position plays a central role in coordinating human subjects research focused on pediatric orofacial pain, particularly temporomandibular disorders (TMD), migraine, and related biopsychosocial factors. The coordinator will serve as the primary operational staff member responsible for the day-to-day implementation of multiple ongoing and future studies involving children, adolescents, and their caregivers. A major focus of this role will be the NIH-funded clinical study on characterizing pressure pain thresholds, orofacial pain symptoms, and psychosocial profiles in adolescents with and without TMD. Responsibilities include participant recruitment and outreach, screening for eligibility, scheduling research visits, preparing study materials, communicating with DDS and undergraduate research assistants, and ensuring timely completion of study procedures. During visits, the coordinator will assist with administering clinical examinations (e.g., pressure pain threshold testing using a Wagner algometer), psychosocial questionnaires, and additional standardized measures. The coordinator will maintain high-quality data collection within REDCap, conduct quality assurance checks, manage study documentation, and ensure adherence to IRB protocols and study-specific standard operating procedures. The coordinator will also support additional active studies within the research program, including a pediatric migraine research study and other emerging or pilot projects aimed at understanding pain, anxiety, and behavioral responses in pediatric dental populations. Responsibilities include participant communication, regulatory documentation, coordination with clinical faculty and staff, preparation of study materials, and assistance with visit flow. As new studies are funded, the coordinator will play an integral role in launching study operations, drafting recruitment and visit workflows, assisting with IRB submissions and modifications, and supporting pilot data collection. This position requires strong organizational skills, excellent communication with children, adolescents, and families, and the ability to collaborate effectively with faculty, residents, dental students, research assistants, and clinical staff across the Adams School of Dentistry. The coordinator must ensure strict compliance with human subject's protections, HIPAA standards, departmental procedures, and UNC institutional policies. Duties include maintaining detailed logs, scheduling calendars, participant contact documentation, and accurate tracking of recruitment activities across multiple concurrent projects. The coordinator will serve as a central point of contact for participants and study team members to ensure smooth implementation of study visits, participant retention, and high-quality data capture. Additional responsibilities include maintaining study supplies and equipment, preparing participant incentives through ClinCard/Tango, providing parking validations, coordinating meeting agendas, and contributing to study progress reports and internal communications. This position requires flexibility, initiative, and the ability to manage multiple priorities in a dynamic research environment. The coordinator must be able to work independently while also contributing to a collaborative team setting. As the research program continues to grow, the coordinator will have opportunities to support evolving projects, assist with protocol development, and contribute to the expansion of pediatric orofacial pain research at UNC. Minimum Education and Experience Requirements Bachelor's degree; or equivalent combination of training and experience. All degrees must be received from appropriately accredited institutions. Required Qualifications, Competencies, and Experience A bachelor's degree in a relevant field (e.g., psychology, neuroscience, biology, public health, dental hygiene, health sciences, or related discipline) from an accredited institution, or an equivalent combination of education and experience. Strong written and verbal communication skills in English are essential, with the ability to interact professionally with children, adolescents, caregivers, faculty, staff, and student research assistants. Experience working with human subjects in U.S.-based research, clinical, or academic setting is required. Candidates must demonstrate familiarity with research procedures such as participant recruitment, screening, scheduling, informed consent/assent processes, administration of questionnaires, and data collection. The ability to follow study protocols and standard operating procedures with high reliability and attention to detail is essential. Candidates must maintain confidentiality of protected health information and comply with HIPAA, IRB regulations, and UNC institutional policies. Competence with computer software and data entry is required, including proficiency with Microsoft Office applications (Word, Excel, Outlook) and the ability to learn new electronic data capture systems. Applicants must be able to maintain detailed participant logs, communication records, and accurate documentation across all study activities. Candidates must demonstrate strong organizational skills, sound judgment, adaptability, and the ability to manage multiple tasks in a fast-paced research environment. The coordinator must be able to work both independently and collaboratively, communicate effectively with pediatric populations, and maintain professionalism during clinical research procedures. This position requires the ability to work occasional adjusted hours to accommodate participant availability. A commitment to high-quality research conduct, participant safety, ethical standards, and consistent follow-through on assigned responsibilities is essential. Preferred Qualifications, Competencies, and Experience Experience coordinating human subjects research involving children or adolescents is strongly preferred. Prior work in clinical, behavioral, dental, or pain-related research settings is highly desirable, particularly experience administering questionnaires, conducting participant interviews, or supporting clinical visit procedures. Candidates with familiarity in orofacial pain, pediatric pain, psychology, neuroscience, or related health sciences will be well-suited for this position. Preference will be given to applicants with experience using REDCap or comparable electronic data capture platforms, particularly those who have managed longitudinal datasets, performed data quality checks, or maintained detailed documentation across multiple phases of study activities. Experience working within IRB-regulated environments including preparation of regulatory documents, submission of modifications, creation of study logs, or maintenance of SOPs is highly desirable. Strong organizational abilities and demonstrated initiative in managing workflows, prioritizing competing tasks, and independently troubleshooting common challenges in research operations are highly valued. Experience coordinating scheduling workflows, interacting with multiple stakeholders, or maintaining recruitment and tracking logs is preferred. Candidates with prior experience communicating with families, especially within health-related or academic environments, will excel in this role. Experience working in interdisciplinary teams, including faculty, clinicians, residents, students, and research assistants, is preferred, as is the ability to provide guidance or support to trainees involved in recruitment and data collection. Familiarity with pediatric clinical settings, dental clinics, or outpatient environments is helpful but not required. Technical competencies such as proficiency with Microsoft Office applications, secure data handling, and digital communication platforms (e.g., Zoom, Teams) are preferred. Applicants with experience conducting clinical procedures such as basic anthropometric measurements, observational coding, or standardized assessments, or a willingness to learn clinical tasks such as pressure pain threshold testing, are highly desirable. Candidates who demonstrate strong problem-solving skills, a high level of professionalism, and a commitment to ethical research conduct are preferred. The ability to maintain composure, communicate clearly, and support pediatric participants and their caregivers in research settings is especially valuable. Experience working in fast-paced, evolving research programs or assisting with the launch of new projects is a significant asset. A strong interest in pediatric research, pain research, behavioral science, or clinical dentistry, and a desire to contribute to a growing, multifaceted research program, is highly desirable. Candidates with prior experience in research coordination or an interest in pursuing advanced training in health-related fields (e.g., dentistry, medicine, psychology, public health) are encouraged to apply. Required Licenses/Certifications Special Physical/Mental Requirements The position requires the ability to work in a clinical research environment involving children and adolescents. The coordinator must be able to stand for extended periods during study visits, move between clinic spaces, and assist with the setup and operation of research equipment. The role requires the ability to lift, carry, or move study materials and equipment weighing up to 20 pounds. Fine motor skills are required for tasks such as handling study devices, preparing materials, and accurately performing standardized clinical procedures. The position requires sustained concentration, attention to detail, and the ability to follow complex study protocols with high accuracy. The coordinator must be able to manage multiple tasks simultaneously, prioritize effectively, and adapt to changing schedules or participant needs. Strong interpersonal communication skills are essential, particularly the ability to interact with pediatric participants and their caregivers in a calm, supportive, and professional manner. The coordinator must be able to maintain confidentiality of sensitive information, comply with HIPAA regulations, and work with protected health information in secure systems. The role may require occasional adjusted work hours to accommodate participant availability. The ability to respond appropriately in unexpected or stressful situations, exercise sound judgment, and maintain professionalism in a busy clinical and research environment is essential. Campus Security Authority Responsibilities Not Applicable. Position/Schedule Requirements Special Instructions Quick Link *******************************************

The Senior Clinical Research Coordinator will perform and manage tasks that are critical to clinical research studies. The Senior Clinical Research Coordinator must ensure compliance with federal regulations, study protocol guidelines, as well as monitor study participants, and take a proactive approach to identify issues on an ongoing basis throughout the clinical research study. To consistently embody AMR Clinical's Core Values: United We Achieve Celebrate Diverse Perspectives Do the Right Thing Adapt and Persevere The Clinical Research Coordinator reports to the Site Manager/Team Lead. Classification: Non-Exempt Primary Responsibilities: Expanded role in team management, mentorship, and training, which includes over-sight of level 1 CRC's, Research Assistants and ancillary staff. Advanced Problem Solving & Decision-Making. Takes ownership of identifying, analyzing, and resolving complex study-related challenges, including protocol deviations, regulatory compliance issues, and operational inefficiencies. Proactively collaborates with QA and Site Manager to develop and implement corrective and preventive action plans to mitigate risks and improve study outcomes. Serves as a key resource for junior staff, providing guidance and training on problem-solving strategies while escalating critical issues to leadership as needed. Advanced knowledge of protocol and procedures. Greater responsibility for regulatory compliance, protocol deviations, and audits. Deeper involvement in recruitment strategy and study performance. Higher engagement with study sponsors, CROs, monitors/CRA's, IRBs, laboratories, and clinical personnel within the research industry. Coordinate clinical trials per FDA requirements and GCP Guidelines per sponsor protocols. Establish understanding of SOP's and implement the SOP's Gain understanding of the pharmaceutical drug per clinical trial. Advanced skills in study start-up and close-out procedures. Manage complex clinical trials, including those with challenging study designs and special patient populations. Work closely with Investigators to optimize site performance, improve study compliance, and facilitate better communication between research staff and investigators. Notify the correct personnel of any adverse events per the study protocol (PI, Sub-I, monitor/CRA, etc.) Be the study ambassador on assigned studies to advise team members on protocols and procedures to ensure successful implementation and completion of the clinical research study. Establish and maintain patient rapport. Clinical data collection (vital signs, EKG recording, weight, height, etc.) Obtain medical records and review as required. Phlebotomy Specimen collection, processing, and storage Transporting clinical specimens to laboratory. Educate subjects on diaries and oversees compliance with diary completion. Provides subjects instructions per study (diaries, restricted meds, study reminders, etc.) Responsible for completing patient phone call visits in accordance to the standard protocol period. Ensure documentation follows ALCOA standards and is completed in a timely manner. Ensure all necessary documents are completed, signed and dated. Provides required information to Contract Research Organization (CRO), Institutional Review Board (IRB), sponsoring organization, Food and Drug Administration (FDA), and/or other appropriate agency as required. Manage study inventory and order supplies as needed. Prepare and assist study monitors during onsite visits. Maintain familiarity with all ongoing clinical research studies. Travel to Investigator meetings as needed. Promote team mentality by working flexible hours as needed and completing tasks outside the scope of everyday duties Mentor team members to promote professional development Position may require occasional weekend and/or overtime hours. Other duties as assigned Desired Skills and Qualifications: 3+ years of experience in clinical research. Completion of formal medical training, educational program, or healthcare experience Strong medical terminology Ability to perform clinical, laboratory, and diagnostic tests (vital signs, height, weight, temperature, etc.). Ability to work independently and lead study-related tasks. Ability to multi-task in a high-paced evolving environment. Exceptional listening, written, and verbal communication skills as well. Demonstrate proficiency in office equipment and software programs. Excellent organizational and task management skills. Ability to be ambulatory most of the workday. Ability to lift/transfer/push/manipulate equipment and patients, which requires strength, gross motor and fine motor coordination. AMR Clinical does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor. ** This job description is intended to be a representative summary of the major responsibilities and accountabilities of the staff holding this position. The staff may be requested to perform job-related tasks other than those stated in this description.

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 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.

The Clinical Trials Office (CTO) and specific disease group Program Manager within the Clinical Operations Unit are recruiting for a Research Coordinator I. Entity Medical University of South Carolina (MUSC - Univ) Worker Type Employee Worker Sub-Type Classified Cost Center CC001332 HCC CTO Administration Pay Rate Type Hourly Pay Grade University-05 Pay Range 39,764.00 - 56,670.00 - 73,576.000 Scheduled Weekly Hours 40 Work Shift Summary: Under general supervision of the Clinical Trials Office (CTO) and specific disease group Program Manager within the Clinical Operations Unit, this position coordinates, establishes, and supervises complex research protocols at the Hollings Cancer enter (HCC) to efficiently and effectively integrate cooperative group and industry sponsored trials at the Medical University of South Carolina (MUSC). Actively promotes and increases awareness of the clinical trial program within HCC, exercises judgment regarding proper patient management, timely and accurately meets established reporting systems to research bases, National Cancer Institute, and MUSC staff. Responsibilities: 35% Coordinates patient research related activities to accurately meet protocol requirements. Ensure protocol compliance for study participants. Ensures database updates to reflect accurate patient status. Utilizes office tools including Sharepoint, Clinical Data Center (CDC), and clinical trial management system (CTMS). Provides protocol specific information to physicians, primary nurses, and patients. Coordinates the clinical work-up to determine patient eligibility. Coordinates treatment plan and required follow-up with study participant, medical staff, nursing staff and ancillary hospital personnel. Ensures that follow-up requirements per protocol are carried out in order to assess for response to treatment. Works closely with clinical nurse staff to coordinate patient care to meet protocol standards. Consults with the investigator to assess study participant for response to protocol therapy including toxicity assessment and disease status. Coordinates and conducts activities associated with the preparation and shipment of protocol related samples within specified parameters. Prepares, transports, and handles bloodborne pathogens and other human specimens following OSHA guidelines. Enters and maintains both current and new study participant information into the clinical trials database. New patient enrollments and status updates are to be entered into the CTMS within 24 hours of the enrollment or status change. This includes Screening, Screen Failures, Consenting, Enrolling, Active on Treatment, Follow up, and Off study status. New patient enrollments and status updates are to be entered/confirmed in EPIC within 24 hours of the enrollment and or status change. This includes Consented- in screening, Enrolled-Receiving treatment and/or intervention, Enrolled-follow up only, Lost to follow up, Screen failure and Completed. Research participant protocol-related visits must be linked in EPIC prior to the encounter. 20% Assists investigators to identify, consent, screen, register/ enroll eligible patients to studies at Hollings Cancer Center. Screens all patients at the Hollings Cancer Center (HCC) that have been newly diagnosed, have progressed, or experienced a recurrence for possible inclusion into a clinical trial. Attends and actively participates in regularly scheduled multidisciplinary tumor boards, clinics, conferences, and any other forum where patients may be discussed. Documents and tracks all screening efforts per departmental guidelines. Establishes communication with physician investigators and care team regarding potential study participants. Effective screening of HCC patient medical records requires knowledge of oncology terminology, medical terminology, disease specific staging and each clinical trial protocol eligibility criterion. Meets weekly with their clinical operations team to discuss potential trial participants and plan for the upcoming week for all clinic coverage needs. Under guidance of the team lead coordinator(s) and program manager, will support research activities at any of the MUSC main campus and HCC satellite locations and make necessary coverage plans in advance, to avoid interruption of quality CTO services. Participates in and supports the informed consent process per departmental and institutional policy. 20% Timely and accurately collects and submits data to established research bases including the National Cancer Institute, industry sponsors and MUSC. Ensures data quality and timely completion and submission of case report forms (CRFs) and queries. Develops and implements an effective daily routine which minimally includes retrieval of ongoing data from local or outside medical records, completion of appropriate case report forms and any data query received. Ensures data is submitted according to sponsor mandated time frames and in a manner that affords maximum accuracy. Ensures source documentation is present in patient chart for case report form completion. Visit-specific CRFs are to be completed per sponsor requirements. Case report submission may include patient reported outcome questionnaires, radiologic scans, reports and staging tests. Proactively plan, prioritize and manage responsibilities to ensure timely and accurate data submission to specified research bases. Data submission is timely and accurate per the protocol, patient calendar, and source documents. Collaborates with Data Coordinators as needed with patient protocol visits including adverse event logs, patient questionnaires, picking up specimens, and transporting study supplies. Maintains established workflows to identify data needs of numerous trials within multiple disease groups and communicates data entry needs to study team. 15% Timely and accurately submits Adverse Events, Serious Adverse Events, and other reportable events to the NCI, sponsors, IRB and DSMC per federal guidelines and institutional policies. Prepares and submits CTO-required and sponsor specific initial and follow up reports. Adheres to the reporting requirements within the Clinical Trials Office, MUSC and various study sponsors. Proactively plans to ensure reports are comprehensive and that reporting requirements are met within the allowable timeframe and in a manner that affords maximum accuracy. Submits regulatory documents upon receipt to the Manager of Regulatory Compliance to ensure timely reporting by the regulatory unit of CTO. This includes Adverse Event reports and protocol deviation reporting as well as any new protocol documents which may include but are not limited to protocol amendments, correspondence from sponsor, or any other documents requiring review and/or submission to IRB. Additional non-regulatory reporting requirements would include submission of screening logs and database updates. Protocol deviations will be reported to the clinical trials office regulatory unit per departmental processes. Items that are outstanding per sponsor monitoring visit letters will be addressed and closed within 4 weeks of receiving the monitoring letter, or by the date of the monitor's next site visit, whichever is earlier. 10% Maintain working knowledge of disease specific trial portfolio and participate in disease focus group meetings to support trial start up process for new studies and maintenance of protocol amendments. Presents pertinent research related data to the research focus group and individual investigators. Maintains up to date protocol information, communication and education of study and clinic personnel. Assists in planning, implementing, and evaluation of program expansion and new projects. Positively and professionally contributes to working groups and meetings. Initiates and organizes meetings and prepares meeting agendas. Discusses high priority trials. Presents protocols to programs and clearly assesses patient population and feasibility of trial. During the "In Approval Process-Step 1" reviews new protocols, completes the initial roadmap submission by designated timeline and obtains study specific credentialing per protocol requirements. Collaborates with the CTO nurse managers in development of initial roadmap and amended roadmaps as applicable. As protocol amendments are received amended roadmaps are completed by the assigned date to ensure patient safety. Completes the Initial roadmap submission by assigned due date. Roadmap submission forms are comprehensive and include all study assessments required per the protocol and study calendar. Roadmap submission forms are accurate including treatment arms, hold and call parameters and dosing modifications per the protocol guidelines. Additional Job Description Minimum Requirements: A bachelor's degree and two years of relevant program experience. Physical Requirements: (Note: The following descriptions are applicable to this section: Continuous - 6-8 hours per shift; Frequent - 2-6 hours per shift; Infrequent - 0-2 hours per shift) Ability to perform job functions in an upright position. (Frequent) Ability to perform job functions in a seated position. (Frequent) Ability to perform job functions while walking/mobile. (Frequent) Ability to work indoors. (Continuous) Ability to work outdoors in all weather and temperature extremes. (Infrequent) Ability to work in confined/cramped spaces. (Infrequent) Ability to perform job functions from kneeling positions. (Infrequent) Ability to squat and perform job functions. (Infrequent) Ability to perform 'pinching' operations. (Infrequent) Ability to fully use both hands/arms. (Frequent) Ability to perform repetitive motions with hands/wrists/elbows and shoulders. (Frequent) Ability to reach in all directions. (Frequent) Possess good finger dexterity. (Continuous) Ability to maintain tactile sensory functions. (Continuous) Ability to lift and carry 15 lbs., unassisted. (Infrequent) Ability to lower objects, up to 15 lbs., from height of 36 inches to floor level, unassisted. (Infrequent) Ability to push/pull objects, up to 15 lbs., unassisted. (Infrequent) Ability to maintain 20/40 vision, corrected, in one eye or with both eyes. (Continuous) Ability to see and recognize objects close at hand. (Frequent) Ability to see and recognize objects at a distance. (Frequent) Ability to determine distance/relationship between objects; depth perception. (Frequent) Good peripheral vision capabilities. (Continuous) Ability to maintain hearing acuity, with correction. (Continuous) Ability to perform gross motor functions with frequent fine motor movements. (Frequent) If you like working with energetic enthusiastic individuals, you will enjoy your career with us! The Medical University of South Carolina is an Equal Opportunity Employer. MUSC does not discriminate on the basis of race, color, religion or belief, age, sex, national origin, gender identity, sexual orientation, disability, protected veteran status, family or parental status, or any other status protected by state laws and/or federal regulations. All qualified applicants are encouraged to apply and will receive consideration for employment based upon applicable qualifications, merit and business need. Medical University of South Carolina participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: ***************************************

The Research Study Coordinator will support multiple clinical-translational research studies focused on pediatric orofacial pain. Core responsibilities include participant recruitment, scheduling, and conducting study visits involving pain and behavioral assessments, patient-reported outcomes, and data collection. This position will also assist with data entry, quality control, and basic data management, with opportunities to learn how to create tables and figures for abstracts, presentations, and manuscripts. The role requires frequent patient and family interaction, as well as communication with dental and medical professionals. The ideal candidate will demonstrate strong attention to detail, professionalism, reliability, and the ability to follow detailed protocols. They must be highly organized, able to work independently, and comfortable collaborating within a multidisciplinary team and in patient-facing settings. Required Qualifications, Competencies, And Experience Experience in a clinical research environment; ability to observe, monitor, collect, and record data with attention to accuracy, validity, and integrity; strong communication and organizational skills; and comfort working directly with pediatric participants and their families. Preferred Qualifications, Competencies, And Experience Course work in a biomedical, behavioral, or related field; previous experience working with children or families; familiarity with clinical-translational research or human subjects research; and proficiency with REDCap or similar data management systems. Work Schedule Monday - Friday; 9:00 AM - 5:00 PM (5 days/week in person)

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.***

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.

M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance. Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data. Due to our continued growth, we are hiring for a Clinical Research Coordinator at Wake Research, an M3 company. This position is on-site and located in Raleigh, NC. The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the guidance of the clinical research site management and Principal Investigator (PI). While the PI is primarily responsible for the overall conduct of the clinical trial, the CRC manages, supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. Essential Duties and Responsibilities: * Assisting trial Investigator in screening and review of potential study participants eligibility * Maintaining case report forms, charts and documentation * Mentoring, training, and high-level oversight of other clinical research coordinators and research assistants * Ensuring that all clinical activities are carried out in accordance with established research protocol and standards in compliance with all applicable laws, regulations, policies, and procedural requirements * Collecting and entering data as necessary * Assist management with potential new hire selection and shadowing process * Assist with study start-up, maintenance, and close-out of studies as needed for those on the team * Ability to be flexible with study assignments Qualifications * Clinical Research Coordinator with 1-2 years of experience * Phlebotomy experience is highly preferred * Previous experience as a medical assistant, LPN, or RN * Excellent verbal & written communication skills * Ability to learn quickly, read and understand complex protocols, follow very detailed directions, and multi-tasking * Must be able to maintain strict confidentiality of patients, employees, and company information at all times and adhere to HIPAA Guidelines * Extensive clinical trial knowledge through education and/or experience * Successful completion of GCP Certification and Advanced CRC preferred * Detail-oriented * Familiarity with the Code of Federal Regulations as they pertain to human subject protection * Strong interpersonal skills Additional Information About M3: M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we've seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems. Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements. Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA. Benefits: A career opportunity with M3 Wake Research offers competitive wages, and benefits such as: * 401(k), 401(k) matching * Dental insurance * Disability insurance * Employee assistance program * Flexible spending account * Health insurance * Life insurance * Paid time off * Vision insurance * M3 reserves the right to change this job description to meet the business needs of the organization #LI-Onsite #LI-LB1