Post job

Research Nurse jobs at Tennessee Oncology - 70 jobs

  • Research Tissue Coordinator

    Tennessee Oncology 4.4company rating

    Research nurse job at Tennessee Oncology

    Tennessee Oncology, one of the nation's largest, community-based cancer care specialists, is home to one of the leading clinical trial networks in the country. Established 1976 in Nashville, Tennessee Oncology's mission remains unchanged: To provide access to high-quality cancer care and the expertise of clinical research for all patients, at convenient locations within their community and close to their home. Our growing network of physicians and locations is based on this mission. Tennessee Oncology is committed to advancing both the science of detection and targeted treatments, and to making these advances available to every patient. We believe caring for cancer patients is a privilege. Why Join Us? We are looking for talented and highly-motivated individuals who demonstrate a natural desire to support the meaningful work of community oncologists and the patients we serve. Job Description: The Clinical Research Tissue Coordinator is responsible for the coordination, collection, processing, documentation, storage, and shipment of biospecimens for oncology clinical trials. This role ensures that all tissue and blood specimens are handled in strict accordance with protocol requirements, laboratory and pathology manuals, and regulatory standards, to support high-quality research data and patient safety. The coordinator serves as a key liaison between clinical research staff, pathology, laboratory services, and external vendors to ensure timeline and compliance with biospecimen management across studies. ESSENTIAL FUNCTIONS: Coordinates the collection of protocol-required biospecimens (e.g., tumor tissue, blood, bone marrow, other biological samples) for oncology clinical trials. Verifies specimen requirements including collection timepoints, volume, preservatives, temperature, and processing timelines. Ensures specimen are collected, processed, labeled, and stored according to protocol, laboratory and pathology manuals, and institutional policies. Labels, receives, and processes samples (blood, urine, tissue, etc.) for clinical trials per specific protocol guidelines to include logging samples into and out of the department. Performs quality checks to ensure specimen integrity and completeness prior to shipment. Ensures appropriate packaging, labeling, and courier scheduling for ambient, refrigerated, frozen, or cryogenic shipments. Communicates shipment status and resolves issues related to delayed, rejected, or compromised specimens. Requests, receives, and returns tissue samples from external pathology facilities. Records all data in specific forms per GCP/GDP (Good Clinical Practice/Good Documentation Practice) and protocol requirements. Identifies, documents, and escalates specimen-related deviation or noncompliance, and participates in root cause analysis and corrective/preventative action (CAPA) activities related to tissue errors as needed. Manages inventory of clinical trial supplies and kits, as well as departmental supplies Coordinates timely ordering and replacement of kits to avoid delays in specimen collection. Ensures proper storage and expiration monitoring of kits and reagents. May serve as an assistant to investigators during dissections or surgery. Maintains laboratory and surgical areas with proper aseptic techniques. Other duties as assigned. KNOWLEDGE, SKILLS & ABILITIES: Ability to make independent decisions, process information accurately, manage multiple projects simultaneously, and be organized. Ability to accurately pipette and maintain sterile conditions as required. Strong attention to detail Ability to follow complex protocols and manuals. Effective communication and cross-functional collaboration REQUIRED QUALIFICATIONS: High School Diploma required. Associate degree or higher preferred. Valid Driver's License required. Minimum of 1 year experience in clinical research, laboratory operations, pathology, or biospecimen management required. Experience working with pathology or histology specimens (e.g., FFPE blocks, slides) preferred. PHYSICAL REQUIREMENTS: Must be willing and able to lift up to 25 pounds. Must be willing and able to travel to biopsy facilities when necessary. Will require travel to location where specimen is being collected to obtain specimens from various sites in. Travel mileage to be reimbursed with properly filled out expense form.
    $44k-61k yearly est. Auto-Apply 5d ago
  • Job icon imageJob icon image 2

    Looking for a job?

    Let Zippia find it for you.

  • Research Nurse

    Tennessee Oncology 4.4company rating

    Research nurse job at Tennessee Oncology

    Tennessee Oncology, one of the nation's largest, community-based cancer care specialists, is home to one of the leading clinical trial networks in the country. Established 1976 in Nashville, Tennessee Oncology's mission remains unchanged: To provide access to high-quality cancer care and the expertise of clinical research for all patients, at convenient locations within their community and close to their home. Our growing network of physicians and locations is based on this mission. Tennessee Oncology is committed to advancing both the science of detection and targeted treatments, and to making these advances available to every patient. We believe caring for cancer patients is a privilege. Why Join Us? We are looking for talented and highly-motivated individuals who demonstrate a natural desire to support the meaningful work of community oncologists and the patients we serve. Job Description: As the Research Nurse for Tennessee Oncology Greco Hainsworth Center for Research you will play a critical role in advancing oncology research by ensuring the successful execution of clinical trials. You will be responsible for screening, enrolling, documenting, and monitoring study subjects by ensuring strict protocol compliance and delivering exceptional patient care. ESSENTIAL FUNCTIONS: * Enroll patients onto clinical trials through recruitment, screening, enrollment, treatment, and follow-up of eligible participants according to protocol requirements. * Provide thorough education about study requirements and expectations. * Complete and document the informed consent process accurately, ensuring all parties sign and date as required, including obtaining HIPAA Authorization. * Obtains and maintains informed consents of each patient for the duration of a study. * Review the study design and inclusion/exclusion criteria with physician and patient. * Complete and submit on-study forms within required timelines. * Maintain accurate and detailed source documentation, including study visits findings, and outcomes. * Screen all new patients or patients returning to office with scan results and document appropriately on patient tracking logs. * Monitor subjects throughout the study, ensuring compliance with protocols and maintaining patient safety. * Ensure that all medications are approved prior to initiating treatment or when changing medication regimens, such as crossover studies. * Dispense oral investigational products to study participants and provide guidance to ensure compliance with medication regimens. * Accurately calculate and document BSA, Creatinine Clearance, Urine Protein: Creatinine ratio, and any other calculations or conversions required per protocol. * Ensure that follow-up appointments, scans, or related procedures are scheduled correctly according to protocol requirements. * Record and report adverse events in accordance with study protocols and regulatory requirements. * Document appropriately when patients are removed from protocol. * Ensure reconsent of patients at the next scheduled visit, following availability of updated ICF, and documents process appropriately. * Provide patient education and medical information to study patients to ensure understanding or proper medication dosage, administration, and disease treatment. * Maintains medication inventory and reconciliation. * Collaborate with the clinical research team to ensure timely completion of study-related tasks and reporting. * Serve as a liaison between study participants, investigators, and the research team to address questions and concerns. * Float to other research Tennessee Oncology clinics as needed KNOWLEDGE, SKILLS & ABILITIES: * Strong attention to detail and organizational skills. * Ability to work independently while collaborating effectively with a multidisciplinary team. * Knowledge of medical and research terminology * Knowledge of FDA Code of Federal Regulations and GCP * Knowledge of the clinical research processes * At least one year of experience in a research setting preferred. * Research Certification (ACRP or CCRP) Preferred EDUCATION & EXPERIENCE: * An Associate Degree; preferably a bachelor's degree * RN License * At least one year of oncology experience PHYSICAL REQUIREMENTS: Job Title: Physical Activity Required Amount of time None Less than 1/3 (Occasionally) 1/3 to 2/3 (Frequently) More than 2/3 (Regularly) Standing X Walking X Sitting X Fingering or manual dexterity X Repetitive finger motion X Lifting or exerting force Up to 10 pounds Up to 25 pounds X Up to 50 pounds Up to 100 pounds Over 100 pounds Reaching or stretching X Climbing or balancing X Crouching or stooping X Speaking X Hearing X Seeing (with correction) X
    $49k-66k yearly est. Auto-Apply 57d ago
  • Clinical Research Coordinator III

    Denali Health 3.8company rating

    Stone Mountain, GA jobs

    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. 1d ago
  • Clinical Research, Clinical Research Associate (Remote)

    Castle Biosciences 3.7company rating

    Nashville, TN jobs

    Castle Biosciences Earns "Top Workplaces USA Award" for Phoenix, Pittsburgh, and Friendswood! Learn more at ************************* Castle Biosciences Inc. is growing, and we are seeking to hire a full-time Clinical Research Associate to work remotely from a home-based office in the USA, preferably located in the greater Chicago area, St. Louis, MO, Ohio, Virginia, Pennsylvania, Nashville, or Atlanta, within close proximity to a major airport. Why Castle Biosciences? * Exceptional Benefits Package: * Excellent Annual Salary + 20% Bonus Potential * 20 Accrued PTO Days Annually * 10 Paid Holidays * 401K with 100% Company Match up to 6% * 3 Health Care Plan Options + Company HSA Contribution * Company Stock Grant Upon Hire Salary Range: $90,000 - $95,000. Salary Range is based on Experience and Education levels. A DAY IN THE LIFE OF A Clinical Research Associate The Clinical Research Associate (CRA) is responsible for managing sites participating in Castle's clinical studies. Daily tasks vary based on study and site needs and may include attending team meetings, training site staff, sending emails, and traveling to U.S. sites to monitor data. The CRA performs all aspects of clinical monitoring and site management in compliance with ICH GCP, FDA guidelines, local regulations, protocols, and Castle's SOPs. This role ensures protocol and regulatory compliance, manages study documentation, and fosters strong relationships with sites. CRAs also play a key role in protecting participant safety, ensuring data quality, and representing Castle in the broader research community. REQUIREMENTS * Bachelor's degree in a science or healthcare-related field or a registered nursing certification, or equivalent certification/licensure from an appropriately accredited institution. * 3 years of CRC experience or previous 1 year experience as a CRA. * Direct patient care or clinical research experience required. * Familiarity with clinical research and study development processes. * Valid Driver's License where applicable. * In some cases, a combination of education, professional training, and demonstrated experience that provides the required knowledge, skills and abilities may be considered. TRAVEL/WORK ENVIRONMENT * Regular overnight travel by car and air, typically 50-60% of the time, with potential peaks up to 80% * Flexibility to accommodate an often changing and unpredictable timeline * Frequent laptop use * When in the office, there is a standard office environment with the use of a desk/phone/computer * Generally, proof of COVID-19 vaccination will be required to access study sites, in accordance with site-specific guidelines and subject to any applicable exceptions as required by Federal, State, and Local laws. SCHEDULE * M-F travel-based position; working remotely from your home based in the USA near a major airport. * Preferred locations include greater Chicago area, St. Louis MO, Ohio, Virginia, Pennsylvania, Nashville or Atlanta within close proximity to a major airport. READY TO JOIN OUR BIOTECH TEAM? We truly appreciate your time. If this feels like the right opportunity for you, we'd love for you to complete our mobile-friendly application. We're excited to learn more about you and look forward to connecting soon! Castle Biosciences Awards and Research Developments! WORK AUTHORIZATION All candidates must be legally authorized to work in the United States. Currently, Castle Biosciences does not sponsor H-1B visas, OPT, or employment-related visas. ABOUT CASTLE BIOSCIENCES INC. At Castle, it all comes down to people. After all, disease doesn't just happen - it happens to people. We believe that disease management and treatment decisions can be better informed through a person's unique biology, which is revealed through the scientific rigor of our innovative, laboratory-developed tests. We are committed to empowering healthcare providers and patients with the goal of improved outcomes. Every employee at Castle has an impact on patient care, and we work to ensure that everyone finds their work to be both challenging and rewarding. We behave with integrity and treat our colleagues with respect and kindness. Our culture fosters an environment of trust, transparency, and collaboration. We prioritize and encourage internal growth and professional development. Castle Biosciences is an equal opportunity employer as to all protected groups, including protected veterans and individuals with disabilities. If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please e-mail ReasonableAccommodationsRequest@castlebiosciences.com. This email was created exclusively to assist disabled job seekers whose disability prevents them from being able to apply online. Only messages left for this purpose will be returned. Messages left for other purposes, such as following up on an application or technical issues not related to a disability, will not receive a response. No third-party recruiters, please
    $90k-95k yearly 7d ago
  • Clin Research Nurse Coord

    Covenant Health 4.4company rating

    Knoxville, TN jobs

    Registered Nurse Coordinator, Cardiology Clinical Research Full Time, 80 Hours Per Pay Period, Day Shift Thompson Cancer Survival Center is our region's largest cancer-fighting network, with more imaging centers, more board-certified physicians and surgeons, and more cancer and radiation centers closer to where you call home. And, we are a proud member of Covenant Health, our region's top-performing healthcare network with 10 hospitals, outpatient and specialty services, and Covenant Medical Group, our area's fastest-growing physician practice division. Thompson Cancer Survival Center (TCSC) was founded to bring world-class cancer care to East Tennessee. At Thompson, leading cancer specialists use the most advanced technologies to achieve breakthrough successes in treating many types of cancer. Our doctors have the support of a complete team: Dieticians, genetics counselors, physicists, pharmacists, therapists, technologists, oncology nurses, social workers and others are all there to treat - and beat - the disease. Position Summary: The Clinical Research Nurse Coordinator promotes good clinical practices in the conduct of oncology clinical trials by possessing in-depth knowledge of federal regulations and guiding documents for the conduct of clinical trials and human participant protection. In addition, the Clinical Research Nurse Coordinator assures compliance with protocol and regulatory requirements, manages patient protocol activities, assures patient safety, collects records and maintains data and source documentation. The Clinical Research Nurse Coordinator performs all the duties and responsibilities associated with high-level, professional nursing practice including autonomous decision making based on predetermined protocol guidelines, nursing assessment and oncology knowledge. Reports to the Clinical Trials Manager. Responsibilities Trial Planning and Strategy Participates in protocol planning by applying knowledge of patient population and anticipated recruitment, considering the ability to maintain the rights, safety, and well-being of the patient and serving as the liaison between the investigator and the sponsor to clarify expectations, goals, procedures, questions, and concerns. Plans and implements pre-study activities by developing timelines for conducting the clinical trial protocol, attending and participating in investigator meetings at the manager's discretion and scheduling and coordinating pre-study site visits, initiation visits, monitoring visits, and close-out visits. Trial Recruitment and Management Manages Subject Recruitment and Enrollment by monitoring enrollment goals and modifying the recruitment plan as necessary, maintaining patient screening/enrollment logs, reviewing information about the protocol including inclusion/exclusion criteria with investigator. Assuring that all screening, eligibility, and enrollment procedures are performed according to protocol requirements by reviewing source documents in the EMR. Attend multidisciplinary conferences/meetings to provide study-related information as needed to the physicians discussed during the conference/meeting. Coordinates patient enrollment in clinical trials by following randomization procedures as per protocol, scheduling patient office visits, required screening assessments, ensuring appropriate specimen collection, batching and shipping per protocol and assessing participant compliance with the test article and follow-up visits. Manages clinical trial patient by scheduling all protocol-required tests, physician and nurse assessment visits, monitoring patient's response to protocol treatment, accompanying the physician for all protocol-required visits at all offices, reporting all serious adverse effects to the appropriate agency and Covenant Health IRB according to protocol guidelines, manages/resolves complex patient/physician/clinical trial issues without supervision. Regulatory Compliance and Safety Maintains federal guidelines for Informed Consent process by communicating information about the protocol, informed consent form and follow-up procedures with potential study patients, conducting interviews to assess the patient's ability and willingness to follow and complete study procedures and visits, obtaining informed consent from the patient prior to any study-related procedures and documenting appropriately. Ensures patient safety with ongoing patient education about cardiovascular treatments and disease process. Perform skilled nursing assessments and promptly report all findings to the investigator and study sponsor. Recognize laboratory values and assessments outside of normal limits. Documents and maintains all study-related procedures, processes, and events by obtaining and reviewing original source documents, i.e., office notes, imaging reports, lab reports, procedure notes, etc.), abstracting data to study forms and flowsheets, recording accurate and timely data entry into electronic or hard-copy case report forms, documenting protocol deviations and exemptions, planning and designing new forms/source document tools to utilize in protocol implementation. Resolve data queries and amend case report forms as appropriate. Resource Management Maintain investigational agents and/or devices provided by study sponsor by accurately accounting for products received onsite. This includes all supplies provided by the study sponsor. Oversee the storage and integration of clinical trial product according to Covenant Health policy. Communication and Report Protect participant confidentiality by adhering to HIPAA regulations, protecting patient privacy at all times, securing safe storage of study-related documents, assuring appropriate disposal of PHI, securely storing all archived files. Communicates effectively with patients, research team, IRB, study sponsor, and Clinical Trials Manager by providing protocol education to ancillary staff. Establishing a contact mechanism for participants regarding follow-up visits, new study information and instructing participants to report study-related events to the research team immediately. Effective communication with investigator and sponsor representative to ensure protocol compliance. Punctually submitting reports, making suggestions or raising concerns to the Clinical Trials Manager. Quality Assurance Participants in monitoring visits and audits by collecting source documents for sponsor review, meeting with monitors during routine visits to discuss case report form completion, query resolution, and other protocol-related issues. Prepare and participate in all audit tasks and meetings as needed. Assists with reviewing and developing standard operating procedures for study-related tasks as needed. Participant in orienting and training new staff involved in study visits. Supervise clinical research associates as needed. Implement Quality Controls and Assurance Measures by monitoring compliance with study procedures and GCP standards, conducting quality assurance audits as requested, working with internal and external quality assurance teams. Local travel required. Will be traveling between Covenant Health Facilities as needed to meet with physicians and patients. Maintains professional and technical knowledge by attending conferences at the discretion of the Clinical Trials Manager; presenting professional education to colleagues, performing self-directed study, reviewing professional publications and participating in professional societies. Completes all IT training to access various EDC systems and EMR. Be proficient with basic office software such as Microsoft Office. Follows policies, procedures, and safety standards. Completes required education assignments annually. Works toward achieving goals and objectives, and participates in quality improvement initiatives as requested. Performs other duties as assigned. Qualifications Minimum Education: None specified; however must be sufficient to meet the standards for achievement of the below indicated license and/or certification as required by the issuing authority. Minimum Experience: Two (2) years of experience in cardiology nursing/relevant nursing care or two (2) years' experience in clinical trials. Excellent written and oral communication skills, project management skills. Good Interpersonal and leadership skills. Excellent computer skills. Licensure Requirement: Must have and maintain Tennessee RN licensure. Employee must have a valid Tennessee driver's license Class D and state mandated minimum insurance coverage. Driving record must meet Covenant Health minimum standards at the date of hire and throughout employment tenure.#cb
    $45k-63k yearly est. Auto-Apply 60d+ ago
  • Coordinator-Multidisciplinary Research

    Northeast Georgia Health System 4.8company rating

    Gainesville, GA jobs

    Job Category: Research & Research Administration Work Shift/Schedule: 8 Hr Morning - Afternoon Northeast Georgia Health System is rooted in a foundation of improving the health of our communities. Responsible for the coordinating, implementing, tracking and evaluating NGHS research studies. This includes all phases of the research cycle: Study and Protocol Design, Feasibility and Implementation IRB, Ethical and Data Review Administration, Recruitment, Data collection Data analyses Completion Formal Closure Maintains appropriate and accurate documentation of study files as well as patient/study participant consent and evaluation data. Leads, coordinates or guides strategies for recruitment of study participants, enrollment of participants, and manages data collection and reporting for institutionally approved research studies. Ensures the requirements are met for subject enrollment and compliance from entry through follow up, investigator participation, data report submission and audits. Responsible for management of assigned grant projects. Responsible for ensuring all research stages are in compliance with all regulatory requirements as outlined in NGHS policies, local, state and Federal 45CFR46. Minimum Job Qualifications Licensure or other certifications: Clinical Research Coordinator or Equivalent Certification (or completed within 2 years of hire); CITI certification or equivalent Human Subjects Research Training (or completed within 60 days of hire). Educational Requirements: Masters Degree Minimum Experience: Minimum of five years experience in healthcare research, public health research and/or academic science or PhD in related area, and evidence of two years experience with healthcare research study design. Other: Masters Degree (with research or dissertation component) in Health Sciences, Educational research, life sciences. Preferred Job Qualifications Preferred Licensure or other certifications: Certification or evidence of skills in database management, data analysis. Certification in Grant Writing and or Grant Management. Preferred Educational Requirements: PhD Preferred Experience: Experience with statistical analysis in healthcare applications. Other: Job Specific and Unique Knowledge, Skills and Abilities Thorough knowledge of processes involved in rigorous healthcare research and departmental specific accreditation requirements. Excellent written and verbal communication skills. Advanced Computer Skills, including proficiency in Windows, Excel, Word, and competency in managing data within large databases. Remains current in knowledge and skills in healthcare research, and research ethics. Essential Tasks and Responsibilities Ensures compliance with IRB approved recruitment, screening and consenting procedures, identifies preliminary cohorts, recruits and screens potential study participants Facilitates the development of study-related training for study stakeholders as required in protocol, and coordinates the deployment of the sessions, running these if needed. Provider and staff research skills education: Develop engaging educational content to address specified outcomes for current stakeholders, and potential stakeholders at all levels of NGHS. Works with relevant data developers, analysts, data scientists and statisticians to collect, organize and manage study relevant data in a structure that aligns with NGHS IT data collection standards. Secures data in compliance with institutional and local, state and Federal requirements as well as study sponsor requirements. Acts as super user and trainer of NGHS data collection and analysis assets. Coordinates and collaborates in collection of departmental specified metrics in a timely and accurate manner, presenting these metrics in a digestible manner for each stakeholder group as set out in departmental standard work. Follows program required standard work and research study processes. Study Initiation (Study Assessment, Development, and Approval) Helps to identify potential cohort numbers (sample frame) through patient cohort development, manages feasibility study, or pilot test as appropriate. Helps coordinate study start up activities. For each activity, the coordinator is responsible for project management of all aspects of the process in line with the approved protocol, including grant sponsored and clinical trial projects Manage and communicate effectively with Research Leadership regarding proposed projects for feasibility, including analyzing scope of work, cost and responding to inquiries and/or complaints Prior to implementation, carry out a needs and resources assessment on the protocol and meet with appropriate service groups/vendors to design and confirm a resource plan and timeline to maximize efficiency of NGHS/study resources in a strategic interdependent manner. Review protocol for potential operational issues, and make alternate recommendations, as needed. Using knowledge of institutional, local, state and Federal research related informed consent requirements, ensure consent documentation and described processes are compliant according to appropriate guidelines. Evaluate IRB requirements for each protocol for completeness, guiding appropriate completion by investigator and appropriately submit and track progress of protocols, informed consents and any necessary documents to Institutional Review Board (IRB) for study determination and/or approvals; communicate with IRB if applicable. Add IRB submission to NGHS IRB tracker and update with approvals. Securely store IRB communication, modifications, approvals etc. in program approved manner. Assist investigators in IRB protocol reviews as necessary. Attend IRB meetings for protocol review, as needed Confirm that all required and /or regulatory documents are submitted to sponsor / securely stored in a timely manner, e.g., 1572, Confidentiality Agreement, clinical trial agreements, IRB approval letter, Financial Disclosures, etc., as needed. Maintain current study team member resumes, CITI certifications, study-specific training and licenses are current. Communicate with Research Leadership regarding study initiation needs, updates central research tracker on a timely basis. Schedules and monitors approved implementation tasks and timeline. Coordinator tracks and documents progress through each stage of the protocol, ensuring that the personnel identified and approved by the PI and listed in the protocol adhere to the protocol, reporting any variances, deviation, or barriers noted to the PI in a timely fashion. Research documentation environment and hard research study assets: Ensure use of approved, secure, digital and building storage space for any study documentation, data storage, device, or product storage. Ensure appropriate maintenance is carried out on device and products used including cleaning and calibration by approved vendors. Study Execution (data collection, analysis, dissemination and completion phases) Ensure that the approved recruitment, screening and consent processes are adhered to for cohort defining and participant enrollment. Securely retain study documentation and report any deviations from approved protocol to the study team and principal investigator. Report any variance following institutional standard policies. Collaborate with approved stakeholders, and oversee specified data management process, providing progress reports to PI and co-investigators. Ensure all phases of data management process are adhered to, and documented. Reporting variances or deviations to Department Director and PI. Maintain strong working knowledge of Standard Operating Procedures (SOPs), FDA regulations and developing data management standards Update central project tracker on a timely basis. Complete Case Report Forms (CRFs) and Study related documents, submit documents to sponsor and or IRB, if applicable. Including interim reports for awarded grant projects, financial summaries as required. Ensure sponsor required documents are completed, e.g., screening logs, Adverse event (A/E) forms, memo to file, etc. Inform Program Director of variances or expected barriers. Plan, organize, and participate in accreditation site visits, site initiation visits and continued monitoring visits. Review research progress tracker and applicable monitoring reports with the Research Department Team, ensuring that the Program Director is aware of variances, barriers, and opportunities for innovation. Ensure studies are completed on time and within budget by maintaining a detailed and up to date financial statement. Report any recommendations or expected, experienced variances to the program director in a timely fashion. Communicate with outside vendors such as device vendors, grant awarding bodies, data mart developers, central laboratories, central IRBs, etc. Provide guidance and troubleshoot issues, documenting these in the research management notes, communicating these to the program director. Proactively address study concerns and develop timely resolutions. Present at internal and external events - academic presentations, professional research conferences and promotion events Prepare interim report for PI, coordinate the documentation, reporting and analyses of safety issues, patients care issues, and study design and/or study conduct issues to the PI and on approval, appropriate IRB, sponsor and Program Director, as per department process. Ensure that Adverse Events (AE) and Serious Adverse Events (SAE) procedures are followed accurately and within federal regulations and sponsor guidelines. Prepare study reports as requested by PI, e.g., modification, amendments, funding requirements, resource needs assessment, Investigational New Drug (IND) reports, etc. Perform required review of studies, completing yearly documents required by grant issuer, sponsor, IRB and FDA. Provide guidance and editing services to non clinical trial investigator study manuscripts, ensuring ethical authorship and citation standards are adhered to. Audit and maintain study and regulatory binders, grant documentation both hard and digital copies and report any gaps to the PI. Ensure timely and accurate communication with the project stakeholders including sponsors, investigators, among research staff, and with the multiple functional areas with Institution, e.g., via regularly scheduled calls, team meetings, etc. Document these appropriately, including attendance. Complete status reports and communicate with the sponsor, research staff, Research Manager and Investigator(s). Update central progress tracker. Work with the key functional departments to coordinate the project-related activities to meet project goals and milestones, based on the study design. work with investigators to ensure study data is submitted on-time to data management for analyses, and coordinate any data validation meetings with the data developer. Ensure the statistical analysis plan is complete, if applicable. Ensure information is available for final study report completion. Performs related responsibilities as required Physical Demands Weight Lifted: Up to 20 lbs, Occasionally 0-30% of time Weight Carried: Up to 20 lbs, Occasionally 0-30% of time Vision: Moderate, Frequently 31-65% of time Kneeling/Stooping/Bending: Occasionally 0-30% Standing/Walking: Frequently 31-65% Pushing/Pulling: Frequently 31-65% Intensity of Work: Occasionally 0-30% Job Requires: Reading, Writing, Reasoning, Talking, Keyboarding, Driving Working at NGHS means being part of something special: a team invested in you as a person, an employee, and in helping you reach your goals. NGHS: Opportunities start here. Northeast Georgia Health System is an Equal Opportunity Employer and will not tolerate discrimination in employment on the basis of race, color, age, sex, sexual orientation, gender identity or expression, religion, disability, ethnicity, national origin, marital status, protected veteran status, genetic information, or any other legally protected classification or status.
    $52k-72k yearly est. Auto-Apply 16d ago
  • Research Nurse- Critical Care Medicine

    Children's Healthcare of Atlanta 4.6company rating

    Atlanta, GA jobs

    Note: If you are CURRENTLY employed at Children's and/or have an active badge or network access, STOP here. Submit your application via Workday using the Career App (Find Jobs). Work Shift Day Work Day(s) Monday-Friday, Variable Shift Start Time 6:00 AM Shift End Time 2:00 PM Worker Sub-Type Regular Children's is one of the nation's leading children's hospitals. No matter the role, every member of our team is an essential part of our mission to make kids better today and healthier tomorrow. We're committed to putting you first, and that commitment is at the heart of our company culture: People first. Children always. Find your next career opportunity and make a difference doing what you love at Children's. Job Description Develops, implements, and supports research process by assisting investigators in study design, completion of approval process, and management of data specific to subspecialty of involvement. Proactively supports efforts that ensure delivery of safe patient care and services and promote a safe environment at Children's Healthcare of Atlanta. Experience * Two or more years of pediatric clinical experience OR two or more years of clinical related experience Preferred Qualifications * Bachelor of Science in Nursing * Pediatric clinical experience * Experience in the subspeciality of involvement * 1 year of experience in research with knowledge about the conduct of clinical trials, research principles/methodologies, and study design * Pediatric Advanced Life Support (PALS) Education * Graduation from an accredited school of nursing * Bachelor of Science in nursing preferred Certification Summary * Licensure as a Registered Nurse in the single State of Georgia or Multi-State through the Enhanced Nurse Licensure Compact * ARUP Handling, Packaging and Shipping Infectious Material or similar certification within 30 days of employment (if role requires specimen acquisition) * Collaborative Institutional Training Initiative (CITI) within 30 days of employment * Basic Life Support (BLS) within 1 year of employment Knowledge, Skills, and Abilities * Working knowledge of federal regulations and regulatory requirements for conducting research * Good computer skills, including working knowledge of a personal computer and Microsoft Office (Word, Access, Excel, and PowerPoint) and basic statistics * Self-directed and motivated to work independently toward short- and long-term goals * Good communication, organization, and interpersonal skills * Ability to collaborate with various research staff, locally and externally * Proficiency in pediatric physical assessment skills Job Responsibilities Develops, conducts, and facilitates research protocols * Supports investigators in writing study protocols. * Performs participant screening, enrollment, study activities, and communication. * Coordinates study visits and procedures, including specimen acquisition, transport, documentation, and shipment. * Maintains equipment and supply resources for research studies. * Obtains informed consent by following Children's Healthcare of Atlanta policies, procedures, and regulatory requirements. * Schedules study-specific visits in conjunction with ancillary departments. Provides direct patient care to conduct research protocols * Provides direct nursing care according to Children's Healthcare of Atlanta standards of practice. * Completes phlebotomy for acquisition of research specimens. * Administers research medications under a study-specific protocol. * Completes nursing physical assessment, vital signs, and venous access. * Completes clinical assessment and safety evaluation of study subjects and notifies Principal Investigator when appropriate. * Reviews and grades adverse events, concomitant medications, VS's, and lab results and notifies Principal Investigator when appropriate. * Provides health education to participants as part of a study protocol. * Completes nursing documentation and order entry within the medical record. Manages all regulatory processes related to clinical research activities * Completes Institutional Review Board preparation, submission, modifications, reporting, and termination activities. * Maintains all regulatory documents. * Participates in sponsor correspondence, monitoring, and study meetings. Completes data management activities * Assists in development and completion of source and case report form documentation. * Completes data entry and ensures data integrity. * Supports statistical services needs. Facilitates grants, contracts, and financial tasks for research and clinical trials * Supports investigator in study budgeting, sponsor interactions, routing, feasibility assessments, account management, and reconciliation. * Completes research administrative duties according to Children's policies regarding Epic enrollment, Clinical Trial Management System data entry, patient care invoice accuracy. Performs quality and education activities. * Monitors compliance throughout all study activities. * Engages compliance oversight as needed. * Participates in education activities to support specific research activities and primary role. * Maintains all licensure, certification, and system education requirements for role. * Participates in educational activities related to study needs for study staff, investigator team, and patient care staff. * Participates in departmental policy and quality projects. Children's Healthcare of Atlanta is an equal opportunity employer committed to providing equal employment opportunities to all qualified applicants and employees without regard to race, color, sex, religion, national origin, citizenship, age, veteran status, disability or any other characteristic covered by applicable law. Primary Location Address 2220 North Druid Hills Road Job Family Nursing-Bedside
    $54k-67k yearly est. 44d ago
  • Clinical Research Associate - NAMSA Future Openings USA

    Namsa 4.2company rating

    Atlanta, GA jobs

    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
  • Clinical Research Associate - NAMSA Future Openings USA

    Namsa 4.2company rating

    Atlanta, GA jobs

    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
  • Cardiology Research Nurse Manager

    Northside Hospital 4.4company rating

    Sandy Springs, GA jobs

    Northside Hospital is award-winning, state-of-the-art, and continually growing. Constantly expanding the quality and reach of our care to our patients and communities creates even more opportunity for the best healthcare professionals in Atlanta and beyond. Discover all the possibilities of a career at Northside today. The Research Nursing Manager is responsible for overseeing nursing operations, including the Northside Hospital Heart Institute or Northside Hospital Cancer Institute Research Network. This role will be responsible for the day-to-day management and oversight of the quality and validity of clinical research data and research patient care and will oversee the work of the Lead Research Coordinators, Clinical Research Nurses (CRN), the Clinical Research Coordinators (CRC), Data Management and regulatory staff. PRIMARY DUTIES AND RESPONSIBILITIES * Oversee Cardiology or Oncology research nursing and maintain awareness of all relevant clinical research projects. * Ensure clinical and regulatory quality and integrity of research conducted. * Develop and implement training programs for CRN, CRC, Data Management Staff and Regulatory staff. * Manage special projects to expand the capabilities of the Research Program or as assigned. * Identifies the needs of those service areas and individuals served by the department and assists in the development of goals, objectives, policies, and procedures to align with strategic initiatives. * Serve as a member or leader of appropriate committees and work groups. * Develop, implement, and analyze work flow procedures to maximize productivity and coordinate with other clinical areas to ensure system effectiveness. * Prepare periodic reports of operations to include workload statistics and staffing needs; assists in development of workload standards and ongoing monitoring of standards to ensure adequate staff levels. * Monitor all clinical research activity and maintain awareness of all clinical research projects. * Develop, maintain, and evaluate SOPs for administering clinical research. * Recruit, hire, orient, and evaluate performance of assigned personnel to assure that department is staffed with individuals who reflect behavior and performance consistent with the hospital's Mission and Values statement. Has authority to hire, terminate and/or take other disciplinary action as may be deemed appropriate and is in accordance with hospital policy * Develop and submit to Director for approval, appropriate capital and operating budget and is accountable for the achievement of capital and operating budget objectives. KNOWLEDGE SKILLS AND ABILITIES/LICENSE OR CERTIFICATION REQUIRED * Bachelor's degree in nursing. * Licensed as a RN in the state of Georgia in good standing, without limitations * Minimum of three (3) years of experience in a clinical research setting. * Minimum of two (2) years of experience in area of specialty nursing. * Minimum of one (1) year experience managing employees.
    $42k-61k yearly est. 60d+ ago
  • Cardiology Research Nurse Manager

    Northside Hospital 4.4company rating

    Atlanta, GA jobs

    Northside Hospital is award-winning, state-of-the-art, and continually growing. Constantly expanding the quality and reach of our care to our patients and communities creates even more opportunity for the best healthcare professionals in Atlanta and beyond. Discover all the possibilities of a career at Northside today. The Research Nursing Manager is responsible for overseeing nursing operations, including the Northside Hospital Heart Institute or Northside Hospital Cancer Institute Research Network. This role will be responsible for the day-to-day management and oversight of the quality and validity of clinical research data and research patient care and will oversee the work of the Lead Research Coordinators, Clinical Research Nurses (CRN), the Clinical Research Coordinators (CRC), Data Management and regulatory staff. PRIMARY DUTIES AND RESPONSIBILITIES * Oversee Cardiology or Oncology research nursing and maintain awareness of all relevant clinical research projects. * Ensure clinical and regulatory quality and integrity of research conducted. * Develop and implement training programs for CRN, CRC, Data Management Staff and Regulatory staff. * Manage special projects to expand the capabilities of the Research Program or as assigned. * Identifies the needs of those service areas and individuals served by the department and assists in the development of goals, objectives, policies, and procedures to align with strategic initiatives. * Serve as a member or leader of appropriate committees and work groups. * Develop, implement, and analyze work flow procedures to maximize productivity and coordinate with other clinical areas to ensure system effectiveness. * Prepare periodic reports of operations to include workload statistics and staffing needs; assists in development of workload standards and ongoing monitoring of standards to ensure adequate staff levels. * Monitor all clinical research activity and maintain awareness of all clinical research projects. * Develop, maintain, and evaluate SOPs for administering clinical research. * Recruit, hire, orient, and evaluate performance of assigned personnel to assure that department is staffed with individuals who reflect behavior and performance consistent with the hospital's Mission and Values statement. Has authority to hire, terminate and/or take other disciplinary action as may be deemed appropriate and is in accordance with hospital policy * Develop and submit to Director for approval, appropriate capital and operating budget and is accountable for the achievement of capital and operating budget objectives. KNOWLEDGE SKILLS AND ABILITIES/LICENSE OR CERTIFICATION REQUIRED * Bachelor's degree in nursing. * Licensed as a RN in the state of Georgia in good standing, without limitations * Minimum of three (3) years of experience in a clinical research setting. * Minimum of two (2) years of experience in area of specialty nursing. * Minimum of one (1) year experience managing employees.
    $42k-61k yearly est. 56d ago
  • Cardiology Research Nurse Manager

    Northside Hospital 4.4company rating

    Atlanta, GA jobs

    Northside Hospital is award-winning, state-of-the-art, and continually growing. Constantly expanding the quality and reach of our care to our patients and communities creates even more opportunity for the best healthcare professionals in Atlanta and beyond. Discover all the possibilities of a career at Northside today. Responsibilities The Research Nursing Manager is responsible for overseeing nursing operations, including the Northside Hospital Heart Institute or Northside Hospital Cancer Institute Research Network. This role will be responsible for the day-to-day management and oversight of the quality and validity of clinical research data and research patient care and will oversee the work of the Lead Research Coordinators, Clinical Research Nurses (CRN), the Clinical Research Coordinators (CRC), Data Management and regulatory staff. PRIMARY DUTIES AND RESPONSIBILITIES Oversee Cardiology or Oncology research nursing and maintain awareness of all relevant clinical research projects. Ensure clinical and regulatory quality and integrity of research conducted. Develop and implement training programs for CRN, CRC, Data Management Staff and Regulatory staff. Manage special projects to expand the capabilities of the Research Program or as assigned. Identifies the needs of those service areas and individuals served by the department and assists in the development of goals, objectives, policies, and procedures to align with strategic initiatives. Serve as a member or leader of appropriate committees and work groups. Develop, implement, and analyze work flow procedures to maximize productivity and coordinate with other clinical areas to ensure system effectiveness. Prepare periodic reports of operations to include workload statistics and staffing needs; assists in development of workload standards and ongoing monitoring of standards to ensure adequate staff levels. Monitor all clinical research activity and maintain awareness of all clinical research projects. Develop, maintain, and evaluate SOPs for administering clinical research. Recruit, hire, orient, and evaluate performance of assigned personnel to assure that department is staffed with individuals who reflect behavior and performance consistent with the hospital's Mission and Values statement. Has authority to hire, terminate and/or take other disciplinary action as may be deemed appropriate and is in accordance with hospital policy Develop and submit to Director for approval, appropriate capital and operating budget and is accountable for the achievement of capital and operating budget objectives. Qualifications KNOWLEDGE SKILLS AND ABILITIES/LICENSE OR CERTIFICATION REQUIRED Bachelor's degree in nursing. Licensed as a RN in the state of Georgia in good standing, without limitations Minimum of three (3) years of experience in a clinical research setting. Minimum of two (2) years of experience in area of specialty nursing. Minimum of one (1) year experience managing employees. Work Hours: 8a - 4:30p Weekend Requirements: No On-Call Requirements: No
    $42k-61k yearly est. Auto-Apply 60d+ ago
  • Clinical Research Coordinator - Full-Time - Wolf River

    West Cancer Center 3.7company rating

    Germantown, TN jobs

    Job Title: Clinical Research Coordinator About Us At West Cancer Center, we are dedicated to providing compassionate, patient-centered care while advancing groundbreaking research. Our team fosters collaboration, innovation, and professional growth, ensuring that every role contributes to making a difference in patients' lives. Join us in our mission to provide comprehensive support to those navigating the challenges of cancer treatment. Position Overview The Clinical Research Coordinator plays a vital role in managing oncology patients participating in pharmaceutical-sponsored clinical trials. This position is responsible for patient screening, enrollment, education, and ongoing monitoring to ensure compliance with study protocols and regulatory standards. The ideal candidate will have prior experience managing clinical trials and a strong understanding of Good Clinical Practice (GCP) and FDA regulations. Key Responsibilities Recruit and screen potential clinical trial subjects Conduct detailed review of patient medical history and current findings for eligibility Educate nursing staff on proper administration and side effects of study therapies Educate patients on study protocols, medication adherence, and symptom management Act as a liaison between the Research Team and non-research clinical staff Maintain patient safety, rights, and informed consent throughout the study Ensure regulatory compliance and maintain current knowledge of the Code of Federal Regulations Monitor study progress and patient outcomes Interface with multiple departments, including Physicians, Nurses, Radiology, Medical Records, Laboratory, Insurance, and Pharmacy Document all relevant patient and study information accurately Maintain a professional demeanor and uphold confidentiality at all times Perform other duties as assigned Qualifications Education & Experience Associate's degree or equivalent from a two-year college or technical school Minimum of 1-2 years of related clinical research experience, or successful completion of 1 year as an Associate Clinical Research Coordinator I Preferred: Registered Nurse (RN) certification Skills & Abilities Strong organizational, follow-up, and problem-solving skills Excellent verbal and written communication abilities Ability to manage multiple priorities in a fast-paced environment Proficiency in computer applications, including word processing and email Ability to collaborate effectively within multidisciplinary teams Strong knowledge of clinical research regulations, data management, and patient safety Comfort working near potentially hazardous materials Ability to analyze complex data and interpret technical documents Competence in performing necessary calculations (BSA, ANC, drug dosing) Ability to travel as required Why West Cancer Center is a Great Place to Work Meaningful Impact: Play a direct role in supporting patients through one of the most challenging times of their lives. Collaborative Culture: Work alongside a multidisciplinary team of dedicated professionals committed to improving cancer care. Professional Development: Benefit from ongoing training, educational resources, and growth opportunities. Mission-Driven Environment: Be part of an organization guided by compassion, integrity, and innovation. No nights, weekends, or holidays. Comprehensive benefits package. Join Us If you are a detail-oriented clinical research professional looking to make a difference in oncology care, apply today to become a Clinical Research Coordinator at West Cancer Center.
    $52k-70k yearly est. Auto-Apply 18d ago
  • Clinical Research Coordinator

    Sarah Cannon Research Institute 3.6company rating

    Nashville, TN jobs

    It's More Than a Career, It's a Mission. Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day. Our Mission People who live with cancer - those who work to prevent it, fight it, and survive it - are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world. As the Clinical Research Coordinator you are responsible for overall clinical operations of the facility's research program including enrollment, regulatory, quality, and site operations. You will support enrolling patients onto clinical trials through recruitment, screening, enrollment, treatment, and follow-up of eligible participants according to protocol requirements. You will review the study design and inclusion/exclusion criteria with physicians and patients You will ensure the protection of study patients by verifying informed consent procedures and adhering to protocol requirements You will collect, complete, and enter data into study specific case report forms (CRFs) or electronic data capture systems within study required timelines You will ensure the integrity of the data submitted on case report forms or other data collection tools by careful source document review and monitoring data for missing or implausible data You will create study specific tools for source documentation when not provided by sponsor You will generate and track drug shipments, lab kits, and other supplies You will be responsible for accurate and complete documentation of protocol requirements according to site work instructions and standard operating procedures (SOPs) You will track and report adverse events, serious adverse events, protocol waivers, and deviations You will maintain accurate and complete records, including regulatory documents, signed informed consent forms, source documentation, drug dispensing logs, screening and enrollment logs, and study communications You will coordinate regular site research meetings You will attend study-specific on-site meetings/visits, investigator meetings, conference calls, and other coordinator meetings, as required and you will work closely with monitors, study teams and site staff to ensure quality study data You will communicate site status through a weekly activity report to appropriate site/management colleagues You should have: An Associate's Degree, preferably a Bachelor's Degree Knowledge of medical and research terminology Knowledge of FDA Code of Federal Regulations and GCP Knowledge of the clinical research processes Public presentation skills The ability to manage multiple ongoing priorities and projects with a diverse team of professionals This position will be open for applications until January 30th. About Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is one of the world's leading oncology research organizations conducting community-based clinical trials. Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development. In 2022, SCRI formed a joint venture with former US Oncology Research to expand clinical trial access across the country. It has conducted more than 750 first-in-human clinical trials since its inception and contributed to pivotal research that has led to the majority of new cancer therapies approved by the FDA today. SCRI's research network brings together more than 1,300 physicians who are actively enrolling patients into clinical trials at more than 250 locations in 24 states across the U.S. Please click here to learn more about our research offerings. We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That's why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves. For more information regarding benefits through our parent company, McKesson, please click here. As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. McKesson has become aware of online recruiting-related scams in which individuals who are not affiliated with or authorized by McKesson are using McKesson's (or affiliated entities, like CoverMyMeds or RxCrossroads) name in fraudulent emails, job postings or social media messages. In light of these scams, please bear the following in mind: McKesson Talent Advisors will never solicit money or credit card information in connection with a McKesson job application. McKesson Talent Advisors do not communicate with candidates via online chatrooms or using email accounts such as Gmail or Hotmail. Note that McKesson does rely on a virtual assistant (Gia) for certain recruiting-related communications with candidates. McKesson job postings are posted on our career site: careers.mckesson.com. 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.
    $43k-59k yearly est. Auto-Apply 20d ago
  • Clinical Research Coordinator

    Campbell Clinic Pc 4.2company rating

    Germantown, TN jobs

    . The Campbell Clinic Foundation Clinical Research Coordinator (CRC) plays a vital role in advancing orthopedic medicine and patient care, both locally and globally. Embracing a culture of collaboration and innovation, this individual will work closely with internal teams and external partners, including industry leaders and healthcare institutions worldwide, to drive impactful research and improve patient outcomes. The CRC is responsible for coordinating clinical research studies, facilitating patient participation, and preparing, submitting, and tracking documentation of research studies. In addition, the CRC will ensure compliance with local and federal regulations, protocols, and safety monitoring through process audits. The CRC will advise research personnel regarding study design, study procedures, data abstraction, and data storage. The CRC supports, facilitates, and coordinates daily research activities and plays a critical role in the conduct of the studies. OVERVIEW: THE CAMPBELL CLINIC FOUNDATION: The Campbell Clinic Foundation is an independent, non-profit 501(c)3 organization with a mission to enhance the quality of life for our patients through the science of orthopaedic medicine, with a strong commitment to education, research, and community healthcare. Foundation staff members strive to uphold five core values: capable, collaborative, conscientious, courageous, and curious. We foster a dynamic, forward-thinking team, culture, and workplace. The Campbell Clinic Foundation is affiliated with Campbell Clinic Orthopaedics, and clinical research across sub-specialties takes place in multiple Clinic locations and in partnership with dozens of healthcare partners. Campbell Clinic is an international leader in sports medicine, pediatric orthopaedics, joint replacement, orthopaedic oncology, orthopaedic trauma, physical medicine and rehabilitation, and surgery of the hand, hip, foot, knee, shoulder and spine. We honor a century-long legacy of teaching, leading and innovating in orthopaedic medicine and healthcare. Our work improves mobility and quality of life for people in our community and around the world. The position will be based in Germantown, TN. Essential Functions Statement(s) Reasonable Accommodations Statement To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions. Essential Functions Statement(s) Prepare IRB (Institutional Review Board) submissions, proviso resolutions, revisions, and continuing reviews utilizing in-depth knowledge of human subject protections, protocol requirements, good clinical practices, and regulatory compliance as set forth by local and federal regulations Manage all aspects of conducting investigator-initiated studies, multicenter studies, and industry-sponsored trials (maintain essential documents, investigation product accountability, monitor visit oversight, etc.) Maintain all data and source documentation, adverse event reporting, and essential regulatory files Review clinical study agreements, protocols, and budgets for feasibility and ensure compliance Apply Good Clinical Practice (GCP) guidelines and principles of Human Subjects Protection in study conduct to include the screening, recruitment, consent, study visit completion and safety monitoring Access medical records (including electronic) for research data and assist physicians, residents, and students with data abstraction (within IRB approvals) Enter data into designated electronic platforms per study protocol from completed source documents Coordinate and communicate with principal investigators and the research team to provide assistance and education as needed among internal and external study partners Participate in and lead respective subspecialty research meetings, including the Campbell Foundation Research Committee, and maintain project and submission status of all projects within the CRC's subspecialty Stay calm and focused with a large volume of work and against pressing deadlines Successfully meets deadlines, works independently, is innovative and proactive in solving problems, and learns and uses medical terminology. Builds rapport and trust with prospective subjects, potential subjects, research personnel, and partners. Maintain strict subject confidentiality of all research records in compliance with Campbell Clinic/Campbell Foundation standards and federal laws Facilitates data collection and analysis and provides study progress updates as indicated Assist with the preparation of oral and written presentation materials as indicated Regular and predictable attendance Ability to work cooperatively with others Fluent in oral and written English and speaks in a manner easily understood by the patient population Perform other duties as required SKILLS & ABILITIES Experience: 2 years of experience in a clinical and/or healthcare setting required. 1 year research experience required. Education: Bachelor's Degree required. Language Skills: Able to communicate effectively in the English language. Computer Skills: Proficiency with word processing, spreadsheets, and electronic data capture systems required. Mathematical Skills: Basic arithmetic skills are required. Reasoning Ability: Identifies and resolves problems promptly. Certifications & Licenses: A current RN license in the state of Tennessee preferred. Certification as a clinical research coordinator (CCRC, CCRP) is preferred. Basic Life Support (BLS) certification is preferred. Other Skills and Abilities: Knowledge of federal regulations governing research to include but not limited to 21 CFR 50 and 45 CFR 46 is preferred. Familiarity with medical terminology and medical codes is required. Knowledge of orthopaedic pathology and surgery preferred. Campbell Clinic Benefit Summary: Campbell Clinic offers a lucrative benefit package to support employees and their families. Medical / Dental / Vision Insurance HRA Option Flexible Spending Account Basic Life Insurance Voluntary Life Insurance Option Long-Term Disability Voluntary Short-Term Disability Accident Insurance Critical Illness Insurance 401(k) Plan Matching + Profit Sharing Employee Assistance Program Paid Time Off 8 Paid Holidays ADA Disclaimer In developing this job description care was taken to include all competencies needed to successfully perform in this position. However, for Americans with Disabilities Act (ADA) purposes, the essential functions of the job may or may not have been described for purposes of ADA reasonable accommodation. All reasonable accommodation requests will be reviewed and evaluated on a case-by-case basis. Equal Opportunity Employer/Veterans/Disabled
    $52k-72k yearly est. Auto-Apply 21d ago
  • Early Phase Research Nurse

    Tennessee Oncology 4.4company rating

    Research nurse job at Tennessee Oncology

    Tennessee Oncology, one of the nation's largest, community-based cancer care specialists, is home to one of the leading clinical trial networks in the country. Established 1976 in Nashville, Tennessee Oncology's mission remains unchanged: To provide access to high-quality cancer care and the expertise of clinical research for all patients, at convenient locations within their community and close to their home. Our growing network of physicians and locations is based on this mission. Tennessee Oncology is committed to advancing both the science of detection and targeted treatments, and to making these advances available to every patient. We believe caring for cancer patients is a privilege. Why Join Us? We are looking for talented and highly-motivated individuals who demonstrate a natural desire to support the meaningful work of community oncologists and the patients we serve. Job Description: Tennessee Oncology is seeking a dedicated and detail-oriented Early Phase Research Nurse to join our team. In this role, you will be responsible for screening, enrolling, and following study subjects, ensuring rigorous protocol compliance, and providing close monitoring throughout their participation in the clinical trial. Your role will be critical in maintaining the integrity of the studies and ensuring the safety and well-being of all participants. ESSENTIAL FUNCTIONS: Facilitate the informed consent process and enroll eligible participants into clinical trials. You will complete and document the informed consent process accurately and has all parties sign/date as required, including HIPAA Authorization. Conduct initial screening of potential study subjects to determine eligibility based on study criteria. Conduct and coordinate pharmacokinetic studies, including the collection of biological samples such as blood, urine, and saliva for pharmacokinetic analysis. You will review the study design and inclusion/exclusion criteria with physician and patient. You will complete and document screening/eligibility accurately. Monitor participants throughout the study to ensure adherence to the protocol. You will accurately complete and submit on-study forms within required timelines. You will document all specific tools required by the protocol (i.e., oral medication forms, pill count diaries, quality of life questionnaires, neuro exams, vital signs sheets, times of PK draws, etc.) Track and document patient progress, including any adverse events, and ensure timely reporting as required by the study protocol. You will complete eligibility screening for all new patient or patients returning to office with scan results and document appropriately on the patient tracking logs. Dispense oral investigation products as required by the study protocol. You will accurately calculate and document BSA, Creatinine Clearance, Urine Protein: Creatinine ratio, and any other calculations or conversions required per protocol. You will ensure that follow-up appointments, scans, or related procedures are scheduled correctly according to protocol requirements. You will document appropriately when patients are removed from protocol. You will ensure reconsent of patients at the next scheduled visit, following availability of updated ICF, and documents process appropriately. Monitor and ensure patient compliance with investigation medications, providing education and support as needed. Work closely with the research team, including principal investigators and coordinators, to support study objectives. Communicate effectively with study subjects, addressing any questions or concerns they may have. KNOWLEDGE, SKILLS & ABILITIES: Knowledge of medical and research terminology Knowledge of FDA Code of Federal Regulations and GCP Knowledge of the clinical research processes EDUCATION & EXPERIENCE: An Associate Degree; preferably a bachelor's degree RN License Minimum of 5 years of clinical oncology nursing experience required, with 1 year of experience clinical research, particularly in Phase 1 trials ACRP certification required within 6 months of meeting certification requirements.
    $49k-66k yearly est. Auto-Apply 22d ago
  • Research Nurse

    Tennessee Oncology 4.4company rating

    Research nurse job at Tennessee Oncology

    Tennessee Oncology, one of the nation's largest, community-based cancer care specialists, is home to one of the leading clinical trial networks in the country. Established 1976 in Nashville, Tennessee Oncology's mission remains unchanged: To provide access to high-quality cancer care and the expertise of clinical research for all patients, at convenient locations within their community and close to their home. Our growing network of physicians and locations is based on this mission. Tennessee Oncology is committed to advancing both the science of detection and targeted treatments, and to making these advances available to every patient. We believe caring for cancer patients is a privilege. Why Join Us? We are looking for talented and highly-motivated individuals who demonstrate a natural desire to support the meaningful work of community oncologists and the patients we serve. Job Description: As the Research Nurse for Tennessee Oncology Greco Hainsworth Center for Research you will play a critical role in advancing oncology research by ensuring the successful execution of clinical trials. You will be responsible for screening, enrolling, documenting, and monitoring study subjects by ensuring strict protocol compliance and delivering exceptional patient care. ESSENTIAL FUNCTIONS: • Enroll patients onto clinical trials through recruitment, screening, enrollment, treatment, and follow-up of eligible participants according to protocol requirements. • Provide thorough education about study requirements and expectations. • Complete and document the informed consent process accurately, ensuring all parties sign and date as required, including obtaining HIPAA Authorization. • Obtains and maintains informed consents of each patient for the duration of a study. • Review the study design and inclusion/exclusion criteria with physician and patient. • Complete and submit on-study forms within required timelines. • Maintain accurate and detailed source documentation, including study visits findings, and outcomes. • Screen all new patients or patients returning to office with scan results and document appropriately on patient tracking logs. • Monitor subjects throughout the study, ensuring compliance with protocols and maintaining patient safety. • Ensure that all medications are approved prior to initiating treatment or when changing medication regimens, such as crossover studies. • Dispense oral investigational products to study participants and provide guidance to ensure compliance with medication regimens. • Accurately calculate and document BSA, Creatinine Clearance, Urine Protein: Creatinine ratio, and any other calculations or conversions required per protocol. • Ensure that follow-up appointments, scans, or related procedures are scheduled correctly according to protocol requirements. • Record and report adverse events in accordance with study protocols and regulatory requirements. • Document appropriately when patients are removed from protocol. • Ensure reconsent of patients at the next scheduled visit, following availability of updated ICF, and documents process appropriately. • Provide patient education and medical information to study patients to ensure understanding or proper medication dosage, administration, and disease treatment. • Maintains medication inventory and reconciliation. • Collaborate with the clinical research team to ensure timely completion of study-related tasks and reporting. • Serve as a liaison between study participants, investigators, and the research team to address questions and concerns. • Float to other research Tennessee Oncology clinics as needed KNOWLEDGE, SKILLS & ABILITIES: • Strong attention to detail and organizational skills. • Ability to work independently while collaborating effectively with a multidisciplinary team. • Knowledge of medical and research terminology • Knowledge of FDA Code of Federal Regulations and GCP • Knowledge of the clinical research processes • At least one year of experience in a research setting preferred. • Research Certification (ACRP or CCRP) Preferred EDUCATION & EXPERIENCE: • An Associate Degree; preferably a bachelor's degree • RN License • At least one year of oncology experience PHYSICAL REQUIREMENTS: Job Title: Physical Activity Required Amount of time None Less than 1/3 (Occasionally) 1/3 to 2/3 (Frequently) More than 2/3 (Regularly) Standing X Walking X Sitting X Fingering or manual dexterity X Repetitive finger motion X Lifting or exerting force Up to 10 pounds Up to 25 pounds X Up to 50 pounds Up to 100 pounds Over 100 pounds Reaching or stretching X Climbing or balancing X Crouching or stooping X Speaking X Hearing X Seeing (with correction) X
    $49k-66k yearly est. Auto-Apply 60d+ ago
  • Research Nurse (Float)

    Tennessee Oncology 4.4company rating

    Research nurse job at Tennessee Oncology

    Tennessee Oncology, one of the nation's largest, community-based cancer care specialists, is home to one of the leading clinical trial networks in the country. Established 1976 in Nashville, Tennessee Oncology's mission remains unchanged: To provide access to high-quality cancer care and the expertise of clinical research for all patients, at convenient locations within their community and close to their home. Our growing network of physicians and locations is based on this mission. Tennessee Oncology is committed to advancing both the science of detection and targeted treatments, and to making these advances available to every patient. We believe caring for cancer patients is a privilege. Why Join Us? We are looking for talented and highly-motivated individuals who demonstrate a natural desire to support the meaningful work of community oncologists and the patients we serve. Job Description: As the Research Nurse for Tennessee Oncology your primary responsibility is to screen, enroll and follow study subjects, ensuring protocol compliance and close monitoring while the subjects are on study. You are responsible for source documentation and recording of adverse events. You are also responsible for dispensing oral investigational products and ensuring patient compliance with these medications ESSENTIAL FUNCTIONS: You will be enrolling patients onto clinical trials through recruitment, screening, enrollment, treatment, and follow-up of eligible participants according to protocol requirements. Obtains and maintains informed consents of each patient for the duration of a study You will review the study design and inclusion/exclusion criteria with physician and patient. You will ensure the protection of study patients by verifying informed consent procedures and adhering to protocol requirements. You will complete and document screening/eligibility accurately. You will complete and document the informed consent process accurately and has all parties sign/date as required, including HIPAA Authorization. You will accurately complete and submit on-study forms within required timelines You will document all specific tools required by the protocol (i.e., oral medication forms, pill count diaries, quality of life questionnaires, neuro exams, vital signs sheets, times of PK draws, etc.) You will screen every new patient or patient returning to office with scan results and document appropriately on the patient tracking logs You will ensure that patient documentation is completed at each clinic visit while in screening. You will ensure that all medications are approved prior to initiating treatment or when changing medication regimens, such as crossover studies. You will accurately calculate and document BSA, Creatinine Clearance, Urine Protein: Creatinine ratio, and any other calculations or conversions required per protocol. You will ensure that follow-up appointments, scans, or related procedures are scheduled correctly according to protocol requirements. You will document appropriately when patients are removed from protocol. You will ensure reconsent of patients at the next scheduled visit, following availability of updated ICF, and documents process appropriately provides patient education and medical information to study patients to ensure understanding or proper medication dosage, administration, and disease treatment. maintains medication inventory and reconciliation KNOWLEDGE, SKILLS & ABILITIES: Knowledge of medical and research terminology Knowledge of FDA Code of Federal Regulations and GCP Knowledge of the clinical research processes At least one year of oncology experience, preferably hematology and/or transplant. At least one year of experience in a research setting preferred Research Certification (ACRP or CCRP) Preferred EDUCATION & EXPERIENCE: An Associate Degree; preferably a bachelor's degree RN License
    $49k-66k yearly est. Auto-Apply 16d ago
  • Manager, Research Nurse

    Tennessee Oncology 4.4company rating

    Research nurse job at Tennessee Oncology

    Tennessee Oncology, one of the nation's largest, community-based cancer care specialists, is home to one of the leading clinical trial networks in the country. Established 1976 in Nashville, Tennessee Oncology's mission remains unchanged: To provide access to high-quality cancer care and the expertise of clinical research for all patients, at convenient locations within their community and close to their home. Our growing network of physicians and locations is based on this mission. Tennessee Oncology is committed to advancing both the science of detection and targeted treatments, and to making these advances available to every patient. We believe caring for cancer patients is a privilege. Why Join Us? We are looking for talented and highly-motivated individuals who demonstrate a natural desire to support the meaningful work of community oncologists and the patients we serve. Job Description: The Research Nurse Manager ensures the integrity and quality of clinical trials are maintained and conducted in accordance with international, federal, state, and local regulations, and Institutional Review Board (IRB) approvals. This role involves recruiting, supervising, evaluating, and coordinating the activities of a team of professional nurses and/or clinical research support staff; ensures that all clinical activities are carried out in accordance with established research protocol, and with acceptable clinical procedure and safety standards. ESSENTIAL FUNCTIONS: Manage day-to-day clinical research nursing operations, from protocol review/initiation to study close-out, ensuring study integrity throughout, under the guidance of the Principal Investigator (PI) and in collaboration with the clinical/medical officer assigned to the study. Oversees daily clinical operations of the Research Nursing Department. Ensure clinical staffing needs are met and manage scheduling. Ensures staff compliance with clinical and research standard operating procedures. Assists adherence to study-related SOPs/scientific manuals; plans, conducts, and evaluates study orientation, oversees protocol-related in-services to research team and clinical staff; institutes process improvements as needed. Conducts staff meetings and training sessions. Generates performance evaluations and proposes disciplinary actions when appropriate. Defines activities in complex clinical research studies to prevent deviations/unanticipated events. Provides expertise and leadership in the development, preparation, and implementation of regulatory strategies to support clinical research missions. Manages the tasks of direct reports to guide patients through the processes of consenting, screening, treatment, and post-treatment follow-up in clinical trials. Ensure timely collection and reporting of adverse events according to institutional, sponsor and FDA timelines. Supervises direct reports in the performance of medical tests, including, but not limited to, vital signs, lab, and EKGs. Collaborates with other research managers in the management of staff, resources/allocation planning and performance assessments for various clinical research, clinical trials implementation and oversight and regulatory and compliance functions. Communicates and collaborates w/ study team including internal and external parties, sponsors, PI, and study participants. Evaluates potential protocols to determine feasibility, resource requirements. Assists in the development and implementation of clinical research technology systems and infrastructure. Develops protocol needs assessment and monitors quality assurance protocol for services provided. Prepares for and attends sponsor and FDA audits. Provides nursing care to research study patients; ensures compliance with each study's protocol; administers investigational medications and performs patient assessment during clinical visits as needed. Ensures that the integrity and quality of the clinical research trial is maintained and that the trial is conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines. Travel to all research site offices as necessary. Maintains a professional approach respecting the dignity and confidentiality of patients. Maintains a good attendance record and reports to work on time. Maintains a professional attitude and appearance. Maintain Tennessee licensure as applicable. Performs other duties as assigned. KNOWLEDGE, SKILLS & ABILITIES: Excellent verbal and written communication skills. Strong organizational and follow-up skills. Ability to handle multiple priorities in a fast-paced environment. Understanding complex clinical trials protocols. Ability to direct, manage, implement, and evaluate department operations. Ability to establish department goals, and objectives that support strategic plan. Effective planning, delegation, and supervision skills. Ability to travel up to 25% (local/regional). Proficiency in Microsoft Office products (Word, Excel, PowerPoint, etc.) Knowledge of protocol and clinical drug development processes, study design, study planning and management, and monitoring. Knowledge of ICH/GCP guidelines EDUCATION & EXPERIENCE: Associate in nursing or Bachelor's in nursing required. Current Tennessee RN license 5+ years of experience as registered nurse 3+ years of experience in oncology setting Previous clinical research experience required, oncology research preferred. Previous supervisory and/or management experience, preferred
    $49k-66k yearly est. Auto-Apply 60d+ ago
  • Research Nurse

    Tennessee Oncology 4.4company rating

    Research nurse job at Tennessee Oncology

    Tennessee Oncology, one of the nation's largest, community-based cancer care specialists, is home to one of the leading clinical trial networks in the country. Established 1976 in Nashville, Tennessee Oncology's mission remains unchanged: To provide access to high-quality cancer care and the expertise of clinical research for all patients, at convenient locations within their community and close to their home. Our growing network of physicians and locations is based on this mission. Tennessee Oncology is committed to advancing both the science of detection and targeted treatments, and to making these advances available to every patient. We believe caring for cancer patients is a privilege. Why Join Us? We are looking for talented and highly-motivated individuals who demonstrate a natural desire to support the meaningful work of community oncologists and the patients we serve. Job Description: As the Research Nurse for Tennessee Oncology Greco Hainsworth Center for Research, you will play a critical role in advancing oncology research by ensuring the successful execution of clinical trials. You will be responsible for screening, enrolling, documenting, and monitoring study subjects, ensuring strict protocol compliance and delivering exceptional patient care. ESSENTIAL FUNCTIONS: Enroll patients in clinical trials through recruitment, screening, enrollment, treatment, and follow-up of eligible participants according to protocol requirements. Provide thorough education about study requirements and expectations. Complete and document the informed consent process accurately, ensuring all parties sign and date as required, including obtaining HIPAA Authorization. Obtains and maintains informed consent of each patient for the duration of a study. Review the study design and inclusion/exclusion criteria with the physician and the patient. Complete and submit on-study forms within required timelines. Maintain accurate and detailed source documentation, including study visits findings, and outcomes. Screen all new patients or patients returning to the office with scan results and document appropriately on patient tracking logs. Monitor subjects throughout the study, ensuring protocol compliance and patient safety. Ensure that all medications are approved before initiating treatment or changing medication regimens, such as crossover studies. Dispense oral investigational products to study participants and provide guidance to ensure compliance with medication regimens. Accurately calculate and document BSA, Creatinine Clearance, Urine Protein: Creatinine ratio, and any other calculations or conversions required per protocol. Ensure that follow-up appointments, scans, or related procedures are scheduled correctly per protocol requirements. Record and report adverse events according to study protocols and regulatory requirements. Document appropriately when patients are removed from the protocol. Ensure reconsent of patients at the next scheduled visit, following the availability of the updated ICF, and document the process appropriately. Provide patient education and medical information to study patients to ensure understanding of proper medication dosage, administration, and disease treatment. Maintains medication inventory and reconciliation. Collaborate with the clinical research team to ensure the timely completion of study-related tasks and reporting. Liaison between study participants, investigators, and the research team to address questions and concerns. Float to other research Tennessee Oncology clinics as needed. KNOWLEDGE, SKILLS & ABILITIES: Strong attention to detail and organizational skills. Ability to work independently while collaborating effectively with a multidisciplinary team. Knowledge of medical and research terminology Knowledge of the FDA Code of Federal Regulations and GCP Knowledge of the clinical research processes At least one year of experience in a research setting is preferred. Research Certification (ACRP or CCRP) Preferred EDUCATION & EXPERIENCE: An Associate Degree, preferably a bachelor's degree RN License At least one year of oncology experience PHYSICAL REQUIREMENTS: Job Title: Physical Activity Required Amount of time None Less than 1/3 (Occasionally) 1/3 to 2/3 (Frequently) More than 2/3 (Regularly) Standing X Walking X Sitting X Fingering or manual dexterity X Repetitive finger motion X Lifting or exerting force Up to 10 pounds Up to 25 pounds X Up to 50 pounds Up to 100 pounds Over 100 pounds Reaching or stretching X Climbing or balancing X Crouching or stooping X Speaking X Hearing X Seeing (with correction) X
    $49k-66k yearly est. Auto-Apply 60d+ ago

Learn more about Tennessee Oncology jobs