Clinical research coordinator jobs in Holly Springs, NC - 91 jobs

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

Clinical Research Associate (CRA) - East Coast ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Clinical Research Associate to join our diverse and dynamic team. As a Clinical Research Associate at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. **What you will be doing** + Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. + Ensuring protocol compliance, data integrity, and patient safety throughout the trial process. + Collaborating with investigators and site staff to facilitate smooth study conduct. + Performing data review and resolution of queries to maintain high-quality clinical data. + Contributing to the preparation and review of study documentation, including protocols and clinical study reports **Your profile** + Bachelor's degree in a scientific or healthcare-related field. + Minimum of 12 months onsite monitoring experience as a Clinical Research Associate; level (CRA I, CRA II, or Senior CRA) determined by total years of experience. In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines. + Strong organizational and communication skills, with attention to detail. + Ability to work independently and collaboratively in a fast-paced environment. + Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license **What ICON can offer you:** Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: + Various annual leave entitlements + A range of health insurance offerings to suit you and your family's needs. + Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. + Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. + Life assurance + Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site (************************************* to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (****************************************************** Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here (****************************************************** to apply

This position will serve as a Senior Clinical Research Coordinator within the Institute for Trauma Recovery. The Institute for Trauma Recovery seeks to advance understanding of trauma recovery and develop interventions that improve recovery. The foundation of our success is our fantastic team of faculty and staff. Our team believes that achieving new discoveries for trauma survivors around the globe, via observational studies and randomized controlled trials, is an extremely meaningful and satisfying way to spend one's professional life. We work to place the trauma survivor at the center of all of our decisions and to serve them through our work. We continuously work to create a community where our team members serve trauma survivors and actualize their career growth and individual leadership potential. 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. The primary purpose of this position is to support the Principal Investigators (PIs) and Institute Manager on several current and pending research projects. This position will be responsible for a broad range of duties related to planning, organizing, executing, and monitoring the implementation of new and existing clinical trials and other research initiatives. Duties will include supporting the PI with maintaining research methods, tracking patients in the study, provide feedback and suggestion on the development/revision of research protocols and regulatory correspondence as well as maintaining accurate and updated manuals of procedures for the studies. This position will serve as senior coordinator on one or more of the ongoing clinical trials in the institute. In addition to the above, this position will assist with study design, and the development of study procedures, budget management, and regulatory oversight. This position will be responsible for supervising research staff and student volunteers. 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. Specialized knowledge in clinical research principles. Ability to plan and design methodologies for monitoring data collection. Ability to take a leadership role in implementing changes in design of clinical research management. Ability to problem solve and resolve quality control issues by changing processes. Strong problem solving skills. Preferred Qualifications, Competencies, And Experience Not applicable.

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 The purpose of this position is to facilitate the conduct of oncology clinical trials, including subject and data management, according to federal regulations, Good Clinical Practice, and local and institutional policies. Reporting to the Clinical Research Manager, the Lead Study Coordinator independently manages multiple complex trials through the protocol life cycles of activation, implementation and closure. As Lead Study Coordinator, provide team lead and programmatic support on a daily basis, lead patient care and advising activities and serve as preceptor for new hire; providing ongoing training and first line support for staff. These responsibilities relate to the mission of the UNC/LCCC Protocol Office by maintaining the quality of research and by addressing patient safety and regulatory compliance which impact research quality and safeguard institutional integrity. 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. * Advanced knowledge of clinical research coordination. * Possess strong decision-making skills and the ability to problem solve and troubleshoot issues. * High level of accuracy and attention to detail. * Strong computer skills. * Ability to gather data and document procedures. * Ability to plan work and coordinate multiple projects. * Ability to contribute to preparation and delivery of reports, trainings and SOPs. * Customer oriented and ability to work in a team environment. * Ability to communicate effectively and professionally verbally and in writing. * 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 in Phase I, II, and III clinical research. * Experience navigating medical records and data extraction. * Three years of clinical trial coordination experience, two of which must be in oncology. * SOCRA/ACRP Certification. Special Physical/Mental Requirements Campus Security Authority Responsibilities Not Applicable. Special Instructions Quick Link *******************************************

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

Science 37's mission is to accelerate clinical research by enabling universal trial access for patients. Through our solutions; Direct-to- Patient Site and Patient Recruitment, we accelerate enrollment by expanding the reach of clinical trials to patients beyond the traditional site and rigorously qualifying patients prior to referring them to a traditional site. Our solutions are powered by in-house medical and operational experts that enhance quality through standardized workflows and best-in-class study orchestration. The Clinical Research Coordinator II fulfills the requirements of recruiting, enrolling and conducting follow-up of study participants in clinical trials under the direct supervision of the Principal Investigator (PI) and Project Manager. In doing so, the Clinical Research Coordinator II is responsible for coordinating trial participation of study volunteers with the trial's protocol, company and trial Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/ International Conference on Harmonization (ICH) guidelines, FDA regulations and other applicable regulations (global, state, etc.). The Clinical Research Coordinator II is responsible for working with the trial delivery team to meet enrollment and retention goals and ensure compliance with the study protocol. DUTIES AND RESPONSIBILITIES Duties include but are not limited to: Actively participates in the implementation and execution of clinical trial activities from study start-up preparations, planning, execution and closure. Attends investigator, project and department meetings/trainings, leads as needed, and assists in gathering agenda topics and creating meeting minutes as required. Participates as temporary Project Manager for smaller studies, as needed, with appropriate training/support. Under direct supervision of a Principal Investigator, is responsible for enlisting, maintaining, and assuring protocol compliance for all study participants in clinical trials. Collaborates with study investigators in determining eligibility of potential participants in clinical trials. Screens potential participants for protocol eligibility. Presents trial concepts and details to the participant, participates in the informed consent process, and enrolls participants in study protocol. Ensures research quality by practicing in compliance with and advocating for any edit needs of Science 37 Standard Operating Procedures (SOP), and ensures research quality by practicing in compliance with principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations. Supports the development, review and distribution of clinical protocols, informed consent forms, study instructions/manuals/guidelines or department generated tools and other study-related clinical documents. Coordinates patient care in compliance with protocol requirements. May provide participants education regarding medication administration. Maintains individual participant investigational drug accountability. In collaboration with the study investigator, reviews study participants for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings. Responsible for accurate and timely data collection, documentation, entry, and reporting. Schedules and participates in monitoring and auditing activities. Maintains comprehensive knowledge of assigned research protocol to coordinate the comprehensive and compliant execution of assigned protocols in accordance with research governing entity requirements, including but not limited to Sponsor, FDA, and IRB requirements. Ensures the completion and maintenance of consent forms, case report forms, SAE's and source documents to ensure that research is being conducted according to guidelines. Establishes and coordinates logistical aspects of clinical research projects to achieve project objectives. Supports the maintenance of regulatory documents in the ISF in accordance with SOPs and applicable regulations. Participates in required training and education programs. Assists with education of other personnel and vendors regarding clinical research. Collaborates closely with Project Manager to ensure compliance to trial procedures and vendor management. Provides process improvement solutions and collaborates on the implementation of the solutions. Additional responsibilities may include working directly with other vendors and/or sponsors. Provides a safe environment for study participants, caregivers, and study personnel at all times through compliance with all federal, state, and professional regulatory standards. Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Provides mentorship and training for other CRCs as needed. Provides assistance to and creates a supportive environment for the CRC team. DUTIES AND RESPONSIBILITIES FOR HYBRID TRIALS Acts as a point of contact for the site and Sponsor, as necessary, with oversight from the Project Manager. Develops project plan outlining planning, execution and closeout processes. Develops the study communication plan in collaboration with the sites. Collaborates with the Science 37 study team and extended members to ensure compliance to trial procedures. Collaborates with Science 37 multi-disciplinary teams to provide clear direction and processes for site study teams and assist with study execution. Other duties, as assigned. QUALIFICATIONS & SKILLS Qualifications The following qualifications are preferred and/or equivalent applicable experience: Bachelor's degree (preferred) or minimum two-year college degree, or an equivalent combination of education, training, experience, and demonstrated skills needed to successfully perform the assigned duties and responsibilities. Advanced degree preferred but not required. A minimum of 5 years of pharmaceutical-sponsored clinical research experience is required or commensurate education, training, and experience within the clinical research field. ACRP (CCRC) or SoCRA (CCRP) certification, highly desired Medical and scientific knowledge, preferred. Experience working with patients in a HIPAA regulated environment and knowledge of good clinical practice (GCP), and applicable regulatory requirements. Excellent time management, organizational skills and ability to manage multiple tasks. Attention to detail and accuracy in work. Must have the ability to conduct collaborative interaction with cross functional team members. Skills/Competencies Expertise in trial management - Demonstrated ability to successfully manage the participation of patients in clinical trials. Proactive problem-solving abilities and follow through. Expert Knowledge of FDA regulations and GCP guidelines - Understands applicable regulations and implications for trial participation. Expert knowledge of clinical research - Knowledgeable about the critical elements for success in clinical trials; participation in and contribution to these activities. Strong communication and presentation skills - Demonstrates strong written and verbal communication skills. Ability to establish and maintain positive study participant rapport, project team members, and internal Science37 relationships. Ability to interact with patients and caregivers in a compassionate and empathetic manner. Leadership skills - Demonstrates the ability to communicate effectively across multifunctional teams. Provides effective solutions to challenges. Is recognized by others as a leader and a resource. Computer skills - Proficient with MS Office and Google Suite applications. Able to generate business correspondence, create forms and generate spreadsheet reports as required. Demonstrates expertise in the use of proprietary software. Practices professionalism and integrity in all actions - Demonstrates ability to foster concepts of teamwork, cooperation, self- control, and flexibility to get the work done. The ability to adapt to a rapidly changing work environment. Able to successfully work in a decentralized team environment. Skilled in situational responsive decision-making. Capabilities Up to 20% travel, as needed, for project team meetings, client presentations and other professional meetings/conferences as needed Ability to communicate in English (both verbal and written) May require extended or unusual work hours based on research requirements and business needs. BENEFITS At Science 37, our focus is to provide you with a comprehensive and competitive total reward package that supports you at all stages of your career - both now and into the future. Our success depends on the knowledge, capabilities, and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work that adds to your professional development. Science 37 is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed. Submit your resume to apply! To learn about Science 37's privacy practices including compliance with applicable privacy laws, please click here

Preferred Qualifications Spanish fluency Work Schedule Monday - Friday, 8:00am - 5:00pm and weekends as needed.

Procom is a leading provider of professional IT services and staffing to businesses and governments in Canada as well as the US. With revenues over $500 million, the Branham Group has recognized Procom as the 3rd largest professional services firm in Canada and is now the largest “Canadian-Owned” IT staffing/consulting company. Specialties• Contract Staffing (Staff Augmentation) • Permanent Placement (Staff Augmentation) • ICAP (Contractor Payroll) • Flextrack (Vendor Management System) Clinical Research Study Coordinator On behalf of our client, Procom Services is searching for a Clinical Research Study Coordinator to join their team in Chapel Hill, NC. The primary purpose of this position will be to run all aspects of the assigned clinical trials. IRB submissions, recruitment, working with investigators as well as the patients. Clinical Research Study Coordinator Job Description Perform independent and dependable work in preparation and coordination of study submission to IRB and other appropriate committees following regular deadlines. They will provide draft IRB, Sponsor and other response to the PI for approval. They will respond on behalf of the PI when appropriate Communicate with study staff, IRB, sponsors, domestic and international study partners in a courteous and professional manner; Meet with study sponsor representatives as needed. Attend IRB, study sponsor, or any other meeting in place of the PI Prepare informed consent forms that follow appropriate regulation and meet sponsor requirements Address queries and memos from IRB and other committees create draft response to query's for PI approval Maintain and organize electronic and paper regulatory documents, study files and patient binders. Perform Quality Assurance/Quality Control of Study files Track and enter regulatory submissions using electronic databases and prepare reports within the databases. Respond to all queries and adverse events in a timely manner. Will be initial contact for all adverse events for their studies See clinical trial patients, follow up with phone calls and make sure all protocols are followed. Will also be responsible for screening and recruitment of clinical trial patients Communicate for themselves and on behalf of the PI potential issues to regulatory supervisor, study team members, and investigators Assist other staff members in completion of work in a team oriented fashion Complete other regulatory duties as assigned. Communication, Teamwork and Compliance Employee uses effective verbal and written communication to accomplish tasks Coordinator must have the technical ability to apply the knowledge of research principles when collecting, editing, analyzing the data and reporting data/information related to the study. The Coordinator will be required to have general computer and technical knowledge as well as an understanding of patient input data bases. Requires ability to identify discrepancies in database information. Coordinator must be able to problem solve and implant new systems to help make Center more effective. This type of work requires extreme organization and attention to detail. Coordinator will support research, develop programs and policies for the Center. Coordinator must be able to work as a productive member of a team by helping develop solutions to meet group needs as well as the structure of the team. Coordinator will have the ability to serve as a team leader. Skills include working effectively with patients, medical faculty and staff, ability to understand and implement protocols and teach them to clinic personnel. Requires ability to develop a flexible work schedule, organized and able to implement clinic clinical trials based on FDA and good clinical practice guidelines and work independently. Experience in research is required. Knowledge of research principles and methods to interpret, and coordinate the collection and analysis of data/information related to the research. Clinical Research Study Coordinator Mandatory Requirements Prior experience in Clinical Trials. Nursing degree preferred, specifically with a focus in Oncology. Clinical Research Study Coordinator Start Date ASAP Clinical Research Study Coordinator Assignment Length 6 months (possible extension/hire) Additional InformationPLEASE NOTE THAT WE ARE NOT ABLE TO WORK WITH CANDIDATES ON H1B VISAS OR CANDIDATES REPRESENTED BY THIRD PARTIES.

Illingworth Research Group provides a range of patient focused clinical services to the pharmaceutical, healthcare, biotechnology and medical device industries. These include mobile research nursing, patient concierge, medical photography and clinical research services. Illingworth are experts with experience across all study phases and in a diverse range of therapeutic areas. Illingworth Research Group is a global organization operating in over 45 countries, bringing clinical research directly into the home of the patient, to improve the experience of patients involved in clinical trials and the quality of their lives. Job Responsibilities Clinical Research Project Planning and Preparation Review of assigned protocols and other protocol documentation (ICF, IB) for accuracy, feasibility, timing, and resources. Prepare and maintain the Investigator Site File and/ or Trial Master File (TMF) for the study. Participate in creation and review of timelines and start-up meetings (Investigator Meeting/SIV, Sponsor discussions, or other related meetings). Take the lead and/or overall coordination of all required start-up activities including, but not limited, to the following: o Clinic logistics planning, schedule of clinic activities, and team training. o Preparation, review, and/or finalization of clinic source documents, time and events tables, and other required study materials; review of Case Report Forms (CRFs), laboratory workbooks, staff requirements, and schedules. o In collaboration with the responsible teams, establishes and/or maintains safety assessment requirements, Quality Control (QC) and monitoring plans, pharmacy/dispensing requirements, study supplies/equipment, meal plans, and other elements as applicable to the study. o Confirms all required regulatory and contractual documentation is present prior to study start. Support the Principal Investigator as needed with study related tasks such as, but not limited to: o Delegation of Authority Log. o Management of daily tasks. o Visit calendar development and maintenance. o Scheduling and attending monitor visits. Advertise, recruit, and screen potential participants for the study. Clinical Conduct Perform all study activities following Good Clinical Practices (GCP). Manage multiple clinical trials simultaneously. Protect the safety of human subjects. Monitor appropriate sources for specific clinical study or federal regulation updates. Collect and enter study data into the appropriate system. Coordinate and monitor screening activities; provides support as required. Assist with informed consent of study subjects. Submit data in required timeframe. Monitor appropriate sources for specific clinical study or federal regulation updates. Complete Case Report Forms. Facilitate audits of study data. Develop patient rapport to explain research protocols and minimize protocol violations. Develop rapport with study team to educate team on study procedures and minimize protocol violations. Respond to inquiries by auditors for data clarification or additional data in required timeframe. Take the lead and/or overall coordination of clinic activities including, but not limited to: o Supervises clinic visits (admission, dosing and randomization, discharge, and follow-up) as required and provides on-call support when applicable. o Screens eligibility prior to randomization; oversees, coordinates and/ or performs study drug administration, and other activities as delegated and required. o In collaboration with the responsible teams, monitors that all study-related activities are conducted according to protocol, SOP, and applicable regulations. Review and manage clinic updates, Adverse Event (AE) or Serious Adverse Events (SAEs) reporting, study logs and tracker, quality control, and Monitor findings. Post-Clinic/Close-Out Activities Coordinate resolution and/or address QC, monitor, CRF, or other internal/external findings. Review and/or oversee close-out of study documentation, deviation reporting, CRF completion and sign-off, and other study-related reports/documentation. Review and update TMF documentation. Finalize study and/or volunteer logs. Ensure completion of other close-out activities as required (return of study supplies, IRB reports, archiving, etc.). Responsible for monitoring subjects' compliance throughout the trial and address day-to-day. subject or study issues and escalate as appropriate. Prepare for and participates in sponsor/monitor/QA audits. Provide accurate and timely project status updates to Project Managers and sponsor. Collaborate within and between teams during process improvement exercises, SOP creation. and/or revision, internal and external meetings, and other company-related initiatives and goals. Accommodate flexible schedule (available days, afternoons, nights, and weekends). Perform other work-related duties as assigned. Coordinate and Perform Regulatory Activities Maintain proper protocol, consent, amendment, and yearly renewal submission if requested. Report adverse events relating to the trial. Maintain study files. Travel up to 100% QUALIFICATION REQUIREMENTS Registered Nurse and/ or University Degree such as Bachelor of Science Degree required. Clinical Research certification preferred. A minimum of 1 year experience in clinical research required, preferably in coordination of clinical research projects. 2+ years preferred. Good knowledge of regulations, ICH GCP, privacy, and applicable guidelines. Required skills: problem solving, planning, and evaluation. Possess good time management, detail-oriented, and able to multi-task. Good interpersonal and communication skills with a team focus. Knowledge of SOP writing. Ability to anticipate problems and provide solutions in a timely manner. Ability to coordinate multiple clinical research projects with competing deadlines. Proficiency in computer software programs (e.g. Word, Excel, Power Point). Proficiency in use of various clinical trial EDC software preferred. Disclaimer: Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the . The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Additional Information: Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Coordinates or co-leads assigned clinical research projects in accordance with Protocols, Standard Operating Procedures (SOPs), and applicable regulations.

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

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

**Voted Raleigh's Best Nonprofit Organization and Raleigh's Best Mental Health Services two years in a row!** Do you have a passion for making a real difference in the lives of people living with mental health challenges and disabilities? At Easterseals PORT Health, we're seeking a compassionate and dedicated full-time Clinical Coordinator to join our NC START Team in Raleigh. As a valued member of our collaborative and supportive team, you will work together to transform the lives of individuals by providing crisis interventions and support to children and adults. This isn't just a job - you will be influencing change and shaping futures as a leader in our shared mission of helping people reach their full potential. Your Role in Our Mission As a Clinical Coordinator, you will care will and make a huge difference in the lives of the people you will be helping. You may expect to implement the START model, a systemic and positive crisis prevention/intervention model, for individuals with intellectual/developmental disabilities and co-occurring mental illness in the region. You will also be collaborating with support teams to develop and refine cross-systems crisis prevention and intervention plans for START recipients along with strong communication skills and a passion for continued growth and development will be important functions of this opportunity. How You'll Benefit As a part of our mission, we help our team members embrace their potential, build resilience, and thrive! You will benefit from ongoing professional growth and development as you work alongside leaders of clinical excellence in mental health and IDD services that care about your success. This position follows a Monday-Friday 8:30a-4:30p with rotating on-call shifts We also offer a full benefits package for benefits-eligible positions. Compensation & Benefits Competitive salary: $60,000 for this full-time exempt position Generous paid time off and paid holidays Full benefits package including Medical, Dental, and Vision benefits Life and Disability Insurance (company paid) 403(b) Retirement Plan Employee Assistance Program and legal services support Public Service Loan Forgiveness (PSLF) qualifying employer Free in-house supervision for licensure! What We're Looking For To join our team as a Clinical Coordinator, you must has a passion for helping others, possess top-tier verbal, and written communication skills. You must also be willing to provide services in various community locations within the region as needed, rotate crisis line coverage for 1-3 days at a time, have a passion for helping others, and be able to link clients to community resources. We also require: Minimum of Master's degree from an accredited university in Social Work, Clinical Mental Health Counseling, Rehabilitation Counseling, Psychology, or other closely-related field and license-eligible in your field (license preferred) Experience with individuals with intellectual/developmental disabilities, mental health diagnoses, or both, particularly those with significant behavioral needs Knowledge of systems of care impacting adults and children with co-occurring I/DD and MH conditions At least one year of working with children and adolescents Flexibility to travel to our Durham location for Onboarding and twice a month throughout employment A valid driver's license, current auto insurance and a good driving record Ready to Apply? Join a team where work isn't just something you do - it's a purpose. Bring your expertise to a mission that matters. Apply now at *************** PORT.com or send your resume to recruiter@easterseals PORT.com. About Easterseals PORT Health Easterseals PORT Health is a trustworthy and compassionate partner, providing exceptional services in disability, mental health, and substance use to help our neighbors live their best lives. Purpose, dedication, and empathy drive our in-person and telehealth service delivery. Our diverse and inclusive 2,600-member team provides more than 10.2 million hours of meaningful support to 40,200 kids, adults, and families in 11,000 home, facility, and community locations across North Carolina and Virginia. Easterseals PORT Health is an Inclusive Culture, Diverse Voices, Embracing Potential, Authentic Self, and Learning and Growing (IDEAL) organization. Applicants of all abilities are encouraged to apply!

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 *******************************************

Department: 37411 Wake Forest Baptist Medical Center - Bone and Joint Service Line Status: Full time Benefits Eligible: Yes Hours Per Week: 40 Schedule Details/Additional Information: in person 8:00am-5:00pm Monday-Friday Pay Range $24.10 - $36.15 JOB SUMMARY Under general supervision, responsible for the compilation and collection of data, recruitment of subjects, and general coordination of clinical studies. EDUCATION/EXPERIENCE Bachelor's degree in a related field of study or an equivalent combination of experience and education. Experience in a medical and/or research setting. Paramedical experience or other clinical experience. LICENSURE, CERTIFICATION, and/or REGISTRATION Registered Record Administrator preferred SKILLS/QUALIFICATIONS Understanding of medical and/or scientific terminology Strong oral, written, and interpersonal communication skills ESSENTIAL FUNCTIONS Assists principal investigator and other health professionals in troubleshooting various problems related to the management of the clinical study. Assists in all aspects of the data collection process. Performs technical procedures on clinical subjects under the direction of the principal investigator or his/her designee. Assists with recruitment of patients for the clinical study including tracking the sources of patient referrals. Follow-up with sources of patient referrals including referring doctors, various Medical Center labs, and other sources. Maintains appropriate patient records as necessary. This includes charting the condition of the patient and determining their continued eligibility in the study. Obtains and interprets pertinent data from medical records as needed to understand past and present condition of the patients. Performs day-to-day administrative and clerical duties such as designing brochures, stationery and data forms. Creates reports and graphs pertinent to the study including presentation of the results of the study. May supervise other personnel including volunteers as assigned. Assists in development of suitable codes and data collection forms for computerization. Consults and cooperates with all faculty, coordination centers, sponsors, and health professionals involved in the clinical study. Performs other related duties incidental to the work described herein. WORK ENVIRONMENT Clean, well-lit, 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.

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.***

Science 37's mission is to accelerate clinical research by enabling universal trial access for patients. Through our solutions; Direct-to- Patient Site and Patient Recruitment, we accelerate enrollment by expanding the reach of clinical trials to patients beyond the traditional site and rigorously qualifying patients prior to referring them to a traditional site. Our solutions are powered by in-house medical and operational experts that enhance quality through standardized workflows and best-in-class study orchestration. The Clinical Research Coordinator II fulfills the requirements of recruiting, enrolling and conducting follow-up of study participants in clinical trials under the direct supervision of the Principal Investigator (PI) and Project Manager. In doing so, the Clinical Research Coordinator II is responsible for coordinating trial participation of study volunteers with the trial's protocol, company and trial Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/ International Conference on Harmonization (ICH) guidelines, FDA regulations and other applicable regulations (global, state, etc.). The Clinical Research Coordinator II is responsible for working with the trial delivery team to meet enrollment and retention goals and ensure compliance with the study protocol. DUTIES AND RESPONSIBILITIES Duties include but are not limited to: * Actively participates in the implementation and execution of clinical trial activities from study start-up preparations, planning, execution and closure. * Attends investigator, project and department meetings/trainings, leads as needed, and assists in gathering agenda topics and creating meeting minutes as required. * Participates as temporary Project Manager for smaller studies, as needed, with appropriate training/support. * Under direct supervision of a Principal Investigator, is responsible for enlisting, maintaining, and assuring protocol compliance for all study participants in clinical trials. * Collaborates with study investigators in determining eligibility of potential participants in clinical trials. * Screens potential participants for protocol eligibility. Presents trial concepts and details to the participant, participates in the informed consent process, and enrolls participants in study protocol. * Ensures research quality by practicing in compliance with and advocating for any edit needs of Science 37 Standard Operating Procedures (SOP), and ensures research quality by practicing in compliance with principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations. * Supports the development, review and distribution of clinical protocols, informed consent forms, study instructions/manuals/guidelines or department generated tools and other study-related clinical documents. * Coordinates patient care in compliance with protocol requirements. May provide participants education regarding medication administration. Maintains individual participant investigational drug accountability. * In collaboration with the study investigator, reviews study participants for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings. * Responsible for accurate and timely data collection, documentation, entry, and reporting. Schedules and participates in monitoring and auditing activities. * Maintains comprehensive knowledge of assigned research protocol to coordinate the comprehensive and compliant execution of assigned protocols in accordance with research governing entity requirements, including but not limited to Sponsor, FDA, and IRB requirements. * Ensures the completion and maintenance of consent forms, case report forms, SAE's and source documents to ensure that research is being conducted according to guidelines. * Establishes and coordinates logistical aspects of clinical research projects to achieve project objectives. * Supports the maintenance of regulatory documents in the ISF in accordance with SOPs and applicable regulations. * Participates in required training and education programs. Assists with education of other personnel and vendors regarding clinical research. * Collaborates closely with Project Manager to ensure compliance to trial procedures and vendor management. * Provides process improvement solutions and collaborates on the implementation of the solutions. * Additional responsibilities may include working directly with other vendors and/or sponsors. * Provides a safe environment for study participants, caregivers, and study personnel at all times through compliance with all federal, state, and professional regulatory standards. Maintains strict patient confidentiality according to HIPAA regulations and applicable law. * Provides mentorship and training for other CRCs as needed. * Provides assistance to and creates a supportive environment for the CRC team. DUTIES AND RESPONSIBILITIES FOR HYBRID TRIALS * Acts as a point of contact for the site and Sponsor, as necessary, with oversight from the Project Manager. * Develops project plan outlining planning, execution and closeout processes. * Develops the study communication plan in collaboration with the sites. * Collaborates with the Science 37 study team and extended members to ensure compliance to trial procedures. * Collaborates with Science 37 multi-disciplinary teams to provide clear direction and processes for site study teams and assist with study execution. * Other duties, as assigned. QUALIFICATIONS & SKILLS Qualifications The following qualifications are preferred and/or equivalent applicable experience: * Bachelor's degree (preferred) or minimum two-year college degree, or an equivalent combination of education, training, experience, and demonstrated skills needed to successfully perform the assigned duties and responsibilities. Advanced degree preferred but not required. * A minimum of 5 years of pharmaceutical-sponsored clinical research experience is required or commensurate education, training, and experience within the clinical research field. * ACRP (CCRC) or SoCRA (CCRP) certification, highly desired * Medical and scientific knowledge, preferred. * Experience working with patients in a HIPAA regulated environment and knowledge of good clinical practice (GCP), and applicable regulatory requirements. * Excellent time management, organizational skills and ability to manage multiple tasks. * Attention to detail and accuracy in work. * Must have the ability to conduct collaborative interaction with cross functional team members. Skills/Competencies * Expertise in trial management - Demonstrated ability to successfully manage the participation of patients in clinical trials. Proactive problem-solving abilities and follow through. * Expert Knowledge of FDA regulations and GCP guidelines - Understands applicable regulations and implications for trial participation. * Expert knowledge of clinical research - Knowledgeable about the critical elements for success in clinical trials; participation in and contribution to these activities. * Strong communication and presentation skills - Demonstrates strong written and verbal communication skills. Ability to establish and maintain positive study participant rapport, project team members, and internal Science37 relationships. Ability to interact with patients and caregivers in a compassionate and empathetic manner. * Leadership skills - Demonstrates the ability to communicate effectively across multifunctional teams. Provides effective solutions to challenges. Is recognized by others as a leader and a resource. * Computer skills - Proficient with MS Office and Google Suite applications. Able to generate business correspondence, create forms and generate spreadsheet reports as required. Demonstrates expertise in the use of proprietary software. * Practices professionalism and integrity in all actions - Demonstrates ability to foster concepts of teamwork, cooperation, self- control, and flexibility to get the work done. The ability to adapt to a rapidly changing work environment. Able to successfully work in a decentralized team environment. Skilled in situational responsive decision-making. Capabilities * Up to 20% travel, as needed, for project team meetings, client presentations and other professional meetings/conferences as needed * Ability to communicate in English (both verbal and written) * May require extended or unusual work hours based on research requirements and business needs. BENEFITS At Science 37, our focus is to provide you with a comprehensive and competitive total reward package that supports you at all stages of your career - both now and into the future. Our success depends on the knowledge, capabilities, and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work that adds to your professional development. Science 37 is an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law. Science 37 values the well-being of its employees and aims to provide team members with everything they need to succeed. Submit your resume to apply!

This position will serve as a Clinical Research Coordinator within the Division of Pulmonary Diseases and Critical Care Medicine. The Clinical Research Coordinator is responsible for the planning, organization, and conduct of multiple clinical research study protocols, including independently collecting and recording data, project administration, and communication with various stakeholders. 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. Preferred Qualifications, Competencies, And Experience N/A Work Schedule M-F 8am - 5 pm

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

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 Clinical Research Coordinator within the UNC Department of Pediatrics, Children's Research Institute ( CRI ). The Clinical Research Coordinator is responsible for the planning, organization, and conduct of multiple clinical research study protocols, including independently collecting and recording data, project administration, and communication with various stakeholders. The role supports research on childhood diseases and disorders across the Department and University, fostering interdisciplinary collaboration to advance the health of children in NC and beyond. Research efforts involving pediatric populations are supported by the CRI Pediatric Clinical Research Unit (PedsCRU), which provides infrastructure such as program management, regulatory support, data management, sample processing, training, and space for study visits. The primary purpose of this position is to coordinate and manage multiple clinical trials, ensuring pediatric researchers have the resources needed to conduct studies. The Study Coordinator oversees day-to-day activities of several pediatric clinical trials involving both drugs and medical devices. Responsibilities include patient recruitment, study procedures, survey administration, and data collection and maintenance. The person in this position with navigate responsibilities based on protocols currently underway and those in development. Other responsibilities include the initiation and maintenance of IRB and other regulatory procedures. Work Schedule Monday - Friday, 8:00am - 5:00pm, with some nights and weekends as needed