Clinical research coordinator jobs in Florence, SC - 250 jobs

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

Participant Management: Screens potential participants, explains study details, obtains informed consent, schedules visits, and acts as a primary contact for subjects. Administrative Oversight: Organizes study files, prepares and submits regulatory documents (like IRB submissions), manages study budgets, and maintains trial-specific logs. Protocol Adherence: Ensures the trial follows the specific scientific protocol, protecting data integrity and participant safety. Data & Documentation: Collects, organizes, and manages research data, including case reports and drug accountability records, often working with data management teams. Staff & Resource Coordination: Trains research staff, arranges study equipment, and communicates with laboratories and investigators. Ethical Compliance: Upholds ethical standards, ensuring patient rights and well-being are prioritized throughout the study.

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 managespre-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.

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

Nutramax desires to provide a drug-free, healthful, and safe workplace. We hold a zero-tolerance policy for drug use. Employment is contingent upon successfully passing a preemployment background check and drug screen (subject to applicable law). This position is 100% on site in our Lancaster, SC Headquarters (roughly 45 min - 1 hour south of Charlotte, NC). Summary of the Position: The Clinical Research Associate is responsible for assisting in clinical trials from initiation to completion through participating in the development of study protocols, case report forms and clinical reports, as well as performing site monitoring visits and interfacing with site staff, Clinical Research Organizations (CRO), and other company representatives. This position is also responsible for supporting clinical trials as required. Roles and Responsibilities: * Facilitate the development of study protocols, reports, SOPs, NDAs and research agreements by coordinating input from various sources including literature, experts, and internal team members. * Coordinates and conducts study protocol training at study sites and appropriate documentation. * Select and manage investigational sites and clinical trial vendors such as CROs and external laboratories. * Facilitate the development of study documentation including case report forms, informed consent forms, source documentation and study-specific plans for sound and thorough data to support the approval process or study objective. * Serve as a resource to site coordinators, investigators, and other staff members regarding investigational products and protocols. * Assure procedures are in adherence with the assigned study protocol and in accordance with good clinical research principals. * Monitors clinical studies and provides reports throughout study execution. * Perform quality checks on data, analytical results, study procedures and materials. * Obtain and coordinate results of information from blood samples and laboratory analysis as described in study protocol. * Prepare data for statistical analysis. * Assist in preparation of final study reports, scientific abstracts and manuscripts for publication. * Represent company at veterinary conferences and trade shows. * Communicate effectively with other departments within the organization and function within a team environment. * Review journals, abstracts and scientific literature to keep abreast of new developments. * Perform other Clinical Operations duties, as requested Requirements Minimum Requirements: Basic knowledge of scientific principles and practices. Excellent writing, interpersonal, communication, and organization skills required. Must be detail oriented and work collaboratively with internal and external teams. Must be proficient in computer usage, such as word processing, spreadsheets, and/or databases. Knowledge of MS Access desired. Experience with Good Laboratory Practices (GLPs), Good Clinical Practices (GCPs) regulations, and Standard Operating Procedures (SOPs), a PLUS. Some travel required for monitoring clinical studies, attending conferences and trade shows (20% travel required). Education and Experience: Master's degree or bachelor's degree with equivalent experience required, preferably in animal science, biology, veterinary, or related life sciences. Certifications such as CVT, LVT, RVT, or CVPM. Supervisory Responsibilities: None

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.

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

CRC Level 2 - Winston Salem, NC (Onsite) ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We have an incredible opportunity for a Clinical Research Coordinator 2 to join ICON's Accellacare team. The CRC ensures the safety of our volunteers, promotes the mission of Accellacare, and strives to meet and exceed study priorities. This individual is responsible for recruiting and promoting our service to suitable participants and sponsor representatives. Additionally, the CRC will perform tasks required to coordinate and complete a study according to the protocol. This role is with Accellacare, part of ICON's clinical research network, where you'll play a key role in transforming the clinical trial experience for patients and sponsors alike. Our global site network is designed with one goal in mind: to deliver better access, greater efficiency, and improved outcomes in clinical research. Location: Onsite (1901 S. Hawthorne Road, Suite 306, Winston-Salem, NC) What you will be doing: * Performing technical and clinical requirements of study protocols, i.e., venipuncture, specimen processing, vital signs, electrocardiograms, IV infusions, IV pump operations, Holtor monitoring, pulmonary function testing, allergy testing, urine/serum pregnancy testing, strep throat screening, injections (IM or SQ) or any procedure necessary for the protocol as ordered by the investigator. * Attending investigator meetings, site initiation visits, and coordinator meetings to obtain training on drug preparation and administration and general knowledge about a protocol with a focus on clinical procedures. * Obtaining knowledge about the study drugs with an emphasis on injection or intravenous infusion medications. * Monitoring for possible complications with the administration of study drugs with an emphasis on injections or intravenous infusions. * Maintaining accurate dispensing logs, separate from those of the coordinator, to include such information as lot number, drug vs. placebo, and information about the third party mixer or un-blinded mixer/preparer of medication. * Documenting laboratory data and adverse reactions, and immediately notifying investigators, sponsors and the Institutional Review Board, if indicated, of any unexpected or serious events. * Assisting other staff members as determined by the needs and priorities of the research organization and as time and abilities permit. * Actively recruiting and effectively selling our service to suitable patient participants for clinical trials with set time allotted each week for recruitment efforts. * Proactively promoting the site with monitors and in-house contacts for future trials. * Responding to queries in a timely manner, prompt data entry and working with the monitor during on-site visits are examples of pro-active behaviors. * Preparing study documentation in the event of a sponsor or FDA audit and assisting the auditor for the duration of the audit. * Ordering clinical supplies, as well as ordering, storing and monitoring of protocol specific rescue drugs and maintaining scheduled assessment of the code/crash cart and AED including maintaining proper documentation for both. * Monitoring and maintaining refrigerators, freezer units and investigational product storage temperatures for safety and stability. * Obtaining and maintaining knowledge in regards to temperature monitoring devices and procedures for lab specimens and investigational products and providing detailed information to all staff and sponsors in regards to how temperatures are monitored and maintained. * Maintaining certification for packaging and shipping specimens on dry ice, as well as maintaining and updating knowledge of lab procedures to assist with work flow. * Acting as the OSHA Representative for the site which would include but not be limited to; maintaining employee immunization records, obtaining vaccines when necessary for site or PMG and administering vaccines to staff. * Performing equipment calibration when needed, if not performed by the lab coordinator or outside service and maintaining equipment calibration records. * Supporting training and additional development of clinical skills for site staff as needed Your Profile: * 1+ years of work experience in a clinical research or pharmaceutical environment, with prior CRC experience * Experience with Neurology or Psychiatric clinical trials * Strong attention to detail * Motivated about a career in clinical research * Excellent time management and planning skills with an organized approach to work * Bachelor's degree in life sciences or other related field #LI-Office #LI-TP1 #LI-Accellacare What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: * Various annual leave entitlements * A range of health insurance offerings to suit you and your family's needs. * Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. * Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. * Life assurance * Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

CRC Level 2 - Winston Salem, NC (Onsite) ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We have an incredible opportunity for a Clinical Research Coordinator 2 to join ICON's Accellacare team. The CRC ensures the safety of our volunteers, promotes the mission of Accellacare, and strives to meet and exceed study priorities. This individual is responsible for recruiting and promoting our service to suitable participants and sponsor representatives. Additionally, the CRC will perform tasks required to coordinate and complete a study according to the protocol. This role is with Accellacare (********************************** , part of ICON's clinical research network, where you'll play a key role in transforming the clinical trial experience for patients and sponsors alike. Our global site network is designed with one goal in mind: to deliver better access, greater efficiency, and improved outcomes in clinical research. **Location:** Onsite (1901 S. Hawthorne Road, Suite 306, Winston-Salem, NC) **What you will be doing:** + Performing technical and clinical requirements of study protocols, i.e., venipuncture, specimen processing, vital signs, electrocardiograms, IV infusions, IV pump operations, Holtor monitoring, pulmonary function testing, allergy testing, urine/serum pregnancy testing, strep throat screening, injections (IM or SQ) or any procedure necessary for the protocol as ordered by the investigator. + Attending investigator meetings, site initiation visits, and coordinator meetings to obtain training on drug preparation and administration and general knowledge about a protocol with a focus on clinical procedures. + Obtaining knowledge about the study drugs with an emphasis on injection or intravenous infusion medications. + Monitoring for possible complications with the administration of study drugs with an emphasis on injections or intravenous infusions. + Maintaining accurate dispensing logs, separate from those of the coordinator, to include such information as lot number, drug vs. placebo, and information about the third party mixer or un-blinded mixer/preparer of medication. + Documenting laboratory data and adverse reactions, and immediately notifying investigators, sponsors and the Institutional Review Board, if indicated, of any unexpected or serious events. + Assisting other staff members as determined by the needs and priorities of the research organization and as time and abilities permit. + Actively recruiting and effectively selling our service to suitable patient participants for clinical trials with set time allotted each week for recruitment efforts. + Proactively promoting the site with monitors and in-house contacts for future trials. + Responding to queries in a timely manner, prompt data entry and working with the monitor during on-site visits are examples of pro-active behaviors. + Preparing study documentation in the event of a sponsor or FDA audit and assisting the auditor for the duration of the audit. + Ordering clinical supplies, as well as ordering, storing and monitoring of protocol specific rescue drugs and maintaining scheduled assessment of the code/crash cart and AED including maintaining proper documentation for both. + Monitoring and maintaining refrigerators, freezer units and investigational product storage temperatures for safety and stability. + Obtaining and maintaining knowledge in regards to temperature monitoring devices and procedures for lab specimens and investigational products and providing detailed information to all staff and sponsors in regards to how temperatures are monitored and maintained. + Maintaining certification for packaging and shipping specimens on dry ice, as well as maintaining and updating knowledge of lab procedures to assist with work flow. + Acting as the OSHA Representative for the site which would include but not be limited to; maintaining employee immunization records, obtaining vaccines when necessary for site or PMG and administering vaccines to staff. + Performing equipment calibration when needed, if not performed by the lab coordinator or outside service and maintaining equipment calibration records. + Supporting training and additional development of clinical skills for site staff as needed **Your Profile:** + 1+ years of work experience in a clinical research or pharmaceutical environment, with prior CRC experience + Experience with Neurology or Psychiatric clinical trials + Strong attention to detail + Motivated about a career in clinical research + Excellent time management and planning skills with an organized approach to work + Bachelor's degree in life sciences or other related field \#LI-Office \#LI-TP1 \#LI-Accellacare **What ICON can offer you:** Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: + Various annual leave entitlements + A range of health insurance offerings to suit you and your family's needs. + Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. + Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being. + Life assurance + Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site (************************************* to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (****************************************************** Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here (****************************************************** to apply

CRC Level 2 - Winston Salem, NC (Onsite) ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We have an incredible opportunity for a Clinical Research Coordinator 2 to join ICON's Accellacare team. The CRC ensures the safety of our volunteers, promotes the mission of Accellacare, and strives to meet and exceed study priorities. This individual is responsible for recruiting and promoting our service to suitable participants and sponsor representatives. Additionally, the CRC will perform tasks required to coordinate and complete a study according to the protocol. This role is with Accellacare, part of ICON's clinical research network, where you'll play a key role in transforming the clinical trial experience for patients and sponsors alike. Our global site network is designed with one goal in mind: to deliver better access, greater efficiency, and improved outcomes in clinical research. Location: Onsite (1901 S. Hawthorne Road, Suite 306, Winston-Salem, NC) What you will be doing: Performing technical and clinical requirements of study protocols, i.e., venipuncture, specimen processing, vital signs, electrocardiograms, IV infusions, IV pump operations, Holtor monitoring, pulmonary function testing, allergy testing, urine/serum pregnancy testing, strep throat screening, injections (IM or SQ) or any procedure necessary for the protocol as ordered by the investigator. Attending investigator meetings, site initiation visits, and coordinator meetings to obtain training on drug preparation and administration and general knowledge about a protocol with a focus on clinical procedures. Obtaining knowledge about the study drugs with an emphasis on injection or intravenous infusion medications. Monitoring for possible complications with the administration of study drugs with an emphasis on injections or intravenous infusions. Maintaining accurate dispensing logs, separate from those of the coordinator, to include such information as lot number, drug vs. placebo, and information about the third party mixer or un-blinded mixer/preparer of medication. Documenting laboratory data and adverse reactions, and immediately notifying investigators, sponsors and the Institutional Review Board, if indicated, of any unexpected or serious events. Assisting other staff members as determined by the needs and priorities of the research organization and as time and abilities permit. Actively recruiting and effectively selling our service to suitable patient participants for clinical trials with set time allotted each week for recruitment efforts. Proactively promoting the site with monitors and in-house contacts for future trials. Responding to queries in a timely manner, prompt data entry and working with the monitor during on-site visits are examples of pro-active behaviors. Preparing study documentation in the event of a sponsor or FDA audit and assisting the auditor for the duration of the audit. Ordering clinical supplies, as well as ordering, storing and monitoring of protocol specific rescue drugs and maintaining scheduled assessment of the code/crash cart and AED including maintaining proper documentation for both. Monitoring and maintaining refrigerators, freezer units and investigational product storage temperatures for safety and stability. Obtaining and maintaining knowledge in regards to temperature monitoring devices and procedures for lab specimens and investigational products and providing detailed information to all staff and sponsors in regards to how temperatures are monitored and maintained. Maintaining certification for packaging and shipping specimens on dry ice, as well as maintaining and updating knowledge of lab procedures to assist with work flow. Acting as the OSHA Representative for the site which would include but not be limited to; maintaining employee immunization records, obtaining vaccines when necessary for site or PMG and administering vaccines to staff. Performing equipment calibration when needed, if not performed by the lab coordinator or outside service and maintaining equipment calibration records. Supporting training and additional development of clinical skills for site staff as needed Your Profile: 1+ years of work experience in a clinical research or pharmaceutical environment, with prior CRC experience Experience with Neurology or Psychiatric clinical trials Strong attention to detail Motivated about a career in clinical research Excellent time management and planning skills with an organized approach to work Bachelor's degree in life sciences or other related field #LI-Office #LI-TP1 #LI-Accellacare What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family's needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply

Department: 36962 Wake Forest University Health Sciences - Cardiology: Adult Status: Full time Benefits Eligible: Yes Hours Per Week: 40 Schedule Details/Additional Information: Full time- On site position Pay Range $26.55 - $39.85 Under departmental direction, coordinates activities to support multiple research studies of all phases. Serves as the principal administrative liaison for assigned studies with the ability to manage a workload that includes studies of increased complexity. Develops and maintains recordkeeping systems and procedures to ensure compliance with study protocols and all appropriate regulations. Attends clinic as needed to perform activities including, but not limited to: assist the research team with recruitment activities, administer questionnaires and answer any questions about future appointments. Responsible for the compilation, registration and submission of data, as required by the Sponsor. EDUCATION/EXPERIENCE Bachelor's degree with two years; experience in clinical research; or an equivalent combination of experience and education. LICENSURE, CERTIFICATION, and/or REGISTRATION SOCRA or ACRP Certification preferred. Must complete the CITI certification for Human Subject Research if not already completed. All additional required WakeOne training for research coordinators. ESSENTIAL FUNCTIONS 1. Works under the direction of the Study Investigators or Clinical Research Nurse Manager with minimal supervision. 2. Plays an active role in recruitment of patients to study. 3. Performs protocol specific duties required per the research protocol. 4. Obtains or assists the Principal Investigator in obtaining informed consent from subjects and reinforces the information that has been provided to subjects and families. 5. Fulfills sponsor requirements related to reportable information including adverse events, unanticipated problems, and other information required by the sponsor protocol. 6. Abstracts data from the medical record and completes paper and electronic case report forms, including responding to any requests for data clarification, and maintains all necessary source documents. 7. Identifies and communicates important protocol and data management issues or problems to the supervisor in a timely manner. 8. Provides staff relief as required to meet the needs of the department. Participates in scheduled team/department meetings. Participates in quality improvement projects on an on-going basis. 9. May mentor new and less experienced staff. 10. Follows established Wake Forest Baptist and department policies, procedures, objectives, performance improvement, attendance, safety, environmental, and infection control guidelines, including adherence to the workplace Code of Conduct and Compliance Plan. Practices a high level of integrity and honesty in maintaining confidentiality. 11. Performs other related duties as assigned or requested. SKILLS/QUALIFICATIONS Excellent interpersonal, oral, and written communication skills Excellent reading comprehension Strong organizational skills EPIC/WakeOne proficiency to include appropriate documentation of research notes Proficient in the use of OnCore/WISER Clinical Trial Management System Basic computer skills Fosters/promotes a positive image and professional appearance Sensitivity to intercultural relations Sensitivity to the maintenance of confidentiality Knowledge of Microsoft Products WORK ENVIRONMENT Clean, comfortable, office environment Our Commitment to You: Advocate Health offers a comprehensive suite of Total Rewards: benefits and well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more - so you can live fully at and away from work, including: Compensation Base compensation listed within the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training Premium pay such as shift, on call, and more based on a teammate's job Incentive pay for select positions Opportunity for annual increases based on performance Benefits and more Paid Time Off programs Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability Flexible Spending Accounts for eligible health care and dependent care expenses Family benefits such as adoption assistance and paid parental leave Defined contribution retirement plans with employer match and other financial wellness programs Educational Assistance Program About Advocate Health Advocate Health is the third-largest nonprofit, integrated health system in the United States, created from the combination of Advocate Aurora Health and Atrium Health. Providing care under the names Advocate Health Care in Illinois; Atrium Health in the Carolinas, Georgia and Alabama; and Aurora Health Care in Wisconsin, Advocate Health is a national leader in clinical innovation, health outcomes, consumer experience and value-based care. Headquartered in Charlotte, North Carolina, Advocate Health services nearly 6 million patients and is engaged in hundreds of clinical trials and research studies, with Wake Forest University School of Medicine serving as the academic core of the enterprise. It is nationally recognized for its expertise in cardiology, neurosciences, oncology, pediatrics and rehabilitation, as well as organ transplants, burn treatments and specialized musculoskeletal programs. Advocate Health employs 155,000 teammates across 69 hospitals and over 1,000 care locations, and offers one of the nation's largest graduate medical education programs with over 2,000 residents and fellows across more than 200 programs. Committed to providing equitable care for all, Advocate Health provides more than $6 billion in annual community benefits.

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

The purpose of this position is to facilitate the conduct of oncology clinical trials, including subject and data management, according to federal regulations, Good Clinical Practice, and local and institutional policies. Reporting to the Clinical Research Manager, the Lead Study Coordinator independently manages multiple complex trials through the protocol life cycles of activation, implementation and closure. As Lead Study Coordinator, provide team lead and programmatic support on a daily basis, lead patient care and advising activities and serve as preceptor for new hire; providing ongoing training and first line support for staff. These responsibilities relate to the mission of the UNC / LCCC Protocol Office by maintaining the quality of research and by addressing patient safety and regulatory compliance which impact research quality and safeguard institutional integrity. Required Qualifications, Competencies, And Experience - Knowledge of ICH GCP , Federal Regulations and Guidelines and ability to follow established regulations, procedures, and protocols. - Advanced knowledge of clinical research coordination. - Possess strong decision-making skills and the ability to problem solve and troubleshoot issues. - High level of accuracy and attention to detail. - Strong computer skills. - Ability to gather data and document procedures. - Ability to plan work and coordinate multiple projects. - Ability to contribute to preparation and delivery of reports, trainings and SOPs. - Customer oriented and ability to work in a team environment. - Ability to communicate effectively and professionally verbally and in writing. - Ability to work on evenings, weekends and/or holidays occasionally required. Preferred Qualifications, Competencies, And Experience - Previous experience with therapeutic clinical research involving drugs and/or devices. - Experience in Phase I, II, and III clinical research. - Experience navigating medical records and data extraction. - Three years of clinical trial coordination experience, two of which must be in oncology. - SOCRA / ACRP Certification.

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

The purpose of the Study Coordinator I position is to support the execution of in vitro and in vivo pharmacology studies by coordinating the technical execution of projects. This includes scheduling, creating and distributing study-related documents, as well as providing hands-on assistance. The Study Coordinator will provide operational input to Study Directors (Scientists) on study protocol design, and they will serve as a team leader for a group of Research Associates whose primary responsibility is executing the hands-on portion of any given study. Responsibilities: - Coordinate the successful execution of client studies with various internal departments - Create and distribute study-related documentation and other materials for required for execution - Support Study Directors (Scientists) in scientific protocol development - Schedule studies with operational flexibility while maintaining competitive timelines - Maintain a daily schedule of all tasks that must be executed by Research Associates - Monitor and assure quality of data collection - Provide hands-on In-vivo support for study milestones - Provide drug formulation, if needed - Ordering study-related materials - Conduct work activities in compliance with all relevant regulations including ethics, environmental health and safety, financial, human resources, SOPs, and general business policies, requirements and objectives Minimum Requirements: - Bachelor's degree in a scientific discipline and 1+ years of experience in oncology related animal studies. - Demonstrated experience leading teams, strong communication skills, maintaining organization, and driving results - Willing and able to work under the pressure of deadlines and find solutions to meet timelines. - Able to work under pressure to meet deadlines - Ability to work across teams by being a flexible team player with strong communication and interpersonal skills. - Willing and able to work within a Quality System with oversight by QA and other regulatory bodies. - Exceptional organizational and time-management skills. - Ability to multi-task with a high degree of professionalism and diplomacy. - Ability to work independently and collaboratively in a fast-paced, team-oriented environment. Preferred Requirements: - CRO industry experience and ability to manage a high volume of customer projects - Preferred experience and knowledge with translational research in oncology - Preferred Animal handling/ In-vivo experience in a laboratory setting - Preferred Animal welfare/ IACUC knowledge - Preferred experience with SmartSheet, Study Director, Outlook, and Microsoft teams Crown Bioscience is committed to a diverse and inclusive workplace. Crown Bioscience is an equal opportunity employer and does not discriminate based on race, national origin, gender, gender identity, sexual orientation, protected veteran status, disability, age, or other legally protected status.

1. Job responsibilities include those listed in competency document. 2. Maintains a professional image and exhibits excellent customer relations to patients, visitors, physicians, and co-workers in accordance with our Service Excellence Standards and Core Values 3. The Research Nurse will be responsible to perform care and execute clinical care to subjects participating in clinical trials when needed by the research team within the comprehensive Cancer program. 4. Screens potential patients for protocol eligibility and enrolls patients according to specific protocol requirements. 5. Maintains high quality data collection through patient (client) observation, review of history and physical examination and analysis of diagnostic data, and patient assessment during treatment. 6. Reviews and interprets new protocol requirements for feasibility as well as lab tests, scans, and other diagnostic data. 7. Implements correct procedures for patient's registration to research protocols. Responsible for reviewing inclusion and exclusion criteria for the PI and for the Informed Consent Process per the policy. 8. Ensures protocol compliance in areas of physician orders, testing, and follow-up visits. 9. Safely and effectively records study medications. Manage research drugs using DARF, drug inventories, and accurate destruction records. 10. Remains up-to-date on current protocols, updates, and new protocols. 11. Spreadsheets on the MRMC J-Drive are maintained accurately, timely, and complete. 12. Maintains accurate, timely, and complete patient records (including toxicities, treatments, dose modifications, patient response, etc.) 13. Responsible for gathering necessary information from the research participants and submitting data as specified by protocol to research base along with transcribing data onto the Case Report Form (CRF). 14. Reports and documents Serious Adverse Events (SAE) per protocol guidelines. 15. Collaboration in a positive and professional manner with a multidisciplinary team within the comprehensive cancer program is required to ensure all research related tasks are completed in an efficient manner. The multidisciplinary team may consist of Physicians, Nurses, Administrative assistance, outside parties, and other necessary supportive team members. Qualifications /Training: * Basic Computer Skills * Completes Protecting Human Research Participants (PHRP) and Good Clinical Practice (GCP) training Licenses/Certifications/Registrations/Education * ADN preferred BSN * Licensed as RN in SC * Preferred specialty certification within 2 years of hire. Founded in 1906, McLeod Health is a locally owned and managed, not for profit organization supported by the strength of more than 900 members on its medical staff and more than 2,900 licensed nurses. McLeod Health is also composed of approximately 15,000 team members and more than 90 physician practices throughout its 18-county service area. With seven hospitals, McLeod Health operates three Health and Fitness Centers, a Sports Medicine and Outpatient Rehabilitation Center, Hospice and Home Health Services. The system currently has 988 licensed beds, including Hospice and Behavioral Health. The hospitals within McLeod Health include: McLeod Regional Medical Center, McLeod Health Dillon, McLeod Health Loris, McLeod Health Seacoast, McLeod Health Cheraw, McLeod Health Clarendon and McLeod Behavioral Health. If you would enjoy working in a dynamic environment and are looking for an opportunity to become part of a stellar team of professionals, we invite you to apply online today. We are an equal opportunity employer.

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. Essential Functions 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 managespre-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 Knowledge of office equipment (fax/copier) 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 Greenville Memorial Med Campus Facility 2507 Upstate Administrative Research Staff Department 25071000 Upstate 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.

Department: 36412 Wake Forest University Health Sciences - Pulmonology Clinic Status: Full time Benefits Eligible: Yes Hours Per Week: 40 Schedule Details/Additional Information: Position will support Pulmonary Critical Care Research Program at Atrium Health Wake Forest Baptist Medical Center. Pay Range $24.10 - $36.15 JOB SUMMARY Under general supervision, responsible for the compilation and collection of data, recruitment of subjects, and general coordination of clinical studies. EDUCATION/EXPERIENCE Bachelor's degree in a related field of study or an equivalent combination of experience and education. Experience in a medical and/or research setting. Paramedical or other clinical experience. LICENSURE, CERTIFICATION, and/or REGISTRATION Registered Record Administrator preferred. ESSENTIAL FUNCTIONS 1. Assists principal investigator and other health professionals in troubleshooting various problems related to the management of the clinical study. Assists in all aspects of the data collection process. 2. Performs technical procedures on clinical subjects under the direction of the principal investigator or his/her designee. 3. Assists with recruitment of patients for the clinical study including tracking the sources of patient referrals. Follow-up with sources of patient referrals including referring doctors, various Medical Center labs, and other sources. 4. Maintains appropriate patient records as necessary. This includes charting the condition of the patient and determining their continued eligibility in the study. 5. Obtains and interprets pertinent data from medical records as needed to understand past and present condition of the patients. 6. Performs day-to-day administrative and clerical duties such as designing brochures, stationary and data forms. Creates reports and graphs pertinent to the study including presentation of the results of the study. 7. May supervise other personnel including volunteers as assigned. 8. Assists in development of suitable codes and data collection forms for computerization. 9. Consults and cooperates with all faculty, coordination centers, sponsors, and health professionals involved in the clinical study. 10. Performs other related duties incidental to the work described herein. SKILLS/QUALIFICATIONS Understanding of medical and/or scientific terminology Strong oral, written, and interpersonal communication skills WORK ENVIRONMENT Clean, well-lit, office environment, clinic Our Commitment to You: Advocate Health offers a comprehensive suite of Total Rewards: benefits and well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more - so you can live fully at and away from work, including: Compensation Base compensation listed within the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training Premium pay such as shift, on call, and more based on a teammate's job Incentive pay for select positions Opportunity for annual increases based on performance Benefits and more Paid Time Off programs Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability Flexible Spending Accounts for eligible health care and dependent care expenses Family benefits such as adoption assistance and paid parental leave Defined contribution retirement plans with employer match and other financial wellness programs Educational Assistance Program About Advocate Health Advocate Health is the third-largest nonprofit, integrated health system in the United States, created from the combination of Advocate Aurora Health and Atrium Health. Providing care under the names Advocate Health Care in Illinois; Atrium Health in the Carolinas, Georgia and Alabama; and Aurora Health Care in Wisconsin, Advocate Health is a national leader in clinical innovation, health outcomes, consumer experience and value-based care. Headquartered in Charlotte, North Carolina, Advocate Health services nearly 6 million patients and is engaged in hundreds of clinical trials and research studies, with Wake Forest University School of Medicine serving as the academic core of the enterprise. It is nationally recognized for its expertise in cardiology, neurosciences, oncology, pediatrics and rehabilitation, as well as organ transplants, burn treatments and specialized musculoskeletal programs. Advocate Health employs 155,000 teammates across 69 hospitals and over 1,000 care locations, and offers one of the nation's largest graduate medical education programs with over 2,000 residents and fellows across more than 200 programs. Committed to providing equitable care for all, Advocate Health provides more than $6 billion in annual community benefits.

This position plays a pivotal role in advancing cancer research and improving patient outcomes by facilitating the conduct of oncology clinical trials in compliance with federal regulations, Good Clinical Practice, and institutional policies. This position independently manages multiple complex trials throughout their life cycle, including activation, implementation, and closure, under the direction of a Clinical Operations Manager. Key responsibilities include: * Recruitment, consent, and enrollment of study participants * Coordination of study visits across various clinic settings * Documentation of procedures and visits, facilitation of sample collection, and data entry * Collaboration with research teams to ensure regulatory compliance and patient safety This position is integral to the mission of the UNC / LCCC Clinical Trials Office, maintaining research quality and safeguarding institutional integrity, and driving discoveries that shape the future of cancer care. Required Qualifications, Competencies, And Experience * Knowledge of ICH GCP , Federal Regulations and Guidelines and ability to follow established regulations, procedures, and protocols * Strong computer skills * Ability to gather data and document procedures High level of accuracy and attention to detail, * Ability to plan work and coordinate multiple projects * Possess strong decision making and problem-solving skills * Customer oriented and ability to work in a team environment * Ability to communicate effectively and professionally verbally and in writing. * Requires study coordinator experience or experience in oncology clinical trials Ability to work on site at UNC Medical Center, UNC Chapel Hill Campus, and any satellite clinic site where trials are conducted. Ability to work on evenings, weekends and/or holidays occasionally required. Preferred Qualifications, Competencies, And Experience Previous experience with therapeutic clinical research involving drugs and/or devices Experience with direct patient contact in the hospital/clinic setting SOCRA / ACRP Certification Experience in Phase I, II, and III clinical research. Experience or familiarity with medical terminology, navigation of medical records and data abstraction Prior experience with translational science research projects Demonstrated ability to operate at a high degree of independence Demonstrated ability to coordinate studies of high complexity Work Schedule Monday - Friday, 8:30AM - 5:00PM