Clinical research associate jobs in Fayetteville, NC

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

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

Title: Study USA Coordinator Position Type: Staff Full-Time Days Per Week: M-F Hours Per Week: 40 VP Area: Office of the Provost and Academic Affairs Department: Global Engagement Reporting to the Director of Study USA within the Isabella Cannon Global Education Center (GEC), this 12-month, full-time position manages a portfolio of Elon's University's signature Study USA programs and serves as a general advisor for students considering study away options. Benefits of Working at Elon As an Elon University employee, you'll join an internationally acclaimed university with a commitment to fostering a thriving community. Ranked among the most innovative, creative and best-run universities in the nation, Elon's personal approach to education extends to employees, whose growth, professional development and success is a hallmark of our training and advancement opportunities. Elon University's home is the charming town of Elon, North Carolina, a small, friendly community located a short distance from the beach and the mountains, and among the vibrant cities of Greensboro, Raleigh and Durham. In addition to the beautiful canopy of historic oak trees iconic to our campus, you'll find boundless opportunities for family-friendly recreation, cultural events and outdoor activities. Hiking, water sports, fine dining and entertainment are just a few of the many happenings in the Elon area, making the region one of the nation's premier travel destinations. Employees at Elon enjoy a generous and comprehensive benefits package that includes: 28 annual days off, including holidays and vacation. Immediate tuition remission for undergraduate courses Tuition remission for approved graduate-level courses after 12 months of employment. Retirement plan with an 8 percent contribution from the university. Immediate eligibility for health, dental and vision insurance, along with free acute care and lab services at our onsite Health & Wellness Clinic. Free use of campus fitness facilities. Free admission to musical and theater performances, guest speakers, religious and ethnic observances, recitals, art exhibitions, entertainment and our Division I Phoenix athletics. Eligibility for tuition remission at Elon for spouses, qualifying domestic partners and dependents begins at two years of service. After two years of employment, eligibility begins for participation in the Tuition Exchange, a national scholarship exchange program that enables dependents to enroll in nationally recognized partner colleges and universities. Elon values and celebrates the diverse backgrounds, cultures, experiences and perspectives of our community members. As an equal opportunity employer, Elon's principles of diversity extend to race and gender identity, age, disability status, veteran status, sexual orientation, religion, and other aspects of one's identity. At Elon, our employees respect human differences, passion for lifelong learning, emphasis on personal integrity and an ethic of service. Minimum Required Education and Experience Bachelor's degree with minimum 1 year of experience with the following relevant work experience: Preference for prior professional experience in a unit related to experiential learning (service, internship, research, leadership) at a four-year college/university, or the equivalent. Commitment to diversity, equity, and inclusion. Preferred Education and Experience Bachelor's degree in in relevant field of study Job Duties * Program Management * Manage logistical aspects of Study USA programs including Study USA in NYC, DC, Charlotte, and other assigned programs, in coordination with the Director of Study USA and other key stakeholders. * Support data collection and analysis to monitor program growth and identify areas for improvement. * Organize and maintain excel spreadsheets of internships, alumni, and student support resources to ensure accurate and accessible information. * Create and maintain records of internships, alumni, and student resources. * Provide support to faculty and staff within assigned programs. * Support on-campus student recruitment in Study USA through programming and campus partners. * Student Support and Advising * Advise students on program selection for Study USA program centers and select short-term programs including tabling at Quick Questions. * In coordination with the Assistant Director of Career Services for Study USA and International Students and Director of Study USA, mentor and prepare students for internships. * Conduct series of predeparture workshops and a reentry experience for participants. * Provide crisis management support and counseling for students participating in assigned programs. * Liaise with other offices on main campus to support students during pre-departure, on-program and during re-entry as necessary. * Communications and Relationships * In coordination with the Communications Manager, assist with updates to Study USA webpages and brochures. * In coordination with the Director of Study USA, assist in development and implementation of outreach and communications plan. * Maintain connections and relationships with Elon alumni who live within New York City and DC through planned events, social media, and regular interaction, in coordination with the SPDC, Alumni Office, and Student Affairs. * Additional Experiential & Non-GEC Programs * Serve as the GEC point person for experiential learning including overseas research, internships, and service-learning. * Serve as liaison and support person for study away Athletics programs, Periclean Scholars, Honors, and the Truitt Center. * Serve as the GEC point person for graduate-level study away programs, providing resources and assistance, as needed. * Inclusive Community Building Community is foundational to Elon and a shared responsibility within our residential campus. All who work at Elon should demonstrate an understanding of and engagement with Elon's foundational commitment to relationships, mentoring and collaboration in a close-knit residential community. We embrace the shared responsibility to foster inclusive excellence within a strong residential community. Accordingly, employees are expected to join together and build connections in activities that foster an active and engaged campus environment and engage in professional development to support the shared responsibility of enriching diversity, equity, and inclusion through meaningful relationships and mentoring at Elon. Employees are encouraged to, for example, attend or participate in campus activities such as College Coffee, Numen Lumen, campus cultural events, athletic events, continuing education, professional development opportunities and trainings, employee resource groups and other university-sponsored activities to demonstrate an active commitment to the Elon community. Special Instructions to Applicants: Applicants are asked to submit both a resume and cover letter for full consideration.

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

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

ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Clinical Research Associate to join our diverse and dynamic team. As a Clinical Research Associate at ICON, you will play a pivotal role in designing and analyzing clinical trials, interpreting complex medical data, and contributing to the advancement of innovative treatments and therapies. What you will be doing * Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. * Ensuring protocol compliance, data integrity, and patient safety throughout the trial process. * Collaborating with investigators and site staff to facilitate smooth study conduct. * Performing data review and resolution of queries to maintain high-quality clinical data. * Contributing to the preparation and review of study documentation, including protocols and clinical study reports Your profile * Bachelor's degree in a scientific or healthcare-related field. * Minimum of 12 months onsite monitoring experience as a Clinical Research Associate; level (CRA I, CRA II, or Senior CRA) determined by total years of experience. In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines. * Strong organizational and communication skills, with attention to detail. * Ability to work independently and collaboratively in a fast-paced environment. * Ability to travel at least 60% of the time (international and domestic - fly and drive) and should possess a valid driver's license What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: * Various annual leave entitlements * A range of health insurance offerings to suit you and your family's needs. * Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. * Global Employee Assistance Programme, 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

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

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

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

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

The UNC LCCC Cellular Therapy Program (************************************************** is seeking a study coordinator to facilitate complex investigational and FDA -approved cellular and gene therapies within according to federal regulations, Good Clinical Practice, and local and institutional policies. This position will ensure that patients who are being evaluated for and undergoing cell therapy receive comprehensive, coordinated care in an organized and high-quality manner. The study coordinator will work with a multi-disciplinary team of pre-clinical faculty, clinical faculty, and UNC Medical Center staff to design, develop and deliver investigational and/or FDA -approved cellular and gene therapies to adult and pediatric populations. This position will coordinate the conduct of early phase cellular and gene therapy clinical trials, including patient and data management. The coordinator will maintain the quality of research by addressing patient safety and regulatory compliance. 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. Knowledge of GCP and ICH Guidelines and ability to follow established regulations, procedures, and protocols. Previous study coordinator or patient navigation experience. High level of accuracy and attention to detail. Ability to plan work and coordinate multiple projects. Strong attention to detail and accuracy; excellent organization skills. Experience navigating medical records and data extraction. Preferred Qualifications, Competencies, And Experience Research Certification - SOCRA / ACRP Experience in early phase interventional clinical research Experience in oncology Work Schedule Monday - Friday, 8:00am - 5:00pm

Full-time Description As a Clinical Research Coordinator, you will play a pivotal role in contributing to revolutionary treatments for those affected by disorders of the spine. You will aid in the development of this innovative area of medicine by managing and facilitating the day-to-day operations of investigational medical device studies for two orthopedic spine surgeons. The ideal candidate is self-motivated, able to work well independently, and comfortable communicating with patients. Clinical trial experience is required. PREFERRED QUALIFICATIONS RN, MA, LPN, or other medical license/certification (preferred) Clinical trial experience (required) Bachelor's, master's, or other advanced degree Requirements POSITION REQUIREMENTS Responsibilities Ensure adherence to study protocols. Complete case report forms and address any queries that arise. Report any protocol deviations or adverse events to Principal Investigator (PI), sponsor, and Institutional Review Board (IRB) as required. Attend study site meetings as necessary. Facilitate the informed consent process and schedule study-related visits. Maintain comprehensive records of study activities, including but not limited to, invoices, source documentation, case report forms, and data management system entries. Abilities Efficient time management skills and ability to multitask. Strong organizational, computer, and communication skills. Commitment to maintaining confidentiality of sensitive information. Proficiency in operating standard office equipment and software (phones, fax machines, EMR, PACS) PERSONAL CHARACTERISTICS High energy level Strong interpersonal skills; tactful Ability to relate sensitively to patients needs Excellent telephone skills and etiquette Maintains confidentiality Uses discretion and sound judgment Ability to establish credibility with physicians, staff, and patients Ability to multi-task; resourceful and well organized; takes initiative Always mindful of quality improvement and cost-efficient care Team player Ability to maintain positive attitude Well-groomed

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

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 into 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: ********************************

Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise: to bring innovative medical treatments to patients. We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step. As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity. Benefits include medical, dental and vision insurance, paid time off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program. Summary: The Clinical Research Assistant assists the Clinical Operations Team in a multi-functional capacity to carry out all assigned tasks associated with the collection, documentation, and maintenance of clinical data including phlebotomy/laboratory, data entry and administrative responsibilities. Responsibilities Duties/Responsibilities: Assist in the conduct of clinical trials in accordance with the study protocol, GCP, ICH Guidelines, and Velocity's SOPs Perform venipuncture, capillary puncture and/or other fluid collection within scope of the protocol and local law and regulations With supervision, perform clinical assessments (vital signs, phlebotomy, ECG, etc) within scope of the protocol, local law and regulations Process, package and ship laboratory specimens as required per protocol and IATA regulations, if applicable Track, order and maintain inventory of all laboratory and study related supplies throughout course of the clinical trial Enter source data into the sponsor's and/or vendor's data portal and resolve basic queries in a timely manner under the direction of the Clinical Research Coordinator Communicate with coworkers, leadership, study subjects, sponsors, CROs, and vendors under the direction of the Clinical Research Team Understand good documentation practices when collecting, transferring data to sponsor/CRO data capture systems and resolving queries under the direction of the Clinical Research Coordinator Understand the informed consent process with emphasis on ensuring initial and ongoing consent of study subjects Understand basic elements of regulatory documentation required to initiate, maintain and close a clinical research trial Understand and participate in patient recruiting tasks including but not limited to prescreening potential subjects for clinical research trials either via phone or in person Maintain confidentiality of patient protected health information, sponsor confidential information and Velocity confidential information Ability to escalate potential patient safety issues such as adverse events, serious adverse events, and adverse events of special interest to the Clinical Research Team Cleaning, organizing, and disinfecting the patient care, lab and lab equipment areas as needed Prepare source document charts, copy and/or file medical records and study related documents as required. Perform front office duties as needed including but not limited to answering phones, scheduling subjects, making reminder calls and updating patient tracking systems. Other duties as assigned Qualifications Education/Experience: High School Graduate and/or technical degree with minimum of 1 year of relevant experience in life sciences industry Required Licenses/Certifications: Phlebotomy if applicable and required by state law Intramuscular dose administration and preparation if applicable and required by state law Required Skills: Demonstrated knowledge of medical terminology Demonstrated ability to use the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone. Understanding of verbal, written, and organizational skills Demonstrated ability to work as a team player Demonstrated ability to read, write, and speak English Demonstrated ability to multi-task Demonstrated ability to follow written guidelines Demonstrated ability to be flexible/adapt as daily schedule may change rapidly Required Physical Abilities: Sit or stand for long periods of time Communicate in person and by a telephone Limited walking required Limited to lifting up to 30 pounds NOTE: The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.

Assist in the collection and documentation of study activities and procedures. Maintain study areas and equipment in a tidy and operational state. Assist study team in conduct of research studies Essential Functions /principal accountabilities Performs competencies and job requirements as trained and delegated and as applicable to study protocols. Collects data according to protocol/clinic SOP' Performs all job responsibilities in accordance with standards of GCP (Good Clinical Practice), clinic SOPs, OSHA guidelines, Federal and local regulations Completes all required training programs per company requirements Honors password protections and confidentiality. Reports to Director/Manager/Coordinator of Clinical Services on all administrative, logistical and staff related site issues. Responsible to the Principal Investigator (PI) on all aspects of study conduct. Timely evaluation/sign-off of study documentation. Ensures Correct Procedures are performed in a timely manner on the correct participant according to Protocol requirements. Ensures study participants confidentiality and HIPAA compliance. As per Job Description and as trained and delegated by the Medical Director or Principal Investigator and as allowed by sponsor: Performs study procedures: Specimen Collection Phlebotomy Perform CLIA waived tests and specimen processing Vital signs, EKG's Height, weight, and BMI calculations Product Dispensing and Accountability Other procedures as trained and delegated Manages receipt, distribution, supervision, and documentation of study participant's meals Monitor bathrooms Preparation of Study Areas: Ensure study and participant areas are cleaned and maintained in a tidy and organized manner Ensure equipment is set up and ready for use Provides study scrubs and linens for study participants Provides other general assistance to the clinic team such as labeling of study supplies, study room arrangement and bed assignment Make calls to study participants to confirm study activities/restrictions/reminders Study Participant Recruitment Represent Facility in Community Events and Health Screening Programs Performance of and Management of Pre-Screening and Screening Procedures Preparation of study source binders Filing of source documents in a timely manner Complete source documentation accurately, legibly and in real time. Review source documents on an ongoing basis to ensure accuracy and completeness. Correct source documentation errors in a timely manner Report deviations or study related issues to supervisor Enforce clinic rules and regulations Search study participants personal belongings brought to the clinical research center for contraband Verification of Investigational Product and Concomitant Medication Administration Ensure study participants are available for procedures in a timely manner Educate study participants regarding study procedures being performed Assisting in the training of new staff members Assist other departments as needed

The Clinical Research Assistant is responsible for coordinating, implementing and completing clinical research studies or clinical trials with the Orthogenetics Department at Nemours Children's Hospital Delaware. The job includes but is not limited to: developing protocols, recruiting patients, assisting in budget and documents preparation, in-servicing research teams, recruiting patients, obtaining patient consents, educating patients, conducting study procedures, collecting data, keeping records, performing analysis, and assisting in manuscript / abstract preparation. A high level of organization with attention to detail and the ability to manage multiple responsibilities is required. This position will work with multiple departments and must maintain a high level of professionalism and a continuous process improvement mindset. The Clinical Research Assistant will be required to complete Human Subjects Protection (HSP) training and CITI training (including Good Clinical Practice (GCP). Required skills include ability to work with children, experience with computer data entry, good verbal and written communication, and skills with Microsoft WORD, EXCEL and ADOBE. Essential Functions: Follows all aspects of Good Clinical Practices in the conduct of clinical research; assists in identifying, reporting, and following up on Serious Adverse Events. Assists in protocol preparation; assists in budget development; prepares documents as required by sponsoring agencies; develops source documents; develops consent and assent documents; prepares IRB memoranda. Attends investigator meetings, as assigned; interacts with representatives of sponsoring agencies. In-services staff for study purposes. Recruits patients. Develops strategies to assure study subject compliance with protocol requirements. Coordinates protocol activities; prepares clinical specimens for shipment to central laboratories. Performs clinical data gathering and measurements. Maintains study medication accountability records; maintains databases; assists in data analysis and manuscript / abstract preparation. Completes Case Report Forms; responds to sponsor queries, prepares for audits by sponsor, IRB and/or the FDA/DHHS. Assists with stipend requests for patients. Additional miscellaneous duties and responsibilities, as may be assigned from time to time by management. Qualifications: At least 1 year clinical research experience Associate Degree is required (or in lieu of associate degree, two years of clinical research experience is required) Effectively uses Microsoft computer software Demonstrates ability to coordinate and establish priorities among diverse tasks Effectively communicates verbally and in writing

Job Details Wilmington Health - Wilmington, NC Part Time $40000.00 Salary/year Description A PRN Clinical Research Assistant is an entry-level research position. This position is responsible for performing a variety of duties including coordinating aspects of clinical trial protocols including but not limited to study initiation, recruitment, study visits, monitor visits, regulatory compliance, and study close-out. RESPONSIBILITIES Act as a liaison between providers, study representatives, and patients. Maintain case report forms, source documents, and regulatory documents. Maintain stock of supplies needed to carry out protocols. Pack and ship patient labs and review lab results. Provide patient care and collect medical information during visits. Initiate and participate in the informed consent process. Conduct screening of prospective study participants and schedule appointments of patients interested in research studies. Identify potential research participant candidates utilizing various channels including medical records, databases, referrals, and community outreach to identify potential candidates for participation in clinical research studies. Obtain informed consent (if required and appropriately delegated) from eligible participants according to established guidelines and protocols, ensuring comprehension and compliance with ethical standards and regulatory requirements. Conduct thorough remote screenings and assessments to determine initial patient eligibility for participation in clinical trials, coordinating with healthcare professionals as needed to verify medical history and suitability. Maintain detailed and accurate records of patient interactions, recruitment efforts, and consent processes in accordance with regulatory standards and study protocols. Collaborate closely with interdisciplinary team members including investigators, research coordinators, healthcare providers, and administrative staff to facilitate seamless recruitment and enrollment processes. Adhere to all relevant regulatory guidelines, institutional policies, and ethical standards governing the conduct of screening, recruitment, and enrollment in clinical research, prioritizing patient safety, privacy, and confidentiality. Use employee calendars to schedule appointments for patients. Instruct patients regarding study protocols. Arrange for or perform phlebotomy. Perform related work as required. Qualifications QUALIFICATIONS High School Diploma or equivalent. Bachelor's Degree preferred. 2-5 years of experience in a clinical setting is a plus. Phlebotomy experience/certification preferred. Certified Nurse Assistant Certificate and/or graduation from an accredited program for medical assistants is a plus. Knowledge of Good Clinical Practices for clinical research is a plus. Knowledge of OSHA and FDA regulations regarding clinical research a plus. Maintaining confidentiality is a must. Knowledge of medical terminology is a plus. Knowledge of electronic medical records and scheduling systems a plus. Experience in working with providers and other department staff. Ability to apply and modify professional research principles, methods, and techniques to provide ongoing patient care. Skilled in identifying problems and recommending solutions. Understand common safety hazards and precautions for maintaining a safe working environment. Prepare/maintain records, write reports, respond to correspondence, and respond to e-mails. High level of computer competency. Ability to maintain quality control standards. Ability to react calmly and effectively in all situations. Ability to work independently, prioritize, and work in a team environment. BENEFITS (full time) Competitive salary Health Insurance Dental Insurance Disability Insurance Life insurance Paid Time Off Vision Insurance WORKING CONDITIONS This job operates in a professional and clinical environment with occasional visits to other Innovo Research partner sites/clinics. This role routinely uses standard office equipment such as computers, phones, and scanners. There is frequent exposure to communicable diseases, toxic substances, ionizing radiation, medicinal preparations, and other conditions common to a clinic environment. Varied activities include standing, walking, reaching, bending, and lifting. Requires full range of body motion including handling and lifting patients, manual and finger dexterity, and eye-hand coordination. It requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 50 pounds. Requires corrected vision and hearing to normal range. Due to the nature of this position, employees are expected to work in person. This is an exempt position under the federal and state wage and hour laws, which means you are not eligible for overtime pay beyond your salary. Employees are expected to work 40 hours a week. Occasional evening and weekend work may be required as job duties demand. The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this position. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel. More in-depth information can be found in SOP's, working guidelines, policies, etc. Innovo Research is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Innovo are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. Innovo Research will not tolerate discrimination or harassment based on any of these characteristics. In addition, Innovo will provide reasonable accommodations for qualified individuals with disabilities. Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Clinical Research Lead Assistant - Pacific time 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 Demonstrate proficiency in various Microsoft applications (e.g., Word, Excel, PowerPoint, SharePoint, Lists, Forms, etc.) Coordinate and schedule internal and external meetings Provide administrative support for clinical trials/to Investigator Engagement (e.g., data entry, troubleshooting, etc.) Support retention-related activities by liaising with sites to address high-risk participants Administrative support for clinical trials as required - (eg: filing, collection of signatures, invoice reconciliation) Document Management - (eg: scan, fax, upload, eTMF maintenance activities) In-house administrative support for Site CDCs (eg: CDA creation/follow-up) Support Investigator Engagement business systems and process as required Internal and External meeting support As applicable, SIP Support for Investigator Engagement: Support retention-related activities including calls with Medical/National Leaders or for Enrollment Support Data entry of Vault Clinical Enrollment Metrics Collate reports/key information in preparation for site discussions/visits Troubleshoot platform issues related to DCT/referral capabilities (e.g., Florence, StudyTeam, etc.) Submit PO increases & support external customer interactions Tracking Diversity to help us make informed decisions for pivoting where needed & Community Outreach Requests Coordination Coordinate IE Site Visit Requests across Therapeutic Areas You are: Knowledge of Good Documentation Practices Excellent computer skills with experience in a variety of software packages Fluency in English both written and oral. High level of attention to detail Strong self-management, communication and organizational skills Flexibility Excellent problem solving skills Ability to work in a virtual team and across cultures Located in the Pacific time zone area 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