Clinical research associate jobs in Mount Pleasant, SC - 64 jobs

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.

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.

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.

The Clinical Trials Office (CTO) and specific disease group Program Manager within the Clinical Operations Unit are recruiting for a Research Coordinator. Entity Medical University of South Carolina (MUSC - Univ) Worker Type Employee Worker Sub-Type Classified Cost Center CC001332 HCC CTO Administration Pay Rate Type Hourly Pay Grade University-05 Pay Range 39,764.00 - 56,670.00 - 73,576.000 Scheduled Weekly Hours 40 Work Shift Summary: Under general supervision of the Clinical Trials Office (CTO) and specific disease group Program Manager within the Clinical Operations Unit, this position coordinates, establishes, and supervises complex research protocols at the Hollings Cancer 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 Senior Clinical Research Coordinator will perform and manage tasks that are critical to clinical research studies. The Senior Clinical Research Coordinator must ensure compliance with federal regulations, study protocol guidelines, as well as monitor study participants, and take a proactive approach to identify issues on an ongoing basis throughout the clinical research study. To consistently embody AMR Clinical's Core Values: United We Achieve Celebrate Diverse Perspectives Do the Right Thing Adapt and Persevere The Clinical Research Coordinator reports to the Site Manager/Team Lead. Classification: Non-Exempt Primary Responsibilities: Expanded role in team management, mentorship, and training, which includes over-sight of level 1 CRC's, Research Assistants and ancillary staff. Advanced Problem Solving & Decision-Making. Takes ownership of identifying, analyzing, and resolving complex study-related challenges, including protocol deviations, regulatory compliance issues, and operational inefficiencies. Proactively collaborates with QA and Site Manager to develop and implement corrective and preventive action plans to mitigate risks and improve study outcomes. Serves as a key resource for junior staff, providing guidance and training on problem-solving strategies while escalating critical issues to leadership as needed. Advanced knowledge of protocol and procedures. Greater responsibility for regulatory compliance, protocol deviations, and audits. Deeper involvement in recruitment strategy and study performance. Higher engagement with study sponsors, CROs, monitors/CRA's, IRBs, laboratories, and clinical personnel within the research industry. Coordinate clinical trials per FDA requirements and GCP Guidelines per sponsor protocols. Establish understanding of SOP's and implement the SOP's Gain understanding of the pharmaceutical drug per clinical trial. Advanced skills in study start-up and close-out procedures. Manage complex clinical trials, including those with challenging study designs and special patient populations. Work closely with Investigators to optimize site performance, improve study compliance, and facilitate better communication between research staff and investigators. Notify the correct personnel of any adverse events per the study protocol (PI, Sub-I, monitor/CRA, etc.) Be the study ambassador on assigned studies to advise team members on protocols and procedures to ensure successful implementation and completion of the clinical research study. Establish and maintain patient rapport. Clinical data collection (vital signs, EKG recording, weight, height, etc.) Obtain medical records and review as required. Phlebotomy Specimen collection, processing, and storage Transporting clinical specimens to laboratory. Educate subjects on diaries and oversees compliance with diary completion. Provides subjects instructions per study (diaries, restricted meds, study reminders, etc.) Responsible for completing patient phone call visits in accordance to the standard protocol period. Ensure documentation follows ALCOA standards and is completed in a timely manner. Ensure all necessary documents are completed, signed and dated. Provides required information to Contract Research Organization (CRO), Institutional Review Board (IRB), sponsoring organization, Food and Drug Administration (FDA), and/or other appropriate agency as required. Manage study inventory and order supplies as needed. Prepare and assist study monitors during onsite visits. Maintain familiarity with all ongoing clinical research studies. Travel to Investigator meetings as needed. Promote team mentality by working flexible hours as needed and completing tasks outside the scope of everyday duties Mentor team members to promote professional development Position may require occasional weekend and/or overtime hours. Other duties as assigned Desired Skills and Qualifications: 3+ years of experience in clinical research. Completion of formal medical training, educational program, or healthcare experience Strong medical terminology Ability to perform clinical, laboratory, and diagnostic tests (vital signs, height, weight, temperature, etc.). Ability to work independently and lead study-related tasks. Ability to multi-task in a high-paced evolving environment. Exceptional listening, written, and verbal communication skills as well. Demonstrate proficiency in office equipment and software programs. Excellent organizational and task management skills. Ability to be ambulatory most of the workday. Ability to lift/transfer/push/manipulate equipment and patients, which requires strength, gross motor and fine motor coordination. AMR Clinical does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, retaliation, parental status, military service, or other non-merit factor. ** This job description is intended to be a representative summary of the major responsibilities and accountabilities of the staff holding this position. The staff may be requested to perform job-related tasks other than those stated in this description.

Internal Job Description Job Title: Clinical Research Coordinator Work Set-Up: Working On-site Schedule: 24 hours per week. Responsibilities: Phlebotomy is required, and pediatric experience is also needed. Additionally, community outreach will be part of the role. Perform a variety of complex clinical procedures on subjects including but not limited to ECG, sample collection including spirometry, and vital signs. Coordinate clinical research studies conducted by a supervising principal investigator. Update and maintain skills, training, and knowledge of current best nursing practices and topics related to clinical research. Safeguard the well-being of the subjects and ensure and maintain high standards: Maintain a safe environment in accordance with Health and Safety policies. Act as a volunteer advocate. Address volunteer and visitor concerns proactively and take remedial action as required. Assist staff, both registered and unregistered, in clinical coordinator practices and the delivery of care to the volunteer. Report any deviation from normal practice to senior staff. Support Study Conduct By: Reviewing the study protocol, case report form (CRF), other study documents, and electronic data capture systems. Participating in project meetings with the project team as needed. Performing clinical set-up and preparation for the study including labeling specimen collection tubes and containers, setting up equipment and documents. Planning logistical activity for procedures as per protocol. Generating volunteer instructions. Identifying and obtaining required supplies and equipment. Preparing and delivering study-specific training materials, documents, and records. Troubleshooting study issues. Participating in huddles to ensure daily tasks assigned to team members are executed to the expected standards. Assisting with data quality checking and query resolution to ensure that data collected on study volunteers adhere to study protocol and ensuring quality control for content accuracy and completeness. Recruiting and screening volunteers for inclusion in the study based on pre-determined criteria. Orienting volunteers to the study and the site including the purpose of the study, procedures, and practical issues such as timelines for visits. Responsible for the correct administration and custody of study drug according to site standard operating procedures. Collecting, recording, and reporting clinical data and findings appropriately in case report forms (CRFs). Collaborating closely with the study investigator, informing on relevant adverse events and serious adverse events according to procedures outlined in the protocol. Cooperating with the study monitor and reserving sufficient time for questions during monitoring. Following ICH GCP guidelines with regards to all study and patient activities. Qualifications: Equivalent education and experience - High School Diploma and 1 years' relevant work experience in clinical research At least 1 year experience working in a clinical research setting preferred. Applicable certifications and licenses as required by company, country, state, and/or other regulatory bodies. Working knowledge of clinical trials. Working knowledge of the principles of Good Clinical Practices (GCP). In-depth knowledge of protocol and study-specific operating procedures, consent forms, and study schedules. Skill in carrying out required clinical procedures. Working knowledge of medical terminology. Ability to pay close attention to detail. Ability to establish and maintain effective working relationships with coworkers, managers, patients, physicians, and clients. Please note, this position is not eligible for sponsorship. #LI-CES and #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.

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

Clinical Research Coordinator (LOCATED in Atlanta, GA) MUST be able to relocate on your own to the Atlanta, GA area (no relocation offered) Manage and coordinate oncology clinical research trials, including patient recruitment, protocol development, and data management. Oversee oncology trials and research projects Develop research protocols and grant proposals Perform patient evaluations and administer medications Train and supervise staff Ensure compliance with regulations through audits Manage financial accounts and authorize purchases Develop strategies for participant recruitment and retention Interface with study sponsors and resolve queries Monitor IRB submissions and respond to requests Qualifications MUST be able to relocate on your own to the Atlanta, GA area (no relocation offered) MUST have Clinical Research Coordinator (CRC) experience 3+ years of solid CRC experience in oncology or interventional drug trials in other therapeutic areas Two years of college in a scientific, health related, or business administration program AND 3 years of clinical research experience OR High School Diploma or GED AND3+ years of clinical research experience Pay and Benefits The pay range for this position is $28.00 - $30.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: * Medical, dental & vision * Critical Illness, Accident, and Hospital * 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available * Life Insurance (Voluntary Life & AD&D for the employee and dependents) * Short and long-term disability * Health Spending Account (HSA) * Transportation benefits * Employee Assistance Program * Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Charleston,SC. Application Deadline This position is anticipated to close on May 2, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Description New Season Treatment Centers is seeking an experienced Clinical Coordinator / Treatment Service Coordinator to provide leadership, clinical oversight, and mentorship within our outpatient Opioid Treatment Program (OTP). This role supports counselors while ensuring compliance, quality of care, and patient-centered treatment for individuals living with Opioid Use Disorder (OUD). About the Role The Treatment Service Coordinator (Clinical Coordinator) oversees the daily clinical operations of counseling services and provides supervision to Substance Abuse Counselors. This role partners closely with Program and Regional Leadership to ensure compliance with local, state, and federal regulations, while promoting professional development and high-quality clinical care. For over 30 years, New Season Treatment Centers has been a leading national provider of outpatient Medication-Assisted Treatment (MAT) services, operating more than 70 treatment centers across multiple states. What You'll Do * Oversee daily clinical operations and counselor duties to ensure regulatory compliance. * Provide clinical supervision and mentorship to counseling staff * Review, sign, and date the required clinical documentation * Ensure compliance with local, state, federal, and CMG policies and procedures * Communicate significant treatment events to Program or Regional Directors * Prepare and submit clinical reports as requested * Monitor patient activities on the center premises * Document patient progress through counseling and group interactions * Report patient abuse, neglect, or exploitation as required * Participate in community relations activities as directed * Ensure understanding and adherence to the Policy and Procedures Manual * Protect patient confidentiality and the company's proprietary data What You Bring Required Qualifications * Clinical Supervisor Credential required (Intern or in process) Required Knowledge * Understanding of Opioid Addiction and Medication-Assisted Treatment (MAT) * Knowledge of counseling practices, HIPAA, Federal Confidentiality Law, and privacy standards * Computer proficiency, including Microsoft Excel and Google products Preferred Experience * Minimum 2 years of management experience * At least 1 year of experience in substance abuse treatment or a related field Why Join New Season * Full benefits available DAY ONE * Up to 3 weeks of PTO accrued starting DAY ONE * Early morning hours for work-life balance * Competitive pay * Medical, dental, and vision insurance * Life insurance and short/long-term disability * 401(k) with up to 3% employer match * Education, license, and tuition reimbursement * Employee referral bonuses up to $2,000 New Season / Colonial Management Group, LP is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind in accordance with federal, state, and local laws. Job or State Requirements South Carolina Clinical Supervisor Credential

Job DescriptionDescriptionAlcanza is a growing multi-site, multi-phase clinical research company with a network of locations in MA, NH, MI, VA, SC, FL, GA, AL, MO, TX and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow. The Clinical Research Coordinator (CRC) works to ensure the execution of assigned studies in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs. Key ResponsibilitiesEssential Job Duties: In collaboration with other members of the clinical research site team, works to ensure the execution of assigned studies. Responsibilities may include but are not limited to: Under the direction of the Site Manager/Director and the Principal/Sub Investigators, conducts the following according to study protocol, company processes & procedures, and in compliance with FDA, GCP, ICH regulations and guidelines: Screening of patients for study enrollment; Patient consents; Patient follow-up visits; Documenting in source clinic charts; Entering data in EDC and answers queries; Obtaining vital signs and ECGs; May perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up; Requesting and tracking medical record requests; Updating and maintaining logs, chart filings; Maintaining & ordering study specific supplies; Scheduling subjects for study visits and conducts appointment reminders; Building/updating source as needed; Conducting monitoring visits and resolves issues as needed in a timely manner; Ensuring study related reports and patient results are reviewed by investigator in a timely manner; Filing SAE/Deviation reports to Sponsor and IRB as needed; Documenting and reporting adverse events; Reporting non-compliance to appropriate staff in timely manner; Maintaining positive and effective communication with clients and team members; Always practicing ALCOAC principles with all documentation; May assist with study recruitment, patient enrollment, and tracking as needed; Maintaining confidentiality of patients, customers and company information, and; Performing all other duties as requested or assigned. Complete all needed activities for study start-up, including completing required training, uploading / printing certificates to file in ISF, etc.; Prepare and attend site initiation visits (SIV's) and Investigator Meetings (IMs), as needed; May set up, train and maintain all technology needed for studies. Skills, Knowledge and ExpertiseMinimum Qualifications: A Medical Assistant diploma, LPN/LVN, EMT credential OR Associate's degree AND a minimum of 1 year of clinical research or clinical experience, OR an equivalent combination of education and experience, is required. Proficiency with performing basic clinical procedures such as (blood pressure, vitals, EKGs, phlebotomy, etc.) is highly preferred. Bi-lingual (English / Spanish) proficiency is a plus. BLS certified/preferred. Required Skills: Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm); Performing basic clinical procedures such as blood pressure, vitals, EKGs, phlebotomy, etc Strong organizational skills and attention to detail. Well-developed written and verbal communication skills. Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers. Ability to effectively handle multiple tasks, and adapt to changes in workloads and priorities. Must be professional, respectful of others, self-motivated, and have a strong work ethic. Must possess a high degree of integrity and dependability. Ability to work under minimal supervision, identify problems and implement solutions. Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines. Benefits Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire. Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.

OVERVIEW: The Clinical Coordinator manages the clinical education component of the curriculum. BUSINESS CONTRIBUTION: The Clinical Coordinator position plans, coordinates, facilitates, administers, and monitors, activities on behalf of the academic program and in coordination with academic and clinical faculty. These activities ensure the quality of our students learning experience during clinical education. Clinical Coordinators accomplish this through: · Assists with the development and assessment of the clinical education component of the curriculum with the Program Director · Coordination and implementation of the clinical education component of the curriculum including site placements, site visits, and evaluation · Responsible for facilitating students' clinical education · Responsible for ensuring clinical education program compliance EDUCATION, and TRAINING: The Clinical Coordinator of Radiologic Technology must have: · Bachelor's degree. · Four years of in field experience. . Two Years of Clinical Experience in Professional Setting · 2 years of Teaching or Clinical Instruction from an accredited JRCERT school · ARRT certified. ESSENTIAL FUNCTIONS: Assists in the development and assessment of clinical education component of the curriculum · Responsible for the administrative, academic, service, and scholarship responsibilities consistent with the mission and philosophy of the academic program · Develops monitors and refines the clinical education component of the curriculum. · Facilitates quality learning experiences for students during clinical education. Coordination and implementation of the clinical education component of the curriculum including site placements, site visits, and evaluation · Selects clinical learning environments that demonstrate characteristics of an ethical and professional facility that incorporates the programs core values. · Documents and assesses clinical education sites and clinical educators to determine efficacy. · Coordinates the ongoing development of the clinical facility database with maintenance of clinical agreements and other appropriate clinical information · Ensure clinical agreements are current and that students are assigned only to those facilities in which there are properly executed and unexpired contracts. · Communicates program curriculum, philosophy, objectives, evaluative criteria, policies, procedures, clinical dates, and other pertinent information to affiliating clinical facilities. · Serves as a liaison between the students and clinical facility. Responsible for facilitating students' clinical education · Communicates and oversees communication with the Center Coordinators of Clinical Education, Clinical Instructors and students to monitor progress and assess students' performance. · Provides guidance and support as required to problem solve and discuss students concerns. · Meets with students prior to clinical affiliations to disseminate information on clinical policies and procedures, clinical site information, clinical education philosophy and objectives. · Assesses students' performance during clinical education. · Administers policies and procedures for immunization, preventative health practices, and for management of student injuries while at clinical site. · Prepares clinical rotation assignment schedules. · Teaches clinical education courses and other related course content based on areas of content and clinical experience. Responsible for ensuring clinical education program compliance · Complies with site requirements · Ensures student physical and/or immunizations forms are current and in compliance · Tracks and issues continuing education hours in conjunction in accordance to the state and local laws. · Ensures liability protection of students (and faculty if required) inclusive of professional, governmental, institutional, and risk management principles. PHYSICAL DEMANDS: The employee may occasionally lift and/or move up to 25 pounds. The employee may be required to stand or sit for long periods of time. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to adjust focus. WORK ENVIRONMENT: Professional office setting; controlled indoor climate; noise level in the work environment is usually moderate. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The Clinical Donation Coordinator I (CDC I) supports the mission and organizational goals of We Are Sharing Hope SC (SHSC) through screening and evaluating potential donors, managing organ donors, allocating donated organs according to Organ Procurement and Transplantation Network (OPTN)/United Network for Organ Sharing (UNOS) policy, and coordinating all aspects of organ recovery. The CDC I assists in delivering hospital development and professional education programs, as needed. Essential Duties & Responsibilities Maintains the highest standards of professional conduct and interpersonal relationship development; promoting a positive and collaborative work environment. Responds on-site to all potential organ donors within a timely manner, unless prior approval is given by the Administrator on call (AOC). Performs clinical screening and evaluation to determine donor suitability for donation after circulatory death (DCD) or brain death donation (BDD) in collaboration with the AOC. Completes referral evaluations for the purpose of determining organ and tissue donor suitability based on SHSC, Centers for Medicare & Medicaid Services (CMS), OPTN/UNOS, Association of Organ Procurement Organizations (AOPO) and Centers for Disease Control and Prevention (CDC) guidelines and recommendations. Completes hospital medical record review, including history of present illness and past medical history, the presence of past or present malignancies, and all surgical interventions/treatments. Demonstrates an understanding of the legal and hospital requirements for death declaration and organ donation. Guides the referring agency to ensure informed consent for organ and tissue donation is requested by SHSC staff in accordance with organizational and hospital policy; ensuring that the legal next-of-kin (NOK) is provided the option of organ and tissue donation in a sensitive and caring manner that meets their emotional and cultural needs. Provides hospital-based education in collaboration with hospital development staff. Works collaboratively with Family Service Counselor (FSC) to obtain informed consent and medical/social history from donor next-of-kin, or family, per SHSC guidelines. Coordinates lymph node recovery for tissue typing, confirms donor ABO, and obtains blood as needed for donor work-up/evaluation. Initiates, performs and oversees donor management according to SHSC guidelines. Writes orders in the medical record under the supervision of the SHSC Medical Director or transplant surgeon according to SHSC and hospital protocol. Identifies organ- and tissue-specific and behavioral risk factors in accordance with SHSC and regulatory guidelines. Collaborates with the Coroner and Medical Examiner's office to ensure jurisdictional medical and legal requirements for death and organ recovery are satisfied. Knowledgeable of the pathophysiological sequelae of brain death and endeavors to physiologically manage the donor to achieve optimal organ function within the parameters defined by the associated protocols under the guidance of the AOC and Medical Director (e.g., monitor bedside and laboratory parameters, initiate donor management directives, maintain optimal ventilation, and seek medical counsel, as appropriate). Coordinates placement of organs, per approved Organ Procurement and Transplantation Network/United Network for Organ Sharing (OPTN/UNOS) guidelines. In conjunction with facility Respiratory Therapist and SHSC Medical Director, manages respiratory care to maximize lung recovery. Coordinates transportation and logistics of organs, blood, tissue typing materials, and recovery teams. Coordinates and communicates with ancillary services related to recovery activity (i.e. SHSC Tissue teams, funeral home, coroner, pathologist, Organ Procurement Organizations (OPO's), and transplant centers, etc.). Maintains current knowledge of all SHSC, Association of Organ Procurement Organizations (AOPO), and OPTN/UNOS policies and procedures. Completes, maintains, and ensures quality of all data forms required for the donation process. Maintains confidentiality on all donor-related activities and internal issues. Utilizes resources with discretion and employs professional laterality, when possible (i.e., utilization of hospital profiles, engagement with donor family and hospital staff, etc.). Completes SHSC donor chart and Donor Net chart according to SHSC policies and guidelines. Coordinates promotional programs with SHSC's Hospital Development Department. Participates in process improvement and data development projects, including case reviews and research opportunities . Performs other duties as requested by Manager of Clinical Services, Director of Clinical Services, President and CEO and/or the SHSC Medical Director. Qualifications Education: Associate degree or higher in nursing, respiratory therapy, paramedic medicine, related biological science (including transplant and donation science), or medical school degree (including foreign degree programs) required. Bachelor's degree or higher in nursing, respiratory therapy, or related biological science preferred. Experience: Critical care nursing, paramedic medicine, medical technician or related medical experience preferred. Organ donor management experience preferred. Computer Skills: Microsoft Office products (e.g., Word, Excel, PowerPoint, etc.) required. Microsoft Outlook required. Electronic medical records (e.g., Cerner, Epic, Meditech) preferred. Certificates & Licenses: Certified Procurement Transplant Coordinator (CPTC) preferred. Certified Transplant Preservationist (CTP) preferred. Other Requirements: Ability to fulfill on-call obligations; case work up to 24 consecutive hours. Prepare to provide proof of COVID-19 immunity (doctor's statement of your COVID-19 immunity or full COVID-19 vaccination documentation)

Anderson University seeks applications for a full-time position as Clinical Coordinator of our online M.S in Clinical Mental Health Counseling program. A Ph.D. in Counselor Education and Supervision from a Council for Accreditation of Counseling and Related Educational Programs (CACREP) approved program is required. The Clinical Coordinator for the online Master of Science in Clinical Mental Health Counseling (CMHC) program plays a vital role in the administration and coordination of this fully online graduate program. This position supports the Program Director, faculty, and students in delivering a high-quality, student-centered academic experience. Faculty rank and status will be determined at the time of appointment based upon experience and record of scholarship. The coordinator ensures effective communication, timely academic and operational support, and collaboration across institutional units to sustain a rigorous and accessible program experience for online learners, and to sustain a rigorous and accessible program experience that prepares online learners for effective clinical practice. The program is pursuing accreditation through (CACREP), and the Clinical Coordinator will play an important role in supporting accreditation efforts and maintaining alignment with emerging CACREP standards. The responsibilities of this position will include the following: * Leading the collection and analysis of clinical data for CACREP accreditation and maintain continuous alignment with emerging accreditation standards for clinical supervision and field placement. * Overseeing the clinical and administrative functions of the online CMHC program, ensuring compliance with clinical standards and facilitating seamless operations for students, faculty and clinical sites. * Serving as the primary clinical liaison for students, faculty, and clinical sites. Date of Appointment: August 2026 Review Date: Review of applications will begin immediately and will continue until the position is filled. The largest private university in South Carolina, Anderson University is an innovative and entrepreneurial comprehensive, liberal arts university affiliated with the South Carolina Baptist Convention. AU is one of just a handful of universities in the world to be receive of Apple's Distinguished School recognition four times. In addition to being named as one of the best Southeastern Colleges by the Princeton Review, AU was recently ranked by U.S News & World Report as the #2 Regional College in the South with a Strong Commitment to Teaching. We are located in South Carolina's Upstate region, a growing and thriving community with award-winning public schools with convenient access to major cities and year-round outdoor recreation. We seek to attract culturally and academically diverse faculty of the highest caliber, active in the scholarship of teaching, discovery, application, and integration of faith. Applications will be accepted until the position is filled. Applicants must submit a digital cover letter of application, curriculum vitae, a statement of teaching philosophy, unofficial copies of their relevant graduate coursework, and an AU faculty application to: Susan Kratko, Administrative Assistant, College of Arts and Sciences Anderson University 316 Boulevard Anderson, SC 29621 **************************

Job Description We're Hiring: Clinical Research Coordinator! Schedule: Full-Time | Must be flexible for occasional extended hours Department: Carolina Nephrology Clinical Research Are you passionate about advancing medicine and improving patient outcomes? Carolina Nephrology Clinical Research is seeking a Clinical Research Coordinator (CRC) to join our growing research team in Spartanburg, SC. This is your opportunity to play a hands-on role in groundbreaking clinical trials while working alongside an expert team in a dynamic, fast-paced environment. Certified Medical Assistants (CMA) are welcome to apply! Why This Role Matters: As a CRC, you'll be the critical link between physicians, patients, sponsors, and regulatory bodies-ensuring that all clinical trial activities run smoothly, ethically, and according to protocol. You'll work closely with the Principal Investigator but carry major responsibility for day-to-day study operations. What You'll Do: Coordinate multiple clinical research studies from initiation through close-out Screen, recruit, and enroll eligible participants; obtain informed consent Ensure compliance with federal, state, and institutional guidelines (GCP, IATA, FDA, IRB, etc.) Collect, manage, and document clinical data, adverse events, and protocol deviations Maintain case report forms, drug/device accountability, and regulatory documentation Serve as the key liaison with sponsors, monitors, labs, and auditors Train and guide research team members in proper procedures and documentation standards Support the development of study protocols, procedural manuals, and reporting documents Stay up to date with industry best practices and emerging clinical research trends Travel to satellite offices and work outside of standard hours as needed What We're Looking For: Strong organizational, critical thinking, and communication skills Prior experience coordinating clinical research studies strongly preferred Familiarity with ICH-GCP and FDA regulations Excellent attention to detail and ability to multitask in a regulated environment Willingness to travel locally between offices and work occasional early mornings/late evenings GCP and IATA certifications preferred (or ability to obtain upon hire) Bachelor's degree in healthcare, life sciences, or related field preferred What You'll Get: The opportunity to be part of cutting-edge research that directly impacts patient care A supportive, collaborative team environment with growth potential Competitive compensation and benefits Travel and mileage reimbursement when visiting satellite locations Ready to contribute to life-changing research? Apply now and help shape the future of kidney care. Carolina Nephrology Clinical Research is an equal opportunity employer. All offers of employment at Carolina Nephrology, PA are contingent upon clear results of a thorough background check. Background checks will be conducted on all final candidates and on all employees who are promoted, as deemed necessary. Background checks will include: Social Security Verification: validates the applicant's Social Security number, date of birth and former addresses. Prior Employment Verification: confirms applicant's employment with the listed companies, including dates of employment, position held and additional information available pertaining to performance rating, reason for departure and eligibility for rehire. This verification will be run on the past two employers or the previous five years, whichever comes first. Personal and Professional References: calls will be placed to individuals listed as references by the applicant. Educational Verification: confirms the applicant's claimed educational institution, including the years attended and the degree/diploma received. Criminal History: includes review of criminal convictions and probation. The following factors will be considered for applicants with a criminal history: The nature of the crime and its relationship to the position. The time since the conviction. The number (if more than one) of convictions. Whether hiring, transferring or promoting the applicant would pose an unreasonable risk to the business, its employees or its customers and vendors. Procedure Final candidates must complete a background check authorization form and return it to Human Resources. Human Resources will order the background check upon receipt of the signed release form, and either internal HR staff or an employment screening service will conduct the checks. A designated HR representative will review all results. The HR representative will notify the hiring manager regarding the results of the check. In instances where negative or incomplete information is obtained, the appropriate management and the director of Human Resources will assess the potential risks and liabilities related to the job's requirements and determine whether the individual should be hired. If a decision not to hire or promote a candidate is made based on the results of a background check, there may be certain additional Fair Credit Reporting Act (FCRA) requirements that will be handled by Human Resources in conjunction with the employment screening service (if applicable). Background check information will be maintained in a file separate from employees' personnel files for a minimum of five years. Carolina Nephrology, PA reserves the right to modify this policy at any time without notice.

We are seeking an experienced Clinical Research Coordinator (CRC) Team Lead to join our dynamic research team. This role is pivotal in supporting clinical trials by working closely with the Principal Investigator (PI) and reporting directly to the Clinical Research Administrator. In addition to standard CRC responsibilities, the Team Lead will oversee site operations, provide guidance to coordinators, and assist with administrative duties to ensure compliance and efficiency in clinical research activities. Key Responsibilities Coordinate with PI, department, and administration to ensure compliance with federal regulations and sponsor policies. Assist PI with study feasibility assessments and protocol review. Prepare and maintain study materials, regulatory binders, and source documentation. Train and supervise CRCs and research assistants; maintain training logs. Develop and implement recruitment strategies in line with IRB requirements. Conduct informed consent processes and maintain accurate documentation. Manage investigational drug/device accountability and study supply inventory. Track enrollment, maintain timelines, and communicate effectively with sponsors and participants. Review and approve budget negotiations; attend weekly leadership meetings. Act as liaison between site coordinators and research leadership team. Qualifications Education: CRC certification required. Experience: Minimum 2 years as a Clinical Research Coordinator with site management experience. Skills: Strong organizational and problem-solving abilities. Excellent communication and interpersonal skills. Ability to interpret protocols and regulatory requirements. Proficiency in documentation and compliance standards. Additional Requirements Ability to work in a demanding environment with required occasional weekend work and travel. Physical ability to perform tasks such as sitting, bending, and lifting up to 25 lbs Benefits (Eligible for Fulltime Employees*) Med/Dent/Vision plus ancillary benefits Vacation/PTO 401k NOTE:This job description may not include all duties assigned to the employee and may be updated and modified by Management, without notice, according to operations at any given time.

Why Join CEENTA? CEENTA is the premier eye, ear, nose, and throat group in the Carolinas. You'll join a supportive, mission‑driven team committed to providing exceptional patient care and a collaborative clinical environment. CEENTA is seeking a compassionate Clinical Assistant to support Providers in our high‑volume ENT clinic. This role combines hands‑on clinical care with essential administrative tasks to ensure an exceptional patient experience. What you will do: Greet and room patients; document medical history, vitals, medications, and allergies Assist Providers with exams, treatments, and in‑office procedures Administer medications and collect lab specimens Provide patient education and serve as a scribe when needed Schedule appointments, procedures, and surgeries Respond to patient messages and prescription requests Maintain exam rooms, supplies, and sterilization standards Update records and manage work queues in the EHR system Clean and restock exam rooms; sterilize equipment and maintain OSHA‑compliant safety standards. Maintain clinic supply inventory and place orders when needed. Support the onboarding and training of new staff and apprentices. Collaborate with Providers and clinical team members to ensure efficient patient flow and high‑quality care. Travel to other CEENTA locations as needed. A Typical Day Your day begins by welcoming patients and bringing them to exam rooms with a warm, professional approach. You'll record medical histories, vital signs, and medication updates in the EHR before assisting the Provider with examinations and procedures. Throughout the day, you'll sterilize rooms and equipment, respond to patient messages, process prescription refill requests, schedule follow‑up visits and surgeries, and keep documents and work queues updated. You'll balance both clinical and administrative tasks to ensure smooth, efficient patient care from start to finish. Schedule: Mon-Fri, 8a-5p; occasional early or late clinic rotation pending provider's schedule. Qualifications What you'll bring High school diploma or equivalent, required Completion of accredited Medical Assisting program (CAAHEP, ABHES, or AMT‑approved) Preferred CMA, RMA, or LPN certification, Preferred 1-2 years' experience (primary care or ENT preferred) Current BLS certification Dependable to travel between sites when needed

We are seeking a Clinical Coordinator to assist with all clinical needs for our Okatie patients. The Clinical Coordinator plays a crucial role ensuing the seamless coordinator of patient care. This position involves proficient chart preparation, communication, scheduling of patient visits, appropriate utilization and logging of chronic care management activities, and provider and patient support. This position will be working in the Okatie clinic daily. This is a full-time, salary-based 8-hr position (8:00AM-5:00PM) (Monday-Friday). About We are a leading physician group serving South Carolina and Georgia, dedicated to delivering quality healthcare directly to patients in care facilities, homes, clinics, and virtual visits. Our services include comprehensive primary care, specialty services, and pharmacy support, tailored to meet diverse patient needs. Committed to excellence and innovation, our team collaborates closely with facilities and families to ensure accessible, coordinated, and compassionate care. Why Choose a Career at Your Health? Providing high quality care for our patients is the center of what we do, and we provide the same care for our employees. Here are some of the benefits that are available to our employees. Competitive Compensation Package with Bonus Opportunities Employer Matched 401K Free Visit & Prescriptive Services with HDHP Insurance Plan Employer Matched HSA Generous PTO Package Career Development & Growth Opportunities What Are We Looking For? Your Health is currently looking for a Clinical Coordinator to join our growing primary care family. A successful Clinical Coordinator will be able to perform these essential duties and responsibilities accurately and efficiently. Prior experience in a similar role is crucial to the success of our team due to the fast past and value-based model of care. The following is a list of essential functions, which may be subject to change at any time and without notice. Management may assign new duties, reassign existing duties, and/or eliminate function(s). Areas of Responsibility: Review and organize patient medical records in preparation for visits. Ensure all necessary documentation, test results, documents, diagnoses, and relevant information are accessible for the provider. Utilize Navina to ensure these are added, completed, and/or updated. Maintain accurate up-to-date patient records, including demographic information, contact details, insurance information, appointment history, etc. Ensure confidentiality and adhere to privacy regulations when handling sensitive patient information. Verify active consent forms and alignment paperwork are completed and in the patient s chart. Reconcile medications. Collaborate with care team to schedule and coordinator patient appointments with the Company s provider(s), and other members of the care team Interact with patients via email, patient portal, telephone, text, in-person, etc. to gather necessary information, schedule and confirm appointments in advance, and provide pre-appointment instructions. Communication methods such as phone, email, AthenaText, Microsoft Teams, etc. will be utilized. Appropriately and accurately document and log care management activities. Qualifications Must be a Certified Medical Assistant (CMA) or licensed nurse (i.e. LPN or RN). Must be licensed in the state of employment. Certification/license must be in good standing with the appropriate board. A minimum of one (1) year experience in a healthcare setting preferred. Must hold and maintain current CPR certificate. High school diploma or equivalent required. Should demonstrate strong interpersonal and communication skills under all conditions and circumstances. Ability to foster a cooperative work environment. Team player with ability to manage multiple responsibilities and demonstrate sound judgment. Ability to read and communicate effectively. Strong written and verbal communication skills. Basic computer knowledge. Must be able to work flexible hours and travel between offices, facilities, etc. Must be a licensed driver with an automobile that is insured in accordance with state and/or organization requirements and is in good working condition.

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.

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