Clinical research associate jobs in Durham, NC - 162 jobs

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

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

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

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

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

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

**Job Purpose:** The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and sponsor standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial. **Key Accountabilities:** **Oversight of Monitoring Responsibilities and Study Conduct** + Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and sponsor standards to achieve project goals, timelines and quality + Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met + During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery + Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites + Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks + Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and + recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level + Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies + Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution + Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics + Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues + Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines + Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities + Support database release as needed + May undertake the responsibilities of an unblinded monitor where appropriate **Clinical/Scientific and Site Monitoring Risk** + Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team + Interact with investigator site heath care professionals in a manner which enhances sponsor's credibility, scientific leadership and in order to facilitate sponsor's clinical development goals + Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators + Drive Quality Event (QE) remediation, when applicable + Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable **Collaboration** + Reports to Director of Clinical Site Operations (DCSO) or Director of Site Management and Monitoring (DSMM) + Partners with SCP and Country Study Operations Manager (SOM) + When required Partners with other Study Team members (e.g. Clinician, Recruitment Specialist, Clinical Data Scientist) + May act as a Mentor for Clinical Research Associates **Skills:** + Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) in a CRO or pharma organization + Preferred therapeutic experience in Oncology + Global clinical trial experience preferred + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations + Must be fluent in English and in the native language(s) of the country they will work in + Travel (60-80%) within area is required + Valid driver's license and passport required **Knowledge and Experience:** + Demonstrated knowledge of clinical research and development processes and ability to gain command of process details + Demonstrated knowledge of global and local regulatory requirements + Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.) + Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s) + Demonstrated ability to support sponsor regulatory interactions/inspections + Demonstrated knowledge of the processes around protocol design and feasibility assessment + Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery + Proven ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trial + Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation + Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization **Education:** + Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical is required \#LI-CF1 \#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.

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

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 Regulatory Coordinator within the Department of Surgery in the Division of Vascular Surgery. The Senior Clinical Research Regulatory Coordinator is responsible for regulatory management for multiple and/or concurrent or complex studies, including meeting regulatory-based objectives and deadlines (e.g., IRB submission approvals, IND/IDE submissions, regulatory binder creation, etc.). The Senior Clinical Research Regulatory Coordinator will use a full knowledge of clinical research regulatory principles to complete various tasks, such as leading root cause analysis processes, creating of corrective and preventative action plans, regulatory study start-up, and promoting regulatory quality assurance and best practices. 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 * Must be able to use considerable judgement and skills in performing work assignments. * Strong written and verbal communication skills. * Must be able to work and communicate with diverse populations effectively and professionally. * Must be able to work independently as well as function as part of a team. * Must be proficient with Microsoft Outlook, Excel, and Word. Preferred Qualifications, Competencies, and Experience Not applicable Special Physical/Mental Requirements Campus Security Authority Responsibilities Not Applicable. Special Instructions Quick Link *******************************************

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

Genius Talent has partnered with a leading Med Tech company in search of a Clinical Project Manager. Reporting to the Associate Director-Portfolio Management/Clinical Operations PoC, the Clinical Project Manager will evaluate and manage all aspects of assigned clinical research studies and/or programs and provide project management oversight of studies and cross-functional teams. RESPONSIBILITIES Evaluates and manages all aspects of assigned clinical research studies and/or programs and provides project management oversight of studies and cross-functional teams. Provide daily management and oversight of assigned clinical research programs, promoting teamwork, and resolving conflicts as needed. Ensure proper conduct of ongoing clinical research trials in compliance with applicable protocols, FDA regulations, ICH/GCP guidelines, appropriate company and /or client SOP's, and professional standards. Manage study budget and scope of work for assigned projects/programs according to contracted scope of work; identify and communicate potential out of scope activities to client and relevant departments. Continuously evaluate assigned projects for areas where improvements can be made and implement efficiencies to improve the quality of work delivered to the client. Establish good working relationships with client project teams to ensure client satisfaction. Ensure efficient identification and successful selection of investigational research sites for participation in clinical research trials (if applicable). Prepare/review investigator clinical trial agreements and negotiate study budgets as required. Develop, implement, and revise project-specific operational plans (e.g., project plan, project specific QC plan, monitoring plan, communication plan, and data management plan) and other guidance documents to ensure efficient workflow. Assist with the development of case report forms, monitoring tools, and necessary study guides for project teams and investigational research sites (as applicable). Develop and implement study/program timelines in conjunction with internal team and client. Develop and maintain project tracking spreadsheets to ensure current monitoring of study/program progress. Define project/program resource needs and manage resources effectively. Carry out any ad-hoc task as assigned by the Line Manager, Department Head and/or Senior Management. SKILLS Excellent communication skills (both written and oral) Ability to coordinate with trial site staff, CRO and clients/sponsor Ability to multi-task and think on your feet Good organizational, IT and administrative skills Excellent computer skills with various software programs including Microsoft Word, Excel, MS Project and Outlook. Skilled in financial control procedures for assigned studies. Excellent organizational and planning skills. Fluent in English with excellent oral and written communication skills used in educating, guiding, training, and negotiating. Demonstrated problem solving, interpersonal and leadership skills MINIMUM REQUIREMENTS At minimum, Bachelor's degree required (preferably in health science). 5+ years of relevant experience in clinical research and operations at a CRO, Biotechnology/ Pharmaceutical company Thorough knowledge of drug development, the project management process, FDA regulations, and ICH/GCP guidelines. Global project management experience recommended. Strong knowledge of relevant US and EU regulations.

Preferred Qualifications Preferred is a bachelor's degree and 2-4 years' experience in accounting or sponsored research. PeopleSoft Human Resources and Financials experience. Experience in PINS , RADAR , NSF FastLane, grants.gov, and WRS Systems Work Schedule M - F, 8:00 - 5:00 (flexible work arrangements may be approved for this position)

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.

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.

The Office -Based Clinical Trial Associate (CTA) will perform tasks related to supporting operational strategy and and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan. This is a position with a pharmaceutical company. Provide support for essential daily clinical study activities, including regulatory inspection readiness, following established protocols under the general management of the CTA Manager. Work with Clinical Operations Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model. Perform departmental tasks. Perform developmental tasks with oversight of CTA Manager. ACCOUNTABILITIES: For assigned complex, accelerated, and business essential studies, provide support to focus on study startup and site initiation activities, including: Approval of study documentation, including essential document packets, study plans, informed consent forms, etc. Support oversight of risk -based monitoring. Attend important team meetings. Support regulatory inspection readiness (e.g. preparation of materials and participation during regulatory inspections.) Support additional ad -hoc activities, as agreed with CTA Manager. Work with internal departments (Legal, Insurance, R&D functions), CROs, and vendors. Escalate clinical trial insurance issues Support vendor contract administration. Requirements Associate or Bachelor's degree in Life Sciences or Healthcare 2 or more years' experience in pharmaceutical industry, clinical research organization, or related role. Experience in Phase 2 and 3 studies and global/international studies is advantageous. Experience working across multiple therapeutic areas is advantageous. Knowledge in global regulatory and compliance requirements for clinical research. Excellence in task management and collaboration. Requires availability for 5 -10% domestic and international travel, including overnight and international travel on an as -needed basis. Benefits 401(k) with company match and Annual Retirement Contribution Plan Tuition reimbursement Company match of charitable contribution Generous time off for vacation and the option to purchase additional vacation days

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 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations. Be you. Operations: Screen participants for all studies independently. Maintain subject level documentation for all studies independently Schedule participants and conduct visits for minimal risk studies independently. Collect, prepare, process, ship, and maintain inventory of research specimens. Assist with management of IP. Employ the required system for handling, dispensing and documentation of IP for sponsored protocols. May be responsible for determining the best methods for handling IP for Investigator-initiated protocols, or coordinating with investigational pharmacies as necessary. Maintain appropriate documentation. Track IP compliance at the protocol-and subject level. Independently maintain appropriate study-level documentation including regulatory binders, enrollment logs, patient registration in the system of record, etc. Employ strategies to maintain recruitment and retention rates, and to assist participants with individual needs. Conduct and document consent for participants in a variety of studies independently Assist with addressing and correcting findings from study monitoring and study audit visits. Collect, prepare or process adverse event information under supervision. Complete and submit Adverse Events Reports, according to institution and sponsor-specific prompt reporting requirements (timelines and forms) under supervision. Develop DUHS IRB documents such as consent forms, protocols, and continuing reviews independently. Ethics: Communicate to research participants, both orally and written, the difference between clinical activities and research activities in all study documents and research participant communications. Be familiar with the ethical conduct of research, and safeguards needed when conducting research with vulnerable populations. Understand that the safety of research participants is a priority. Assist with the development of Conflict of Interest (COI)/Data Safety Monitoring Plans (DSMPs)/Research Data Security Plans (RDSPs). Assist with the coordination of efforts of external monitoring boards. Identify and the explain the risk and benefits to a subject as these pertain to your clinical trial Leadership: Encourage and support colleagues in completing project work. Assist research colleagues in identifying efficiencies and improving process. Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research. Maintain Duke and project specific training requirements. Evaluate the need for cultural diversity and cultural competency in the design and conduct of clinical research. Make recommendations to investigative team. Study and Site Management: Collect information to determine appropriate feasibility, recruitment and retention strategies. Maintain study's compliance with institutional requirements and other policies (e.g., NIH Public Access policy, ct.gov, Research Data Security Plans, Social Media policy, etc.). Oversee maintenance of Delegation of Authority Logs and training of key personnel on study specific duties. Take part in site initiation/closeout visits as directed. Assist with the development of protocol-specific systems and documents including process flows, training manuals, standard operating procedures, and case report forms. Take part in or lead closeout and document storage activities Communication: Serve as primary liaison with single sponsor, subcontractor, or vendors. Communicate concerns clearly and in a professional manner. Participate in study team meetings. Respond to routine questions related to study protocol and refer more complex questions to others as appropriate. Communicate and coordinate with other study personnel as required for study implementation and routine problem resolution. Be Bold. Anticipated Pay Range: Duke Universityprovides an annual base salary range for this position 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, andkey 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 anddental care programs, generous retirement benefits, and a wide array of family- friendly and cultural programs to eligible team members. Learn more at: ***************************** Choose Duke. Minimum Qualifications Education Completion of an Associate's degree Experience Work requires a minimum of two years of relevant research experience. Completion of the DOCR North Carolina state approved Clinical Research Apprenticeship program may substitute for one year of required experience. A Bachelor's degree may substitute for 2 years required experience. Degrees, Licensures, Certifications Work requires a minimum of two years of relevant research experience. Completion of the DOCR North Carolina state approved Clinical Research Apprenticeship program may substitute for one year of required experience. A Bachelor's degree may substitute for 2 years required experience. Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex (including pregnancy and pregnancy related conditions), sexual orientation or military status. Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values. Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department. Nearest Major Market: Durham Nearest Secondary Market: Raleigh

Department: 38922 Wake Forest University Health Sciences - Nephrology Status: Full time Benefits Eligible: Yes Hours Per Week: 40 Schedule Details/Additional Information: Monday- to Friday 8am - 5pm Pay Range $26.10 - $39.15 JOB SUMMARY Under departmental direction, coordinates activities to support multiple research studies of all phases. Serves as the principal administrative liaison for assigned studies with the ability to manage a workload that includes studies of increased complexity. Develops and maintains recordkeeping systems and procedures to ensure compliance with study protocols and all appropriate regulations. Attends clinic as needed to perform activities including, but not limited to: assist the research team with recruitment activities, administer questionnaires and answer any questions about future appointments. Responsible for the compilation, registration and submission of data, as required by the Sponsor. EDUCATION/EXPERIENCE Bachelor's degree with two years; experience in clinical research; or an equivalent combination of experience and education. LICENSURE, CERTIFICATION, and/or REGISTRATION SOCRA or ACRP Certification preferred. Must complete the CITI certification for Human Subject Research if not already completed. All additional required WakeOne training for research coordinators. ESSENTIAL FUNCTIONS 1. Works under the direction of the Study Investigators or Clinical Research Nurse Manager with minimal supervision. 2. Plays an active role in recruitment of patients to study. 3. Performs protocol specific duties required per the research protocol. 4. Obtains or assists the Principal Investigator in obtaining informed consent from subjects and reinforces the information that has been provided to subjects and families. 5. Fulfills sponsor requirements related to reportable information including adverse events, unanticipated problems, and other information required by the sponsor protocol. 6. Abstracts data from the medical record and completes paper and electronic case report forms, including responding to any requests for data clarification, and maintains all necessary source documents. 7. Identifies and communicates important protocol and data management issues or problems to the supervisor in a timely manner. 8. Provides staff relief as required to meet the needs of the department. Participates in scheduled team/department meetings. Participates in quality improvement projects on an on-going basis. 9. May mentor new and less experienced staff. 10. Follows established Wake Forest Baptist and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality. 11. Performs other related duties as assigned or requested. SKILLS/QUALIFICATIONS Excellent interpersonal, oral, and written communication skills Excellent reading comprehension Strong organizational skills EPIC/WakeOne proficiency to include appropriate documentation of research notes Proficient in the use of OnCore/WISER Clinical Trial Management System Basic computer skills Fosters/promotes a positive image and professional appearance Sensitivity to intercultural relations Sensitivity to the maintenance of confidentiality Knowledge of Microsoft Products WORK ENVIRONMENT Clean, comfortable, office environment Our Commitment to You: Advocate Health offers a comprehensive suite of Total Rewards: benefits and well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more - so you can live fully at and away from work, including: Compensation Base compensation listed within the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training Premium pay such as shift, on call, and more based on a teammate's job Incentive pay for select positions Opportunity for annual increases based on performance Benefits and more Paid Time Off programs Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability Flexible Spending Accounts for eligible health care and dependent care expenses Family benefits such as adoption assistance and paid parental leave Defined contribution retirement plans with employer match and other financial wellness programs Educational Assistance Program About Advocate Health Advocate Health is the third-largest nonprofit, integrated health system in the United States, created from the combination of Advocate Aurora Health and Atrium Health. Providing care under the names Advocate Health Care in Illinois; Atrium Health in the Carolinas, Georgia and Alabama; and Aurora Health Care in Wisconsin, Advocate Health is a national leader in clinical innovation, health outcomes, consumer experience and value-based care. Headquartered in Charlotte, North Carolina, Advocate Health services nearly 6 million patients and is engaged in hundreds of clinical trials and research studies, with Wake Forest University School of Medicine serving as the academic core of the enterprise. It is nationally recognized for its expertise in cardiology, neurosciences, oncology, pediatrics and rehabilitation, as well as organ transplants, burn treatments and specialized musculoskeletal programs. Advocate Health employs 155,000 teammates across 69 hospitals and over 1,000 care locations, and offers one of the nation's largest graduate medical education programs with over 2,000 residents and fellows across more than 200 programs. Committed to providing equitable care for all, Advocate Health provides more than $6 billion in annual community benefits.

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.

Job Description Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine , which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers , which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit ******************* How This Role Makes a Difference The Clinical Research Assistant is an entry level clinical position and is designed to fully integrate the individual in the Care Access Research process while learning the skills necessary to be a Clinical Research Coordinator. This position has potential growth and advancement within the Care Access Research organization. How You'll Make An Impact Ability to understand and follow institutional SOPs Participate in recruitment and pre-screening events (may be at another location) Assist with preparation of outreach materials Identify potential participants by reviewing medical records, study charts and subject database Assist with recruitment of new participants by conducting phone screenings Request medical records of potential and current research participants Schedule visits with participants, contact with reminders Obtain informed consent per Care Access Research SOP, under the direction of the CRC Complete visit procedures as required by protocol, under the direction of the CRC Collect, process and ship specimens as directed by protocol, under the direction of the CRC Record data legibly and enter in real time on paper or e-source documents Request study participant payments Update all applicable internal trackers and online recruitment systems Assist with query resolution Assist with administrative tasks such as copying, scanning, filing, mailing, emailing, etc. Assist with maintaining all site logs Assist with inventory and ordering equipment and supplies Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials. Maintain effective relationships with study participants and other care Access Research personnel. Interact in a positive, professional manner with patients/participants, sponsor representatives, Investigators and Care Access Research personnel and management. Communicate clearly verbally and in writing. Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. The Expertise Required Ability and willingness to work independently with minimal supervision Ability to learn to work in a fast-paced environment Excellent communication skills and a high degree of professionalism with all types of people Excellent organizational skills with strong attention to detail A working knowledge of medical and research terminology A working knowledge of federal regulations, Good Clinical Practices (GCP) Critical thinker and problem solver Friendly, outgoing personality with the ability to maintain a positive attitude under pressure Contribute to team and site goals Proficiency in Microsoft Office Suite High level of self-motivation and energy An optimistic, "can do" attitude Certifications/Licenses, Education, and Experience: A minimum of 1-year recent working experience as a Medical Assistant, EMT, LPN, Clinical Research Assistant or Phlebotomist. Phlebotomy Experience and Proficiency Required Some Clinical Research experience preferred California based roles require National phlebotomy certification by an organization approved by the California Department of Public Health Louisiana based roles require National phlebotomy certification by an organization approved by the Louisiana State Board of Medical Examiners Washington based roles require National phlebotomy certification by an organization approved by the Washington State Department of Health Nevada based roles require Laboratory Assistant certification by the Division of Public and Behavioral Health How We Work Together Location: This is an on-site position with regional commute requirements. Regularly planned travel within the region will be required as part of the role. Overnight travel will be minimal ( Physical demands associated with this position Include: The ability to use keyboards and other computer equipment. The expected salary range for this role is $19.00-$33.00 USD per hour. In addition to base pay, employees may be eligible for 401k, stock options, health and wellness benefits and paid time off. Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************