Clinical research associate jobs in Columbia, SC

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.

Key Responsibilities: Lead and manage operational aspects of global clinical trials from study start-up through close-out Oversee study timelines, deliverables, and budgets to ensure milestones are met Coordinate with cross-functional teams, external vendors, and CROs to ensure high-quality study conduct Oversee site activation, clinical monitoring, data integrity, and adherence to protocol Conduct study-level risk assessments and ensure inspection readiness Manage safety and pharmacovigilance activities in collaboration with internal and external teams Lead internal and external study meetings; provide training to relevant stakeholders Contribute to the development of study-related documents and clinical study reports Perform other duties as needed to support successful trial execution Qualifications: Bachelor's degree in life sciences or a related (advanced degree preferred) Minimum of 8 years of clinical trial management experience, particularly in respiratory trials or pediatric studies Demonstrated success in leading global trials and working with cross-functional and vendor teams Deep understanding of GCP, ICH guidelines, and global regulatory requirements Specific therapeutic experience in respiratory diseases, especially COPD, strongly preferred Strong project management, problem-solving, and communication skills Proficiency in using clinical trial systems (e.g., eTMF, EDC), Microsoft Office, and Excel

**Seeking a Clinical Research Coordinator in Greenville, NC** Job Title: Research Coordinator Position Type : Full-Time Reports To: Clinical Trials Supervisor Pay: $60,000-75,000 (Depending on experience) Position Summary The research coordinator is primarily responsible for coordinating research patient visits according to both the International Council for Harmonisation Good Clinical Practice (ICH-GCP) guidelines and the Institutional Review Board (IRB)-approved study protocol and/or manual of procedures. Day-to-day activities may include all or some of the essential functions listed below, depending upon individual experience / knowledge and the needs of the organization which are subject to change from time to time. Duties: • Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study • Administer sponsor required questionnaires (i.e. Visual Function Questionnaire [VFQ]) • Works with team member responsible for ordering study supplies (lab kits, shippers, etc.) to ensure adequate inventory is on hand • Ensures study staff is properly trained on study-related information (i.e. protocol, Informed Consent Form [ICF], manuals, etc.) and that the training is documented • Creates, manages, and maintains source documents for each trial • Attends teleconferences and Investigator Meetings as requested by research director • Reviews and comprehends all study protocols, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections • Works with other members of the study team and clinical team to recruit eligible candidates to meet enrollment goals

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.

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

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

**Job Purpose:** The Senior Clinical Research Associate I (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.

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. The Trial Master File (TMF) Specialist will be responsible for ensuring that SMPA studies have comprehensive and quality Trial Master Files (TMFs) ready for audits and inspections. Partnering with the Associate Director, Clinical Business Operations, the specialist ensures accountable functions follow the requirements of the TMF SOP and system work instructions. Provide support and guidance to study team members during the full lifecycle of the study, including planning, set-up, maintenance, QC and closure of the study TMF. **Key Responsibilities** + Responsible for overall quality, maintenance, and completeness of Trial Master Files. + Working closely with the TMF Process Owner, identify trends or quality concerns and oversee resolution of issues. + Develop project specific TMF plan and structure and update the plan as needed. + Participate in system UAT as needed and collaborate with Information Technology to ensure system validation is maintained. + Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory requirements. + Act as a liaison between the Site IRBs and study team to resolve queries and concerns. + Provide study team reports or updates regarding status of TMF on a regular basis. + Participate in audits and provide documents as requested. + Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings. + Oversee TMF maintenance done by CROs and ensure final transfer of TMF is sufficient to support any potential regulatory filings. + Champion best practices for building and maintaining TMF health. **Professional Experience / Qualifications** + BA/BS with minimum of 3 year of clinical research experience in academic and/or industry settings + Knowledge of and direct experience with Trial Master Files. + Prior eTMF (e.g. Veeva) administration required. + Strong Microsoft Office skills required. + Demonstrate a comprehensive knowledge of Good Clinical Practice, Good Documentation Practice, and International Council for Harmonization E6(R2). + Fundamental knowledge of the conduct of clinical trials is preferred. + Strong focus on teamwork, attention to detail, excellent organizational skills. Must have ability to prioritize, and the ability to work in a multi-task environment. The base salary range for this role is $72,500 to $90,600. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. **Confidential Data** : All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential. **Compliance** : Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. **Mental/Physical Requirements** : Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time. **Sumitomo Pharma America (SMPA)** **is an Equal Employment Opportunity (EEO) employer** Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website ********************************** or follow us on LinkedIn. Sumitomo Pharma America (SMPA) endeavors to make its application process accessible to all. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact SMPA at ********************************************** This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. At Sumitomo Pharma America, our work is guided by the Sumitomo Pharma mission, vision and values, which tie closely to our company's cultural pillars. **Our** **Mission** _To broadly contribute to society through value creation based on innovative research and development activities for the betterment of healthcare and fuller lives of people_ _worldwide_ **Our** **Vision** _For Longer and Healthier Lives, we unlock the future with cutting edge technology and_ _ideas_

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: ***************************************

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs. The Central Study Coordinator position is responsible for the coordination and support of remote site activities for assigned projects. Essential Functions: Serve as point of contact for day-to-day Site communications, document submissions and activity coordination. Support pre-screening, screening and recruitment activities, as assigned. Responsible for subject re-consenting, acquiring medical records, conducting protocol activities, as directed by the Principal Investigator. Perform data-entry, evaluate and respond to system queries and monitor clinical databases as assigned. Establish and maintain timely Site communication as assigned. Maintain documentation which complies with IRB/FDA policies. Assist with study closeout. Assist site with other study-related activities as directed. Other duties as assigned. Necessary Skills and Abilities: Ability to manage technology and web-based research platforms on PC (Microsoft OS) laptop in the remote workspace. Study Tearn experience is ideal. Critical thinking skills. Strong communication Skills (verbal and written). Ability to work independently, and collaboratively with other CSCs to delegate tasks as needed. Working location that has the ability to maintain privacy. Current knowledge of and the ability to apply ICH / GCP and applicable regulations and guidelines. Competent in the application of standard business procedures including but not limited to SOPs, global regulations. Well organized and able to multitask. Able to work independently and as a team member. Able to take initiative while following directives. Educational Requirements: Bachelor's degree or equivalent experience defined as a minimum of 2 years related, combined experience in education, knowledge and skills that will allow one to perform the tasks of the role proficiently. #LI Remote We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

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 DescriptionBenefits: 401(k) Health insurance Paid time off The purpose of Southeastern College is to offer quality career education in an atmosphere of personalized attention. At Southeastern College we focus on the specialized skills and knowledge needed for todays marketplace by providing courses that apply to skill performance and career management development. At Southeastern College we select industry experienced individuals as members of our faculty. This allows our students to be educated by professionals who have practical knowledge in their particular field; as well as the appropriate level of formal education. This philosophy assists our faculty in recreating a similar atmosphere to that which you will encounter in your new career. DESCRIPTION The Clinical Coordinator position plans, coordinates, facilitates, administers, and monitors, activities on behalf of the academic program and in coordination with academic and clinical faculty. These activities ensure the quality of our students learning experience during clinical education. Clinical Coordinators accomplish this through: Assists with the development and assessment of the clinical education component of the curriculum with the Program Director Coordination and implementation of the clinical education component of the curriculum including site placements, site visits, and evaluation Responsible for facilitating students clinical education Responsible for ensuring clinical education program compliance Radiologic Technology Clinical Coordinator must have a Bachelor's Degree, a Radiology Technologist license and 4 years of professional experience. In addition, some previous teaching experience is preferred. This is a full time position that requires day, evening and weekend availability. For consideration, only online applications will be accepted. For further information, you may contact your local campus. Campus contact information listed on our website at *********** Thank you for your interest in our school system. Our schools prohibit discrimination and harassment based on race, color, creed, religion, sex, gender, national origin, citizenship, ethnicity, marital status, age, disability, sexual orientation, gender identity and gender expression, genetic information, veteran status, or any other status protected by applicable law to the extent prohibited by law.

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: ********************************

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

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.