Clinical research associate jobs in Burlington, NC - 163 jobs

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 Comfortable with doing 10-12 DOS 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.

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

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

**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.

The Aixial Group is an International Contract Research Organization (CRO), a member of the ALTEN Group, with offices located in France, UK, US, Belgium, Denmark, Sweden, Switzerland, Romania, and India. The CRO occupies a unique position in the clinical research industry, supporting biotech in clinical trials across all phases (Ph. I - IV) and non-interventional studies, as an expert in the operational delivery of clinical trials. Our vision is to conduct clinical trials better than anyone else, to help patients and ultimately save lives. We have earned a strong reputation for successfully delivering complex, demanding and innovative clinical trials, with specialist therapeutic expertise in oncology, cell & gene therapy, radiopharmaceuticals and rare diseases. We are currently looking for an enthusiastic and talented contract Sr. CRA for up to 1 FTE for 4 months. Core Accountabilities: The Sr. CRA is responsible for site management and monitoring activities associated with clinical studies. This position may be assigned to monitor a specific study or studies, co-monitor with other CRAs, assist in the assessment of Cmed or contract CRAs, or provide other support to Clinical Operations which is appropriate for their level of expertise. Principal Responsibilities: Site Management * Perform site qualification, site initiation, interim monitoring, close-out visits for Phase I - IV studies onsite or remotely in accordance with current ICH GCP guidelines, local regulatory requirements and appropriate SOPs. * Confirm investigator adherence to ICH GCP, local regulatory requirements and to the protocol procedures. * Adhere to the project plans, as applicable, for assigned studies. * Complete and submit timely site visit reports per the monitoring plan/SOPs. * Verify investigator maintenance of study documentation throughout the life of the study including essential documents, Investigator Site File, source documentation, drug accountability, and safety reporting. * Serve as primary point of contact for assigned sites establishing and maintaining a good working relationship with site staff. * Discuss, review, and document patient recruitment strategies with assigned sites. * Work with Project Leader (PL), and/or Clinical Team Lead (CTL)/Clinical Trial Manager (CTM) to ensure that clinical monitoring activities are conducted on time, in accordance with the monitoring plan. * Support assigned sites with vendor issues (e.g., Central Laboratory, IXRS, imaging, etc.) as they arise. * Provide any additional training as identified throughout the study (e.g., protocol amendment, query trends) to site staff as needed. * Work with site staff on timely data entry and query resolution Study Management * Assist in the development of study related trackers and monitoring tools as requested. * Review, in conjunction with Clinical and/or Data Managers, the quality and integrity of the clinical data through source data review, source data verification, and inhouse review of electronic CRF data. * Liaise with Data Management during all stages of a study to assist with query resolution as required. * Assist the PL, and/or CTM/CTL with updating study metrics and compiling status reports. * Assist with training of CRAs. * Participate in study team meetings as required. * May lead CRA meetings, if required. Other Clinical Operations Activities * Co-monitor as needed. * Perform onsite or remote visits to assess CRA performance. * Provide additional support to Clinical Operations staff as needed. * Participate in department initiatives to enhance Clinical Operations Additional The above job description in no way states or implies these duties are the only duties performed by this employee. The incumbent is expected to perform other related duties necessary for the effective operation of the department and company. The Company reserves the right to change or alter any of the above duties and responsibilities according to the operational needs of the department and Company Essential Work Experience, Qualifications and Knowledge: * Bachelor's (or equivalent) degree in science, medical health, or related discipline or equivalent relevant experience * A minimum five years of clinical monitoring experience in the Pharmaceutical/CRO industry * Good clinical and therapeutic knowledge with understanding of medical and pharmaceutical industry terminology * Excellent oral and written communication skills * Strong knowledge of ICH GCP guidelines and applicable regulations Desirable Work Experience, Qualifications and Knowledge: * Medical professional with experience in clinical research * Experience in oncology and/or rare disease clinical research * Proactive problem-solving skills * Interpersonal and organizational skills with strong attention to detail Technical * An understanding of physiology, pharmacology, clinical study objectives and the drug development process * Excellent computer skills * Skills in working with Microsoft Office products, particularly Word, Excel, PowerPoint For more information on Aixial Group recruitment and consideration for other opportunities, please review the recruitment statement on our careers page - ************************************ Please be aware that we do not accept resumes from outside agencies or recruiters unless specifically requested by Aixial Group CRO Talent Acquisition. Unsolicited agency or recruiter resumes will not be eligible for referral fees and will be considered candidates Aixial may directly contact for employment application.

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.

Sr Clinical Research Coordinator - Cary, NC 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. This role is with Accellacare, part of ICON's clinical research network, where you'll play a key role in transforming the clinical trial experience for patients and sponsors alike. Our global site network is designed with one goal in mind: to deliver better access, greater efficiency, and improved outcomes in clinical research. Title: Sr Clinical Research Coordinator (Sr CRC) Location: On-Site Cary, NC - 530 New Waverly Place, Suite 200A, Cary, NC 27518 USA The Sr CRC ensures the safety of our participants, promotes the mission of Accellacare, and consistently strides to meet and exceed priorities discussed with supervisor. The Sr CRC will actively recruit and promote our service to suitable participants and sponsor representatives. Additionally, the Sr CRC will autonomously perform tasks required to coordinate and complete multiple studies according to the protocol. Lastly, they will assist the Manager of Clinical Operations and Sr. Clinical Research Coordinators with staff development through mentoring and site level quality assurance. Duties: * Performs study start-up duties including the production of a recruitment tool, and progress notes, as well as phone screening patients and identifying participants for trials on site * Proactively develops and executes recruitment plans that meet and exceed enrollment goals * Performs study start-up duties including the production of a recruitment plan, recruitment tool, and progress notes, as well as phone screening participants. * Completes training on Clinical Trial Management System and maintains proper skills to update database, complete participant reimbursement, capture referral source of participants, and create calls lists to promote recruitment. * Attends investigator meetings * Creates and updates source documents/progress notes and utilizes templates provided in the Core Operating Guidelines * Accurately collects study data via source documents/progress notes as required by the protocol * Performs technical requirements of the study protocol, i.e., lab work (phlebotomy and processing), blood pressure, electrocardiograms, Holtor monitoring, pulmonary function testing, allergy testing, urine/serum pregnancy testing, strep throat screening, or any procedure necessary for the protocol as ordered by the investigator or specified by a protocol * Performs continuous reviews of the inclusion and exclusion criteria for each participant during the trial for their trials as well as peer review of inclusion and exclusion for trials * Documents laboratory data and adverse reactions, presents this information to an investigator in a timely manner, and immediately notifies investigators, the Institutional Review Board and sponsor of any serious adverse events * Builds and maintains strong relationships with Investigators and provides ongoing communication about trial status and participants * Dispenses study medication at the direction of the Investigator * Maintains communication with the monitor from the sponsoring company through telephone contact, written communication and on-site visits * Enters visit data in the Electronic Data Capture (EDC) or Case Report Forms (CRF) within timelines provided by sponsor To be successful, you will have: * Bachelor's Degree * 3 + years of experience as a clinical research coordinator or equivalent role * High attention to detail * Interest in a clinical research career #LI-SB4 #LI-onsite #LI-Accellacare What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: * Various annual leave entitlements * A range of health insurance offerings to suit you and your family's needs. * Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. * Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. * Life assurance * Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

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 will serve as a Senior Clinical Research Coordinator within the Carolina Institute for Developmental Disabilities. 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. This position requires a high level of motivation and independence, and requires the ability to interact effectively with diverse community members and researchers. Experience with following research protocols and training modules. Experience with multiple sponsored research/projects. 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. * Basic working knowledge of research in the area of assignment, retrieval of data/information, working within established deadlines, and working with a project of limited scope and complexity. Preferred Qualifications, Competencies, and Experience Preferred candidate has experience with methods and Good Clinical Practice used in data collection, patient facing enrollment and consent, intervention dissemination, data entry in sponsor EDC platforms, screening for patient enrollment in EPIC, and database storage and management. Special Physical/Mental Requirements Campus Security Authority Responsibilities Not Applicable. Special Instructions Quick Link *******************************************

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 The SSU Clinical Study Administrator is responsible for ensuring vendor spreadsheets are completed correctly and processed (submitted to vendor or global team) according to study team guidelines. SSU CSA will attend weekly Study Team meetings to report on vendor Spreadsheets. SSU CSA will participate in vendor management activities Your profile Bachelor's degree or relevant clinical trial experience Industry expereince in clinical trial support required (CRO/Pharma) with a focus on vendor support during Start-Up Experience with vendor management, strong verbal & written communication skills, and strong organizational skills Previous administrative experience Proven organizational and administrative skills Computer proficiency Display excellent organization and time management skills, excellent attention to detail, and ability to multi-task in a high-volume environment with shifting priorities Team oriented and flexible; ability to respond quickly to shifting demands and opportunities Working knowledge of the Clinical Study Process and an understanding of the range of working procedures relating to study Start-up, together with an understanding of the ICH/GCP guidelines Ability to develop advanced computer skills to increase efficiency in day-to-day tasks Good interpersonal skills and ability to work in an international team environment Willingness and ability to train others on study administration procedures Integrity and high ethical standards 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

Sr Clinical Research Coordinator - Cary, NC 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 This role is with Accellacare , part of ICON's clinical research network, where you'll play a key role in transforming the clinical trial experience for patients and sponsors alike. Our global site network is designed with one goal in mind: to deliver better access, greater efficiency, and improved outcomes in clinical research. Title: Sr Clinical Research Coordinator (Sr CRC) Location: On-Site Cary, NC - 530 New Waverly Place, Suite 200A, Cary, NC 27518 USA The Sr CRC ensures the safety of our participants, promotes the mission of Accellacare, and consistently strides to meet and exceed priorities discussed with supervisor. The Sr CRC will actively recruit and promote our service to suitable participants and sponsor representatives. Additionally, the Sr CRC will autonomously perform tasks required to coordinate and complete multiple studies according to the protocol. Lastly, they will assist the Manager of Clinical Operations and Sr. Clinical Research Coordinators with staff development through mentoring and site level quality assurance. Duties: Performs study start-up duties including the production of a recruitment tool, and progress notes, as well as phone screening patients and identifying participants for trials on site Proactively develops and executes recruitment plans that meet and exceed enrollment goals Performs study start-up duties including the production of a recruitment plan, recruitment tool, and progress notes, as well as phone screening participants. Completes training on Clinical Trial Management System and maintains proper skills to update database, complete participant reimbursement, capture referral source of participants, and create calls lists to promote recruitment. Attends investigator meetings Creates and updates source documents/progress notes and utilizes templates provided in the Core Operating Guidelines Accurately collects study data via source documents/progress notes as required by the protocol Performs technical requirements of the study protocol, i.e., lab work (phlebotomy and processing), blood pressure, electrocardiograms, Holtor monitoring, pulmonary function testing, allergy testing, urine/serum pregnancy testing, strep throat screening, or any procedure necessary for the protocol as ordered by the investigator or specified by a protocol Performs continuous reviews of the inclusion and exclusion criteria for each participant during the trial for their trials as well as peer review of inclusion and exclusion for trials Documents laboratory data and adverse reactions, presents this information to an investigator in a timely manner, and immediately notifies investigators, the Institutional Review Board and sponsor of any serious adverse events Builds and maintains strong relationships with Investigators and provides ongoing communication about trial status and participants Dispenses study medication at the direction of the Investigator Maintains communication with the monitor from the sponsoring company through telephone contact, written communication and on-site visits Enters visit data in the Electronic Data Capture (EDC) or Case Report Forms (CRF) within timelines provided by sponsor To be successful, you will have: Bachelor's Degree 3 + years of experience as a clinical research coordinator or equivalent role High attention to detail Interest in a clinical research career #LI-SB4 #LI-onsite #LI-Accellacare What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family's needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity. Oversees site interactions post activation through site closeout. This may include patient recruitment, investigator payments or other related activities. May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT). Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/CeMs) is aware of the contractual obligations and parameters. Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables. Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope. Employs strategic thinking and problem-solving skills to propose and implement risk mitigations. Participates and presents in key meetings such as Kick Off Meeting. Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members. This may include accompanying CRA team members to sites for observation or conflict resolution. Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines. Reviews and provides feedback on other functional plans (e.g. Data Management Plan, Communication Plan) as they relate to the clinical trial management activities. Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan. Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as needed. Ensures access and audit trail reviews are conducted as required. Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study. Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality. Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools. Reviews the project oversight dashboards and other clinical trial systems (e.g. Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs), Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to oversee site and patient activities, study team conduct and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency) according to plan. Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan. Is accountable for their assigned clinical team members' understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans. Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports and pertinent correspondence), to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity. Document requested revisions and approvals in CTMS. Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines. Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables. Provides status updates on the clinical deliverables and risks to clients, project management and leadership as per departmental or study agreements. Provides solutions for obstacles in protocol execution and site management. Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations This may include data management, study start up, patient recruitment, medical monitoring, pharmacovigilance and Quality Assurance (QA). Supports Inspection Readiness for clinical trial management scope. Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance, CMP compliance, and identifies emerging risks. Develop and support execution of corrective action plans at site and study level. Supports and completes activities to achieve data cut and lock deadlines. Provides feedback to line managers on staff performance including strengths as well as areas for development. May be assigned to larger, more complex trials or may coordinate clinical activities for a team of CTMs across a portfolio of projects May coach and mentor CTMs regarding functional clinical delivery, evaluation of project risks, and action implementation. Qualifications: Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience Demonstrated ability to lead and align teams in the achievement of project milestones Demonstrated capability of working in an international environment. Demonstrated expertise in site management and monitoring (clinical or central) Preferred experience with risk-based monitoring Demonstrates understanding of clinical trial management financial principles and budget management Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements Must demonstrate good computer skills Strong conflict resolution skills Demonstrated ability to apply problem solving techniques to resolve complex issues and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project. Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues Moderate travel may be required, approximately 20% We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. *************************** Additional Information Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health * We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. * We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. * We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities * Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity. Oversees site interactions post activation through site closeout. This may include patient recruitment, investigator payments or other related activities. May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT). * Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/CeMs) is aware of the contractual obligations and parameters. Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables. Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope. * Employs strategic thinking and problem-solving skills to propose and implement risk mitigations. Participates and presents in key meetings such as Kick Off Meeting. * Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members. This may include accompanying CRA team members to sites for observation or conflict resolution. * Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines. Reviews and provides feedback on other functional plans (e.g. Data Management Plan, Communication Plan) as they relate to the clinical trial management activities. * Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan. Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as needed. Ensures access and audit trail reviews are conducted as required. * Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study. * Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality. Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools. * Reviews the project oversight dashboards and other clinical trial systems (e.g. Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs), Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to oversee site and patient activities, study team conduct and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency) according to plan. * Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan. Is accountable for their assigned clinical team members' understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans. * Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports and pertinent correspondence), to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity. Document requested revisions and approvals in CTMS. Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines. * Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables. Provides status updates on the clinical deliverables and risks to clients, project management and leadership as per departmental or study agreements. Provides solutions for obstacles in protocol execution and site management. * Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations This may include data management, study start up, patient recruitment, medical monitoring, pharmacovigilance and Quality Assurance (QA). Supports Inspection Readiness for clinical trial management scope. * Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance, CMP compliance, and identifies emerging risks. Develop and support execution of corrective action plans at site and study level. Supports and completes activities to achieve data cut and lock deadlines. * Provides feedback to line managers on staff performance including strengths as well as areas for development. * May be assigned to larger, more complex trials or may coordinate clinical activities for a team of CTMs across a portfolio of projects * May coach and mentor CTMs regarding functional clinical delivery, evaluation of project risks, and action implementation. Qualifications: * Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience * Demonstrated ability to lead and align teams in the achievement of project milestones * Demonstrated capability of working in an international environment. * Demonstrated expertise in site management and monitoring (clinical or central) * Preferred experience with risk-based monitoring * Demonstrates understanding of clinical trial management financial principles and budget management * Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements * Must demonstrate good computer skills * Strong conflict resolution skills * Demonstrated ability to apply problem solving techniques to resolve complex issues and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project. * Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues * Moderate travel may be required, approximately 20% We are always excited to connect with great talent. This posting is intended for a [possible] upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. *************************** Additional Information Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Roles within the Clinical Trial Management job family are responsible for all aspects of the development, coordination, and implementation of Phase 1 clinical research studies at the organization's facilities. Collaborates with the principal investigator, liaisons between research subjects, client teams, investigators, and clinic operations teams, and plans logistics and resource usage. Tracks study progress in alignment with project milestones, client deliverables, and budget, and follows applicable regulations globally and by region. Impact and Contribution Includes executives as well as managers, supervisors and team leads providing strategic vision and/or tactical direction across a discipline and/or broader organization. The majority of time is spent overseeing their area of responsibility, planning, prioritizing, and/or directing the responsibilities of employees. Goal are achieved through management of process, policy, and performance of direct and/or indirect reports. Manages a team of individual contributors and/or Supervisors. Delivers operational results that have direct impact on immediate or short-term department results. In-depth knowledge and skills within a scientific/technology or professional discipline, understanding impact of work on related areas. Requires practical knowledge in managing the execution of processes, projects and tactics within team.

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. Our team is looking for a proactive, self-motivated team member who is comfortable working both independently and, in a team setting, and interfacing with Principal Investigators. * Essential skills and qualities include: * Highly organized * Excellent attention to detail and communication skills * Ability to successfully balance multiple competing priorities * Comfortable in an Operating Room setting * Comfortable collecting, processing, and transporting biological specimens * Has a valid driver's license and reliable means of transportation Preferred qualifications: ACRP or SOCRA certification preferred. This individual will support multiple research studies in the Reproductive Endocrinology and Infertility (REI) division of OBGYN, conducted by multiple investigators. Duties will include screening for research studies, obtaining written consent, conducting study visits, maintaining participant level documentation, and collecting, processing, and transporting research specimens. This position may also assist the Assistant Research Practice Manager with regulatory tasks. This position will work alongside and interact with multiple team members including: research staff, clinic staff and providers, surgeons, OR staff, hospital staff. This position is 100% on site. Minimum Requirements Education/Training: Completion of an Associate's Degree Experience: Work requires a minimum of two years relevant research experience. A bachelor's degree may substitute for 2 years required experience. Be Bold. Operations: * Knowledgeable in regulatory and institutional policies and processes; * Applies appropriately in study documentation, protocol submissions, and SOPs. * May train others in these policies and processes. * Is responsible for all aspects of managing and documenting Investigational Product (IP); including arrival, storage, tracking, and provision to research participants. * Serves as the primary liaison with sponsors, IDS, and other parties as necessary. Follows protocol schema for randomization and blinding/unblinding. May train others. Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. * Addresses and corrects findings. * Maintain all participant level documentation for studies that are complex in nature (e.g., procedural and interventional studies) and/or require access to the Duke EHR. * Employ strategies to maintain retention rates. Evaluate processes to identify problems with retention. * Employs and may develop strategies to maintain recruitment rates and evaluate processes to identify problems. Escalates issues. * Screens participants for all studies, including those that are complex in nature (e.g., procedural and interventional studies). * Provides oversight and training in screening activities to multiple study teams. Develops or helps develop SOPs. * Independently employs simple procedures for collecting, preparing, processing, shipping, and maintaining inventory of specimens. * Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies). * Conducts activities for study visits in compliance with the protocol. * Participates in study team meetings. Ethics: * Identifies all Adverse Events(AE), and determines whether or not they are reportable. Collaborates with the Principal Investigator to determine AE attributes, including relatedness to study. * May train or oversee others. * Conducts and documents consent for participants for all types of studies, including those that are complex in nature and/or require any orders in Maestro Care. * Assists with the development of consent plans and documents for participants. * Develop and submit documentation for IRB review in iRIS. * Communicate with the IRB staff and reviewers and handle issues appropriately. Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies. Data: * Develops data entry or collection SOPs or tools. * Enters and collects data. * May provide oversight or training to study team members collecting or entering data. Ensures accuracy and completeness of data for all studies, including those that are complex in nature. * Recognizes data quality trends and escalates as appropriate. May develop tools for, and train others in, data quality assurance procedures. * Follows required processes, policies, and systems to ensure data security and provenance. Innovatively uses technology to enhance a research process. * Under supervision, assists in preparing tables, data visualizations, and lay summaries to communicate study results to participants. * Assists in updating and may develop reports on study progress for the PI and other study team members and collaborators. Science: * Demonstrates a basic understanding of the elements of research study designs. Provides some contribution to scientific publications or presentations (no authorship). Study and Site Management: * Prepares for, coordinates, and actively participates in site visits. Communicates effectively with sponsors and/or CROs. * Uses clinical research management system and its reports to manage research participants' activities, calendars, tracking/marking financial milestones, and all aspects of study visits. Uses required EMR functionalities to manage participants and study visits. * Uses OnCore and eREG systems and system reports to manage research protocols. For studies with supplies or equipment, ensures that there are ample supplies and that equipment is in good working order. May forecast effort needs. * Ensure that studies are conducted in compliance with institutional requirements and other policies. Follow, and may develop or implement, operational plans (e.g. protocol-specific systems and documents including process flows). * Prepares studies for closeout and document storage. Leadership: * Proactively seeks opportunities to add relevant skills and certifications to own portfolio. Keeps current with research updates by attending key external offerings (i.e. Research Wednesday, RPN, events outside of Duke, etc.) and applies the learned material to the job. May disseminate information to others. * Serves on committees and workgroups internal to Duke or externally in therapeutic area of research. * Demonstrates interpersonal skills to get work done efficiently. Recognizes and escalates organizational issues that could be optimized to improve research process. Demonstrates resilience and is adaptive to change. * Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems across multiple study teams. * Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives. Choose Duke. Join our award-winning team as identified by Forbes magazine as America's Best Large Employer 2024 and be part of an inclusive culture that values excellence, innovation, and discovery. As an organization, we have exciting opportunities to be forward-thinking leaders in our field. We want talented individuals to join us, examine our current operations, and create innovative solutions that will revolutionize and enhance the way we approach our work. Duke University is consistently ranked among the top universities worldwide and is renowned for its cutting-edge research across disciplines. Beyond the engaging work, you'll also benefit from Duke's competitive benefits package including health insurance plans, generous paid time off, retirement programs with employer contributions, tuition assistance for employees and their children, and more. Anticipated Pay Range: Duke University provides an annual base salary range for thisposition as USD $ 59,829.00 to USD $99,960.00. 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 den tal careprograms, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members. Learn more at: ***************************** 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 onthe 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

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 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.

Back to Search Results Clinical Studies Coordinator I, Orthopedics Winston Salem, NC, United States Shift: Various Job Type: Regular Share: mail

The Licensed Practitioner is responsible for : Conducting Assessments of consumers Conducting Outpatient therapy Conducting Intakes Submitting clients for Reauthorization Conducting Group sessions Complete updates as neccessary for client's file Working with both populations Adults and Adolescence Provide screening and therapeutic consuling to consumers Assisting in other areas that is required by the agency Qualifications Licensed Clinical Practitioner must have Masters Degree in Human Services field with at least one year documented experience in mental health and/or substance abuse. Licensed Practitioner must maintain valid CPR, TB Skin Test, Medication Management, BBP, NCI or training on Alternative to Restictive Intervention. Licensed Practitioner must maintain trainings required by board. Additional Information All your information will be kept confidential according to EEO guidelines.

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

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.

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