Clinical research coordinator jobs in Mebane, NC - 159 jobs

High Point University's Coordinator of Advancement in the Office of Institutional Advancement works closely with the Advancement staff and strategizes to provide relevant research on prospective benefactors, including individuals, corporations, and foundations, for major and endowed gifts, special project funding, and annual/sustaining support. The role also involves preparing written reports on benefactors that analyze the information gathered and requires the use of initiative, sound judgment, and discretion in carrying out responsibilities within the framework of Advancement policies and procedures. QUALIFICATIONS: Education Undergraduate degree from an accredited college or university. Experience and Training Minimum three years experience with database management and/or institutional research. Experience using relational database programs. Strong background in creating and managing data in Excel spreadsheets. Knowledge, Skills, Ability: Knowledge of research resources and skills for seeking information. Ability to maintain confidentiality and utilize discretion and good judgment, as well as a commitment to professional ethics. Ability to prioritize work assignments. Strong attention to detail. Strong written and verbal communication skills. An aptitude for logical thinking. Ability to work with Advancement staff in a non-profit sector with sensitive and confidential information. Strong computer skills, including proficiency with Microsoft Office software, and searching on-line databases and the Internet. Raiser's Edge or comparable fundraising system and Power BI/Automate knowledge is a plus. Demonstrated ability to work in a team environment and meet goals in a timely manner. ESSENTIAL FUNCTIONS: Assumes primary responsibility for meeting the benefactor identification and research needs of the Advancement staff, enabling them to meet fundraising goals. Meet regularly with Advancement staff, keeping abreast of their activities and the initiatives and programs underway within their departments. Reviews local/national news, business publications, local/regional business developments and economic trends to keep abreast of benefactor information. Send articles to Advancement staff as appropriate. Advises Advancement staff about new benefactor possibilities as appropriate or requested. Serves as a resource to provide Advancement staff with information relative to constituents as needed, within confidentiality guidelines. Maintains existing dashboards and provide routine reports to the Major Gift Team utilizing Raiser's Edge and Power BI/Automate. Monitor Moves Management processes and provides reporting to inform leadership of statuses. Manages Target Analytics data update process, educate appropriate IA staff on any changes, and provide reporting to support major initiatives based on the updated indicators. Creates specific prospecting segmentations for upcoming major capital projects with goal of a pool of prospective major donors. Routinely assess actions in Raiser's Edge NXT to proactively determine any additional research needs, as well as to ensure that ‘Prospect Pool' prospects are sent to Advancement Officer team get touched. Serves as a key resource for managing data relative to prospective donors for other departments, such as Admissions, Institutional Assessment & Research, etc. Use both standard and novel research techniques and tools to identify new, potential benefactors. Complete benefactor background requests, including periodical and electronic screening and/or information provided by the benefactor or his/her organization. Attains proficiency in Raiser's Edge NXT software to interpret and provide reporting, assist Gift Officers in pulling reports, and provide routine training and support. Maintains policies and procedures for the benefactor research program; manage research information services and assist in negotiating annual contracts; utilize the Raiser's Edge and other appropriate database products to track/store profile data; assess current and future software tools to support and enhance research and prospect management. Safeguards the confidentiality of benefactor information at all times. Must adhere to ethical and confidential guidelines and standards. Maintains the professional and ethical standards set forth for the field by the Association of Professional Researchers for Advancement (APRA). Performs other responsibilities as required. ACCOUNTABILITY: Ensures timely and accurate development/updating of benefactor profiles. Ensures timely and accurate reports to be utilized by the President and other University leadership as required for successful fundraising activities. For more information about this position, please contact Rita Williams, Assistant Vice President of Advancement Services at ********************** or Harry Stillwell, Director of Advancement Data Analysis and Research at **********************

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

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

Fortrea's Clinical Pharmacology Team is hiring a CRA 2 with Phase I experience in Dallas, Texas! WHAT YOU WILL DO You will utilize your skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards. Responsibilities: Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned - Responsible for all aspects of site management as prescribed in the project plans General On-Site Monitoring Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document Monitor data for missing or implausible data Responsible for all aspects of registry management as prescribed in the project plans - Undertake feasibility work when requested Complete Serious Adverse Event (SAE) reporting, process production of repo11s, narratives and follow up of SAEs Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management Assist with training of new employees, eg. co-monitoring Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assigned Perform other duties as assigned by management Requirements University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure) 2+ years of Clinical Monitoring experience Phase I experience preferred Must reside in Dallas Texas area The important thing for us is you are comfortable working in an environment that is: Fast paced: where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue. Changing priorities constantly asking you to prioritize and adapt on the spot. Teamwork and people skills are essential for the study to run smoothly. Technology based. We collect our data directly into an electronic environment. What do you get? Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to: Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers) 401(K) Paid time off (PTO) - Flex Plan Employee recognition awards Multiple ERG's (employee resource groups) Target Pay Range: $100-113K #LI - Remote Applications will be accepted on an ongoing basis. Learn more about our EEO & Accommodations request here.

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. The Clinical Research Associate assists in the management of the clinical monitoring process to ensure site adherence to applicable regulatory requirements, ICH/GCP Guidelines, company SOPs, and study protocols. Ensures coordination of an accelerated study start-up including pre-study visits, initiation, interim, and closeout activities associated with clinical trials to ensure timelines and metrics are met and maintained throughout the study. Primary responsibilities include: * Tracking study specific tasks and progress of the trial. * Performing regulatory document review and approval for IP release. * Assisting in the coordination and planning of meetings (e.g. Investigator Meetings, Kick-off meetings). * Conducting monitor training. * Performing monitoring/co-monitoring activities for site initiation visits, interim site monitoring, and closeout visits, in conformance to all relevant laws, regulations, guidelines and internal SOPs/policies. * Understanding and implementing processes for distribution and tracking of SAE's, safety documentation, and pregnancies. Monitors compliance of these processes. * Collaborating with data management to resolve queries. * Facilitating investigator site payments, as applicable. * Reviews/creates/tracks trial newsletters, memos, mass correspondence, or other appropriate trial-related documentation. * Assisting in evaluation of vendor performance during conduct of the study. * Acquiring a basic knowledge of the therapeutic area and product. * Obtaining a complete understanding of all trial-related documents and operational procedures. * Gaining exposure/participates in CRF development, IVRS set-up, central lab set-up, and other vendor selection processes. * Maintaining clinical trial management system (CTMS) information pertaining to the study as applicable * Assisting with auditing of study files and retrieval of outstanding documents as needed (in-house and on-site document reconciliation). * Reviewing and tracking study documents, including: project files both electronically and in the Trial Master File and Project Status Reports. * Preparing accurate and complete meeting minutes for various meetings. * Communicating and interacting with relevant study personnel, including: develops and maintains collaborative relationships to manage study issues and support milestone achievement; conveys project information; answers study questions in a timely manner while using discretion when to escalate to study manage; troubleshoots and follows up on study progress; and, reviews report data for completeness and accuracy. * Assists with effective and timely audit/inspection responses. For studies monitored in house by Grifols, additional responsibilities may include: * Identifies/screens/qualifies investigators through feasibility questionnaires and pre-study visits. * Assists with expedited identification, retrieval, and review of study documents particularly those required for site activation/study start-up. * Conducts/oversees completion of Pre-Study Visits, Site Initiation Visits, Interim Monitoring Visits, and Close-Out Visits, to determine protocol and regulatory compliance. * Verifies study documents (e.g., case report forms, source documents, adverse events) are tracked and reviewed for completeness and accuracy to ensure data integrity. * Reconciles clinical supplies and drug accountability records at study sites. * Identifies and effectively documents site findings with an equal ability to re-train, place corrective action in place with the site, and follow-up as required. * Reviews, clarifies, and obtains, data changes via query resolutions with site personnel. * Prepares telephone contact reports, confirmation letters, site visit reports (PSV, SIV, IMV, and COV), and follow-up letters to accurately and completely document site status and activities. Additional responsibilities: Leads the activities of the CRA team to meet the study objectives. Identifies and addresses weaknesses in individual or team performance. Assists study manager in overall study management. Monitors and/or co-monitors as required with CRO and CRA staff to insure study integrity and compliance. Develops ICF templates and reviews study specific ICF(s). Participates in CRF development and completion. Reviews monitoring reports and QA reports from site visits. Manages clinical study set-up and follow-up study activities through tracking and review. Assists in the development of the clinical risk management plan. Develops, implements, and maintains monitoring plan for studies run internally. Coordinates and presents at investigator meetings, kick-off meetings, etc. Interacts as functional lead with data management, safety, regulatory personnel, and other functional groups. Leads team members in reviewing data listings in reviewing data listings and writing queries. Tracks and manages the distribution of study drug and clinical supplies. Contributes to development of site budget. Knowledge, Skills, and Abilities: Excellent knowledge of medical terminology, protocol, clinical trial process, regulatory requirements, and company SOPs. Excellent knowledge of therapeutic area assigned. Excellent knowledge of ICH/GCP Guidelines and EDC process. Strong verbal and written communication skills. Ability to train others in using MS Office Suite, Impact, and EDC systems. Ability to meet deadlines, multitask, and prioritize based on study needs. Ability to make sound decisions based on available information. Ability to establish rapport with site personnel/ colleagues. Ability to work both in a team and independently. Ability to facilitate team meetings and teleconferences. Ability to present at internal study team meeting(s). Ability to train and mentor junior CRAs. Ability to seek new learning opportunities within and outside of the assigned project. Ability and willingness to travel. Requirements: * Associate's degree in a life science field required. Bachelor's degree in a life science field preferred. * Typically requires 5 years of experience in clinical research, including a minimum of 2 years field monitoring experience and 3 years in lead CRA role. * Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience. Occupational Demands: Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues. Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws. Location: NORTH AMERICA : USA : NC-RTP:[[cust_building]]

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

A global higher education leader in innovative teaching, research and public service, the University of North Carolina at Chapel Hill consistently ranks as one of the nation's top public universities. Known for its beautiful campus, world-class medical care, commitment to the arts and top athletic programs, Carolina is an ideal place to teach, work and learn. One of the best college towns and best places to live in the United States, Chapel Hill has diverse social, cultural, recreation and professional opportunities that span the campus and community. University employees can choose from a wide range of professional training opportunities for career growth, skill development and lifelong learning and enjoy exclusive perks for numerous retail, restaurant and performing arts discounts, savings on local child care centers and special rates on select campus events. UNC-Chapel Hill offers full-time employees a comprehensive benefits package, paid leave, and a variety of health, life and retirement plans and additional programs that support a healthy work/life balance. Primary Purpose of Organizational Unit The UNC School of Medicine has a rich tradition of excellence and care. Our mission is to improve the health and wellbeing 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. We strive to promote faculty, staff, and learner development in a diverse, respectful environment where our colleagues demonstrate professionalism, enhance learning, and create personal and professional sustainability. We optimize our partnership with the UNC Health System through close collaboration and commitment to service. OUR VISION Our vision is to be the nation's leading public school of medicine. We are ranked 2nd in primary care education among all US schools of medicine and 5th among public peers in NIH research funding. Our Allied Health Department is home to five top-ranked divisions, and we are home to 18 top-ranked clinical and basic science departments in NIH research funding. OUR MISSION 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 will 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 will prepare tomorrow's health care professionals and biomedical researchers by facilitating learning within innovative curricula and team-oriented interprofessional education. We will cultivate outstanding teaching and research faculty, and we will recruit outstanding students and trainees from highly diverse backgrounds to create a socially responsible, highly skilled workforce. Research: We will develop and support a rich array of outstanding health sciences research programs, centers, and resources. We will provide infrastructure and opportunities for collaboration among disciplines throughout and beyond our University to support outstanding research. We will foster programs in the areas of basic, translational, mechanistic, and population research. Position Summary 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. 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 * 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. Special Physical/Mental Requirements Campus Security Authority Responsibilities Not Applicable. Special Instructions Quick Link *******************************************

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

The Senior Administrator for Clinical Trials Recruitment, Site Set-Up, and Management is responsible for strengthening the Department of Medicine's clinical research program by enhancing research quality, ensuring compliance, and advancing discoveries into improved patient outcomes. This position plays a pivotal role in leading participant recruitment, expediting site start-up, and overseeing trial operations across multiple divisions. The Senior Administrator provides strategic leadership, fosters interdisciplinary collaboration, and manages risks related to financial performance, patient safety, and regulatory compliance. In doing so, this role sustains a thriving research environment that benefits both the institution and the broader medical community. This role is critical in the Department's transition to a larger and more diversified research portfolio that brings together a mix of federal funding, industry funding, and other extramural support compared to the current portfolio which is primarily federally funded. Required Qualifications, Competencies, And Experience Applicant must have minimum of 10 years of experience in an Academic Medical Center / Department of Medicine with multiple medical subspeciality research programs providing oversight for operations and finance, demonstrating experience in management/supervision, project management, clinical trials and clinical research operations/compliance, a high attention to detail, and successful resolution of complex problems. Preferred Qualifications, Competencies, And Experience Preference for individuals with established knowledge of clinical trials development, deployment, and management.

Clinical Trial Manager 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 What you will be doing Manage the day-to-day operations of assigned trials and responsibilities to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements Leads or supports cross-functional trial teams, including vendors Ensures accurate and up-to-date trial information within relevant tracking systems and provide regular updates of trial progression to Clinical Operations Lead, Clinical Trial Lead, and other defined stakeholders Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues Participate in or lead the development of core trial documents, trial plans and system set-up; participate in preparation and ensure operational excellence of protocol and implementation of appropriate systems, standards, and processes to ensure quality across investigative sites, vendors, and data Participate in or lead preparation of vendor requirements and project scope and selection of trial vendors; effectively manage interactions and escalations with vendor trial team Participate in or lead feasibility assessment and selection of countries and sites for trial conduct Participate in or facilitates site engagement and communications with investigators and/or staff to support trial milestones and deliverables Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews and review of statistical analysis plans Participate in or lead set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external trial team members Provide oversight and direction to trial team members for trial deliverables Manage clinical trial budget and associated vendor contracts, including tracking and data in associated systems Ensure quality and completeness of TMF for assigned clinical trials Participates in inspection readiness activities including coordination of clinical trial team deliverables Participate in the evaluation and implementation of patient-focused strategies for assigned trials, as applicable Responsible for the management of budgets, timelines and resources for assigned clinical trial responsibilities Your profile BA/BS degree with at least 3 years clinical trial experience or advanced degree (MS/PhD/PharmD) with at least 2 years clinical trial experience Must have strong knowledge of ICH/GCP guidelines and regulatory requirements Must have knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring Requires project management skills and trial leadership ability Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability Fluent in English Experience in Phase I oncology Global experience with primary focus on independent vendor set up and management, oncology cohort management and experience in supporting dose escalation safety meetings. Some travel may be required What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family's needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Clinical Research Coordinator I DEPARTMENT: Global Project Delivery Ora Values the Daily Practice of … Prioritizing Kindness * Operational Excellence * Cultivating Joy * Scientific Rigor At Ora, we are building the future of ophthalmic clinical research. As the world's leading full-service ophthalmic drug and device development firm, we guide our clients across all phases of clinical research to efficiently bring new products and therapies to market. Over the past 45 years, our expert teams have helped earn more than 85 new product approvals. Ora's pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies have been refined and proven across thousands of global projects. Today, our team continues to expand across the globe, with over 400 employees across North America, Europe, Asia, and Latin America. The Role: Ora's Clinical Research Coordinator I (CRC I) has close relationships with the subjects who participate in our clinical trials located regionally, domestically, and at times, internationally. You will travel with a team of other CRCs to clinical sites as assigned to conduct world-class research using proprietary methodologies. Once onsite, our CRC I's will administrate various technician-based tasks by collecting, recording, and organizing subject and research information during clinical research study visits while ensuring compliance with clinical project protocol and overall clinical objectives. Our CRC I's will partner with tenured Clinical Research Coordinators and Clinical Project Managers to execute protocol directives and work cross-functionally with internal and external teams such as other Research Coordinators and Investigators. What You'll Do: Participate in a 3 week-long introductory onboarding (part virtual, part in person) to prepare to learn and demonstrate mastery in various introductory skill sets required to begin clinic work Travel to research sites as assigned for study visits to prepare for or continue clinical study conduct Participate in study start-up activities such as putting together charts, pulling patient charts, ensuring site cleanliness Contribute to and maintain study documents, including source documentation, case report forms, and regulatory documentation Perform various tasks (post-onboarding) such as use of proprietary technology, performing the Informed Consent process, documenting medical history and medications, taking vitals, scribing for medical staff, dispensing study drug, performing allergy skin tests, documenting controlled environment stats, and other ophthalmic assessments Prioritize and deliver an exceptional subject experience, putting subject safety and protocol adherence to the forefront of your work Collaborate with on-site staff, whether they be other Ora team members or clinic-based staff and Investigators Performs patient screening, recruitment, and enrollment Perform clinical skills identified in the SOP at study visits Participate in various parallel and compounding trainings to continue advancement of required clinic skills Maintain protocol compliance during clinical projects and adherence to work instructions and discretion in handling intellectual property Remain compliant and timely with SOP, ICH-GCP and regulations Enter and submit time sheets and expenses related to site travel in a timely manner, following the company expense policy. Prompt submission of work availability on a monthly basis Enter data into electronic database and resolves data queries Be willing to travel domestically up to 90% of the time including back-to-back trips and weekends, if necessary. Adhere to all essential systems and processes that are required at Ora to maintain compliance to Ora's data integrity & business ethics and regulatory requirements. Clear and sustained demonstration of Ora's values -- prioritizing kindness, operational excellence, cultivating joy and scientific rigor - as well as their linked behaviors. Responsibilities may differ from the above based on the specific needs of the business. What We Look For: Experience needed for the Role: Bachelor's degree in Life Sciences OR 1-year experience in a clinical setting Additional Skills & Attributes: Previous experience as a research coordinator is strongly preferred Certified Ophthalmic Associate or Certified Ophthalmic Technician certifications is strongly preferred Medical skills and/or certifications such as (CPT) certified phlebotomist technician, (EMT) Emergency Medical Technician is preferred This role requires a flexible schedule, including weekend availability, and the ability to travel domestically as needed A team player attitude with a strong interest in clinical studies and enjoy interacting with patients Competencies and Personal Traits: What We Do: Execution Excellence: Ability to set goals, create structure and maintain a focused and collaborative approach to the delivery of timely and high-quality work. How We Do It: IQ, EQ and SQ: Agile and positive thinker, communicator and collaborator who uses a growth mindset to work and lead with authenticity, transparency, resilience, and empathy. Scientific, intellectual, and emotional/social curiosity creates the willingness and ability to innovate, make mistakes, learn and try again. Clear and Direct Communication, Feedback and Conflict Resolution: Practice radical candor in your communication and participate in active Giving and receiving feedback frequently, with an open heart and mind creates psychological safety and promotes faster, individual, team and company growth. Why We Do It: Seek Meaning and Purpose and a Desire to be Part of Something Bigger than Yourself: Crave being part of a team that works together under shared values to achieve significant positive impact in the wider world. At Ora, we are creating vision beyond what we see. Benefit Eligibility: Full-time employees of Ora working a minimum of 30 hours per week. Our per diem workforce is eligible for Medical and Dental coverage once they have hit 6 months of service and work an average of 30 hours per week. Our mission is to weave together people, processes, and technology to support innovation in ophthalmology around the world. We believe our business should be a force for good - to improve, heal, and change how we see. As a global company, our vibrant community and culture are nurtured by our core values: Prioritizing kindness, cultivating joy, operational excellence, and scientific rigor. Through our commitment to these values, we have built an inclusive and supportive work environment that fosters respect, accountability, and a fulfilling work-life balance for every team member. We know a diverse workforce adds to our collective value and strength as an organization. People of color, the LGBTQIA+ community, disabled candidates and veterans are strongly encouraged to apply. Ora is proud to be an Affirmative Action and Equal Opportunity Employer, committed to equal employment opportunity and fair, equitable compensation regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Our Privacy Policy | Ora (oraclinical.com)

This individual will play a key role in assisting in the conduct of clinical trial activities, in accordance with all applicable regulations governing the conduct of clinical trials. The primary skills include logical thinking, ability to prioritize, “can- do” attitude, the ability to adapt quickly to changing business conditions, strong interpersonal and team building skills. Elligo is looking for candidates that are able to recognize and synthesize information about the organizational climate and partner with key individuals to accomplish organizational goals. The candidate will have overall responsibilities for coordinating efforts with other study team members in order to achieve protocol objectives and corporate goals, including: Develop strong working relationships and maintain effective communication with study team members. Develop strong working relationships and become the point of contact for the clinic as well as the sponsor for clinic related activities. Manage multiple concurrent trials Assist with mentoring and training study team members Completes all protocol related training Perform patient/research participant scheduling Collect patient/research participant history Collects and maintains source documentation Performs data entry and query resolution Support the collection and review of required essential study documents and reports. Order supportive study supplies (e.g., contracts, IXRS, lab kits, non- clinical supply materials, imaging and laboratory handling manuals, etc.). Adhere to an IRB approved protocol Assist in the informed consent process of research subjects. Support the safety of research subjects, report adverse events. Coordinate protocol related research procedures, study visits, and follow- up Assist with the screening, recruiting and enrollment of research subjects. Facilitate pre- study, site qualification, study initiation, monitoring visits, and study close out activities Collect, process and ship laboratory specimens Comply with Elligo, Clinic, and Sponsor policies, standard operating procedures (SOPs) and guidelines. QUALIFICATION AND EDUCATION REQUIREMENTS At least 3 years of experience coordinating clinical trials, including the activities listed above BS/BA in Life Science or related discipline Previous nursing experience in a clinical setting a plus CCRC certification a plus Previous GCP training and certification required Demonstrated ability in positive relationship building, with strong verbal and written skills required. Previous experience with training and mentoring other clinical research professionals a plus Strong interpersonal skills with attention to detail a must Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint) and with clinical trial master filing systems. Ability to travel for Clinic activities, attend investigator meetings or vendor visits/audits, as required. Strong organization/prioritization skills for the management of multiple concurrent projects WORKING CONDITIONS This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, and photocopiers. Some flexibility in hours is allowed, but the employee must be available during the “core” work hours of 9:30 a.m. to 3:30 p.m. and must work 37.5 hours each week to maintain full-time status. Occasional evening and weekend work may be required as job duties demand. Regular local and regional travel is required for this position. The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel. More in-depth information can be found in SOP's, working guidelines, policies, etc. Elligo is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Elligo are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. Elligo will not tolerate discrimination or harassment based on any of these characteristics. In addition, Elligo will provide reasonable accommodations for qualified individuals with disabilities.

**CRA and Sr CRA positions- Remote - Need for SE Region - FL** **ONCOLOGY preferred** **Job Purpose:** The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. **Key Accountabilities** : **Site Management Responsibilities** + Contributes to the selection of potential investigators. + In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. + Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. + Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times. + Actively participates in Local Study Team (LST) meetings. + Contributes to National Investigators meetings, as applicable. + Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. + Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. + Updates CTMS and other systems with data from study sites as per required timelines. + Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. + Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines, and discusses with LSAD the correct timing and type of visits. + Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. + Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. + Ensures data query resolution in a timely manner. + Works with data management to ensure robust quality of the collected study data. + Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. + Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP. + Follows up on outstanding actions with study sites to ensure resolution in a timely manner. + Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. + Assists site in maintaining inspection ready ISF. + Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. + Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF. + Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. + Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line manager. **Compliance with Sponsor Standards** + Ensures compliance with the Client's Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment). + Ensures compliance with local, national, and regional legislation, as applicable. + Completes timesheets accurately as required. **Compliance with Parexel Standards** + Complies with required training curriculum. + Completes timesheets accurately as required. + Submits expense reports as required. + Updates CV as required. + Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements. **Skills (Essential):** + Excellent attention to detail. + Good written and verbal communication skills. + Good collaboration and interpersonal skills. + Good negotiation skills. + Proficient in written and spoken English language required. + Fluency in local language(s) required. **Skills (Desirable):** + Ability to work in an environment of remote collaborators. + Manages change with a positive approach for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business. + Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. + Good analytical and problem-solving skills. + Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. + Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. + Team oriented and flexible; ability to respond quickly to shifting demands and opportunities. **Knowledge and Experience (Essential)** **:** + Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. + Good knowledge of relevant local regulations. + Good medical knowledge and ability to learn relevant Client Therapeutic Areas. + Basic understanding of the drug development process. + Good understanding of Clinical Study Management including monitoring, study drug handling and data management. **Knowledge and Experience (Desired):** + Familiar with risk-based monitoring approach including remote monitoring. + Good cultural awareness. **Education:** + Bachelor's degree in related discipline, preferably in life science, or equivalent qualification (adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers. **Other:** + Ability to travel nationally/internationally as Required + Valid driving license per country requirements, as applicable. LI-LG4 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

Department: 36412 Wake Forest University Health Sciences - Pulmonology Clinic Status: Full time Benefits Eligible: Yes Hours Per Week: 40 Schedule Details/Additional Information: Position will support Pulmonary Critical Care Research Program at Atrium Health Wake Forest Baptist Medical Center. Pay Range $23.65 - $35.50 JOB SUMMARY Under general supervision, responsible for the compilation and collection of data, recruitment of subjects, and general coordination of clinical studies. EDUCATION/EXPERIENCE Bachelor's degree in a related field of study or an equivalent combination of experience and education. Experience in a medical and/or research setting. Paramedical or other clinical experience. LICENSURE, CERTIFICATION, and/or REGISTRATION Registered Record Administrator preferred. ESSENTIAL FUNCTIONS 1. Assists principal investigator and other health professionals in troubleshooting various problems related to the management of the clinical study. Assists in all aspects of the data collection process. 2. Performs technical procedures on clinical subjects under the direction of the principal investigator or his/her designee. 3. Assists with recruitment of patients for the clinical study including tracking the sources of patient referrals. Follow-up with sources of patient referrals including referring doctors, various Medical Center labs, and other sources. 4. Maintains appropriate patient records as necessary. This includes charting the condition of the patient and determining their continued eligibility in the study. 5. Obtains and interprets pertinent data from medical records as needed to understand past and present condition of the patients. 6. Performs day-to-day administrative and clerical duties such as designing brochures, stationary and data forms. Creates reports and graphs pertinent to the study including presentation of the results of the study. 7. May supervise other personnel including volunteers as assigned. 8. Assists in development of suitable codes and data collection forms for computerization. 9. Consults and cooperates with all faculty, coordination centers, sponsors, and health professionals involved in the clinical study. 10. Performs other related duties incidental to the work described herein. SKILLS/QUALIFICATIONS Understanding of medical and/or scientific terminology Strong oral, written, and interpersonal communication skills WORK ENVIRONMENT Clean, well-lit, office environment, clinic Our Commitment to You: Advocate Health offers a comprehensive suite of Total Rewards: benefits and well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more - so you can live fully at and away from work, including: Compensation Base compensation listed within the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training Premium pay such as shift, on call, and more based on a teammate's job Incentive pay for select positions Opportunity for annual increases based on performance Benefits and more Paid Time Off programs Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability Flexible Spending Accounts for eligible health care and dependent care expenses Family benefits such as adoption assistance and paid parental leave Defined contribution retirement plans with employer match and other financial wellness programs Educational Assistance Program About Advocate Health Advocate Health is the third-largest nonprofit, integrated health system in the United States, created from the combination of Advocate Aurora Health and Atrium Health. Providing care under the names Advocate Health Care in Illinois; Atrium Health in the Carolinas, Georgia and Alabama; and Aurora Health Care in Wisconsin, Advocate Health is a national leader in clinical innovation, health outcomes, consumer experience and value-based care. Headquartered in Charlotte, North Carolina, Advocate Health services nearly 6 million patients and is engaged in hundreds of clinical trials and research studies, with Wake Forest University School of Medicine serving as the academic core of the enterprise. It is nationally recognized for its expertise in cardiology, neurosciences, oncology, pediatrics and rehabilitation, as well as organ transplants, burn treatments and specialized musculoskeletal programs. Advocate Health employs 155,000 teammates across 69 hospitals and over 1,000 care locations, and offers one of the nation's largest graduate medical education programs with over 2,000 residents and fellows across more than 200 programs. Committed to providing equitable care for all, Advocate Health provides more than $6 billion in annual community benefits.

The Clinical Research Coordinator II works closely with study subjects and other research staff and is responsible for the day-to-day clinical research process to collect, compile, document, and analyze clinical research data. Working under general supervision, the position conducts subject follow-up visits, completes clinical tasks, prepares research documentation, reports, and graphs while keeping appropriate logs, tracking participants, and preparing study materials. Essential Job Function * Coordinates multiple clinical trials simultaneously or clinical trials with unique complexity, managing and organizing various research activities efficiently, ensuring optimal use of resources and timely execution of research protocols. * Assesses patients for protocol eligibility, ensuring the appropriate selection of participants for clinical trials, thereby enhancing the accuracy and validity of research outcomes. * Confers with study participants to explain the purpose of the study and obtains informed consent, fostering transparency and trust with patients and their families throughout the research process. * Collects data from various sources, including patient charts, medical records, interviews, and diagnostic tests, and prepares comprehensive documentation, ensuring the accurate and reliable analysis of research data. * When applicable, completes documentation in the electronic health/medical record (EMR) system to securely maintain patient health records. * Completes clinical tasks (ie, ECGs, PFTs, phlebotomy, drug administration, etc) when not prohibited by state or licensing board requirements under the supervision of the principal investigator. * Serves as study coordinator for pharmaceutical and/or device trials, successfully coordinating site initiation visits, monitoring visits, and close-out visits, and ensuring adherence to protocol guidelines and regulatory requirements. * Supports the regulatory process in the submission of study protocols, consent forms, and recruiting materials to the Institutional Review Board and the department for approval, facilitating the regulatory compliance necessary for research projects in the hospital/medical group setting. * Mentors and trains Clinical Research Coordinators and Clinical Research Specialists to ensure an effective and compliant team. * Performs other duties as assigned. Education * Required: Associate degree with 4 years of Clinical Research experience OR Bachelor's degree with 2 years of clinical research experience Experience * Required: 6 years (education and/or experience) Licensure/Certification/Listing * Required: Clinical Research Coordinator (CCRC) and/or Clinical Research Associate (CCRA) certification

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

Senior Clinical Research Associate (home based) (level dependent on experience) Job Purpose/Summary To help support the unique job functions of our CRAs, we have a dedicated training department that offers ongoing therapeutic training sessions from our world-class medical directors, and an experienced and supportive management team that is there to offer continual guidance. Additionally, all CRAs are able keep their hotel points and airline miles and are offered a home office allowance. Maintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each department can provide an update on a study or milestone that they have achieved. Each employee also has the opportunity join one of our CTI Cares committees that not only help support our culture, but also focus on our various philanthropic efforts. What You'll Do Manages investigative site activity for multiple protocols / indications and provides ongoing updates of site status to Project Manager / sponsor. Creates and implements subject enrollment strategies for assigned investigative sites. Conducts study site visits (pre-study, initiation, monitoring, and close-out) and completes site visit deliverables within given timelines in the Monitoring Plan. Ensures proper storage, dispensation, and accountability of all investigational product(s) and trial-related material. Maintains tracking records for assigned sites including tracking of subject status, subject case report form (CRF) retrieval / source document review (SCV), regulatory documents, and investigational product. Participates in development of CRFs and other study related documents What You Bring Bachelor's or Master's Degree in allied health fields, such as nursing, pharmacy, or health / natural science, or RN with Associate's Degree or 3-year Nursing Diploma with at least 2 years of clinical nursing experience Why CTI? At CTI, we recognize that our people are what make our company successful. Our work moves medicine forward. For that reason, we treat our team members with the respect they deserve, and our numbers show it: We support career progression - We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward We value education and training - We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training department We value our people - We have never had a layoff in our three decade history and we guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked. We support a work-life balance and the importance of time with family by offering generous vacation time, a hybrid work from home schedule, and paid parental leave. Our culture is unparalleled - We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry We think globally and act locally - With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work. Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world. We are looking toward the future - We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROs Our work makes a difference - We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market

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.