Clinical research associate jobs in Columbia, SC - 23 jobs

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Lead Clinical Research Associate
Oracle 4.6
Clinical research associate job in Columbia, SC
With ongoing and ground-breaking developments in Oncology and Rare Disease, an increased focus on more scientific, targeted medicine and continuous integration of technology into development and delivery of medicine, there has never been a more exciting time to join us! As a global leader we're looking for a Senior **Lead Clinical Research Associate (CRA)** to drive success as part of our Non-interventional Study team. Join Oracle as a Lead CRA and make a real impact by guiding teams, ensuring top-quality clinical research, and driving groundbreaking projects on a global scale! **What you will do** **As a Senior Lead Clinical Research Associate at Oracle, you will:** + **Drive study start-up:** Develop feasibility questionnaires, identify and assess potential study sites, and ensure proper site selection in close collaboration with Project Managers and Sponsors. + **Oversee contracts and budgets:** Review and track site contracts and budgets for study specifications, working closely with CRA and contracting teams, and involve contract specialists for legal matters. + **Ensure regulatory compliance:** Coordinate with regulatory teams and CRAs to ensure all ethical committee (EC) requirements are met and support the preparation and submission of essential site documents. + **Lead study site management:** Supervise site activation and ongoing management, including monitoring activities from feasibility to close-out, in line with GCP, SOPs, study protocols, and plans. + **Train and coordinate CRAs:** Oversee, mentor, and train a cross-country team of Clinical Research Associates, develop project-specific training materials, and ensure delivery of high-quality site management. + **Monitor progress and quality:** Create and maintain study trackers, monitor CRA activities and site deliverables, identify and escalate critical issues, and review/approve monitoring reports. + **Foster team collaboration:** Act as the key point of contact between the study team, Sponsor, study sites, and CRAs, supporting strong working relationships and continuous process improvement. + **Travel for site initiations, closures or quality visits:** Be available to travel to clinical sites to train and monitor site activities as needed. While there is no guaranteed travel, flexibility is required. **Required Experience** + **Education** : Bachelor's degree in Life Sciences, Medical Science, Pharmacy, Public Health, or equivalent, with a minimum of three years' hands-on clinical research experience. + **Clinical research expertise** : At least 3 years of experience as a CRA, including site initiation, Trial Master File (TMF) management, and site monitoring for both clinical and non-interventional studies. + **Communication skills** : Outstanding spoken and written proficiency in English (C1 level minimum).Additional languages are considered a strong asset. + **Technical proficiency** : Comfort with MS Office, EDC, CTMS exprience and willingness to learn and handle various technical systems and tools. + **Personal qualities** : Exceptional organizational and problem-solving skills, strong cross-culturalteamwork, initiative in process optimization, and the ability to manage competing priorities in a fast-paced environment. + **Financial management:** Experience reviewing site contracts, budget and invoices. + **Attention to detail** : Ability to work independently with careful, precise, and thorough execution of complex tasks. **Responsibilities** **What you will do** **As a Senior Lead Clinical Research Associate at Oracle, you will:** + **Drive study start-up:** Develop feasibility questionnaires, identify and assess potential study sites, and ensure proper site selection in close collaboration with Project Managers and Sponsors. + **Oversee contracts and budgets:** Review and track site contracts and budgets for study specifications, working closely with CRA and contracting teams, and involve contract specialists for legal matters. + **Ensure regulatory compliance:** Coordinate with regulatory teams and CRAs to ensure all ethical committee (EC) requirements are met and support the preparation and submission of essential site documents. + **Lead study site management:** Supervise site activation and ongoing management, including monitoring activities from feasibility to close-out, in line with GCP, SOPs, study protocols, and plans. + **Train and coordinate CRAs:** Oversee, mentor, and train a cross-country team of Clinical Research Associates, develop project-specific training materials, and ensure delivery of high-quality site management. + **Monitor progress and quality:** Create and maintain study trackers, monitor CRA activities and site deliverables, identify and escalate critical issues, and review/approve monitoring reports. + **Foster team collaboration:** Act as the key point of contact between the study team, Sponsor, study sites, and CRAs, supporting strong working relationships and continuous process improvement. + **Travel for site initiations, closures or quality visits:** Be available to travel to clinical sites to train and monitor site activities as needed. While there is no guaranteed travel, flexibility is required. Disclaimer: **Certain US customer or client-facing roles may be required to comply with applicable requirements, such as immunization and occupational health mandates.** **Range and benefit information provided in this posting are specific to the stated locations only** US: Hiring Range in USD from: $70,600 to $141,200 per annum. May be eligible for bonus and equity. Oracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle's differing products, industries and lines of business. Candidates are typically placed into the range based on the preceding factors as well as internal peer equity. Oracle US offers a comprehensive benefits package which includes the following: 1. Medical, dental, and vision insurance, including expert medical opinion 2. Short term disability and long term disability 3. Life insurance and AD&D 4. Supplemental life insurance (Employee/Spouse/Child) 5. Health care and dependent care Flexible Spending Accounts 6. Pre-tax commuter and parking benefits 7. 401(k) Savings and Investment Plan with company match 8. Paid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week, the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment. Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation. 9. 11 paid holidays 10. Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours. 11. Paid parental leave 12. Adoption assistance 13. Employee Stock Purchase Plan 14. Financial planning and group legal 15. Voluntary benefits including auto, homeowner and pet insurance The role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted. Career Level - IC3 **About Us** As a world leader in cloud solutions, Oracle uses tomorrow's technology to tackle today's challenges. We've partnered with industry-leaders in almost every sector-and continue to thrive after 40+ years of change by operating with integrity. We know that true innovation starts when everyone is empowered to contribute. That's why we're committed to growing an inclusive workforce that promotes opportunities for all. Oracle careers open the door to global opportunities where work-life balance flourishes. We offer competitive benefits based on parity and consistency and support our people with flexible medical, life insurance, and retirement options. We also encourage employees to give back to their communities through our volunteer programs. We're committed to including people with disabilities at all stages of the employment process. If you require accessibility assistance or accommodation for a disability at any point, let us know by emailing accommodation-request_************* or by calling *************** in the United States. Oracle is an Equal Employment Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability and protected veterans' status, or any other characteristic protected by law. Oracle will consider for employment qualified applicants with arrest and conviction records pursuant to applicable law.
$70.6k-141.2k yearly 12d ago

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Clinical Research Associate (CRA)
TJ Consulting Group
Clinical research associate job in Lancaster, SC
Seeking an entry-level Clinical Research Associate to support clinical trials related to pharmaceutical or nutraceutical products. This role is ideal for candidates looking to grow within clinical research and regulatory environments. Responsibilities Support clinical trials through monitoring, documentation, and compliance activities Assist with FDA-regulated studies and trial phase processes Review clinical data and ensure adherence to protocols and SOPs Collaborate with internal teams and external research partners Qualifications Bachelor's degree in life sciences or related field Exposure to FDA-regulated environments or clinical trials preferred Strong attention to detail and organizational skills We are committed to fostering an inclusive workplace and provides equal employment opportunities (EEO) to all employees and applicants for employment. We do not employ AI tools in our decision-making processes. Regardless of race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran. ensures that all employment decisions are made in accordance with applicable federal, state, and local laws. Our commitment to non-discrimination in employment extends to every location in which our company operates.
$50k-79k yearly est. 14d ago
Clinical Scientist
Eliassen Group 4.7
Clinical research associate job in Columbia, SC
**Anywhere** **Type:** Permanent **Category:** Clinical Ops **Industry:** Life Sciences **Workplace Type:** Remote **Reference ID:** JN -112025-104407 **Shortcut:** ********************************** + Description + Recommended Jobs **Description:** _Remote_ Our client is a PE-backed medical device organization advancing next-generation technologies in atrial fibrillation and cardiac ablation. As the team prepares for two global Class III IDE studies, the Clinical Development and Science function is expanding to support protocol development, safety oversight, and scientific leadership. The role provides exposure to electrophysiology and Pulse Field Ablation, contributing to the scientific, clinical, and strategic elements of cardiac ablation innovation. _This is a full-time, permanent opportunity, offering a competitive salary and comprehensive benefits package. Qualified applicants must be willing and able to work on a w2 basis._ Salary: $130,000 - $150,000/ yr. w2 **Responsibilities:** **Responsibilities** + Lead development of clinical study protocols, case report forms, and associated study documents. + Support clinical safety oversight, including adverse event review, vigilance, and coordination with the Clinical Events Committee. + Contribute scientific input into study design, endpoints, and overall clinical strategy. + Review and interpret clinical data to support study reports, publications, and regulatory submissions. + Collaborate closely with Clinical Operations, Field Clinical, Regulatory, and Quality teams. + Participate in discussions with key opinion leaders, investigator meetings, and internal scientific reviews. + Ensure scientific consistency across programs and alignment with regulatory and clinical goals. + Support the development of data collection tools and ensure clarity, accuracy, and completeness. + Assist with medical writing elements related to clinical reports and study documentation. **Experience Requirements:** **Experience Requirements** + Electrophysiology and Pulse Field Ablation experience required. + Background supporting clinical studies in industry or academia. + Strong understanding of clinical research methods and safety reporting. + Ability to evaluate and interpret clinical data. + Strong scientific writing skills and attention to detail. + Ability to collaborate effectively across Clinical Development, Operations, and Regulatory functions. + Excellent communication and analytical capabilities. + Prior experience as a Clinical Scientist in medical devices preferred. + Experience with Class III devices or IDE studies preferred. + Experience contributing to regulatory submissions or interacting with health authorities preferred. + Experience working with electrophysiologists, key opinion leaders, or clinical event committees preferred. **Education Requirements:** **Education Requirements** + MS, PhD, or MD. **_Recruitment Transparency Notice_** **_Eliassen Group values transparency in our recruitment practices. Please be advised that Eliassen Group utilizes artificial intelligence (AI) tools as part of its initial application screening process. You may receive email and SMS notifications from the Eliassen Virtual Recruiting Team (_** **_noreply@eliassen.com_** **_, ************* inviting you to complete a brief voice screening as part of your application process. These tools assist our hiring teams in different ways, including but not limited to, assistance in reviewing application materials to help identify candidates whose qualifications most closely match the requirements of the position. All AI-assisted evaluations and responses are reviewed by human recruiters before any hiring decisions are made. The use of AI in our process is intended to support fairness, efficiency, and consistency, and Eliassen Group takes measures to prevent bias or discrimination in connection with its hiring practices. By proceeding, you acknowledge, agree, and consent to Eliassen Group's use of these tools, including AI tools, as part of the application and hiring process._** _Skills, experience, and other compensable factors will be considered when determining pay rate. The pay range provided in this posting reflects a W2 hourly rate; other employment options may be available that may result in pay outside of the provided range._ _W2 employees of Eliassen Group who are regularly scheduled to work 30 or more hours per week are eligible for the following benefits: medical (choice of 3 plans), dental, vision, pre-tax accounts, other voluntary benefits including life and disability insurance, 401(k) with match, and sick time if required by law in the worked-in state/locality._ _Please be advised- If anyone reaches out to you about an open position connected with Eliassen Group, please confirm that they have an Eliassen.com email address and never provide personal or financial information to anyone who is not clearly associated with Eliassen Group. If you have any indication of fraudulent activity, please contact_ _********************_ _._ _About Eliassen Group:_ _Eliassen Group is a leading strategic consulting company for human-powered solutions. For over 30 years, Eliassen has helped thousands of companies reach further and achieve more with their technology solutions, financial, risk & compliance, and advisory solutions, and clinical solutions. With offices from coast to coast and throughout Europe, Eliassen provides a local community presence, balanced with international reach. Eliassen Group strives to positively impact the lives of their employees, clients, consultants, and the communities in which they operate._ _Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status._ _Don't miss out on our referral program! If we hire a candidate that you refer us to then you can be eligible for a $1,000 referral check!_
$130k-150k yearly 13d ago
Sr. Clinical Research Associate - Oncology - FSP
Parexel 4.5
Clinical research associate job in Columbia, SC
The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and the Sponsor's 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. **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 the Sponsor's 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 Site Care Partner 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 Site Care Partner 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 the Sponsor's credibility, scientific leadership and in order to facilitate their 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 **Skills:** + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations + Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) + Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases + Must be fluent in English and in the native language(s) of the country they will work in + Ability to travel 60-80% + Valid driver's license and passport required **Education:** + Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent \#LI-LO1 \#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.
$91k-118k yearly est. 49d ago
Specialist, Clinical Business Operations, Oncology
Sumitomo Pharma 4.6
Clinical research associate job in Columbia, SC
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. **Job Duties and Responsibilities** + Collaborate effectively with key internal and external stakeholders at the departmental and cross-department levels leading the creation and execution of Confidential Disclosure Agreements (CDA). + Assist with the entry of Contractual Agreements into an electronic document repository. + Ensure all outsourcing decisions are properly documented, compliant, and audit-ready. + Manage and/or facilitate issue escalations at the operational level and ensure timely escalation to senior leadership when appropriate. + Work cross-functionally with clinical teams, Finance and Legal, towards solutions; process, and communication improvements. + Perform other duties as requested. **Key Core Competencies** + Strong strategic and analytical reasoning and problem-solving ability. Able to deliver at high quality, in a fast-paced, dynamic environment and able to manage competing priorities + Ability to proactively identify and act on opportunities for operational efficiencies + Ability to work within a team as well as independently on specifically assigned tasks. The individual will be organized, detail-oriented, and will possess a financial aptitude + Proficient with MS Office Suite (Excel, Word and PowerPoint), Smartsheet and Contract Repository Solution + Excellent written and oral communication skills **Education and Experience** + BA/BS preferred with at least 2 years experience, or 5 years equivalent experience + Clinical Operations, Project Management, Clinical Outsourcing, and/or CRO relevant industry provider Outline the relevant work experience required, including any specific industries or roles. 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_
$72.5k-90.6k yearly 60d+ ago
Clinical Research Coordinator - Columbia, MD
Iqvia Holdings Inc. 4.7
Clinical research associate job in Columbia, SC
Work Setup: On-site Schedule: Part-time (16 hours per week) Shape the Future of Medicine with IQVIA! Are you passionate about advancing healthcare and improving patient outcomes? Join IQVIA as a Clinical Research Coordinator (CRC) and play a vital role in supporting clinical research studies that drive meaningful innovation. This hands-on role blends clinical procedures, patient recruitment, and study compliance to ensure the highest standards of safety and care. About IQVIA IQVIA is a global leader in advanced analytics, technology solutions, and clinical research services. We partner with leading pharmaceutical, biotechnology, and medical device organizations to accelerate innovation and improve patient lives. Our teams combine scientific expertise with advanced technology to transform clinical trials and healthcare delivery. What You'll Do * Perform complex clinical procedures including ECG, spirometry, sample collection, phlebotomy, and vital signs * Coordinate clinical research studies while ensuring adherence to study protocols and Good Clinical Practice (GCP) * Prepare study materials, manage logistics, and support overall site operations * Recruit, pre-screen, and orient volunteers, including chart reviews, physician referrals, and community outreach * Communicate study details effectively to potential participants and assess patient eligibility based on inclusion/exclusion criteria * Collect, verify, and accurately document clinical data in case report forms (CRFs) and electronic CRFs (eCRFs), including corrections and query resolution * Assist with Investigator Site File maintenance and collaborate with investigators and monitors to resolve study-related issues * Maintain a safe environment for volunteers in alignment with Health & Safety policies What We're Looking For * High School Diploma or equivalent education/experience * Minimum 1 year of relevant clinical research experience (preferred) * Working knowledge of clinical trials, GCP principles, and medical terminology * Strong attention to detail and ability to build effective working relationships * Recruitment-focused with strong patient-facing experience as a Clinical Research Coordinator (CRC) * Demonstrated knowledge of the full study lifecycle from start-up to close-out * Hands-on experience performing CRC tasks in a clinic setting * Skilled in patient recruitment, prescreening, and using study protocols to identify inclusion/exclusion criteria * Proficient with Electronic Data Capture (EDC) systems and query resolution * Experience supporting lead CRCs with patient visits, data entry, query resolution, and prescreening referrals * Experience in both research and clinical settings * Regulatory experience is a plus Please Note: This position is not eligible for sponsorship. #LI-CES #LI-DNP #LI-HCP #ONSITE IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at ********************** IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe The potential base pay range for this role is $35.00-$42.00 per hour. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
$35-42 hourly 14d ago
Research Coordinator II, Orthopedics Research, Full Time, Days
Prisma Health-Midlands 4.6
Clinical research associate job in Columbia, SC
Inspire health. Serve with compassion. Be the difference. Responsible for the implementation, management and oversight of clinical trial research studies including the education of research staff, healthcare team member, participants and their caregivers. Registers, compiles, submits and oversees clinical data, monitors study compliance and maintains a system for effective data flow for patients on clinical trials. Manages patient visits and implements protocol related procedures. Responsible for monitoring and communicating study participant progress and safety issues with the investigators, applicable regulatory agencies, health care team and study staff.Accountabilities All team members are expected to be knowledgeable and compliant with Prisma Health's purpose: Inspire health. Serve with compassion. Be the difference. Assists in determining patient eligibility for enrollment in research studies. Identifies individual patient needs to facilitate participation including identifying and pre-screening potential participants. Registers patients into research studies to meet protocol parameters. Assists MD investigator in the informed consent process. Provides coordination over assigned research staff. Ensures assigned study staff practice within the parameters of their qualifications and collaborates with team members for optimal functioning of the unit/department. Trains and oversees personnel managing studies and regulatory matters. Collaborates with other health team members to formulate an interdisciplinary plan of care and plans a schedule of patient activities related to the study requirements. Instructs participating health care team members in clinical trials procedures, and orients health care professionals to the clinical studies program Interacts with other members of health team to monitor protocol compliance and to ensure that the assigned patient care needs are met. Identifies specific learning needs and abilities of patients/families to provide appropriate education at the level of the recipient. Provides patients/families with information regarding clinical trial participation and provides education regarding individual treatment including purpose, potential side effects, and self-care measures, documents interaction. Maintains patient privacy per institutional and study related policies. Gathers and abstracts study data and documents in a factual, concise manner which meets regulatory/unit standards. Achieves, timely, thorough and accurate completion and evaluation of case report forms. Reviews records/forms for compliance with protocol requirements. Prepares for and manages pre-site, study initiation, interim monitoring, and close-out visits. Assists investigator in the completion of data queries. Gathers records, reports, lab results, radiographs, scans, and other materials required for institutional, sponsor and FDA audits. Collaborates with Prisma Health Research services, including the CRMO (Clinical Research Management office, IRB (Institutional Review Board) and OSP (Office of Sponsored Programs) and sponsoring agencies as well as local agencies, when applicable, to ensure global awareness regarding the progression of various studies, amendments and regulatory monitoring. Attends Investigator Meetings as appropriate. Prepares and presents lectures and/or written materials for health care provider education and participates in presentations or seminars related to the research study when necessary. Manages study related inventory including, data collection tools, study supplies and study medication, if applicable. Schedules visits with the sponsoring agencies. Assists department manager/supervisor to coordinate resources to appropriately conduct the trial including the development of data collection tools, communication with ancillary departments to implement study related procedures. Collaborates with study team to develop new strategies for the growth of the Research program. Communicates study related issues with research management. Assists investigator in the development of investigator-initiated research studies including the development of protocols, literature searches, and data collection tools as well as assistance in the submission of investigator-initiated studies to the IRB and sponsoring agencies, if applicable. Maintains professional growth and development through seminars, workshops, in-service meetings, current literature and professional affiliations to keep abreast of latest trends in field of expertise. Performs other duties as assigned. Supervisory/Management Responsibilities This is a non-management job that will report to a supervisor, manager, director or executive. Minimum Requirements Education - Associates degree in Allied Health OR Bachelor's Degree in health sciences or business-related field of study. Experience - Two (2) years of research experience in at least one of the following areas: pharmaceutical, academic, device, NIH, investigator-initiated studies or registry trials. In Lieu Of In lieu of education and experience noted above an equivalent combination of work experience and academic experience may be considered. . Required Certifications, Registrations, Licenses BLS is required within six (6) months of employment. Collaborative Institutional Training Initiative (CITI) preferred. If Allied Health Degree: Sate certification/license in field. Research Coordinator IIs may be required to have a valid driver's license, an acceptable motor vehicle record as defined by the Acceptable Motor Vehicle Record (MVR) Chart, and proof of auto insurance. Knowledge, Skills and Abilities Proficient computer skills (word processing, spreadsheets, database, data entry) Knowledge GCP, FDA Rules and Regulations and policies in relation to clinical trials. Familiar with Electronic Medical Record (EMR) and Electronic Data Capture (EDC) systems Work Shift Day (United States of America) Location 2 Medical Park Rd Richland Facility 3954 Midlands Administrative Research Staff Department 39541000 Midlands Administrative Research Staff-Practice Operations Share your talent with us! Our vision is simple: to transform healthcare for the benefits of the communities we serve. The transformation of healthcare requires talented individuals in every role here at Prisma Health.
$35k-53k yearly est. Auto-Apply 60d+ ago
Clinical Research Coordinator
MUSC (Med. Univ of South Carolina
Clinical research associate job in Columbia, SC
The Clinical Research Coordinator (CRC) is responsible for coordinating and executing clinical research studies in compliance with regulatory requirements and institutional guidelines. Additionally, the position will be responsible for maintaining study database, completing study documents, recruiting study patients, and preparing/conducting monitor and auditor visits. The CRC ensures the integrity of study data, subject safety, and protocol adherence while working closely with investigators, sponsors, and clinical teams. Some travel is required. Entity Medical University Hospital Authority (MUHA) Worker Type Employee Worker Sub-Type Regular Cost Center CC005146 COL - Research Service Center - Columbia Pay Rate Type Salary Pay Grade Health-28 Scheduled Weekly Hours 40 Work Shift Job Title: Clinical Research Coordinator Location: MUSC Columbia Medical Center Downtown Entity: MUHA Worker Type: Employee Worker Sub-Type: Pay Rate Type: Non-Exempt Scheduled Weekly Hours: 40 Summary The Clinical Research Coordinator (CRC) is responsible for coordinating and executing clinical research studies in compliance with regulatory requirements and institutional guidelines. Additionally, the position will be responsible for maintaining study database, completing study documents, recruiting study patients, and preparing/conducting monitor and auditor visits. The CRC ensures the integrity of study data, subject safety, and protocol adherence while working closely with investigators, sponsors, and clinical teams. Some travel is required. Job Duties Responsibility Description 1. Study Coordination & Execution Coordinate day-to-day operations of assigned clinical trials, including subject recruitment, scheduling, and visit management. 2. Regulatory Compliance & Documentation Prepare and maintain IRB submissions, regulatory binders, informed consent documents, and other essential documents. Ensure compliance with FDA, GCP, ICH, and institutional policies. 3. Data Collection & Management Collect, enter, and review study data in case report forms (CRFs) or electronic data capture (EDC) systems. Perform data queries and ensure accuracy and completeness. 4. Participant Interaction & Informed Consent Conduct informed consent discussions and maintain ongoing communication with participants throughout the study to ensure adherence and safety. 5. Sponsor & Monitor Communication Liaise with sponsors, CROs, and monitors during site initiation, monitoring visits, and close-outs. Ensure timely query resolution and protocol adherence. 6. Training & Education Stay current with regulatory requirements and clinical research practices. Participate in ongoing training and continuing education. May assist in training new staff. 7. Budget & Financial Tracking Support budget development and track participant stipends and study-related billing. Communicate with finance teams as needed. 8. Other Duties as Required Other duties as assigned Qualifications - * Bachelor's degree in a health-related field or equivalent combination of education and experience; Bachelor RN preferred but not required. * Working knowledge of GCP, FDA regulations, and clinical trial operations * Familiarity with medical terminology, HIPAA, or Good Clinical Practice (GCP) * Excellent communication, organization, and interpersonal skills * Ability to collect, organize and analyze information in a clear and concise manner * Proficiency with EDC systems, Microsoft Office Suite, and medical terminology Additional Knowledge and Skills Preferred * Minimum 1-2 years of experience in clinical research coordination preferred * Prior exposure to clinical research in an academic, hospital, or lab setting (through coursework, volunteering, or work-study) * Laboratory or phlebotomy experience is preferred but not required * Certification as a Clinical Research Coordinator (e.g., ACRP or SOCRA) is a plus Working Conditions * Standard office and clinical setting * May require occasional travel to satellite locations or sponsor meetings * Must be able to work flexible hours to accommodate patient schedules or protocol requirements Additional Job Description Qualifications - * Bachelor's degree in a health-related field or equivalent combination of education and experience; Bachelor RN preferred but not required. * Working knowledge of GCP, FDA regulations, and clinical trial operations * Familiarity with medical terminology, HIPAA, or Good Clinical Practice (GCP) * Excellent communication, organization, and interpersonal skills * Ability to collect, organize and analyze information in a clear and concise manner * Proficiency with EDC systems, Microsoft Office Suite, and medical terminology Additional Knowledge and Skills Preferred * Minimum 1-2 years of experience in clinical research coordination preferred * Prior exposure to clinical research in an academic, hospital, or lab setting (through coursework, volunteering, or work-study) * Laboratory or phlebotomy experience is preferred but not required * Certification as a Clinical Research Coordinator (e.g., ACRP or SOCRA) is a plus 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: ***************************************
$34k-49k yearly est. 60d+ ago
Clinical Research Coordinator
Medical University of South Carolina 4.6
Clinical research associate job in Columbia, SC
The Clinical Research Coordinator (CRC) is responsible for coordinating and executing clinical research studies in compliance with regulatory requirements and institutional guidelines. Additionally, the position will be responsible for maintaining study database, completing study documents, recruiting study patients, and preparing/conducting monitor and auditor visits. The CRC ensures the integrity of study data, subject safety, and protocol adherence while working closely with investigators, sponsors, and clinical teams. Some travel is required. Entity Medical University Hospital Authority (MUHA) Worker Type Employee Worker Sub-Type Regular Cost Center CC005146 COL - Research Service Center - Columbia Pay Rate Type Salary Pay Grade Health-28 Scheduled Weekly Hours 40 Work Shift Job Title: Clinical Research Coordinator Location: MUSC Columbia Medical Center Downtown Entity: MUHA Worker Type: Employee Worker Sub-Type: Pay Rate Type: Non-Exempt Scheduled Weekly Hours: 40 Summary The Clinical Research Coordinator (CRC) is responsible for coordinating and executing clinical research studies in compliance with regulatory requirements and institutional guidelines. Additionally, the position will be responsible for maintaining study database, completing study documents, recruiting study patients, and preparing/conducting monitor and auditor visits. The CRC ensures the integrity of study data, subject safety, and protocol adherence while working closely with investigators, sponsors, and clinical teams. Some travel is required. Job Duties Responsibility Description 1. Study Coordination & Execution Coordinate day-to-day operations of assigned clinical trials, including subject recruitment, scheduling, and visit management. 2. Regulatory Compliance & Documentation Prepare and maintain IRB submissions, regulatory binders, informed consent documents, and other essential documents. Ensure compliance with FDA, GCP, ICH, and institutional policies. 3. Data Collection & Management Collect, enter, and review study data in case report forms (CRFs) or electronic data capture (EDC) systems. Perform data queries and ensure accuracy and completeness. 4. Participant Interaction & Informed Consent Conduct informed consent discussions and maintain ongoing communication with participants throughout the study to ensure adherence and safety. 5. Sponsor & Monitor Communication Liaise with sponsors, CROs, and monitors during site initiation, monitoring visits, and close-outs. Ensure timely query resolution and protocol adherence. 6. Training & Education Stay current with regulatory requirements and clinical research practices. Participate in ongoing training and continuing education. May assist in training new staff. 7. Budget & Financial Tracking Support budget development and track participant stipends and study-related billing. Communicate with finance teams as needed. 8. Other Duties as Required Other duties as assigned Qualifications - Bachelor's degree in a health-related field or equivalent combination of education and experience; Bachelor RN preferred but not required. Working knowledge of GCP, FDA regulations, and clinical trial operations Familiarity with medical terminology, HIPAA, or Good Clinical Practice (GCP) Excellent communication, organization, and interpersonal skills Ability to collect, organize and analyze information in a clear and concise manner Proficiency with EDC systems, Microsoft Office Suite, and medical terminology Additional Knowledge and Skills Preferred Minimum 1-2 years of experience in clinical research coordination preferred Prior exposure to clinical research in an academic, hospital, or lab setting (through coursework, volunteering, or work-study) Laboratory or phlebotomy experience is preferred but not required Certification as a Clinical Research Coordinator (e.g., ACRP or SOCRA) is a plus Working Conditions Standard office and clinical setting May require occasional travel to satellite locations or sponsor meetings Must be able to work flexible hours to accommodate patient schedules or protocol requirements Additional Job Description Qualifications - Bachelor's degree in a health-related field or equivalent combination of education and experience; Bachelor RN preferred but not required. Working knowledge of GCP, FDA regulations, and clinical trial operations Familiarity with medical terminology, HIPAA, or Good Clinical Practice (GCP) Excellent communication, organization, and interpersonal skills Ability to collect, organize and analyze information in a clear and concise manner Proficiency with EDC systems, Microsoft Office Suite, and medical terminology Additional Knowledge and Skills Preferred Minimum 1-2 years of experience in clinical research coordination preferred Prior exposure to clinical research in an academic, hospital, or lab setting (through coursework, volunteering, or work-study) Laboratory or phlebotomy experience is preferred but not required Certification as a Clinical Research Coordinator (e.g., ACRP or SOCRA) is a plus 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: ***************************************
$27k-34k yearly est. Auto-Apply 60d+ ago
Research Coordinator
University of South Carolina 4.4
Clinical research associate job in Columbia, SC
Qualifications Key Responsibilities: Conduct literature reviews and synthesize findings to inform research projects. Manage, clean, and analyze quantitative data. Prepare manuscripts, reports, and other scholarly outputs. Provide biostatistics and statistical consulting services for the INBRE program and other research entities. Assist with the coordination, development, and facilitation of INBRE summer workshops. Support consultations for INBRE and affiliated research programs. Assist with planning for summer training programs as needed. Perform additional related tasks as needed to advance research objectives. Qualifications: Master's degree in a health data-related field (e.g., Public Health, Statistics, Biostatistics, Data Science, or Quantitative Economics) by the time of appointment. Strong foundation in quantitative methodology and data analysis. Demonstrated ability to work independently and take initiative. Excellent oral and written communication skills. High professional standards and strong work ethic. Proficiency in statistical and programming software such as SAS , STATA , R, Python, or similar tools. Work Schedule Must be willing to work a flexible schedule to meet the needs of the department.
$28k-41k yearly est. 60d+ ago
Clinical Donation Coordinator I
We Are Sharing Hope Sc 4.1
Clinical research associate job in West Columbia, SC
The Clinical Donation Coordinator (CDC I) responds to referrals of potential organ donors and is responsible for evaluating and setting the plan for medical management for optimal organ function to obtain and assure effective organ donation. Essential Duties & Responsibilities Responsible for traveling to the donor hospital within one hour of receiving information regarding the potential donor from the Administrator on Call (AOC). Conducts thorough physical and medical assessments with information obtained from the hospital staff as well as the patient's medical record. Collaboratively works with the AOC and/or Medical Director to determine when the potential donor is not deemed suitable for organ donation. Initiates standing orders and begins donor evaluation, management, organ placement, and recovery processes. Enters all donor information into the Electronic Medical Record (EMR). Keeps the AOC informed of any medical status changes, including abnormal lab values, hemodynamics, and diagnostic test results. Conducts routine hospital development activities and professional education, when not involved in donor activity. Accepts on-call responsibilities as assigned. Prepares for on-call responsibilities with current recovery information and functioning recovery equipment, electronic medical record (EMR) access, hospital and ID badges. Provides a prompt and professional response to all hospital referral calls in a manner consistent with policy and procedures. Provides on-site clinical evaluation of all potential donors. Under the direction of the AOC, helps to determine medical suitability for organ donation. Acts as the professional resource on donation for the hospital staff. Confirms brain death diagnosis aligns with hospital policy and all regulations. Provides prompt and professional site evaluation of all potential donors. Obtains all relevant information required to make a comprehensive assessment of medical suitability for donation potential. Determines the legal next-of-kin for a potential donor. Completes all paper and electronic records per policy. Ensures that all other donation related documentation, including, but not limited to documentation required to comply with hospital protocol are properly completed. Identifies cases that fall under the jurisdiction of the Coroner. Contacts the Coroner and obtain approval for organ and tissue donation as required. Notes and documents any restrictions or special requests of the Coroner. Ensures that all requests from the Coroner are completed. Directs the clinical management of the donor. This includes ordering organ specific tests, evaluating those tests, and correcting any abnormalities that exist. This clinical management is performed under the guidance of the Medical Director. Documents all management activity completely and clearly in the donor record. Allocates donated organs and tissues per SHSC and the Organ Procurement and Transplantation Network (OPTN) policies. Documents all allocation activity completely and clearly in the donor record. Contacts the operating room (OR) to notify of upcoming organ and tissue recovery procedure. Ensures availability of an OR for recovery of organs and tissues. Confirms time of recovery with OR personnel. Coordinates the surgical recovery of donated organs and tissues to include communication with all appropriate recovery teams and the confirmation of the availability of hospital operating rooms for recovery. Oversees the recovery procedure, including OR donor management and personnel workflow, to ensure optimal organ viability and respect for the donor and their gifts. Assists with the surgical recovery of organs as required. Assists with the preparation and administration of preservation solutions and packaging of organs. Documents the physical characteristics of organs and all OR related processes. Maintains detailed, complete, and accurate records of all donor referrals, donation discussions, donor management, organ allocation, and donor recovery as required through iTransplant. Maintains current knowledge of all organ and tissue recovery policies and procedures. Adheres to the professional standards and practices for quality assurance as established within the organization. Actively participates in post-donor review with peers, Manager(s) and Director(s). Assists Hospital Development staff in hospital development activities. Facilitates comprehensive huddles to help safeguard the donation process. Actively contributes to the organization's hospital development goals to increase donation. Makes presentations to healthcare professionals and the general public regarding donation, as assigned. Represents SHSC at exhibit booths at public displays as needed. Serves as a resource to healthcare professionals and the public regarding organ and tissue donation. Provides donor chart to all recovery partners and the medical examiners/coroners as required. Informs the Coroner's office when the donation is complete and the donor is ready for transport as required. Routinely reviews email, voice mail, and all routine communication and correspondence. Maintains all patient and organizational information factually, confidentially, and appropriately. Ensures thorough and accurate completion of the donor charts in a timely manner, including completion of all forms according to policies and the organizations professional standards and practice. Ensures all QA is completed timely. Ensures all training assignments are completed on time. Maintains in good working order all assigned equipment. Maintains complete and accurate records of expenses, attendance, and daily calendar of business. Submits timesheets documenting hours worked accurately according to policy. Communicates effectively with his/her supervisor regarding daily schedule and activities. Other duties as assigned. Qualifications • AS degree acquired through extensive and prolonged training in the biological sciences, paramedicine, allied health; • Two (2) years of experience in critical care and/or emergency care; or, • An equivalent combination of education and experience. • The Certified Procurement Transplant Coordinator (CPTC) certification is required after two years as a CDC I.
$47k-62k yearly est. 17d ago
Clinical Coordinator
Davita Inc. 4.6
Clinical research associate job in Orangeburg, SC
Posting Date 01/16/2026 124 Fire Tower Rd, Orangeburg, South Carolina, 29118-1401, United States of America DaVita is seeking a Clinical Coordinator (RN) to lead patient care in a home hemodialysis outpatient setting. You'll manage care for patients with end-stage renal disease, guide a clinical team, and support patients as they transition to home-based treatment. Key Responsibilities: * Coordinate care for home hemodialysis patients (labs, vitals, outcomes) * Supervise and mentor clinical staff and PCTs * Provide hands-on dialysis care and patient education * Ensure safety, comfort, and regulatory compliance * Train in multiple locations and float as needed * Flexible scheduling, including mornings, evenings, weekends, and holidays Requirements: * Current RN license and CPR certification * 18+ months of RN experience, including 6+ months of dialysis * Charge RN readiness approval * ADN required; BSN preferred * ICU, ER, or Med/Surg experience preferred * CNN/CDN certification a plus * Basic computer skills (MS Word, Outlook) What We Offer: * Medical, dental, vision, 401(k) match * PTO and PTO cash-out * Paid training * Family and mental health support (Headspace, EAP, child/elder care) * Career development opportunities Join a mission-driven team and help patients live better lives-at home. Apply now. #LI-CC2 At DaVita, we strive to be a community first and a company second. We want all teammates to experience DaVita as "a place where I belong." Our goal is to embed belonging into everything we do in our Village, so that it becomes part of who we are. We are proud to be an equal opportunity workplace and comply with state and federal affirmative action requirements. Individuals are recruited, hired, assigned and promoted without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, protected veteran status, or any other protected characteristic. This position will be open for a minimum of three days. For location-specific minimum wage details, see the following link: DaVita.jobs/WageRates Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies and experience. DaVita offers a competitive total rewards package, which includes a 401k match, healthcare coverage and a broad range of other benefits. Learn more at *********************************** Colorado Residents: Please do not respond to any questions in this initial application that may seek age-identifying information such as age, date of birth, or dates of school attendance or graduation. You may also redact this information from any materials you submit during the application process. You will not be penalized for redacting or removing this information.
$51k-62k yearly est. Auto-Apply 12d ago
Clinical Coordinator - 8a-4:30p flex
Babcock Center 3.7
Clinical research associate job in West Columbia, SC
General Purpose: The Clinical Services Coordinator oversees all medical and nursing needs within his or her assigned Residential Facilities as well as throughout the associated residential and vocational programs. The Clinical Support Coordinator provides direct guidance and instruction to management and staff to ensure all assessments, audits, and required clinical needs are completed and met appropriately. Job Duties: Work with management and staff to ensure DDSN guidelines as well as Federal, State, and/or facility regulations pertaining to the medical/nursing aspects of the waiver program, Community Training Homes (CTHs), Supervised Living Programs (SLPs), Intermediate Care Facilities (ICFs), and Vocational Programs are compliant and implemented and followed appropriately. Assist residential supervisors as needed in providing direct care staff with the knowledge necessary to perform assigned duties. Monitor and confirm appropriateness of level of care. Recommend and assist in implementation of modifications as appropriate. Oversee the implementation of health care services as directed by the Babcock Center Healthcare Policies and Procedures. Promote quality health care for all supported persons. Provide direct consultation and instruction to House Managers, Coordinators and Administrators of CTH/SLP Day Programs. Review provider orders for prompt and accurate implementation. Participate as a team member for consultation, direction and medical specialist services. Monitor CTH/SLP, supported person with acute and chronic illnesses for appropriateness of health care service delivery. Identify issues and provide recommendations for necessary modifications. Review of Documentation Administration Record (DAR) and physician orders to identify and reconcile discrepancies with notification to Director of Clinical Services/designee. Perform medication area checks for medication administration and appropriate storage, security and labeling of medications. Ensure monthly and appropriate disposal of discontinued medications with Administrator or designee. Monitor and ensure management of medication count to coincide with preparation of DAR for pharmacy. Monitor acute inpatient health care services to hospitalized CTH/SLP supported persons with daily visits and/or telephone contact. Provide nursing evaluations 24-48 hours post hospitalization. Attend Dr.'s appointments as appropriate to resident's medical condition. Maintain resident profile, tracking sheets and audit medical books. Assist in the formulation and modification of Health Care Services Standards of Care with continual review. Provide in-service training and new employee orientation for staff in health care areas. Participate in pre-admission evaluation of supported persons in terms of health care services needs and the capacity of the facility to supply the needed services. Participate in program formulation for supported persons in the following areas: hygiene, sex education, family living and health related areas. Participate in Psychotropic Drug Review Process as appropriate to include consent forms, diagnostic studies, and quarterly review with the psychiatrist. Work with Behavior Specialist and management to notify psychiatrist of occurrences warranting psychiatric intervention or treatment. Work in conjunction with a Registered Dietician to provide optimum dietary services. Ensure that admissions, transfers and discharges of supported persons are conducted and performed in such a manner to provide continuity of care as well as adherence to all State and Federal regulations. Assist with and conduct the Medication Technician Program functions as assigned by the supervisor. Represent the nursing services in professional and community activities, i.e., coordination of services with outside health agencies. Promote effective working conditions and relationships with the administration, other disciplines, volunteers and agencies affiliated with the residential division of Babcock Center. Assist and advise provider pharmacists in providing quality pharmaceutical services. Provide medical monitoring for assigned work activity centers and Senior Programs. Assist with coordination of ordering and procurement of medical supplies and medications. Maintain personal and medical records in a secure, concise, and reviewable manner. Rotates administrative call for clinical services as assigned. Function as a staff nurse when necessary, i.e., administration of medications and treatments, scheduling of appointments, follow-up visits, audits, in-service staff, first aid, and other necessary job duties as needed. Perform all other duties as assigned. Maintain approved driving privileges with Babcock Center. Qualifications Qualifications: Licensed Practical Nurse with current licensure with the South Carolina State Board of Nursing required. 1-2 years of experience with adults with disabilities preferred. Proficiency with the Microsoft Office Suite including Outlook, Word, Excel, and PPT. Experience with Therap preferred. Working Hours: The Clinical Services Coordinator will typically work 40 hours per week, Monday - Friday, 8:00am - 4:30pm but must be available for on-call hours including 24-hour emergency call and as-needed weekends and evenings. Typical Physical Demands: Sitting, standing, bending, kneeling, stooping, pulling, pushing, and reaching. Frequent lifting. Must be able to lift at least 50 pounds. Manual dexterity sufficient to operate standard office machines. Normal range of hearing and vision. Typical Mental Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk and hear. This position is very active and requires standing, walking, bending, kneeling, stooping, crouching, crawling, and climbing all day. The employee must frequently lift and/or move items over 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must be able to multi-task and deal with stress associated with fast-paced work environment. Formulate decisions and act upon them. Adapt to changing work situations. Grasp and apply new ideas. Communicate with various personalities at all levels. Maintain confidentiality of all sensitive information. Working Conditions: Works in administrative setting, residential homes, activity centers, company facilities, and medical facilities. Travel to other Babcock Center facilities throughout the weekend duty. Due to the independent nature this position requires a high level of responsibility and accountability. Subject to working relationships with all employees of Babcock Center and other program staff. Supervision: The direct supervisor for the Clinical Support Coordinator is the Nurse Manager. Hazards/Potential Hazards: Aerosolized medication, aggression/violence, biological/infectious hazards, electrical, ergonomic hazards (i.e. patient handling, lifting), pushing/pulling, hazardous drugs, latex allergy, needle punctures, trip hazards and wet floor.
$38k-50k yearly est. 17d ago
Associate Directer, Clinical Research
TJ Consulting Group
Clinical research associate job in Lancaster, SC
Seeking an experienced Associate Director of Clinical Research to lead and oversee clinical trials for products regulated by the FDA. This role requires deep experience in managing clinical trial phases within pharmaceutical or supplement companies. Responsibilities Oversee and manage clinical research programs from planning through completion Ensure compliance with FDA regulations and GCP guidelines Lead cross-functional teams and external research partners Review and analyze clinical data and reporting Contribute to regulatory strategy and submissions Qualifications Extensive experience in clinical research within FDA-regulated environments Prior experience managing clinical trials for pharmaceutical or supplement products Strong leadership, analytical, and regulatory knowledge We are committed to fostering an inclusive workplace and provides equal employment opportunities (EEO) to all employees and applicants for employment. We do not employ AI tools in our decision-making processes. Regardless of race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran. ensures that all employment decisions are made in accordance with applicable federal, state, and local laws. Our commitment to non-discrimination in employment extends to every location in which our company operates.
$50k-79k yearly est. 14d ago
Senior Clinical Research Associate/Clinical Research Associate II - Oncology - US - FSP
Parexel 4.5
Clinical research associate job in Columbia, SC
**Job Purpose:** The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and sponsor standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company's image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial. **Key Accountabilities:** **Oversight of Monitoring Responsibilities and Study Conduct** + Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and sponsor standards to achieve project goals, timelines and quality + Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met + During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery + Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites + Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks + Attend investigator meeting when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and + recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level + Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with emerging issues and technologies + Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution + Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File (TMF) documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics + Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues + Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines + Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities + Support database release as needed + May undertake the responsibilities of an unblinded monitor where appropriate **Clinical/Scientific and Site Monitoring Risk** + Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team + Interact with investigator site heath care professionals in a manner which enhances sponsor's credibility, scientific leadership and in order to facilitate sponsor's clinical development goals + Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators + Drive Quality Event (QE) remediation, when applicable + Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable **Collaboration** + Reports to Director of Clinical Site Operations (DCSO) or Director of Site Management and Monitoring (DSMM) + Partners with SCP and Country Study Operations Manager (SOM) + When required Partners with other Study Team members (e.g. Clinician, Recruitment Specialist, Clinical Data Scientist) + May act as a Mentor for Clinical Research Associates **Skills:** + Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) in a CRO or pharma organization + Preferred therapeutic experience in Oncology + Global clinical trial experience preferred + Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations + Must be fluent in English and in the native language(s) of the country they will work in + Travel (60-80%) within area is required + Valid driver's license and passport required **Knowledge and Experience:** + Demonstrated knowledge of clinical research and development processes and ability to gain command of process details + Demonstrated knowledge of global and local regulatory requirements + Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.) + Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s) + Demonstrated ability to support sponsor regulatory interactions/inspections + Demonstrated knowledge of the processes around protocol design and feasibility assessment + Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery + Proven ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trial + Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation + Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization **Education:** + Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical is required \#LI-CF1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
$91k-118k yearly est. 53d ago
Research Coordinator
MUSC (Med. Univ of South Carolina
Clinical research associate job in Lancaster, SC
The "In Our DNA SC" community health research project is designed to improve health care outcomes by integrating genetic insights into clinical care and research. The Research Coordinator will provide technical and professional services within this statewide project. The position will assist the Principal Investigator (PI) involved in the coordination of human subject activities as delegated by the PI. Responsibilities may include the recruitment of study participants, coordinating collection events, and completing collection events. Entity Medical University Hospital Authority (MUHA) Worker Type Employee Worker Sub-Type Regular Cost Center CC004382 LAN - Research Service Center - Lancaster Pay Rate Type Hourly, Salary Pay Grade Health-23 Scheduled Weekly Hours 40 Work Shift Day (United States of America) Under the general supervision of the Clinical Trials Manager, the Research Coordinator coordinates and oversees complex data management and regulatory activities for clinical research studies, including industry-sponsored, investigator-initiated, and funded or unfunded trials. This role supports protocol management, patient screening and enrollment, follow-up, and overall data integrity. The Research Coordinator manages multiple studies involving human subjects, including trials with drugs and medical devices. The position requires close collaboration with Principal Investigators (PIs), patients, sponsors, and institutional partners to ensure compliance with institutional policies, Internal Review Board (IRB) requirements, and study protocols. The Coordinator is responsible for accurate data collection, regulatory documentation, participant tracking, and reporting of adverse events and protocol deviations. Required Experience, Skills, and Knowledge * Strong attention to detail with a high level of accuracy * Ability to exercise sound judgment and discretion * Excellent written and verbal communication skills * Strong interpersonal and organizational skills * Professional demeanor and ability to work effectively with diverse stakeholders * Proven proficiency with computer-based data management systems, including Microsoft Office Additional Job Description Minimum Education & Experience * Bachelor's degree required * Minimum of one year of relevant research or program-related experience 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: ***************************************
$34k-50k yearly est. 5d ago
Noninvasive CVT Clinical Coordinator
Medical University of South Carolina 4.6
Clinical research associate job in Columbia, SC
The Noninvasive Cardiovascular Technology Clinical Coordinator is responsible for providing professional quality work as a teaching faculty member. Work includes conducting, teaching and foreseeing pre-practicum and clinical courses within the prescribed curriculum for students enrolled in MUSC's Health Noninvasive CVT Program at the Claude W. Smith MD School of Cardiovascular Technology; preparing and delivering simulation education & lectures to students; compiling, administering and grading pre-practicum/ clinical competencies, evaluation, projects and examinations; and providing academic assistance to students as needed. Entity Medical University Hospital Authority (MUHA) Worker Type Employee Worker Sub-Type Regular Cost Center CC003733 COL - School of CV Diagnostics (DMC) Pay Rate Type Salary Pay Grade Health-34 Scheduled Weekly Hours 40 Work Shift Description: The Noninvasive Cardiovascular Technology Clinical Coordinator is responsible for providing professional quality work as a teaching faculty member. Work includes conducting, teaching and foreseeing pre-practicum and clinical courses within the prescribed curriculum for students enrolled in MUSC's Health Noninvasive CVT Program at the Claude W. Smith MD School of Cardiovascular Technology; preparing and delivering simulation education & lectures to students; compiling, administering and grading pre-practicum/ clinical competencies, evaluation, projects and examinations; and providing academic assistance to students as needed. Job summary: Assists with schedules and instruction in the classroom and clinical environment as assigned; coordinates with the Claude W. Smith MD School of CVT Program Director and faculty on didactic and laboratory courses; assists with instruction and ensures that all students receive adequate programmatic and technical instruction, exposure, and experience. Works with faculty and clinical sites to evaluate student clinical and didactic performance as assigned in the cognitive, affective, and psychomotor domains of learning; communicates regularly with Echo and Vascular Lab Leadership (managers, directors, and clinical preceptors) regarding student performance and curriculum issues. Teaches in the pre-practicum, clinical, simulation education, and/or didactic setting, as determined by the School's Program Director. Assists with the set-up and take down of the pre-practicum/simulation supplies and/or equipment; Maintains inventory of appropriate pre-practicum/simulation supplies and equipment at clinical and/or laboratory training sites. Assists the CVT faculty with maintaining simulation education & Clinical records including outcome measures such as student learning in simulation experiences as well as performance measures in the educational delivery of Clinical education, experiences and exposure as led by the instructional faculty and clinical affiliates. Coordinates activities in the pre-clinical, clinical, laboratory, and simulation education settings as determined by the needs of the School's Program Director. Supervises and coordinates schedules of Adult Echo and Vascular CVT students and clinical associates within the program; provides guidance and direction to assigned clinical instructors and clinical associates for proper evaluative and instructional techniques. Evaluates clinical experiences at affiliated clinical sites, in terms of quality, quantity, and appropriateness of student learning experiences using various techniques, including student evaluations. Performs as a liaison with clinical sites which are used for extramural clinical or laboratory educational experiences. Visits clinical sites on a regularly scheduled basis to ensure uniform and consistent practice within accreditation guidelines. Develops and maintains records that demonstrate outcome measures such as clinical experiences, student records, and employer data. Provide students with access to hospital/clinical affiliate orientation documents and any other relevant documents required by the hospital/clinical affiliates. Monitors student's compliance in completing, submitting, and/or uploading any required health reports, drug screens, criminal background checks, and hospital/clinical affiliate's requirements, as determined by the School's Program Director. Participates actively in assigned program curriculum planning and development within accreditation guidelines. Participates in admission selection efforts. Participates in departmental, committee and other program meetings; attends local, state, and regional meetings to support the development of assigned programs. Performs other duties as assigned. These essential job functions are not to be construed as a complete statement of all duties performed; employees will be required to perform other job-related duties as required. Minimum Experience and Training Requirements: Graduated from an accredited Echocardiography and Vascular Ultrasound Technology Program; and/or equivalent education and/or experience being no less than three years within the field of CVT as an Echocardiography and Vascular Ultrasound Technologist. Previous teaching experience preferred. Required License Certification and Registration: Current Registered Diagnostic Cardiac Sonographer (RDCS) or Registered Cardiac Sonographer (RCS) and Registered Vascular Technologist (RVT) or Registered Vascular Sonographer (RVS). Current Basic Life Support (BLS) required, either a certification from an American Heart Association (AHA) BLS for Healthcare Providers Physical Requirements: Physical: Routinely requires the ability to see, hear, and speak. Routinely requires sitting, bending, stooping, walking. On occasion, incumbents may be required to lift 20 or more pounds. Environmental: Normal classroom and clinical settings. Mental: Routinely requires the ability to interpret, analyze, perform critical thinking skills, and communicate effectively and professionally. Additional Job Description Minimum Experience and Training Requirements: Graduated from an accredited Echocardiography and Vascular Ultrasound Technology Program; and/or equivalent education and/or experience being no less than three years within the field of CVT as an Echocardiography and Vascular Ultrasound Technologist. Previous teaching experience preferred. Required License Certification and Registration: Current Registered Diagnostic Cardiac Sonographer (RDCS) or Registered Cardiac Sonographer (RCS) and Registered Vascular Technologist (RVT) or Registered Vascular Sonographer (RVS). Current Basic Life Support (BLS) required, either a certification from an American Heart Association (AHA) BLS for Healthcare Providers 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: ***************************************
$29k-38k yearly est. Auto-Apply 13d ago
Clinical Associate Professor
University of South Carolina 4.4
Clinical research associate job in Columbia, SC
To navigate through this form, please use the "Prev" and "Save & Continue" buttons at the top of the page. Do not use your browser's "Back" button as it will not save your progress and data will be lost. Logo Posting Number RTF00288PO25 USC Market Title Clinical Associate Professor Link to USC Market Title Business Title Clinical Associate Professor Campus School of Medicine Columbia Work County Richland College/Division School of Medicine Columbia Department SOMC Brain Health Location of Vacancy Part/Full Time Full Time Hours per Week 37.5 Type of Faculty Position Faculty Time-Limited (FTL) Basis 12 months Job Search Category Faculty About USC About University of South Carolina From the Upstate to the Lowcountry, the University of South Carolina system is transforming the lives of South Carolinians through the impact of our eight institutions and 20 locations throughout the state. More than 50,000 students are enrolled at one of eight institutions, including the research campus in Columbia and comprehensive four-year universities in Aiken, Upstate and Beaufort. In addition, our Palmetto College campuses in Salkehatchie, Union, Lancaster and Sumter enable students to earn associate or bachelor's degrees through a combination of in-person, online or blended learning. All of our system institutions place strong emphasis on service - helping to build healthier, more educated communities in South Carolina and beyond. Benefits for Research Grant or Time-Limited Positions Are Indicated Below The University of South Carolina (UofSC), through the State of SC and Public Employee Benefit Authority (PEBA), offers employees a valuable benefits package, including health and life insurance, generous paid leave and retirement programs. To learn more about UofSC benefits, access the "Working at USC" section on the Applicant Portal at *********************** Research Grant or Time-limited positions may be eligible for all, some, or no benefits, based on the grant or project funding. South Carolina Retirement Yes State Insurance Programs Yes Annual Leave Yes Sick Leave Yes Position Description Advertised Job Summary The University of South Carolina School of Medicine - Columbia invites applications for a faculty position at the rank of Clinical Associate Professor (Professional Track), specializing in exercise programs and clinical and community translational research with an emphasis in Brain Health. We seek a Ph.D. or equivalent-level clinical/scientific candidate whose focus is on exercise for clinical populations, including individuals with cognitive impairments, dementia, and other neurologic diagnoses. Job Related Minimum Required Education and Experience * PhD in Exercise Science or related discipline. Required Certification, Licensure/Other Credentials Preferred Qualifications * Licensure as a registered Physical Therapist by the South Carolina Board of Physical Therapy. Knowledge/Skills/Abilities * Knowledge of exercise science principles and practices. * Ability to plan and direct work. * Ability to communicate with cognitively impaired patients and their families. * Demonstrated knowledge of brain health and neuroscience. * Ability to work independently and in collaborative, multidisciplinary teams. Job Duties Job Duty The faculty member will oversee assessments of patients with cognitive impairments to evaluate functional mobility, strength, balance, endurance, and safety awareness. The hire will oversee the day-to-day operations of the Brain Health fitness program and plan and execute the program's expansion across South Carolina, including developing strategic partnerships. Essential Function Yes Percentage of Time 25 Job Duty The hire will evaluate documentation and progress notes while overseeing fitness program procedures and patient interactions to ensure that services adhere to the highest standards of patient experience and clinical best practices. The hire will oversee the hiring and supervision of certified personal trainers and other program support staff in consultation with Brain Health Network leadership. Essential Function Yes Percentage of Time 25 Job Duty The hire will evaluate documentation and progress notes while overseeing fitness program procedures and patient interactions to ensure that services adhere to the highest standards of patient experience and clinical best practices. The hire will oversee the hiring and supervision of certified personal trainers and other program support staff in consultation with Brain Health Network leadership. Essential Function Yes Percentage of Time 25 Job Duty The hire will contribute to institutional service through committee work, community outreach, and engagement in academic and professional societies. Essential Function Yes Percentage of Time 15 Job Duty The hire will perform other duties as assigned by the Brain Health Network as necessary for the day-to-day operations and strategic needs of the program. Essential Function Yes Percentage of Time 10 Position Attributes Hazardous weather category Non-Essential Employees in Safety-Sensitive or Security-Sensitive positions will be subject to pre-employment and post-employment drug testing in accordance with University policy HR 1.95 Drug and Alcohol Testing. No Posting Detail Information Desired Start Date 07/01/2026 Position End Date 06/30/2027 Job Open Date 01/07/2026 Job Close Date Open Until Filled Yes Special Instructions to Applicant Positions are advertised for a minimum of forty- five (45) days on our job website. After forty-five (45) days, positions can be closed at the discretion of the department at any time. This position is open until filled. This employment site is updated on a regular basis. The length of the recruitment and screening process may vary from position to position, depending upon a variety of factors. Should review of your qualifications result in a decision to pursue your candidacy, you will be contacted by phone or email. Quicklink for Posting ************************************** EEO Statement The University of South Carolina does not discriminate in educational or employment opportunities or decisions for qualified persons on the basis of age, ancestry, citizenship status, color, disability, ethnicity, familial status, gender (including transgender), gender identity or expression, genetic information, HIV/AIDs status, military status, national origin, pregnancy (false pregnancy, termination of pregnancy, childbirth, recovery therefrom or related medical conditions, breastfeeding), race, religion (including religious dress and grooming practices), sex, sexual orientation, veteran status, or any other bases under federal, state, local law, or regulations. Supplemental Questions Required fields are indicated with an asterisk (*). Applicant Documents Required Documents * Cover Letter * Curriculum Vitae * Resume * List of References and Contact Information Optional Documents
$33k-43k yearly est. 20d ago
Clinical Research Associate/Senior Clinical Research Associate- FSP
Parexel 4.5
Clinical research associate job in Columbia, SC
**Parexel FSP is looking for a CRA/Sr CRA in the US.** **Oncology Experience required. Cell therapy experience is strongly preferred.** **Job Purpose:** The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study. The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies. **Key Accountabilities** : **Site Management Responsibilities** + Contributes to the selection of potential investigators. + In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study. + Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles. + Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times. + Actively participates in Local Study Team (LST) meetings. + Contributes to National Investigators meetings, as applicable. + Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST. + Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate. + Updates CTMS and other systems with data from study sites as per required timelines. + Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable. + Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines, and discusses with LSAD the correct timing and type of visits. + Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan. + Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. + Ensures data query resolution in a timely manner. + Works with data management to ensure robust quality of the collected study data. + Ensures accurate and timely reporting of Serious Adverse Events and their follow ups. + Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP. + Follows up on outstanding actions with study sites to ensure resolution in a timely manner. + Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. + Assists site in maintaining inspection ready ISF. + Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate. + Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF. + Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. + Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line manager. **Compliance with Sponsor Standards** + Ensures compliance with the Client's Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment). + Ensures compliance with local, national, and regional legislation, as applicable. + Completes timesheets accurately as required. **Compliance with Parexel Standards** + Complies with required training curriculum. + Completes timesheets accurately as required. + Submits expense reports as required. + Updates CV as required. + Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements. **Skills (Essential):** + Excellent attention to detail. + Good written and verbal communication skills. + Good collaboration and interpersonal skills. + Good negotiation skills. + Proficient in written and spoken English language required. + Fluency in local language(s) required. **Skills (Desirable):** + Ability to work in an environment of remote collaborators. + Manages change with a positive approach for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business. + Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time. + Good analytical and problem-solving skills. + Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines. + Ability to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environment. + Team oriented and flexible; ability to respond quickly to shifting demands and opportunities. **Knowledge and Experience (Essential)** **:** + Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. + Good knowledge of relevant local regulations. + Good medical knowledge and ability to learn relevant Client Therapeutic Areas. + Basic understanding of the drug development process. + Good understanding of Clinical Study Management including monitoring, study drug handling and data management. **Knowledge and Experience (Desired):** + Familiar with risk-based monitoring approach including remote monitoring. + Good cultural awareness. **Education:** + Bachelor's degree in related discipline, preferably in life science, or equivalent qualification (adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers. **Other:** + Ability to travel nationally/internationally as Required + Valid driving license per country requirements, as applicable. **EEO Disclaimer** **Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.** \#LI-KW1 \#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.
$91k-118k yearly est. 4d ago
Noninvasive CVT Clinical Coordinator
MUSC (Med. Univ of South Carolina
Clinical research associate job in Columbia, SC
The Noninvasive Cardiovascular Technology Clinical Coordinator is responsible for providing professional quality work as a teaching faculty member. Work includes conducting, teaching and foreseeing pre-practicum and clinical courses within the prescribed curriculum for students enrolled in MUSC's Health Noninvasive CVT Program at the Claude W. Smith MD School of Cardiovascular Technology; preparing and delivering simulation education & lectures to students; compiling, administering and grading pre-practicum/ clinical competencies, evaluation, projects and examinations; and providing academic assistance to students as needed. Entity Medical University Hospital Authority (MUHA) Worker Type Employee Worker Sub-Type Regular Cost Center CC003733 COL - School of CV Diagnostics (DMC) Pay Rate Type Salary Pay Grade Health-34 Scheduled Weekly Hours 40 Work Shift Description: The Noninvasive Cardiovascular Technology Clinical Coordinator is responsible for providing professional quality work as a teaching faculty member. Work includes conducting, teaching and foreseeing pre-practicum and clinical courses within the prescribed curriculum for students enrolled in MUSC's Health Noninvasive CVT Program at the Claude W. Smith MD School of Cardiovascular Technology; preparing and delivering simulation education & lectures to students; compiling, administering and grading pre-practicum/ clinical competencies, evaluation, projects and examinations; and providing academic assistance to students as needed. Job summary: Assists with schedules and instruction in the classroom and clinical environment as assigned; coordinates with the Claude W. Smith MD School of CVT Program Director and faculty on didactic and laboratory courses; assists with instruction and ensures that all students receive adequate programmatic and technical instruction, exposure, and experience. Works with faculty and clinical sites to evaluate student clinical and didactic performance as assigned in the cognitive, affective, and psychomotor domains of learning; communicates regularly with Echo and Vascular Lab Leadership (managers, directors, and clinical preceptors) regarding student performance and curriculum issues. Teaches in the pre-practicum, clinical, simulation education, and/or didactic setting, as determined by the School's Program Director. Assists with the set-up and take down of the pre-practicum/simulation supplies and/or equipment; Maintains inventory of appropriate pre-practicum/simulation supplies and equipment at clinical and/or laboratory training sites. Assists the CVT faculty with maintaining simulation education & Clinical records including outcome measures such as student learning in simulation experiences as well as performance measures in the educational delivery of Clinical education, experiences and exposure as led by the instructional faculty and clinical affiliates. Coordinates activities in the pre-clinical, clinical, laboratory, and simulation education settings as determined by the needs of the School's Program Director. Supervises and coordinates schedules of Adult Echo and Vascular CVT students and clinical associates within the program; provides guidance and direction to assigned clinical instructors and clinical associates for proper evaluative and instructional techniques. Evaluates clinical experiences at affiliated clinical sites, in terms of quality, quantity, and appropriateness of student learning experiences using various techniques, including student evaluations. Performs as a liaison with clinical sites which are used for extramural clinical or laboratory educational experiences. Visits clinical sites on a regularly scheduled basis to ensure uniform and consistent practice within accreditation guidelines. Develops and maintains records that demonstrate outcome measures such as clinical experiences, student records, and employer data. Provide students with access to hospital/clinical affiliate orientation documents and any other relevant documents required by the hospital/clinical affiliates. Monitors student's compliance in completing, submitting, and/or uploading any required health reports, drug screens, criminal background checks, and hospital/clinical affiliate's requirements, as determined by the School's Program Director. Participates actively in assigned program curriculum planning and development within accreditation guidelines. Participates in admission selection efforts. Participates in departmental, committee and other program meetings; attends local, state, and regional meetings to support the development of assigned programs. Performs other duties as assigned. These essential job functions are not to be construed as a complete statement of all duties performed; employees will be required to perform other job-related duties as required. Minimum Experience and Training Requirements: Graduated from an accredited Echocardiography and Vascular Ultrasound Technology Program; and/or equivalent education and/or experience being no less than three years within the field of CVT as an Echocardiography and Vascular Ultrasound Technologist. Previous teaching experience preferred. Required License Certification and Registration: Current Registered Diagnostic Cardiac Sonographer (RDCS) or Registered Cardiac Sonographer (RCS) and Registered Vascular Technologist (RVT) or Registered Vascular Sonographer (RVS). Current Basic Life Support (BLS) required, either a certification from an American Heart Association (AHA) BLS for Healthcare Providers Physical Requirements: Physical: Routinely requires the ability to see, hear, and speak. Routinely requires sitting, bending, stooping, walking. On occasion, incumbents may be required to lift 20 or more pounds. Environmental: Normal classroom and clinical settings. Mental: Routinely requires the ability to interpret, analyze, perform critical thinking skills, and communicate effectively and professionally. Additional Job Description Minimum Experience and Training Requirements: Graduated from an accredited Echocardiography and Vascular Ultrasound Technology Program; and/or equivalent education and/or experience being no less than three years within the field of CVT as an Echocardiography and Vascular Ultrasound Technologist. Previous teaching experience preferred. Required License Certification and Registration: Current Registered Diagnostic Cardiac Sonographer (RDCS) or Registered Cardiac Sonographer (RCS) and Registered Vascular Technologist (RVT) or Registered Vascular Sonographer (RVS). Current Basic Life Support (BLS) required, either a certification from an American Heart Association (AHA) BLS for Healthcare Providers 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: ***************************************
$40k-56k yearly est. 19d ago

Learn more about clinical research associate jobs

How much does a clinical research associate earn in Columbia, SC?

The average clinical research associate in Columbia, SC earns between $40,000 and $97,000 annually. This compares to the national average clinical research associate range of $43,000 to $91,000.

Average clinical research associate salary in Columbia, SC

$63,000

$40,00010%

$63,000Median

$97,00090%

What are the biggest employers of Clinical Research Associates in Columbia, SC?

The biggest employers of Clinical Research Associates in Columbia, SC are:

Oracle

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Clinical Research Associate Columbia, SC Jobs

Clinical research associate jobs in Columbia, SC - 23 jobs

Lead Clinical Research Associate

Clinical Research Associate (CRA)

Clinical Scientist

Sr. Clinical Research Associate - Oncology - FSP

Specialist, Clinical Business Operations, Oncology

Clinical Research Coordinator - Columbia, MD

Research Coordinator II, Orthopedics Research, Full Time, Days

Clinical Research Coordinator

Clinical Research Coordinator

Research Coordinator

Clinical Donation Coordinator I

Clinical Coordinator

Clinical Coordinator - 8a-4:30p flex

Associate Directer, Clinical Research

Senior Clinical Research Associate/Clinical Research Associate II - Oncology - US - FSP

Research Coordinator

Noninvasive CVT Clinical Coordinator

Clinical Associate Professor

Clinical Research Associate/Senior Clinical Research Associate- FSP

Noninvasive CVT Clinical Coordinator

Learn more about clinical research associate jobs

How much does a clinical research associate earn in Columbia, SC?

What are the biggest employers of Clinical Research Associates in Columbia, SC?