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  • Clinical Research Coordinator III

    Denali Health 3.8company rating

    Clinical research associate job in Stone Mountain, GA

    Denali Health is a fast-growing clinical research organization dedicated to improving patient outcomes through innovative, high-quality clinical trials. We partner with leading physicians and sponsors to accelerate breakthrough treatments and foster greater access to research opportunities across diverse communities. Position Summary The Clinical Research Coordinator III (CRC III) is responsible for leading the coordination and execution of complex clinical research studies, ensuring compliance with study protocols, regulatory requirements, and institutional guidelines. The ideal candidate is a proactive professional with strong organizational and leadership skills, capable of managing multiple studies and mentoring junior coordinators. Key Responsibilities Coordination of Clinical Trials: Oversee all aspects of assigned clinical studies, including start-up, recruitment, informed consent, data collection, and study close-out. Serve as the primary liaison between investigators, sponsors, CROs, and regulatory agencies. Study Management: Ensure that study activities are conducted in accordance with GCP, IRB guidelines, and sponsor requirements. Maintain accurate and up-to-date source documentation and regulatory binders. Participant Coordination: Schedule and coordinate participant visits, assessments, and follow-ups while maintaining excellent communication and care for study participants. Regulatory and Compliance Oversight: Prepare and submit IRB documents, safety reports, and study updates. Ensure audit readiness at all times. Data Management: Enter, review, and verify data in EDC systems and ensure timely query resolution. Team Coordination & Leadership: Mentor and support CRC I and II staff, ensuring consistent application of best practices and promoting a culture of quality and accountability. Communication & Reporting: Coordinate communication among multidisciplinary teams to ensure efficient trial operations and timely reporting of progress and outcomes. Qualifications Bachelor's degree in health sciences, nursing, or a related field (advanced degree preferred). Minimum 3-5 years of experience in clinical research coordination. Strong understanding of GCP, ICH, and FDA regulations. Exceptional coordination, multitasking, and communication skills. Experience with EDC systems and clinical trial management software preferred. CCRC/CCRP certification a plus. Why Join Denali Health Work with a mission-driven team advancing clinical research accessibility. Competitive salary and comprehensive benefits package. Professional growth and leadership opportunities. Collaborative environment focused on innovation and patient care. To Apply: Please send your resume, video recording as to why you feel you would be a good fit for this role, and cover letter to ******************** with the subject line “Clinical Research Coordinator III - Stone Mountain.”
    $45k-67k yearly est. 5d ago
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  • Clinical Research Associate 1

    Allen Spolden

    Clinical research associate job in Atlanta, GA

    Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team. Essential Duties And Responsibilities Participate and assist in design and preparation of protocols and case report forms. Generate clinical SOPs, policies, charters, and plans according to US and international guidelines. Participate in the evaluation of potential clinical sites according to established criteria of acceptability. Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials. Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow -up actions for assigned study sites. Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. Assist with the maintenance of clinical archive and electronic files. Other tasks as assigned. Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. BA, BS, RN, BSN or equivalent Basic knowledge and adherence to GCPs 1 -2 years of clinical research experience or equivalent experience or training Strong attention to detail Ability to multi -task Unquestionable integrity and highest ethical standards Excellent written and verbal communication skills Self -motivated, assertive, and driven BenefitsDental, Medical, Vision, PTO and 401K
    $50k-80k yearly est. 60d+ ago
  • Clinical Research Associate II - Transplant and Transfusion

    Associate Project Manager In Bedford, Massachusetts

    Clinical research associate job in Norcross, GA

    Introduction Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care Overview A Clinical Research Associate II (CRA-II) plays a key role in monitoring and ensuring the integrity of clinical studies that evaluate the safety, performance, and effectiveness of medical devices and related products. This position supports the clinical operations function by ensuring compliance with applicable regulatory requirements and study protocols. By safeguarding data quality and patient safety, the CRA-II enables the organization to bring innovative healthcare solutions to market efficiently and ethically. The role adds value by bridging scientific research with operational excellence, ensuring studies are executed on time and to the highest quality standards Responsibilities Key Accountabilities Conduct site qualification, initiation, monitoring, and close-out visits to ensure compliance with study protocols and regulatory requirements. Serve as the primary point of contact between the sponsor and investigator sites, fostering effective communication and issue resolution. Verify that investigator sites have adequate resources, qualified staff, and investigational products throughout the study lifecycle. Ensure adherence to Good Clinical Practice (GCP), company SOPs, and applicable regulatory guidelines for all assigned studies. Monitor data integrity by reviewing source documents, case report forms, and ensuring accurate and complete trial records. Identify, document, and communicate protocol deviations, non-compliance, and safety issues promptly. Assist in managing study timelines, budgets, and deliverables, escalating risks. Prepare and maintain essential clinical trial documentation, including protocols, agreements, study reports, and site communications. Assist with reagent inventory management - ordering, storage and dispostion of investigation products and study supplies Uses the English language effectively in both written and verbal communication to convey complex clinical concepts with clarity and precision. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions. Networking/Key relationships Work closely and collaboratively with members of clinical affairs (Clinical Project Leader, Senior CRA,CRA,Statistician) Interface regularly with crossfunctional teams (R&D,Regulatory) as well as other functions across the organization as needed Qualifications Minimum Knowledge & Experience required for the position: Bachelor's degree in life sciences or related field (Medical Technology, Biology.) Minimum of 3 years clinical research experience in coordinating or monitoring Medical Device (IVD) Trials or working with a CRO Strong understanding of GCP guidelines, International Conference on Harmonization (ICH) and regulatory requirements (FDA,IVDR) Excellent understanding of clinical trial design Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement. Skills & Capabilities: Demonstrates strong regulatory knowledge to maintain compliance across global studies. Executes effective site monitoring and management, ensuring adherence to study protocols and timely issue resolution. Maintains meticulous attention to detail in documentation, source data verification, and reporting to support high-quality outcomes. Communicates clearly and professionally with investigators, sponsors, and cross-functional teams to foster collaboration and alignment. Manages multiple projects and timelines efficiently, prioritizing tasks to meet study milestones and regulatory deadlines. Adapts quickly to change, responding to evolving protocols, site needs, and regulatory updates with flexibility and composure. Travel requirements: Will vary by project. Travel requirement could be approx. 20% Closing If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact ****************************** for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team. **************
    $50k-80k yearly est. Auto-Apply 60d+ ago
  • Clinical Research Associate II - Transplant and Transfusion

    Werfen

    Clinical research associate job in Norcross, GA

    Introduction Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care Overview A Clinical Research Associate II (CRA-II) plays a key role in monitoring and ensuring the integrity of clinical studies that evaluate the safety, performance, and effectiveness of medical devices and related products. This position supports the clinical operations function by ensuring compliance with applicable regulatory requirements and study protocols. By safeguarding data quality and patient safety, the CRA-II enables the organization to bring innovative healthcare solutions to market efficiently and ethically. The role adds value by bridging scientific research with operational excellence, ensuring studies are executed on time and to the highest quality standards Responsibilities Key Accountabilities Conduct site qualification, initiation, monitoring, and close-out visits to ensure compliance with study protocols and regulatory requirements. Serve as the primary point of contact between the sponsor and investigator sites, fostering effective communication and issue resolution. Verify that investigator sites have adequate resources, qualified staff, and investigational products throughout the study lifecycle. Ensure adherence to Good Clinical Practice (GCP), company SOPs, and applicable regulatory guidelines for all assigned studies. Monitor data integrity by reviewing source documents, case report forms, and ensuring accurate and complete trial records. Identify, document, and communicate protocol deviations, non-compliance, and safety issues promptly. Assist in managing study timelines, budgets, and deliverables, escalating risks. Prepare and maintain essential clinical trial documentation, including protocols, agreements, study reports, and site communications. Assist with reagent inventory management - ordering, storage and dispostion of investigation products and study supplies Uses the English language effectively in both written and verbal communication to convey complex clinical concepts with clarity and precision. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions. Networking/Key relationships Work closely and collaboratively with members of clinical affairs (Clinical Project Leader, Senior CRA,CRA,Statistician) Interface regularly with crossfunctional teams (R&D,Regulatory) as well as other functions across the organization as needed Qualifications Minimum Knowledge & Experience required for the position: Bachelor's degree in life sciences or related field (Medical Technology, Biology.) Minimum of 3 years clinical research experience in coordinating or monitoring Medical Device (IVD) Trials or working with a CRO Strong understanding of GCP guidelines, International Conference on Harmonization (ICH) and regulatory requirements (FDA,IVDR) Excellent understanding of clinical trial design Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement. Skills & Capabilities: Demonstrates strong regulatory knowledge to maintain compliance across global studies. Executes effective site monitoring and management, ensuring adherence to study protocols and timely issue resolution. Maintains meticulous attention to detail in documentation, source data verification, and reporting to support high-quality outcomes. Communicates clearly and professionally with investigators, sponsors, and cross-functional teams to foster collaboration and alignment. Manages multiple projects and timelines efficiently, prioritizing tasks to meet study milestones and regulatory deadlines. Adapts quickly to change, responding to evolving protocols, site needs, and regulatory updates with flexibility and composure. Travel requirements: Will vary by project. Travel requirement could be approx. 20% Closing If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV. Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact ****************************** for assistance. We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team. **************
    $50k-80k yearly est. Auto-Apply 60d+ ago
  • Clinical Research Associate - NAMSA Future Openings USA

    Namsa 4.2company rating

    Clinical research associate job in Atlanta, GA

    NAMSA pioneered the industry and was the first independent company in the world to focus solely on medical device materials for safety. NAMSA started testing medical devices before the U.S. Food and Drug Administration started regulating such products in 1976. We are shaping the industry. NAMSA has been a key contributor to the development of the test methods that govern our industry. We have become the industry's premier provider. We provide support for clients during every step of the product development lifecycle and beyond. Come and work for an organization with the: Vision to inspire innovative MedTech solutions that advance global healthcare, improve patient lives and accelerate Client success and the Mission to deliver best-in-class global MedTech development solutions through our people, expertise and technology by adhering to our core Values: Act with integrity in everything we do. Provide best-in-class customer experiences. Develop superior talent and deliver expertise. Respond with agility and provide timely results. Embrace collaboration, diverse perspectives and ideas. Job Description: • Works on assigned studies to ensure that human subject protection is maintained, Good Clinical Practice (GCP), and applicable regulations are followed. • Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines. • May conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits. • Serve as primary point of contact for site questions relating to study enrollment, conduct, and close-out issues: liaise with appropriate study team members as needed. • Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns. • Supports study start-up activities such as tracking and performing quality review of study documents, completing, and distributing site activation letters, etc. • Performs study-related training. • Manages the development and maintenance of study documents, processes and systems as assigned. • Ensures quality and completeness of central and site master files. Tracks and maintains required study documents, performs quality control review, manages renewals. • Tracks study site and over all study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenance. • Attends internal and external meetings as required. • Provides all job-related progress reports and visit documentation as required. • May support safety activities such as narrative writing, managing the CEC/DSMB, etc. • OUS: Prepares and coordinates submissions to regulatory authorities. • May perform other activities as assigned. Qualifications & Technical Competencies: • Fluency in English and local language, if different, required. • Higher education degree or equivalent education, training, and experience. • Preferred 2 years clinical trial experience. • Preferred monitoring experience. • Able to work independently once trained. • Good verbal and written communication skills. • Strong organizational skills. • Basic computer proficiency. • Understanding of clinical research processes and regulations. • Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required Working Conditions: • Up to 20% travel for In-House Clinical Research Associates; up to 80% travel for Field Clinical Research Associates. • 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus. • Extensive use of a computer keyboard. Pay Range Minimum: $54,400.00 Pay Range Target: $80,100.00 Pay Frequency: Annual Please Note: Individual base pay depends on various factors, in addition to primary work location, such as complexity and responsibility of role, job duties/requirements, and relevant experience and skills. NAMSA is an equal employment opportunity company. NAMSA participates in pre-employment background and drug screen processes aligned to local, state and federal laws. Fair Chance Employment Statement: At NAMSA, we are committed to providing equal employment opportunities to all qualified applicants, including those with arrest or conviction records. In accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act, we will consider qualified applicants with a criminal history. Please note that NAMSA conducts a review of criminal history after the interview process and offer acceptance. This review is conducted to ensure that there is no direct, adverse, or negative relationship between the criminal history and the material job duties of the specific position. The following is a list of material job duties for this position: • May operate equipment • Records data timely and accurately • May analyze and interpret data • Conducts studies on medical devices that have an impact on human life A criminal history that directly impacts the ability to perform these duties may result in the withdrawal of a conditional offer of employment. We believe in fair chance hiring and are committed to evaluating each applicant on a case-by-case basis.
    $54.4k-80.1k yearly Auto-Apply 60d+ ago
  • Associate Directer, Clinical Research

    TJ Consulting Group

    Clinical research associate job in Lancaster, SC

    Seeking an experienced Associate Director of Clinical Research to lead and oversee clinical trials for products regulated by the FDA. This role requires deep experience in managing clinical trial phases within pharmaceutical or supplement companies. Responsibilities Oversee and manage clinical research programs from planning through completion Ensure compliance with FDA regulations and GCP guidelines Lead cross-functional teams and external research partners Review and analyze clinical data and reporting Contribute to regulatory strategy and submissions Qualifications Extensive experience in clinical research within FDA-regulated environments Prior experience managing clinical trials for pharmaceutical or supplement products Strong leadership, analytical, and regulatory knowledge We are committed to fostering an inclusive workplace and provides equal employment opportunities (EEO) to all employees and applicants for employment. We do not employ AI tools in our decision-making processes. Regardless of race, color, religion, sex (including pregnancy), sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran. ensures that all employment decisions are made in accordance with applicable federal, state, and local laws. Our commitment to non-discrimination in employment extends to every location in which our company operates.
    $50k-79k yearly est. 13d ago
  • Research Associate - Clinical Trials Office

    Augusta University 4.3company rating

    Clinical research associate job in Augusta, GA

    * About Us Augusta University is Georgia's innovation center for education and health care, training the next generation of innovators, leaders, and healthcare providers in classrooms and clinics on four campuses in Augusta and locations across the state. More than 10,500 students choose Augusta for educational opportunities at the center of Georgia's cybersecurity hub and experiential learning that blends arts and application, humanities, and the health sciences. Augusta is home to Georgia's only public academic health center, where groundbreaking research is creating a healthier, more prosperous Georgia, and world-class clinicians are bringing the medicine of tomorrow to patient care today. Our mission and values ***************************************** make Augusta University an institution like no other. Augusta University's distinct characteristics in education and research include real-world experiences and community engagement, as well as a culture of building community, corporate and government partnerships that address health, security, economic and societal concerns locally and across the state. The University System of Georgia ******************************************************************************************* is comprised of our 26 institutions of higher education and learning as well as the System Office. Our USG Statement of Core Values are Integrity, Excellence, Accountability, and Respect. These values serve as the foundation for all that we do as an organization, and each USG community member is responsible for demonstrating and upholding these standards. More details on the USG Statement of Core Values and Code of Conduct are available in USG Board Policy 8.2.18.1.2 and can be found online at ************************************************************************** Additionally, USG supports Freedom of Expression as stated in Board Policy 6.5 Freedom of Expression and Academic Freedom found online at ************************************************ Location Augusta University Our Health Sciences Campus: 1120 15th Street, Augusta, GA 30912 Our Summerville Campus: 2500 Walton Way, Augusta, GA 30904 College/Department Information Augusta University is actively participating in ways to improve the health and lives of the people of our community, our state, and around the world. To do this, we conduct research, a great deal of which is done through clinical trials in humans (known as human subject research). There are many federal requirements that all research institutions must meet in order to conduct human subject research. We have an outstanding, dynamic, and growing group of researchers, administrators, and office staff ready to assist. Our defined strengths lie in the areas of: Conventional clinical trials; Community, population health, social, behavioral, and educational research; Community education; Well-defined research initiation process; Ongoing and continued support for conduct of research; Integrated and technology advanced IT systems to support efficient research processes. Job Summary The Research Associate conducts research responsibilities for assigned studies. Be familiar with study protocols, assist investigators with recruiting patient studies. Screen potential patients, help enroll and randomize patients with into studies. Collect and enter study data, prepare and maintain regulatory documents, resolve data queries. Schedule patient visits and procedures, perform or assist with venipuncture, prepare specimens for shipment. This position will provide assistance to the overall functioning activities of the Clinical Trials Office (CTO). Responsibilities Responsibilities to include, but are not limited to: Coordination of clinical research trials to include meeting with drug and device company representatives, screening, recruiting and consenting patients, scheduling follow-up appointments, coordinating care with other departments, and performing all laboratory and other tests as required by the protocol. Attend meetings, computer training, and workshops as requested. Keep investigator informed of patients' condition and provide assistance to investigators in the management of adverse events. Receive and respond to all correspondence received in a timely manner. Complete all reports including the annual study continuation report in a timely manner ' accurately communicate all necessary information to patients, families, investigators, sponsors, IRB, and institutional entities. Responsible for collection, processing, storage, and inventory of specimens for specific studies, assessing for adverse events, maintaining investigational devices, staff development and completion of regulatory paperwork as required by the FDA, study sponsor, and institutional policies and procedures for all assigned studies as well as the Annual IRB Continuation Reports and other IRB activities as requested. Maintain all FDA, sponsor, and institutional review board documentation. Obtain and maintain complete source documentation. Accurate and timely completion of all case report forms and other data entry as required by the sponsor and local institutional data management programs. Enter data into the OnCore research data management system as dictated per institutional policy as well as the Greenphire patient debit system. Review study bills received for accuracy ensuring that the correct codes are used and the correct amount is billed according to the billing grid for that study in a timely manner. Perform all other related duties as assigned. Required Qualifications Master's degree from an accredited college or university in chemistry, biology, biochemistry, cell biology or other natural, life, health care or materials science directly related to the research area to which the position is assigned and experience in research, basic science or clinical laboratory particularly clinical trial research. OR Bachelor's degree from an accredited college or university in chemistry, biology, biochemistry, cell biology or other natural, life, health care or materials science directly related to the research area to which the position is assigned and a minimum of three years' research and/or clinical experience. Knowledge, Skills, & Abilities KNOWLEDGE Proficient in Microsoft Office and other computer software/databases. SKILLS Excellent interpersonal, written, and verbal communication skills. Detail-oriented with strong multi-tasking and prioritization. ABILITIES Ability to maintain confidentiality. Ability to recognize potential adverse events and follow SOPs for reporting of such. Ability to follow protocols as designed, remember protocols, and communicate with patients. Ability to adapt workflow to accommodate study amendments and principal investigator directions. Ability to work as a team player and adjust daily schedule in order to accommodate patient and investigator schedules. Must be willing to work flexible hours which may include early mornings, after hours, nights and weekends which may include up to two weeks on call per month. Ability to communicate clearly at all times, convey information in a professional manner which will most often involve sensitive patient data or other information. Must be able to communicate in non-abrasive manner. Shift/Salary/Benefits Shift: Days; Monday - Friday (Work outside of normal business hours may be required). Salary Range: $45,400-$56,700 annually. Pay Band: B8 Salary to be commensurate with qualifications of the selected candidate within the established range (generally minimum-midpoint) of the position. Recruitment Period: Until Filled. Augusta University offers a variety of benefits to full-time benefits-eligible employees and some of our half-time (or more) employees. Benefits that may be elected could include health insurance, dental insurance, life insurance, Teachers Retirement System (or Optional Retirement Plan), as well as earned vacation time, sick leave, and 13 paid holidays. Also, our full-time employees who have been employed with us successfully for more than 6 months can be considered for the Tuition Assistance Program. Consider applying with us today! Conditions of Employment All selected candidates are required to successfully pass a Background Check review prior to starting with Augusta University. If applicable for the specific position based on the duties: the candidate will also need to have a credit check completed for Positions of Trust and or approved departmental Purchase Card usage. Motor vehicle reports are required for positions that are required to drive an Augusta University vehicle. For Faculty Hires: Final candidates will be required to provide proof of completed academic degree(s) as well as post-secondary coursework in the form of original transcript(s). Those candidates trained by a foreign institution will also be required to provide an educational/credential evaluation. All employees are responsible for ensuring the confidentiality, availability, and integrity of sensitive [patient, student, employee, financial, business, etc.] information by exercising sound judgment and adhering to cybersecurity and privacy policies during their employment and beyond. Other Information This position is also responsible for promoting a customer-friendly environment and providing superior service to our patients, students, faculty, and employees. "Augusta University is a patient-and family-centered care institution, where employees partner every day with patients and families for success." Augusta University is a tobacco-free environment, and the use of any tobacco products on any part of the campus, both inside and outside, is strictly prohibited. Equal Employment Opportunity Augusta University is proud to be an equal opportunity employer, welcoming applicants from underrepresented groups, including individuals with disabilities and veterans. How To Apply Consider applying with us today! ******************************** Search for Job ID: 288933. Select University Faculty & Staff > External Applicants if you are a candidate from outside the university. Select University Faculty & Staff > Internal Applicants if you are a current university employee. If you need further assistance, please contact us at ************.
    $45.4k-56.7k yearly 60d+ ago
  • Senior Clinical Research Site Manager

    HCA Healthcare 4.5company rating

    Clinical research associate job in Savannah, GA

    is incentive eligible. **Introduction** Last year alone, HCA Healthcare colleagues invested over 156,000 hours impacting our communities. As a Senior Clinical Research Site Manager with Memorial Health University Medical Center, you can be a manager in an organization that is devoted to giving! **Benefits** Memorial Health University Medical Center, offers a total rewards package that supports the health, life, career and retirement of our colleagues. The available plans and programs include: + Comprehensive medical coverage that covers many common services at no cost or for a low copay. Plans include prescription drug and behavioral health coverage as well as free telemedicine services and free AirMed medical transportation. + Additional options for dental and vision benefits, life and disability coverage, flexible spending accounts, supplemental health protection plans (accident, critical illness, hospital indemnity), auto and home insurance, identity theft protection, legal counseling, long-term care coverage, moving assistance, pet insurance and more. + Free counseling services and resources for emotional, physical and financial wellbeing + 401(k) Plan with a 100% match on 3% to 9% of pay (based on years of service) + Employee Stock Purchase Plan with 10% off HCA Healthcare stock + Family support through fertility and family building benefits with Progyny and adoption assistance. + Referral services for child, elder and pet care, home and auto repair, event planning and more + Consumer discounts through Abenity and Consumer Discounts + Retirement readiness, rollover assistance services and preferred banking partnerships + Education assistance (tuition, student loan, certification support, dependent scholarships) + Colleague recognition program + Time Away From Work Program (paid time off, paid family leave, long- and short-term disability coverage and leaves of absence) + Employee Health Assistance Fund that offers free employee-only coverage to full-time and part-time colleagues based on income. Learn more about Employee Benefits (********************************************************************** **_Note: Eligibility for benefits may vary by location._** Come join our team as a Senior Clinical Research Site Manager. We care for our communities and employees! HCA Hope Fund in fourteen years reached a historic milestone: $50 million in help to our colleagues in need. Last year, HCA Healthcare and our colleagues donated $13.8 million dollars to charitable organizations. Apply Today! **Job Summary and Qualifications** The Senior Site Manager is responsible for overall clinical operations and management of a specified HCA Research Institute site and its affiliated physician groups. The Site Manager serves as a liaison with local investigators, hospital administration, and local research personnel. **Duties include but are not limited to:** Research Operations Management · Oversee and manage routine operational activities of HRI site research staff · Liaise between site research personnel, industry sponsors, and HRI Division Director/leadership · Collaborate closely with various site departments/teams, including finance, relevant hospital administrative representatives, and the local IRB, if applicable · Review proposed budgets for adequate coverage and recommends changes to Supervisor · Facilitate contracting with hospitals, provider groups, and/or vendors, as needed · Engage with revenue integrity to assist with reconciling study payments at the site · Actively engage in tracking of studies conducted at the site · Oversee study progress at the site from initial submission of feasibility until study closeout · Coordinate submission and approval for the Site's Facility Review Committee, if applicable · Manage HRI site team responsible for coordinating multiple research studies across several therapeutic areas · Leads division operations counsel and manages accuracy of research billing compliance in partnership with HCA Division Director of Revenue Integrity as · Manages relationships across programs with multiple service lines Site development: · Work with site personnel, local investigators, and hospital administration to assess site feasibility and resourcing for existing and upcoming research protocols · Assist in development and tracking of quarterly site goals · Regularly meet with physicians and administrators to assess site performance and investigator satisfaction · Provide a research update during Site Administrative meetings (Section meetings, Site Service Line meetings, etc.) Reporting and Analysis: · Monitor patient enrollment at the site through weekly reports, and reports results to Supervisor · Communicate site status and site development through a monthly activity report · Facilitate continuing education and training to investigators and site research team members · Evaluate operational metrics to continuously improve study quality and/or improve processes · Complete performance evaluations for direct reports · Partners with site CFO to support growth strategies and reporting **Education & Experience:** · Bachelor's Degree required; Master's Degree preferred · 7+ years of experience in healthcare, research, or other science related field **Licenses, Certifications & Training:** · Research certification (ACRP or CCRP) "The great hospitals will always put the patient and the patient's family first, and the really great institutions will provide care with warmth, compassion, and dignity for the individual."- Dr. Thomas Frist, Sr. HCA Healthcare Co-Founder Become a manager with an organization that invests in your career while giving to the community. We are seeking distinguished applicants for our Senior Clinical Research Site Manager opening. Help HCA Healthcare create healthier tomorrows for patients and communities. We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
    $74k-92k yearly est. 60d+ ago
  • Senior Clinical Research Coordinator

    Alliance for Multispecialty Research

    Clinical research associate job in Myrtle Beach, SC

    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.
    $42k-64k yearly est. Auto-Apply 10d ago
  • Clinical Research Coordinator II

    Cenexel 4.3company rating

    Clinical research associate job in Savannah, GA

    About Us: Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. Job Summary: Responsible for coordinating all aspects of clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies. Essential Responsibilities and Duties: Under supervision, coordinates aspects of patient involvement for complex and/or multiple studies from study initiation until study completion. Organizes research information for clinical trials. Observes subjects and assists with data analysis and reporting. Schedules the collection of data. Reviews, and reports adverse events, protocol deviations, and other unanticipated problems appropriately. Monitors, and reports research data to maintain quality and compliance. Performs administrative and regulatory duties related to the study as appropriate. Participates in other protocol development activities. Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.) Educates potential participants and caregivers on protocol specific details and expectations. Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned). Assists Clinical Trial Manager (CTM) with oversight of vendors, accounting, regulatory, client satisfaction, recruitment, quality, and trial outcomes. Assists the CTM in planning, creating processes, trainings and development of staff. Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive. Education/Experience/Skills: Must have proper experience and demonstrate mastery of Clinical Research Coordinator I position. High school graduate or equivalent; Bachelors Degree, preferred CCRC certification preferred 2-3 years of experience in the medical field, preferred Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials. Strong leadership and mentorship skills. Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level. Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations. Works independently as well as functioning as part of a team. Must be able to effectively communicate verbally and in writing. Working Conditions Indoor, Office environment. Shift work, depending on location. Essential physical requirements include sitting, typing, standing, and walking. Lightly active position, occasional lifting of up to 20 pounds. Reporting to work, as scheduled, is essential. Overnight travel may be required for training and/or investigative meetings. CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.
    $45k-66k yearly est. 32d ago
  • UNIV- Research Study Coordinator - Hollings Cancer Center

    MUSC (Med. Univ of South Carolina

    Clinical research associate job in Charleston, SC

    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: ***************************************
    $41k-59k yearly est. 6d ago
  • Clinical Research Study Assistant II - Psychiatry

    Washington University In St. Louis 4.2company rating

    Clinical research associate job in Forest Park, GA

    Scheduled Hours40The Cruchaga Lab, the NeuroGenomics and Informatics (NGI) Center, at WashU Medicine is recruiting a Clinical Research Study Assistant. We are seeking an experienced, self-motivated, self-driven person to work as a part of vibrant group in a fast-paced environment. This person will work in a collegial environment and join a multidisciplinary, diverse team in a well-established, well-funded research group, currently 30+ dynamic members, to explore the frontiers of neurodegenerative diseases. The NGI generates and analyzes Whole-Genome and high-throughput multi-dimensional omics data to study neurodegenerative diseases of the central nervous system. The goal of our research is to use genomic and multi-omic approaches to understand the biology neurodegenerative diseases. Under the direction of the Research Coordinators or PI, they will participate in moderately complex clinical research study activities. The Clinical Research Study Assistant will be responsible for multiple study's biospecimens including, but not limited to: blood, plasma, serum, and brain. They will perform a variety of duties including the oversight, organization and handling of these biospecimen samples for these multiple studies. They will ship samples and be responsible for an accurate manifest. They will be trained on the lab's database system to maintain the order of the samples. They will be responsible for assembling outgoing biospecimen kits for multiple studies. As needed, they will draw blood from research participants at our various clinics. They will work with the research coordinators for any other responsibilities that may be needed.Job Description Primary Duties & Responsibilities: Assists clinical research coordinators with management of clinical trials, by creating outgoing biospecimen kits for blood collection and recording data appropriately. Assists clinical research coordinators by receiving biospecimen samples from off-campus clinics, evaluating condition of samples, entering into the database, and reporting any issues to the coordinators. Assists with study sample tracking of home locations and shipping outgoing samples, as needed. Assists with general supply/equipment orders, material shipments to collaborators, maintenance and cleaning. Complies with established safety procedures and maintains required documentation on laboratory and specimen conditions. Working knowledge of computer programs and systems such as Excel and Word, as well as Filemaker Pro and/or Freezerworks. Assists current phlebotomists with blood drawing duties as needed. Assists with other duties as assigned by research team. The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel so classified. Management reserves the right to revise or amend duties at any time.Required Qualifications Education: High school diploma or equivalent high school certification or combination of education and/or experience. Certifications/Professional Licenses: The list below may include all acceptable certifications, professional licenses and issuers. More than one credential, certification or professional license may be required depending on the role.Basic Life Support - American Heart Association, Basic Life Support - American Red Cross Work Experience: Administrative Or Research (2 Years) Skills: Not Applicable Driver's License: A driver's license is not required for this position.More About This Job For more information about the NeuroGenomics and Informatics Center, please visit our website at this link. Required Qualifications: Basic Life Support certification must be obtained within one month of hire date Basic Life Support certification (Online Basic Life Support certifications, those without a skills assessment component, are not sufficient to meet the Basic Life Support requirements). Preferred Qualifications Education: Associate degree Certifications/Professional Licenses: No additional certification/professional licenses unless stated elsewhere in the job posting. Work Experience: Customer Service (1 Year) Skills: Clinical Trials, Data Entry, Data Management, FileMaker Pro, Freezerworks (Software), Interpersonal Communication, Oral Communications, Ordering Supplies, Organizing, Safety Protocols, Sample Collection, Written CommunicationGradeC07-HSalary Range$19.21 - $28.85 / HourlyThe salary range reflects base salaries paid for positions in a given job grade across the University. Individual rates within the range will be determined by factors including one's qualifications and performance, equity with others in the department, market rates for positions within the same grade and department budget.Questions For frequently asked questions about the application process, please refer to our External Applicant FAQ. Accommodation If you are unable to use our online application system and would like an accommodation, please email **************************** or call the dedicated accommodation inquiry number at ************ and leave a voicemail with the nature of your request. All qualified individuals must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship.Pre-Employment ScreeningAll external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. The screenings will include criminal background check and, as applicable for the position, other background checks, drug screen, an employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. All offers are contingent upon successful completion of required screening.Benefits Statement Personal Up to 22 days of vacation, 10 recognized holidays, and sick time. Competitive health insurance packages with priority appointments and lower copays/coinsurance. Take advantage of our free Metro transit U-Pass for eligible employees. WashU provides eligible employees with a defined contribution (403(b)) Retirement Savings Plan, which combines employee contributions and university contributions starting at 7%. Wellness Wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more! Family We offer 4 weeks of caregiver leave to bond with your new child. Family care resources are also available for your continued childcare needs. Need adult care? We've got you covered. WashU covers the cost of tuition for you and your family, including dependent undergraduate-level college tuition up to 100% at WashU and 40% elsewhere after seven years with us. For policies, detailed benefits, and eligibility, please visit: ****************************** EEO StatementWashington University in St. Louis is committed to the principles and practices of equal employment opportunity and especially encourages applications by those from underrepresented groups. It is the University's policy to provide equal opportunity and access to persons in all job titles without regard to race, ethnicity, color, national origin, age, religion, sex, sexual orientation, gender identity or expression, disability, protected veteran status, or genetic information.Washington University is dedicated to building a community of individuals who are committed to contributing to an inclusive environment - fostering respect for all and welcoming individuals from diverse backgrounds, experiences and perspectives. Individuals with a commitment to these values are encouraged to apply.
    $19.2-28.9 hourly Auto-Apply 52d ago
  • Clinical Research Coordinator II

    Care Access 4.3company rating

    Clinical research associate job in Dalton, GA

    Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine , which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers , which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit ******************* How This Role Makes a Difference The Clinical Research Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. How You'll Make An Impact Patient Coordination Prioritize activities with specific regard to protocol timelines Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials. Maintain effective relationships with study participants and other care Access Research personnel. Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management. Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives. Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate) Prescreen study candidates Obtain informed consent per Care Access Research SOP . Complete visit procedures in accordance with protocol. Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc. Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion. Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff. Documentation Record data legibly and enter in real time on paper or e-source documents Accurately record study medication inventory, medication dispensation, and patient compliance. Resolve data management queries and correct source data within sponsor provided timelines Assist regulatory personnel with completion and filing of regulatory documents. Assist in the creation and review of source documents. Patient Recruitment Assist with planning and creation of appropriate recruitment materials. Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database. Actively work with recruitment team in calling and recruiting subjects Review and assess protocol (including amendments) for clarity, logistical feasibility Ensure that all training and study requirements are met prior to trial conduct Communicate clearly verbally and in writing Attend Investigator meetings as required Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) The Expertise Required Ability to understand and follow institutional SOPs. Excellent working knowledge of medical and research terminology Excellent working knowledge of federal regulations, good clinical practices (GCP) Ability to communicate and work effectively with a diverse team of professionals. Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel. Critical thinker and problem solver Friendly, outgoing personality; maintain a positive attitude under pressure. High level of self-motivation and energy Excellent professional writing and communication skills Ability to work independently in a fast-paced environment with minimal supervision. Certifications/Licenses, Education, and Experience: Bachelor's Degree preferred, or equivalent combination of education, training and experience. A minimum of 3 years prior Clinical Research Coordinator experience required Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator Recent phlebotomy experience required Licenses: California based roles require National phlebotomy certification by an organization approved by the California Department of Public Health Louisiana based roles require National phlebotomy certification by an organization approved by the Louisiana State Board of Medical Examiners Washington based roles require National phlebotomy certification by an organization approved by the Washington State Department of Health Nevada based roles require Laboratory Assistant certification by the Division of Public and Behavioral Health How We Work Together Location: This is an on-site position with regional commute requirements, located in Dalton, Georgia Travel: This role requires up to 10% travel requirements further explained below. Length of travel will depend upon study requirements, staff needs, and company initiatives. Type of travel required: Regional (within 100 miles) Physical demands associated with this position Include: The ability to use keyboards and other computer equipment. Walking - 20% Standing - 20% Sitting - 20% Lifting - 20% Up to 25lbs Over 25lbs Overhead Driving - 20% The expected salary range for this role is $60,000 - $90,000 USD per year for full time team members. Benefits & Perks (US Full Time Employees) Paid Time Off (PTO) and Company Paid Holidays 100% Employer paid medical, dental, and vision insurance plan options Health Savings Account and Flexible Spending Accounts Bi-weekly HSA employer contribution Company paid Short-Term Disability and Long-Term Disability 401(k) Retirement Plan, with Company Match Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************
    $60k-90k yearly Auto-Apply 5d ago
  • Clinical Research Coordinator/DHS II - Calhoun, GA 1.14.26

    N-Power Medicine

    Clinical research associate job in Calhoun, GA

    About N-Power Medicine N-Power Medicine aims to establish a new paradigm in drug development by reinventing the ‘how' and transforming clinical trials through better integration with clinical practice, ensuring broader participation by physicians and patients. We are building an exceptional multi-disciplinary team with diverse expertise spanning healthcare, engineering, technology and regulatory, and with people who share our core value of Empowering Community through generosity, curiosity and humility. We are working with urgency to bring better therapies to patients faster. Position Summary You will be a part of the rapidly changing clinical oncology environment with the opportunity to impact the future of clinical research and improve patients' lives while growing professionally at a dynamic, fast-growing, start-up organization. As the Digital Health Specialist II (internal title), you will work at a clinical site in Calhoun, GA. The ideal candidate has clinical oncology research experience or research experience in a healthcare setting. You are confident in your understanding of clinical workflow, patient data systems and clinical research in an oncology setting. We are looking for individuals who are motivated and ambitious professionals who desire to positively influence and innovate upon the quality of care for patients diagnosed with cancer. Roles and Responsibilities Serve as the Company's trusted face to the clinical practice, providing clinical support while advancing research data collection. Interface directly with the healthcare providers and patients. Perform peer review of clinical documentation for data quality and completeness. Partner with Senior DHS to address any clinic or team issues and concerns. Obtain informed consent for N-Power Medicine's clinical trials. Assist and participate in the site clinical trial initiation and clinical trial(s) activities as assigned. Ensure adherence to study protocols, data completeness and patient consent. Assist in patient recruitment strategies where appropriate. Foster collaborative relationships by effectively communicating with clinical site staff, internal stakeholders, and the N-Power Medicine team by attending site specific meetings. Build and maintain relationships at the clinical site, becoming part of the functional team of practitioners. Ensure quality and integrity of data capture, compliance and confidentiality with N-Power Medicine's and site's policies, standard operating procedures (SOPs), and Good Clinical Practice (GCP). Respond to queries regarding missing, aberrant, or potential outlier data and data verification- escalate to the health care provider as necessary for resolution. Provide proactive input and user experiences for our software. Additional duties and responsibilities as required. Generous, curious and humble. Qualifications 3+ years of experience in oncology clinical research and/or oncology ambulatory care preferred Bachelor's degree, focused in health science or related field preferred Certified Clinical Research Coordinator, Associate or Professional (CCRC, CCRA or CCRP) preferred Knowledge of clinical trials, study-specific operating procedures and patient consent forms Strong desire to drive a paradigm change in clinical research conduct and improve patients' lives Compassionate focused patient care Supports and encourages other team members, contributing to a positive team environment Self-starter, able to work independently, prioritize actively, seek input, and problem solve in complex and fast-evolving environments Results oriented focused on delivering the goals set-forth Attention to detail and strong organizational skills Excellent oral/written communication and interpersonal skills Critical thinking and proven problem-solving skills Work hours are dependent on local Network Partner Clinics (typically M-F, 8-5pm) Please note that state-specific background checks and screenings may be required for this role. Employment is contingent upon successfully passing all applicable screenings.Travel Requirements Daily travel between sites may be required More About UsWe are a mission driven, well -funded, rapidly growing company, eager to attract passionate professionals offering a highly attractive compensation package with a balanced and flexible work environment, competitive industry benefits as well as a 401K plan and other great company “perks.” We are an Equal Opportunity Employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. Covid-19 Policy - The Company is committed to providing and maintaining a safe workplace, and to safeguard the health and well-being of our employees, families, visitors, and the community. While vaccination remains one of the most important tools in advancing the health and safety of employees and promoting the efficiency of workplaces, we are now in a different phase of our response when these measures are no longer necessary. We currently do not have mandatory COVID-19 vaccination requirements for our employees and contractors, as the COVID-19 public health emergency has ended. However, there are certain N-Power Medicine employees and contractors who, based on their role, will be required to continue to follow our 2021 COVID-19 vaccination and other requirements as mandated by N-Power Medicine's partners they serve. We reserve the right to modify or amend our corporate policy at any time. Applicants must be currently authorized to work in the U.S. on a full-time basis. The Company will not sponsor applicants for work visas. If you find this opportunity compelling, we encourage you to apply today! We promptly review all applications. Highly qualified candidates will be directly contacted by a team member.
    $43k-63k yearly est. Auto-Apply 13d ago
  • Imaging Clinical Coordinator/Sign on bonus

    Southcoast Health 4.2company rating

    Clinical research associate job in Savannah, GA

    Job Description SouthCoast Health is looking for a Full-time Clinical Coordinator for our Imaging Department Sign on bonus $5,000 The Imaging Center Clinical Coordinator works collaboratively with the Imaging Office Manager and Radiologists to oversee daily clinical operations within the Radiology Department. This role ensures high-quality patient care, compliance with regulatory and accreditation standards, and effective supervision and development of clinical staff. The Coordinator serves as a clinical leader, resource, and liaison among physicians, technologists, staff, students, and patients. Responsibilities & Duties: Clinical Leadership & Operations •Provide day-to-day clinical leadership and supervision of imaging technologists and ancillary clinical staff. •Ensure delivery of safe, high-quality, patient-centered care that is culturally and linguistically appropriate. •Coordinate staffing, scheduling, and coverage across all modalities to ensure operational efficiency. •Oversee cross-training of technologists to support staffing flexibility and service continuity. •Monitor clinical work queues and workflow to optimize patient throughput and service quality. Staff Management & Development •Participate in interviewing, hiring, onboarding, coaching, disciplinary actions, and termination of clinical staff in accordance with organizational policies. •Conduct regular performance evaluations and provide constructive feedback to support staff development. •Maintain documentation of required credentials including licensure, CPR/BLS, TB testing, radiation safety training, and continuing education. •Organize and lead monthly staff meetings and annual technologist development events. Quality, Safety & Compliance •Ensure compliance with all applicable federal, state, and local regulations, including OSHA, HIPAA, and radiation safety standards. •Maintain and oversee quality assurance (QA) programs for all imaging modalities, including monthly audits and peer review processes. •Support and maintain ACR and other accreditation requirements. •Oversee equipment quality control, preventive maintenance schedules, physicist visits, film badge monitoring, and lead apron inspections. •Maintain pediatric CT dose charts and ensure adherence to ALARA principles. •Coordinate FDA and regulatory inspections as required. Equipment & Technology •Ensure imaging equipment is maintained in proper working order; promptly report and coordinate repair of malfunctions. •Participate in evaluation and planning for new equipment purchases and technology upgrades. •Track and manage learning management system (LMS) training requirements for clinical staff. Patient Relations & Service Recovery •Address and resolve patient complaints or clinical concerns related to quality of care. •Identify trends in patient feedback and recommend improvements to policies, procedures, and clinical protocols. Education/ Experience: Associate's degree (A.A.) or equivalent two-year program from an accredited college or university, or diploma from an accredited technical school. Licensure and certifications from registry boards applicable to modality registered in. Minimum of five (5) years of clinical experience and minimum of two (2) years supervisory experience preferred or equivalent combination of education and experience. Benefits: Competitive salary, health, HSA/FSA, dental, vision, life, long term disability, 401(K) along with employer contribution, supplemental insurance policies. PTO, holidays, and bereavement leave. EEO, DFW, MFVD
    $49k-62k yearly est. 20d ago
  • Clinical Research Coordinator

    No-Resistance Consulting Group

    Clinical research associate job in Atlanta, GA

    : Headquartered in Birmingham, No Resistance is a clinical trial site management organization that performs clinical trials in urgent care centers throughout the north and southeast. We focus on sample collection and testing trials for lab device manufacturers with the purpose of collecting data to support the device's 510(k) or emergency use approval by the FDA. Notably, the trials we have participated in have directly led to the FDA EUA approval of three separate COVID-19 PCR testing platforms. No clinical trial experience is required. No Resistance will train the right candidate(s). Hours are Monday-Friday 8:30 am to 5:00 pm with no weekend requirements. Job Description: No Resistance is seeking motivated individuals to join our team! In this role, you'll play a pivotal part in the implementation and execution of clinical research projects, ensuring the successful attainment of quality, safety, regulatory, and financial objectives. Job Duties: Maintaining regulatory binders, inventory of study-specific and clinical supplies. Recruiting, and enrolling study subjects. Obtaining informed consent. Collecting nasal swab samples. Testing samples on investigational laboratory PCR analyzers. Data collection and entry. Query resolution. Assuring protocol compliance and efficient workflow including organizing clinical work areas, tracking and ordering study supplies and shipping materials, checking and replacing expired items, etc. Key Success Factors: Ability to work independently. Desire to work in a clinical environment with direct patient contact. Genuine interest in research. Timely in all communications. Superior attention to detail. While not a requirement, senior pre-medical students who hope to gain experience in clinical research or recent graduates who have a "gap" year before they start medical school are encouraged to apply. This position offers an exceptional opportunity to earn a competitive income while gaining invaluable experience highly regarded by medical school admission committees. Job Type: Full-time Pay: $25.00 per hour Expected hours: 40 per week Benefits: 401(k) Dental Insurance Health Insurance Paid time off Vision Insurance Schedule: Monday to Friday Work Location: In person
    $25 hourly 18d ago
  • Clinical Assistant- Dr. Rao- Ft. Mill (46630)

    Charlotte Eye Ear Nose and Throat Associates Pa 3.2company rating

    Clinical research associate job in Fort Mill, SC

    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
    $39k-51k yearly est. 17d ago
  • Clinical Research Assistant / Medical Assistant

    Alcanza Clinical Research

    Clinical research associate job in Woodstock, GA

    Job DescriptionDescriptionAlcanza is a growing multi-site, multi-phase clinical research company with a network of locations in AL, AZ, FL, GA, IL, MA, MI, MO, NV, SC, TX, VA, 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 Research Assistant (RA) provides support to the Clinical Research Coordinators (CRCs), Site Manager, Principal and Sub Investigators, and other site staff in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs. The RA performs clinical, lab, and administrative tasks as needed for the successful operation of the clinical research site. Key ResponsibilitiesEssential Job Duties: In collaboration with other members of the clinical research site team, assists with the execution of assigned studies, and support functions as needed. Responsibilities may include but are not limited to: Under the direction of the Site Manager/Director and the Principal/Sub Investigators, assists the CRCs and other site staff in their responsibilities by conducting the following according to study protocol: Assists with the basic screening of patients for study enrollment; Assists with patient follow-up visits; Documents in source clinic charts; Enters data in EDC and answers queries; Obtains vital signs and ECGs; May perform blood draws; 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; Request and track medical record requests; Enters data in EDC and answers queries; Assists the CRC with updating and maintaining logs and filing in charts, and with chart filing; and Schedules subjects for study visits, conducts appointment reminders, and reschedules visits if needed; Ensures study related reports and patient results are reviewed by the Research Coordinator and/or investigator in a timely manner. Assists the CRC and/or Manager with study recruitment, patient enrollment, and tracking as needed; Maintains strict confidentiality of patients, employees, customers and company information at all times and adheres to HIPAA Guidelines; and Perform all other duties as requested or assigned. Skills, Knowledge and ExpertiseMinimum Qualifications: A High School diploma and 1 year of administrative / clinical experience is required. 1 year or more years of clinical research or clinical experience is preferred. Bi-lingual (English / Spanish) proficiency is a plus. Required Skills: Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm). Must possess 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.
    $31k-43k yearly est. 13d ago
  • UNIV - Research Study Coordinator - Hollings Cancer Center

    MUSC (Med. Univ of South Carolina

    Clinical research associate job in Charleston, SC

    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: ***************************************
    $41k-59k yearly est. 20d ago
  • Clinical Research Assistant / Medical Assistant

    Alcanza Clinical Research

    Clinical research associate job in Woodstock, GA

    Department Operations Employment Type Full Time Location North Georgia Clinical Research Workplace type Onsite Reporting To Stephanie Hurst Key Responsibilities Skills, Knowledge and Expertise Benefits About Alcanza Clinical Research Alcanza Clinical Research (“Alcanza”) is a national, collaborative network of clinical research sites, founded on the mission to accelerate the development of new therapies by reducing barriers to clinical research participation for all. We conduct research on dozens of conditions in several therapeutic areas including psychiatry, neurology, dermatology, and infectious disease. Our work is important to the patients who participate, the scientists who develop these new therapies, and the entire medical community. Because all approved medications require clinical trials, the impact of your work is exponential, reaching many thousands of future patients and improving their quality of life. Alcanza is a culturally competent organization. We treat each other with dignity, creating an environment where all individuals feel welcome, heard, and respected for their unique perspectives and aspirations. We put considerable effort into finding exceptional employees who mirror the values most important to us: Inclusive, Impactful, Compassionate, and Determined. Alcanza Clinical Research is an Equal Opportunity Employer that values and respects the importance of a diverse and inclusive workforce. It is the policy of the company to recruit, hire, train and promote persons in all job titles without regard to race, color, religion, sex, age, national origin, marital status, veteran status, disability, sexual orientation, gender identity or expression, genetic information, or any other category protected by law. We recognize that diversity and inclusion is a driving force in the success of our company.
    $31k-43k yearly est. 12d ago

Learn more about clinical research associate jobs

How much does a clinical research associate earn in Savannah, GA?

The average clinical research associate in Savannah, GA earns between $42,000 and $100,000 annually. This compares to the national average clinical research associate range of $43,000 to $91,000.

Average clinical research associate salary in Savannah, GA

$65,000
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