Clinical Research Coordinator jobs at Vanderbilt University Medical Center - 142 jobs

Research Nurse Specialist 2
Vanderbilt Health 4.6
Clinical research coordinator job at Vanderbilt University Medical Center
Discover Vanderbilt University Medical Center: Located in Nashville, Tennessee, and operating at a global crossroads of teaching, discovery, and patient care, VUMC is a community of individuals who come to work each day with the simple aim of changing the world. It is a place where your expertise will be valued, your knowledge expanded, and your abilities challenged. Vanderbilt Health is committed to an environment where everyone has the chance to thrive and where your uniqueness is sought and celebrated. It is a place where employees know they are part of something that is bigger than themselves, take exceptional pride in their work and never settle for what was good enough yesterday. Vanderbilt's mission is to advance health and wellness through preeminent programs in patient care, education, and research. Organization: VMAC Job Summary: The Vanderbilt Memory and Alzheimer's Center seeks qualified applicants for a Research Nurse Specialist 2 (RNS 2) position. The RNS-II will be part of a portfolio of clinical research studies focused on cognitive decline and Alzheimer's disease in aging adults. The Vanderbilt Memory and Alzheimer's Center houses an interdisciplinary team of scientists and clinicians engaged in ground-breaking science to discover the root cause of Alzheimer's disease. The Center, which includes doctoral-level experts in nursing, neuropsychology, neurology, neuroscience, genetics, cardiology, and radiology, is highly collaborative in nature. This position will work Monday-Friday, traditional daytime business hours, but flexibility is key to be successful in this role. Because this role will be very participant-visit heavy, you will largely work on site at the VUMC Crystal Terrace location in Nashville. There may be limited opportunities to work remotely, but this is not guaranteed. . DEPARTMENT SUMMARY: At the Vanderbilt Memory and Alzheimer's Center, we are at the forefront of advancing knowledge in Alzheimer's disease prevention, early diagnosis, and treatment. Through our research, we aim to pave the way for a new era of understanding and managing Alzheimer's disease and related dementias. For more information, please visit ******************************* Primary Responsibilities * This position is primarily participant-facing working closely with research participants and their loved ones. * Key responsibilities include consenting participants and their loved ones, facilitating biospecimen collection (including completing blood draws and supporting lumbar punctures), completing visit protocols (including clinical interviews for dementia diagnosis), providing visit feedback to participants and their loved ones, and managing follow-up for any adverse events or incidentals. * This position requires managing excellent participant relationships to enhance retention over the longitudinal follow-up period. Serving as a trusted resource and advocate for the participant and their family is an essential responsibility. * This position is responsible for assuring that the integrity and quality of the clinical research study is maintained and conducted in accordance with appropriate regulations, guidelines, policies, and procedures. Position Requirements Registered Nurse licensure is required. One year of related experience is required. Candidates must be able to multi-task and manage multiple assignments while maintaining excellent documentation. Excellent organizational skills, verbal communication, written communication, interpersonal skills, professionalism, and attention to detail are required. This position requires a great deal of flexibility, creative thinking, and customer service working with sensitive and confidential information. Successful applicants will enjoy working in a fast-paced environment with colleagues and participants from diverse backgrounds while growing their clinical research skills. GENERAL KEY RESPONSIBILITIES for RESEARCH NURSE SPECIALIST 2: * Possesses knowledge and understanding of policies, procedures, and regulations governing human subject's research and incorporation of them in the conduct of research and care of participants. * Proficiently prepares and processes new research proposals, amendments, continuing review applications and adverse events. * Perform administrative duties for trials, including but not limited to: Procuring equipment, preparing documentation, and packaging and shipping medications. * Utilize nursing skills to perform procedures, deliver individualized care, and abide by research protocols. If problems arise, identify and implement solutions, assuring goals are met. * Performs the procedures required of each study protocol, understanding standard of care versus research. Continually assesses the need for additional protections for research participants. * Recruit and identify the eligibility of candidates, regularly assessing them to ensure continued eligibility for participation. Troubleshoots trial recruitment strategies to ensure trials are completed in a timely manner. * Provides education and training to appropriate personnel and participants in research specific methodology and procedures. * Utilizes knowledge of disease processes to observe for and report adverse events to the principal investigator and all regulatory authorities as required by protocol, policies and procedures and regulations. * The responsibilities listed are a general overview of the position and additional duties may be assigned. TECHNICAL CAPABILITIES: * Scientific Knowledge (Novice): Knowledge of different scientific studies including but not limited Biomedical, Applied, and Physical. * Regulatory Compliance (Novice): Demonstrates knowledge of the appropriate rules and regulations and apply them in difficult, stressful and complex situations. Able to interpret and explain rules and regulations that are ambiguous or unclear. Directs others in interpreting rules and regulations on the job and trains others in them. * Nursing Patient Assessment & Evaluation (Novice): Possesses sufficient fundamental proficiency to successfully demonstrate the ability to assess and evaluate patients in practical applications of moderate difficulty. Conducts primary care patient interviews and physical examinations. Demonstrates sufficient acumen to recognize problems, ask questions and to contact the patient's primary care provider and other members of the healthcare team. Has experience in gathering pertinent clinical data that aid in referral, treatment, or other primary care pathways. * Nursing Patient Education (Novice): Possesses sufficient fundamental proficiency in providing patient education in practical applications of moderate difficulty. * Care Planning (Novice): Demonstrates ability to anticipate resource needs, identify distinct tasks, set priorities, schedule activities, meet deadlines, and organize work within areas of direct responsibility. Competently handles multiple assignments often simultaneously by prioritizing work into manageable and measurable units. Ability to adapt to changes to patient care and area needs with minimal disruption and loss of productivity. Follows up to assure problems and issues are resolved. * Evidence-Based Practice (Novice): Possesses sufficient fundamental proficiency to successfully search for evidence to answer clinical questions. Generally works under the direction of others while accomplishing assignments. Our Nursing Philosophy: We believe highly skilled and specialized nursing care is essential to Vanderbilt University Medical Center's mission of quality in patient care, education and research. We believe nursing is an applied art and science focused on helping people, families and communities reach excellent health and well-being. As a Vanderbilt University Medical Center employee, you make a difference to our patients and their families by bringing compassion and care to those in need of hope and healing. Please see our current employee benefits offered: * Affordable High Quality Health Plan Options * Dental and /or vision plan * 403 (b) retirement plan * Paid Time off (flex PTO) * Tuition Reimbursement and adoption assistance (maximums applied) * Short-Long term disability * Subsidized backup childcare * And many more... Ask us about our current inpatient nursing supplemental Pay Program! Achieve the Remarkable: Learn more about VUMC Nursing here. Core Accountabilities: Organizational Impact: Executes job responsibilities with the understanding of how output would affect and impact other areas related to own job area/team with occasional guidance. Problem Solving/ Complexity of work: Analyzes moderately complex problems using technical experience and judgment. Breadth of Knowledge: Has expanded knowledge gained through experience within a professional area. Team Interaction: Provides informal guidance and support to team members. Core Capabilities : Supporting Colleagues:- Develops Self and Others: Invests time, energy, and enthusiasm in developing self/others to help improve performance e and gain knowledge in new areas.- Builds and Maintains Relationships: Maintains regular contact with key colleagues and stakeholders using formal and informal opportunities to expand and strengthen relationships.- Communicates Effectively: Recognizes group interactions and modifies one's own communication style to suit different situations and audiences. Delivering Excellent Services:- Serves Others with Compassion: Seeks to understand current and future needs of relevant stakeholders and customizes services to better address them.- Solves Complex Problems: Approaches problems from different angles; Identifies new possibilities to interpret opportunities and develop concrete solutions.- Offers Meaningful Advice and Support: Provides ongoing support and coaching in a constructive manner to increase employees' effectiveness. Ensuring High Quality: - Performs Excellent Work: Engages regularly in formal and informal dialogue about quality; directly addresses quality issues promptly.- Ensures Continuous Improvement: Applies various learning experiences by looking beyond symptoms to uncover underlying causes of problems and identifies ways to resolve them. - Fulfills Safety and Regulatory Requirements: Understands all aspects of providing a safe environment and performs routine safety checks to prevent safety hazards from occurring. Managing Resources Effectively: - Demonstrates Accountability: Demonstrates a sense of ownership, focusing on and driving critical issues to closure.- Stewards Organizational Resources: Applies understanding of the departmental work to effectively manage resources for a department/area.- Makes Data Driven Decisions: Demonstrates strong understanding of the information or data to identify and elevate opportunities. Fostering Innovation:- Generates New Ideas: Proactively identifies new ideas/opportunities from multiple sources or methods to improve processes beyond conventional approaches.- Applies Technology: Demonstrates an enthusiasm for learning new technologies, tools, and procedures to address short-term challenges.- Adapts to Change: Views difficult situations and/or problems as opportunities for improvement; actively embraces change instead of emphasizing negative elements. Position Qualifications: Responsibilities: Certifications: LIC-Registered Nurse - Licensure-Others Work Experience: Relevant Work Experience Experience Level: 1 year Education: Graduate of an approved discipline specific program Vanderbilt Health is committed to fostering an environment where everyone has the chance to thrive and is committed to the principles of equal opportunity. EOE/Vets/Disabled.
$45k-63k yearly est. Auto-Apply 39d ago

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Clinical Research Associate - NAMSA Future Openings USA
Namsa 4.2
Remote
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 II
Glaukos Corporation 4.9
Remote
How will you make an impact? Responsible for assessing the study capabilities of potential study sites, training, on-site monitoring, closure, and management of sites participating in clinical research studies sponsored by Glaukos. The Clinical Research Associate (CRA) is responsible for maintaining data integrity and monitoring study conduct in accordance with regulations and the study protocol at the site level. What will you do? CLINICAL SITE MONITORING Travel to investigative sites to conduct site qualification, initiation, interim monitoring, and close-out visits Assist with selection of potential investigators Conduct initial and ongoing site training throughout the course of the study Verify informed consent process is properly followed Evaluate investigator compliance with the study protocol and applicable regulations Verify sites are collecting all required source data per protocol, accurately completing Case Report Forms, and resolving all data queries Review the regulatory binder and essential documents at the site and verify all documents are appropriately filed Verify and reconcile site's essential documents against the trial master file as required Oversee and conduct monitoring activities, including remote monitoring when applicable Verify investigational product is properly stored, dispensed, returned, and that accountability of the product and masking requirements are maintained throughout the study CLINICAL SITE MANAGEMENT Lead/manage assigned sites through regular contact with investigators and site staff to monitor progress, answer questions, and provide guidance during the course of the clinical study Critically review and analyze site activities through frequent visits and contacts to monitor study sites and performance Build relationships with the Investigators and site staff to enhance productivity, as well as collaborate with study management on protocol discrepancies, improving efficiency, and monitoring data integrity Manage the progress of assigned studies by tracking subject enrollment, data collection, CRF completion, source data verification, data query generation and resolution, and investigational product accountability Monitor subject safety and address protocol deviations, data quality issues, drug accountability, and identify process improvements for assigned sites. Create and maintain appropriate documentation (e.g., visit reports/letters) regarding site management, monitoring visit findings, and action plans Ensure audit and inspection readiness of assigned sites Advise on pre-audit activities for GCP requirements Be familiar with assigned study timelines and communicate potential issues to study management How will you get here? Works independently with minimal supervision Conducts all types of site visits Build strong productive relationships with study investigators, site staff, and study management personnel Participates in department projects 2 to 5 years work experience as a regional CRA; 5 years direct clinical research experience Experience in the medical device and pharmaceutical industry is preferred, and ophthalmology experience is strongly preferred for all levels of a CRA Knowledge and understanding of Good Clinical Practices (ICH E6 R2) Knowledge and understanding of FDA's Code of Federal Regulations applicable to conducting clinical research studies Must have proficient computer skills and experience with Microsoft Office Must be willing and able to travel approximately 75-80%, including overnight, domestic and international Must have Self-directed behavior #GKOSUS
$53k-81k yearly est. Auto-Apply 16d ago
Clinical Research Finance Coordinator III - Post Award
Cedars-Sinai 4.8
Los Angeles, CA jobs
This role offers a **fully remote work arrangement** . Please note that **applicants must be based in California** to be considered for this opportunity This position is a **post-award** role, meaning the incumbent will support sponsored research projects **after funding has been awarded** . Responsibilities include financial management and oversight of active grants and contracts, such as monitoring budgets and expenditures, ensuring compliance with sponsor and institutional policies, processing financial transactions, preparing financial reports, and partnering closely with investigators and research teams to support the ongoing fiscal health of awarded studies. This role does not focus on proposal development or grant submission activities. The Clinical Research Finance Coordinator III develops highly complex clinical trial budgets for industry, National Institutes of Health (NIH), and investigator-initiated clinical research. Evaluates research protocols to assess resource needs, procedures, clinical research staff time, investigator time, and costs from ancillary departments. Determines cost allocation, negotiates budgets, details budgets, and responsible for monitoring and invoicing. Plans and coordinates strategies for improving efficiency, action plans to improve quality, and training and education of personnel. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board. **Primary Duties and Responsibilities** + Works closely with investigators and ancillary departments to identify research procedures needed, budget estimates and cost details. + Evaluates highly complex research protocols to assess resource needs, research procedures, clinical research staff time, investigator time, and costs from ancillary departments. Processes Ancillary Agreements with departments providing research services. + Determines whether research procedures in the protocol are standard-of-care or a research-related cost in order to correctly classify expenses. + Develops highly complex clinical trial budgets sponsored for industry and the National Institutes of Health (NIH), investigator-initiated clinical research. Works with the CSMC office of Sponsored Research to develop final budgets for clinical trials and research projects. Reviews and approves internal and/or satellite site budgets. + Negotiates trial budgets and payment terms with industry sponsors. + Monitors study accounts to evaluate that cost expenses/details are appropriate and within expected limits, reconciles accounts receivable and payments, and determines the best course of action for any deficits and/or surpluses. Negotiates with sponsors the final payment due for account closeout. Conducts quality review and/or audits of clinical trial budgets. Serves as point of contact for fiscal related questions and engages management as appropriate. + Responsible for invoicing sponsors, patient research billing, reimbursement to ancillary departments, and payment tracking. Issues and submits invoices for protocol-related items and patient-related expenses per the executed contract and internal invoices for staff time and effort allocation into study accounts. Works closely with sponsors and clinical teams to resolve queries regarding invoices and/or payments due. + Extracts and defines relevant information, analyzes and interprets data to determine financial performance and/or to project a financial probability, and makes recommendations and/or creates proposals to influence business results. Prepares and delivers data, reports and/or presentations to investigators, management and/or leadership. + Enters financial information from finalized clinical trial budgets and clinical trial agreements into the Clinical Trial Management System. Reviews and finalizes study calendars to ensure agreement with Medicare coverage analysis and clinical trials budget. + Performs Medicare coverage analysis for clinical trials and collaborates with Institutional Review Board (IRB) to finalize and obtain approval. + Reviews protocol amendments for impact to sponsored research budget/contract. Processes budget/contract amendments as applicable. + Provides training, education, onboarding and mentors other personnel. + Plans and coordinates strategies to improve existing standard operating procedures related to budgeting and clinical trials finance. Identifies quality and performance improvement opportunities and work with management to lead the development of new (or improvement of existing) processes, policies or standard operating procedures. Assists with business software launches, implementation or optimization. + May lead or facilitate team meetings. **Qualifications** **Requirements:** + High School Diploma/GED. + 5 years of Experience with billing, accounting, accounting, finance, financial analysis or related field. + 2 years of Experience in clinical research. **Preferred:** + Bachelors in Accounting, Finance, or other related degree **Req ID** : 13660 **Working Title** : Clinical Research Finance Coordinator III - Post Award **Department** : Cancer - SOCCI Clinical Research **Business Entity** : Cedars-Sinai Medical Center **Job Category** : Academic / Research **Job Specialty** : Contract & Grant Budget/Fund **Overtime Status** : EXEMPT **Primary Shift** : Day **Shift Duration** : 8 hour **Base Pay** : $41.42 - $70.41 Cedars-Sinai is an EEO employer. Cedars-Sinai does not unlawfully discriminate on the basis of the race, religion, color, national origin, citizenship, ancestry, physical or mental disability, legally protected medical condition (cancer-related or genetic characteristics or any genetic information), marital status, sex, gender, sexual orientation, gender identity, gender expression, pregnancy, age (40 or older), military and/or veteran status or any other basis protected by federal or state law.
$41.4-70.4 hourly 7d ago
Clinical Research Finance Coordinator III - Post Award
Cedars-Sinai 4.8
California jobs
This role offers a fully remote work arrangement. Please note that applicants must be based in California to be considered for this opportunity This position is a post-award role, meaning the incumbent will support sponsored research projects after funding has been awarded. Responsibilities include financial management and oversight of active grants and contracts, such as monitoring budgets and expenditures, ensuring compliance with sponsor and institutional policies, processing financial transactions, preparing financial reports, and partnering closely with investigators and research teams to support the ongoing fiscal health of awarded studies. This role does not focus on proposal development or grant submission activities. The Clinical Research Finance Coordinator III develops highly complex clinical trial budgets for industry, National Institutes of Health (NIH), and investigator-initiated clinical research. Evaluates research protocols to assess resource needs, procedures, clinical research staff time, investigator time, and costs from ancillary departments. Determines cost allocation, negotiates budgets, details budgets, and responsible for monitoring and invoicing. Plans and coordinates strategies for improving efficiency, action plans to improve quality, and training and education of personnel. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board. Primary Duties and Responsibilities Works closely with investigators and ancillary departments to identify research procedures needed, budget estimates and cost details. Evaluates highly complex research protocols to assess resource needs, research procedures, clinical research staff time, investigator time, and costs from ancillary departments. Processes Ancillary Agreements with departments providing research services. Determines whether research procedures in the protocol are standard-of-care or a research-related cost in order to correctly classify expenses. Develops highly complex clinical trial budgets sponsored for industry and the National Institutes of Health (NIH), investigator-initiated clinical research. Works with the CSMC office of Sponsored Research to develop final budgets for clinical trials and research projects. Reviews and approves internal and/or satellite site budgets. Negotiates trial budgets and payment terms with industry sponsors. Monitors study accounts to evaluate that cost expenses/details are appropriate and within expected limits, reconciles accounts receivable and payments, and determines the best course of action for any deficits and/or surpluses. Negotiates with sponsors the final payment due for account closeout. Conducts quality review and/or audits of clinical trial budgets. Serves as point of contact for fiscal related questions and engages management as appropriate. Responsible for invoicing sponsors, patient research billing, reimbursement to ancillary departments, and payment tracking. Issues and submits invoices for protocol-related items and patient-related expenses per the executed contract and internal invoices for staff time and effort allocation into study accounts. Works closely with sponsors and clinical teams to resolve queries regarding invoices and/or payments due. Extracts and defines relevant information, analyzes and interprets data to determine financial performance and/or to project a financial probability, and makes recommendations and/or creates proposals to influence business results. Prepares and delivers data, reports and/or presentations to investigators, management and/or leadership. Enters financial information from finalized clinical trial budgets and clinical trial agreements into the Clinical Trial Management System. Reviews and finalizes study calendars to ensure agreement with Medicare coverage analysis and clinical trials budget. Performs Medicare coverage analysis for clinical trials and collaborates with Institutional Review Board (IRB) to finalize and obtain approval. Reviews protocol amendments for impact to sponsored research budget/contract. Processes budget/contract amendments as applicable. Provides training, education, onboarding and mentors other personnel. Plans and coordinates strategies to improve existing standard operating procedures related to budgeting and clinical trials finance. Identifies quality and performance improvement opportunities and work with management to lead the development of new (or improvement of existing) processes, policies or standard operating procedures. Assists with business software launches, implementation or optimization. May lead or facilitate team meetings. Requirements: High School Diploma/GED. 5 years of Experience with billing, accounting, accounting, finance, financial analysis or related field. 2 years of Experience in clinical research. Preferred: Bachelors in Accounting, Finance, or other related degree
$55k-74k yearly est. Auto-Apply 8d ago
Jr. Clinical Trials Data Specialist
Tempus Ai 4.8
Remote
Passionate about precision medicine and advancing the healthcare industry? Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time. Responsibilities: Review patient clinical records and use relevant data to determine clinical trial matches. Independently manage clinical trial workflows, adapting to changing priorities and business needs to ensure efficiency and consistency. Work collaboratively with cross-functional teams at Tempus (including scientists, pathologists, and product development) to create customized clinical reports. Navigate and synthesize information from multiple data sources and systems. Ensure clinical reports are accurate, clear, and aligned with requirements. Support ongoing and future projects within the team. Contribute to a dynamic work environment by maintaining flexibility and responsiveness to shifting workflows. Other duties as assigned. Qualifications: Bachelor's or Master's degree in Genetics, Molecular Genetics, Cancer Biology, or Biological Sciences. Willingness to work flexible hours and adapt to business needs. Strong written and verbal communication skills. Proficient in critical thinking, interpersonal, and problem-solving abilities. Ability to manage complex tasks efficiently under time constraints. Highly detail-oriented with a commitment to accuracy and consistency. Self-motivated and able to thrive independently as well as within a collaborative, high-performing team. Demonstrated passion for making an impact in a fast-paced, mission-driven environment. Preferred Qualifications: Experience reviewing hematology/oncology clinical records. Experience critically evaluating clinical trials. Basic knowledge of generative AI. CHI: $46,000-$50,000 The expected salary range above is applicable if the role is performed from Illinois and may vary for other locations (California, Colorado, New York). Actual salary may vary based on qualifications and experience. Tempus offers a full range of benefits, which may include incentive compensation, restricted stock units, medical and other benefits depending on the position. We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
$46k-50k yearly Auto-Apply 60d+ ago
Clinical Research Coordinator II- School of Medicine, Cardiology
Emory Healthcare/Emory University 4.3
Atlanta, GA jobs
**Discover Your Career at Emory University** Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the excellence of our academic community. **Description** The Clinical Research Coordinator II handles administrative activities generally associated with the conduct of clinical trials. **KEY RESPONSIBILITIES:** + Manages research project databases, develops flow sheets and other study related documents, and completes source documents/case report forms. + Provides guidance to less experienced staff. + Interfaces with research participants, determines eligibility and consents study participants according to protocol. + Approves orders for supplies and equipment maintenance. + Assists in developing recruitment strategies and conducting screenings for study participants including interviews and questionnaires. + Supervises collection of study specimens and processing. + Establishes case packages for study procedures, monitors scheduling of procedures and charges, coordinates other services as needed. + Ensures compliance with research protocols, reviews case report forms and audits for accuracy with source documents, attends monitoring meetings with sponsors. + Prepares regulatory submissions. + With appropriate credentialing and training may perform phlebotomy or diagnostics. + Performs related approved responsibilities as required. **MINIMUM QUALIFICATIONS:** + High School Diploma or GED and five years of clinical research experience. + Or two years of college in a scientific, health related, or business administration program and three years clinical research experience. + Or a licensed as a practical nurse (LPN) and two years clinical research experience. + Or a Bachelor's degree in a scientific, health related, or business administration related program and one year of clinical research experience. + Or a Master's degree, MD or PhD in a scientific, health related or business administration program. This position is intended to support clinical research and all clinical training requirements must be tracked and monitored through Emory Healthcare under the credentialing category of Clinical Researcher. NOTE: Position tasks are required to be performed in-person at an Emory University location; working remote is not an option. Emory reserves the right to change this status with notice toemployee. **Additional Details** Emory is an equal opportunity employer, and qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by state or federal law. Emory University does not discriminate in admissions, educational programs, or employment, including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training. Students, faculty, and staff are assured of participation in university programs and in the use of facilities without such discrimination. Emory University complies with Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veteran's Readjustment Assistance Act, and applicable executive orders, federal and state regulations regarding nondiscrimination, equal opportunity, and affirmative action (for protected veterans and individuals with disabilities). Inquiries regarding this policy should be directed to the Emory University Department of Equity and Civil Rights Compliance, 201 Dowman Drive, Administration Building, Atlanta, GA 30322. Telephone: ************ (V) | ************ (TDD). Emory University is committed to ensuring equal access and providing reasonable accommodations to qualified individuals with disabilities upon request. To request this document in an alternate format or to seek a reasonable accommodation, please contact the Department of Accessibility Services at accessibility@emory.edu or call ************ (Voice) | ************ (TDD). We kindly ask that requests be made at least seven business days in advance to allow adequate time for coordination. **Connect With Us!** Connect with us for general consideration! **Job Number** _158980_ **Job Type** _Temporary Full-Time_ **Division** _School Of Medicine_ **Department** _SOM: Medicine: Cardiology_ **Job Category** _Clinical Research_ **Campus Location (For Posting) : Location** _US-GA-Atlanta_ **_Location : Name_** _Emory Hospital Midtown_ **Remote Work Classification** _No Remote_ **Health and Safety Information** _Position involves clinical patient contact, Working with human blood, body fluids, tissues, or other potentially infectious materials_
$48k-63k yearly est. 2d ago
Clinical Research Coordinator I - School of Medicine, Pulmonary
Emory Healthcare/Emory University 4.3
Atlanta, GA jobs
**Discover Your Career at Emory University** Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the excellence of our academic community. **Description** The Clinical Research Coordinator handles or assists with the administrative activities generally associated with the conduct of clinical trials. KEY RESPONSIBILITIES: + Maintains data pertaining to research projects, completes source documents/case report forms, and performs data entry. + Assists with patient recruitment. + Attends study meetings. + Orders and maintains equipment and supplies. + Reviews medical records and/or conducts screenings for recruitment of study participants, performs interviews and QOL questionnaires. + Collects study specimen according to protocol which may include phlebotomy, processing, and preparation for shipping. + Coordinates services, schedules procedures, creates and maintains case packages, and monitors charges. + Assists with quality assurance and tracks regulatory submissions. + Performs related approved responsibilities as required. MINIMUM QUALIFICATIONS: + High School Diploma or GED and three years of administrative support experience. + Or two years of college in a scientific, health related, or business administration program and one year of admin support or customer service experience. + Or be a licensed as a practical nurse (LPN) and one year admin support or one year of licensed practical nursing experience. + Or a Bachelor's degree, Master's degree, MD or PhD in a scientific, health related or business administration program. This position is intended to support clinical research and all clinical training requirements must be tracked and monitored through Emory Healthcare under the credentialing category of Clinical Researcher. NOTE: Position tasks are required to be performed in-person at an Emory University location; working remote is not an option. Emory reserves the right to change this status with notice to employee. **Additional Details** Emory is an equal opportunity employer, and qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by state or federal law. Emory University does not discriminate in admissions, educational programs, or employment, including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training. Students, faculty, and staff are assured of participation in university programs and in the use of facilities without such discrimination. Emory University complies with Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veteran's Readjustment Assistance Act, and applicable executive orders, federal and state regulations regarding nondiscrimination, equal opportunity, and affirmative action (for protected veterans and individuals with disabilities). Inquiries regarding this policy should be directed to the Emory University Department of Equity and Civil Rights Compliance, 201 Dowman Drive, Administration Building, Atlanta, GA 30322. Telephone: ************ (V) | ************ (TDD). Emory University is committed to ensuring equal access and providing reasonable accommodations to qualified individuals with disabilities upon request. To request this document in an alternate format or to seek a reasonable accommodation, please contact the Department of Accessibility Services at accessibility@emory.edu or call ************ (Voice) | ************ (TDD). We kindly ask that requests be made at least seven business days in advance to allow adequate time for coordination. **Connect With Us!** Connect with us for general consideration! **Job Number** _149911_ **Job Type** _Regular Full-Time_ **Division** _School Of Medicine_ **Department** _SOM: Medicine: Pulmonary_ **Job Category** _Clinical Research_ **Campus Location (For Posting) : Location** _US-GA-Atlanta_ **_Location : Name_** _Emory Campus-Clifton Corridor_ **Remote Work Classification** _No Remote_ **Health and Safety Information** _Not Applicable, Working in a laboratory_
$48k-63k yearly est. 60d+ ago
Study Coordinator
McKesson 4.6
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 Study Coordinator you will plan the execution and monitor the completion of complex Phase I-IV assigned clinical research protocols. Including abstracting, assembling and organizing research data while monitoring adherence to the clinical protocol and preparing reports on the data. Will work closely with the physician principal investigator, manager of data operations, clinical trial sponsor and study team. You will lead the execution of trials for the research team You will plan and track all assigned clinical activity in the lifecycle phases of the startup, interim and close out You will confirm patient eligibility and discuss discrepancies with nursing staff and physicians You will verify study procedures are performed within the protocol specified window You will participate in teleconferences with sponsors to update on patients including research visits, toxicity, and overall response. Responsible for sending notification out to department before and after calls to update study staff You will present in weekly protocol meeting to investigators, research staff, and management You will provide pertinent safety information to sponsor and study teams by monitoring patient toxicity, including serious adverse events, on trial according to Common Toxicity Criteria You will update internal research teams on protocol modifications and specifications including visit schedule, assessment windows, dose modifications, central and local laboratory assessments You will create study specific tools for source documentation including eligibility worksheets, screening checklists and worksheets capturing vital signs, blood sampling (as applicable) You will ensure study specific tools, including source documents (including paper and/or EMR), are updated with any amendment(s) or study changes You will investigate root cause of major protocol deviations and manages the follows up with responsible departments for corrective and preventative actions You will ensure pharmacy has Investigative Product and supplies You will interface with laboratory technician for lab kits and processing You will track and report adverse events, serious adverse events, protocol waivers, deviations and violations You will participate in monitor visits for each assigned trial at each monitoring visit You will review and comment on monitor letters within 5 business days of receipt and insures resolution of open items You will review source documentation and queries for missing documentation You will collect, complete and enter data into study-specific case report forms or electronic data capture systems within the contractually agreed upon timeframe You will maintain case report forms tracking management database You will review trial data for clinical relevance and answers appropriate queries Apprises research scientists and management team of all study specific medical issues for guidance You will assist in ensuring physician oversight by updating on protocol issues and obtaining signatures and clinical significance of laboratory reports, ECGs, and adverse events You will assist in external sponsor audit and US FDA inspection preparation, conduct, and close out processioning You will review and responds to audit findings and escalates issues You will maintain and archive study documentation and correspondence per company policy You will reports patient visit and data entry information in financial tracking system. You will provide required metrics to leadership You will initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects You will adhere to professional standards and SOP's established for clinical research You will assist internal quality team in preparation for sponsor and US FDA audit teams You should have for this role: An understanding of clinical trial data. Knowledge of FDA guidelines and GCP is required. The ability to work independently in a fast paced environment. Interpersonal skills, detailed-oriented and meticulous. Computer skills with ability using clinical trial databases, electronic data capture, MS Access or Excel Bachelor Degree is preferred At least one year of experience in healthcare, research or other science related field At least one year of experience planning and managing clinical trial process This position will be open for applications until January 20 2026. 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.
$35k-48k yearly est. Auto-Apply 14d ago
Senior Clinical Trial Specialist - Remote Position
Puma Biotechnology, Inc. 4.3
South San Francisco, CA jobs
The Senior Clinical Trial Specialist (Sr. CTS) is responsible for providing operational support for the day-to-day execution of clinical trials, following established SOPs, GCP and applicable regulatory requirements in the execution of all activities; proactively identifying and resolving operational project issues; and participating in process improvement initiatives as required. Major Duties/Responsibilities * Ensures timely and accurate study-related communication to clinical personnel (eg, internal and external study teams, consultants and investigative site personnel); prepares and disseminates clinical trial correspondence, newsletters, and IND safety letters (working with project clinician); and assists with the creation of study-specific manuals, tools, and templates * Participates in selection and management/oversight of external vendors and develops vendor specifications; reviews vendor reports, budgets, and metrics; acts as liaison between vendors and sites (eg, assists sites with laboratory sample queries) * Coordinates specified clinical trial meetings (eg, investigator meetings, study team meetings, CRA and CRO meetings) by arranging logistics, preparing necessary materials and recording and distributing minutes * Sets up, tracks, collects and maintains audit-ready clinical trial documentation and study status in an electronic system; manages and tracks regulatory/IRB/IEC documentation, IND safety letter distribution, confidentiality disclosure agreements, and other clinical trial documents; performs initial QC of electronic data feeds; generates, reviews and distributes reports; assists with quality assurance audits and resolution of audit findings * Participates in study design and execution by contributing operational experience and expertise: provides input into protocol, ICF, CRF design, monitoring conventions, edit checks and vendor specifications; assists with study or site feasibility process; posts and maintains study-related information on external websites when applicable * Ensures that necessary study supplies are available as per study timelines: sources clinical trial supplies through external vendors (eg, case report forms, study manuals, lab kits); manages, reviews and tracks drug shipment, destruction, and return; coordinates internal lab sample supply set-up and shipment * Maintains ongoing communication with site staff to resolve issues (eg, data queries, study management), support the staff, oversee the efficient conduct of the trial, and ensure continued compliance * May also be responsible for acting as a central point of communication between Puma and investigative sites for all assigned clinical trial-related activities to assure trials are conducted on time and budget, while fully compliant with ICH GCP and the SOPs in effect. In this role, the Sr. CTS may be responsible for: * Conducting on-site visits consistent with the applicable Clinical Monitoring Plan and SOPs for site qualification, site initiation, routine monitoring, site close-out and other site visits (eg, booster), as requested * Overseeing site recruitment, implementing appropriate contingency plans, as needed * Assessing site performance and conducting training/re-training when necessary to ensure site compliance with the protocol, applicable regulations and Puma expectations * Writing confirmation letters, follow-up letters and site visit reports that conform with guidelines and timelines stated in the applicable Clinical Monitoring Plan and SOPs * Mentors more junior staff * Manages study team meetings in absence of Clinical Trial Manager * Performs other tasks, as assigned by the manager/designee to promote the efficient conduct of the trial Skills & Abilities * Clear and timely communication, both written and verbal * Ability to handle a moderate volume of highly complex tasks within an established timeframe * Strong organizational skills and ability to prioritize * Ability to build relationships within the team, across departments, and with external contacts (eg, vendors, site staff) * Proactively identify and resolve/escalate project-related operational issues * Ability to work independently on routine assignments, and take over new assignments based on previous experience * Familiarity with word processing, spreadsheet and document management systems Travel Travel required up to 25%. Education & Professional Experience Required: * Bachelor's degree or equivalent combination of education/experience, preferably in science or a health-related field * Strong understanding of GCP, ICH and knowledge of regulatory requirements * Minimum one year prior Clinical Trial Specialist experience or commensurate Preferred: * One year of clinical research experience or health-related experience (eg, study coordinator, data management, nursing) * Completion of Puma Field Monitoring Course or equivalent, as required for field monitoring activities * Oncology experience * Global trial experience Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that ae required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Physical Demands The physical demands of the office are normally associated with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing the duties of this job, the employee is frequently required to stand, walk and sit. Periodic light lifting of supplies and materials may apply. Compensation Range The salary range for this role is $90,000 - $100,000 per year. Higher compensation may be available for someone with advanced skills and/or experience. At Puma Biotechnology, we offer an attractive compensation package to our team members. Any offer would include a competitive base salary (estimate shared above), an annual bonus target, and a robust benefits package. Actual individual pay is determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. #LI-Remote
$90k-100k yearly 35d ago
Clinical Research Coordinator I/II
Benaroya Research Institute 4.3
Seattle, WA jobs
Join a collaborative team at the Clinical Trials Unit of Benaroya Research Institute (BRI), where your work will directly support cutting-edge clinical research in partnership with Virginia Mason physicians. Our studies focus on a variety of specialties including Cardiology (treatment of either new medications or cardiac devices), Neurology, and Allergy studies. This role offers exposure to a wide range of clinical trials across various phases of development. You will be part of a supportive, team-oriented environment with unparalleled support from our physicians, clinic staff, and dedicated study teams. We are seeking a motivated and detail-oriented Clinical Research Coordinator (CRC) to support our Principal Investigators in executing high-quality research protocols. Schedule: Typically Monday through Friday from 8:00 AM to 4:30 PM, with a 30-minute lunch break. Work schedule may vary. Responsibilities Facilitate clinical research, including collaboration with affiliate or partnering research sites and conducting BRI-based studies Prepare for new studies, including regulatory document filing and study monitor visit preparation Screen and recruit study subjects, obtain informed consent, and document subject history Review adverse events, concomitant medications, and ensure protocol compliance and subject safety Handle test articles (TA), complete case report forms, and maintain source documents Manage proper standard or research billing and ensure site quality Coordinate subject care, including appointment scheduling, record reviews, treatment coordination, and health assessments Collect vital signs, perform telephone triage/screening, and assist with subject arrivals Conduct phlebotomy, specimen processing using universal precautions, and other procedures as appropriate Participate in process improvement activities and develop corrective and preventive action plans Qualifications Clinical Research Coordinator I Minimum of one year full-time related experience required Must maintain subject and document confidentiality at all times Understand and comply with sponsor requirements, FDA regulations, Good Clinical Practices (GCP), International Conference on Harmonization (ICH), HIPAA, IRB, and institutional policies and procedures Requires good medical knowledge, including medical terminology and basic subject care May require phlebotomy and vital sign collection skills, as well as the ability to operate centrifuges and EKG machines Preferred: Higher education or vocational training specializing in healthcare May require healthcare licensure or other specialized training Clinical Research Coordinator II Minimum of two years full-time related experience in clinical research required Must maintain subject and document confidentiality at all times and comply with sponsor requirements, FDA regulations, Good Clinical Practices (GCP), International Conference on Harmonization (ICH), HIPAA, Institutional Review Boards (IRB), and institutional policies and procedures Ability to provide guidance or informal supervision to a Research Assistant or CRC I in the conduct of their study, as applicable Bachelor's degree and SOCRA or ACRP certification strongly preferred A Master's degree in clinical research or a related field, or an M.D., may substitute for the two years of clinical research experience Compensation Clinical Research Coordinator I - $25.66 to $37.21 hourly Clinical Research Coordinator II - $30.00 to $44.69 hourly Benefits Medical, dental, vision insurance Flexible spending accounts: health care, dependent care, commuter Short and long-term disability Life and AD&D insurance 403(b) retirement plan with matching funds after one year of employment PTO: 13 holidays, three weeks of vacation and two weeks of sick leave per year Employee assistance program Educational assistance program Subsidized ORCA pass Wellness benefits Voluntary benefits About Us The Clinical Research Program at Benaroya Research Institute (BRI) works together with clinicians at Virginia Mason Medical Center to bring clinical research opportunities to patients, giving them access to clinical trials for over 100 different conditions including cancer, digestive disease, cardiology, and neuroscience. The Clinical Research Program at BRI oversees all clinical research at Virginia Mason Medical Center, combining the expertise of a world-renowned research institute with remarkable healthcare to support studies that contribute to improving the diagnosis, treatment, and prevention of a variety of diseases. BRI is an independent, nonprofit research institute affiliated with Virginia Mason Franciscan Health and based in Seattle. Our culture is based on the values of collaboration, respect, innovation, and inquiry; team members work together to support patients and clinicians with the goal of better outcomes for all. At BRI, each role is valued and an important contributor to our vision and mission. BRI is committed to a safe, caring and diverse workplace; as well as to taking action to further our commitments to foster inclusion, equity and belonging so employees feel comfortable bringing their full selves to work. Consider making a difference by joining our team. Because together, we are powering possibility. To learn more, visit benaroyaresearch.org and connect with us on Facebook, Instagram, Threads, LinkedIn, Bluesky and YouTube. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by state or federal law. If you need an accommodation or assistance completing the online application, please contact Human Resources at ************ or email *************************. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications.
$25.7-37.2 hourly Auto-Apply 49d ago
Study Coordinator
Sarah Cannon Research Institute 3.6
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 Study Coordinator you will plan the execution and monitor the completion of complex Phase I-IV assigned clinical research protocols. Including abstracting, assembling and organizing research data while monitoring adherence to the clinical protocol and preparing reports on the data. Will work closely with the physician principal investigator, manager of data operations, clinical trial sponsor and study team. You will lead the execution of trials for the research team You will plan and track all assigned clinical activity in the lifecycle phases of the startup, interim and close out You will confirm patient eligibility and discuss discrepancies with nursing staff and physicians You will verify study procedures are performed within the protocol specified window You will participate in teleconferences with sponsors to update on patients including research visits, toxicity, and overall response. Responsible for sending notification out to department before and after calls to update study staff You will present in weekly protocol meeting to investigators, research staff, and management You will provide pertinent safety information to sponsor and study teams by monitoring patient toxicity, including serious adverse events, on trial according to Common Toxicity Criteria You will update internal research teams on protocol modifications and specifications including visit schedule, assessment windows, dose modifications, central and local laboratory assessments You will create study specific tools for source documentation including eligibility worksheets, screening checklists and worksheets capturing vital signs, blood sampling (as applicable) You will ensure study specific tools, including source documents (including paper and/or EMR), are updated with any amendment(s) or study changes You will investigate root cause of major protocol deviations and manages the follows up with responsible departments for corrective and preventative actions You will ensure pharmacy has Investigative Product and supplies You will interface with laboratory technician for lab kits and processing You will track and report adverse events, serious adverse events, protocol waivers, deviations and violations You will participate in monitor visits for each assigned trial at each monitoring visit You will review and comment on monitor letters within 5 business days of receipt and insures resolution of open items You will review source documentation and queries for missing documentation You will collect, complete and enter data into study-specific case report forms or electronic data capture systems within the contractually agreed upon timeframe You will maintain case report forms tracking management database You will review trial data for clinical relevance and answers appropriate queries Apprises research scientists and management team of all study specific medical issues for guidance You will assist in ensuring physician oversight by updating on protocol issues and obtaining signatures and clinical significance of laboratory reports, ECGs, and adverse events You will assist in external sponsor audit and US FDA inspection preparation, conduct, and close out processioning You will review and responds to audit findings and escalates issues You will maintain and archive study documentation and correspondence per company policy You will reports patient visit and data entry information in financial tracking system. You will provide required metrics to leadership You will initiate improvements to enhance the efficiency and the quality of the work performed on assigned projects You will adhere to professional standards and SOP's established for clinical research You will assist internal quality team in preparation for sponsor and US FDA audit teams You should have for this role: An understanding of clinical trial data. Knowledge of FDA guidelines and GCP is required. The ability to work independently in a fast paced environment. Interpersonal skills, detailed-oriented and meticulous. Computer skills with ability using clinical trial databases, electronic data capture, MS Access or Excel Bachelor Degree is preferred At least one year of experience in healthcare, research or other science related field At least one year of experience planning and managing clinical trial process This position will be open for applications until January 20 2026. 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.
$33k-44k yearly est. Auto-Apply 14d ago
Clinical Research Coordinator
Gastro Health 4.5
Birmingham, AL jobs
Gastro Health is seeking a Full-Time Clinical Research Coordinator to join our team! Gastro Health is a great place to work and advance in your career. You'll find a collaborative team of coworkers and providers, as well as consistent hours. This role offers: A great work/life balance No weekends or evenings - Monday thru Friday Paid holidays and paid time off Rapidity growing team with opportunities for advancement Competitive compensation Benefits package Duties you will be responsible for: General Administrative Coordinates with Principal Investigator, local site, and Central Hub to help ensure that clinical research and related activities are performed in accordance with federal regulations and sponsoring agency policies and procedures. Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training. Assists Principal Investigator to assure that all key personnel or persons ‘engaged' in the research project have met training requirements in accordance with federal regulations and university and sponsoring agency policies and procedures. Cooperates with compliance and monitoring efforts related to sponsored program administration and respond to any audit findings and implement approved recommendations. Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by FDA and sponsors. Protocol Preparation & Review Attends investigator meetings as required or requested by the PI. Collaborates with the Regulatory Specialist to prepare IRB and any other regulatory submission documents as required by the protocol. Prepares other study materials as requested necessary. These study materials include, but are not limited to, the informed consent document, source documents, enrollment logs, and drug/device accountability logs. Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials. Conduct of Research Reviews and comprehends the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections. Assists PI in communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log. Develops and implement recruitment strategies in accordance with HRPO (IRB) requirements and approvals. Conducts or participates in the informed consent process and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed. Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant's eligibility or exclusion. Registers each participant in CTMS to ensure billing of study procedures to the appropriate funding source. Coordinates participant tests and procedures. Collects data as required by the protocol. Assures timely completion of Source Documents. Maintains study timelines. Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol and/or Gastro Health Research Policy on Investigational Drug/Device Accountability. Completes study documentation and maintains study files in accordance with sponsor requirements and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms. Retains all study records in accordance with sponsor requirements and Gastro Health Research policies and procedures. Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study. Works with the PI to manage the day to day activities of the study including problem solving, communication and protocol management. Project Closeout Assists the Principal Investigator and Regulatory Specialist in submission of accurate and timely closeout documents to applicable federal agencies, and the sponsoring agency in accordance with federal regulations and sponsoring agency policies and procedures. Arranges secure storage of study documents that will be maintained according to Gastro Health Research policy or for the contracted length of time, whichever is longer. Minimum Requirements Clinical research experience preferred Previous phlebotomy skills High School Diploma Interested in learning more? Click here to learn more about the location. Gastro Health is the one of the largest gastroenterology multi-specialty groups in the United States, with over 130+ locations throughout the country. Our team is composed of the finest gastroenterologists, pediatric gastroenterologists, colorectal surgeons, and allied health professionals. We are always looking for individuals that share our mission to provide outstanding medical care and an exceptional healthcare experience. We offer a comprehensive benefits package to our eligible employees. Gastro Health is proud to be an Equal Opportunity Employer. We do not discriminate based on race, color, gender, disability, protected veteran, military status, religion, age, creed, national origin, gender identity, sexual orientation, marital status, genetic information, or any other basis prohibited by local, state, or federal law. We thank you for your interest in joining our growing Gastro Health team!
$50k-64k yearly est. Auto-Apply 57d ago
Clinical Research Coordinator
Sonic Healthcare USA 4.4
Birmingham, AL jobs
We're not just a workplace - we're a Great Place to Work certified employer! Proudly certified as a Great Place to Work, we are dedicated to creating a supportive and inclusive environment. At Sonic Healthcare USA, we emphasize teamwork and innovation. Check out our job openings and advance your career with a company that values its team members! Quality is in our DNA -- is it in yours? You put the pro in medical laboratory professional. You've got problem-solving instincts, a passion for patient care, and the technical training to deliver quality results. You're also looking for great benefits, the support of an all-star team, and an opportunity to grow your career. Join our front line of #HealthcareHeroes! Our mission is to advance the health and wellbeing of our communities as a leader in clinical laboratory solutions. The Clinical Research Coordinator will be responsible for assisting the Director of Research Operations in operationalizing clinical protocols relevant to Bio-specimen procurement initiatives. Location: Birhmingham, Alabama Days: Monday - Friday Hours: 8:00 AM - 5:00 PM Full-time: Benefit Eligible Essential Key Responsibilities: Responsible for, recruiting, consenting, detailing and tracking eligible study subjects for clinical trials Introduces the details, and parameters of the study to study candidates and appropriate medical staff Field candidates' questions and concerns about the study Obtains signed informed consent from all study participants Functions as the liaison between study candidates and the principal investigator Tracks the number of study candidates that were recruited vs. the number of successful specimen collections Coordinates pre-operative blood collection handling and storage when required Education: Nursing or Med-tech degree and certification desired. BA/BS science related degree preferred Experience: Experience working with clinical research protocols Experience obtaining informed consents is preferred Knowledge of hospital departmental policies and operations is preferred Requirements: A valid state driver's license with an acceptable Motor Vehicle Report (MVR) Must have personal and reliable transportation Proof of current vehicle registration and personal automobile insurance Excellent verbal and written communications skills Experience with patient interaction Knowledge of basic medical terminology Ability to understand and abide by Food & Drug Administration: Good Clinical Practice Guidelines Equipment: General office equipment including but not limited to personal computers, fax machines, copiers, and printers Proficiency in Microsoft Office applications, including Microsoft Word and Excel Must have personal and reliable transportation Scheduled Weekly Hours: 40 Work Shift: Job Category: Accounts Receivable Company: Cunningham Pathology LLC Sonic Healthcare USA is an equal opportunity employer that celebrates diversity and is committed to an inclusive workplace for all employees. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, age, national origin, disability, genetics, veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
$40k-59k yearly est. Auto-Apply 36d ago
Clinical Research Coordinator - Full-Time - Wolf River
West Cancer Center 3.7
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 11d ago
Clinical Research Coordinator
Sarah Cannon Research Institute 3.6
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 14d ago
Clinical Research Coordinator I
BHS 4.3
Lexington, KY jobs
Baptist Health is looking for a Clinical Research Coordinator I to join their team in Lexington. Under limited supervision, the Clinical Research Coordinator I (CRC) coordinates patient care in compliance with local, state and federal guidelines and regulations through IRB approved protocol requirements. The CRC uses their developing and/or basic knowledge of clinical trial research along with their hospital experience to work collaboratively with individuals associated with the care and treatment of the patient. It is the expectation the CRC will utilize day-to-day experience and collaborations with senior staff to broaden their knowledge base and capabilities. They will seek out opportunities to build their knowledge of the organization, research processes and scope of work. They will understand the guidelines, regulations, and policies associated with conducting clinical trial research and use that insight to evaluate and resolve problems or seek out guidance. The CRC collaborates with the investigators, research staff and other departmental stakeholders to conduct clinical trial coordination per protocol. Through clear documentation, the CRC will define any changes in condition, adverse events, concomitant medication use, protocol compliance, and response to study intervention. The CRC works collaboratively with individuals associated with the care and treatment of the patient. Qualifications: Technical Diploma or Degree/certification must be in biology, public health, pharmacy, or health related field. 3 years' experience. Previous experience in oncology clinical research or as a clinical trial coordinator. Proficient with a computer including navigating websites, electronic data systems, electronic medical records, Excel, Word, PowerPoint. Work Experience Relevant Work Experience Education If you would like to be part of a growing family focused on supporting clinical excellence, teamwork and innovation, we urge you to apply now! Baptist Health is an Equal Employment Opportunity employer.
$42k-60k yearly est. Auto-Apply 11d ago
Training and Research Coordinator
Healing Lodge of The Seven Nations 3.6
Spokane Valley, WA jobs
Training & Research Coordinator Department: Program and Support Services FLSA Status: Non-Exempt Work Schedule: Monday-Friday 9AM-6PM (Varies based on travel needs) Reports to: CIRCLE Director & NARCH Principal Investigator NARCH XII Grant Wage Range: $26.43-$35.46/hr DOE/DOQ Updated: 5/16/25 Benefits: Full Medical, Dental and Vision benefits first of the month after 60 days employment. HL7N pays 100% of the insurance premium for Full-time Employees (30 hours+). HL7N pays 100% of the Employees $6,000 toward out of pocket medical/dental/vision expenses with the Navia card. $75,000 Life Insurance, Short and Long-Term disability after 90 days. HL7N pays 100% of the Life Insurance premium for Full-time Employees (30 hrs.+). Annually Employees receive 12 paid holidays; 20 Paid-Time-Off (PTO) days per year after the employee has been employed FTE (30 hrs.+) and achieve successful 90-days performance evaluation rating. 403(b) Thrift Savings Plan with the HL7N maximum pension contribution of 4%, completed 12 months of employment (1000 hrs.) and successful performance evaluation rating. Healing Lodge employment may qualify for the Federal Public Service Loan Forgiveness (PSLF) program as well as loan repayment through Health Resources and Services Administration (HRSA) About the Company The Healing Lodge of the Seven Nations is a youth residential treatment facility which provides a safe and caring healing environment for adolescents in need. Located on 51 acres, our wellness program provides a peaceful environment for treatment balanced in traditional, cultural and spiritual values and practices. These values and practices foster respect, honesty, generosity, strong cultural identification and hope for positive life changes. The Healing Lodge treatment program integrates traditional, spiritual and cultural values with chemical dependency and mental health counseling to create a holistic approach toward healing. Residents include both Native American and non-Native from all areas of the country. About the Position As a key member of the NARCH grant staff, and as part of a four-year federally-funded grant (currently in its second year), the Training & Research Coordinator will have a variety of responsibilities, including, but not limited to assisting the Principal Investigators and other project staff. Training activities will include co-creating, promoting, planning, and delivering Tribal mental health emergency response training. Research activities will include assisting with drafting Institutional Review Board (IRB) protocols and applications; recruiting study participants; administering informed consent procedures; administering research surveys; engaging in participant retention activities; complying with IRB protocols; processing research subject reimbursements; entering data; conducting literature searches; contributing to survey development; supporting research pre-registration; and conducting research-related record keeping. The Training & Research Coordinator also will attend multiple weekly NARCH team meetings. Position Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Essential Duties and Responsibilities include the following: Provide support to the Principal Investigators (PIs) for research and training development activities; Provide support for research execution activities; Attend weekly NARCH team meeting; Help organize and administer quarterly Tribal working group meetings; Prepare and organize meeting materials; Assist with drafting IRB protocols and applications; Co-create, promote, plan, and deliver training events, which will require travel to the Seven Tribal nations of the Healing Lodge, and may require overnight stays; Engage in study participant recruitment and retention activities; Assist in data collection activities at the Seven Tribal nations of the Healing Lodge and within the Healing Lodge; Help to prepare written reports; Help prepare written manuscripts, slide decks, posters, and presentations; Complete IRB (human subjects) certification; Provide support with grant writing activities; Other duties as assigned. Supervisory Responsibilities: This position has no supervisory responsibilities. Education and/or Experience: Associate's Degree or Bachelor's Degree in related field required, OR 5-7 years of advanced professional training experience on topics of concern for the mental health field and/or Native American culture; Demonstrated interest and experience working in a mental health field; Knowledge of working in remote Tribal communities and in cross-cultural contexts; Demonstrated training/group facilitation skills; Knowledge of using social science research methods, particularly for indigenous studies (Preferred). Certificates, Licenses, or Registrations: Native American preference applies and highly preferred for this position. HL7N reserves the right to hire according to our Indian Hiring Preference. A valid unrestricted Driver's License and experience driving in all types of weather conditions is a plus; IRB (human subjects) certification, which can be accomplished as part of the position duties. Travel: The candidate will be required to travel frequently to various in/out of State locations to assist in delivering mental health emergency response training to tribal communities of the Seven Tribal nations. Some overnight stay is projected and expected. Hiring Preference The Healing Lodge of the Seven Nations (HL7N) is an Equal Opportunity Employer. As a tribal organization under Indian Health Service (IHS), the HL7N is required by law to provide absolute preference in employment to American Indians and Alaska Natives who are enrolled in a federally recognized tribe as defined by the Secretary of the Interior. Indian preference requirements apply to all actions involved in filling vacant position (e.g., initial hiring, reassignment, transfer, competitive promotion, reappointment or reinstatement), no matter how the vacancy arises. Any individual who claims Indian preference: 1) Must submit proof of tribal enrollment/Certificate of Indian Blood (CIB); 2) Must meet all qualification requirements as defined by HL7N qualification standards; and 3) Must be deemed suitable for employment. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. The Healing Lodge believes that each employee makes a significant contribution to our success. That contribution should not be limited by the assigned responsibilities. This position description is designed to outline primary duties, qualifications and job scope, but not limit our employees nor the organization to just the work identified. It is our expectation that each employee will offer his/her services wherever and whenever necessary to ensure the success of the company. Healing Lodge of The Seven Nations is an EEO Employer - M/F/Disability/Protected Veteran Status View all jobs at this company
$26.4-35.5 hourly 4d ago
Clinical Trial Specialist
Tennessee Oncology 4.4
Nashville, TN jobs
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: This position works closely with the research team to help coordinate the approval processes and conduct of research protocols, assured that the integrity and quality of the research is maintained and that the research is conducted in accordance with Good Clinical Practice Guidelines, federal and sponsor regulations and guidelines, GHCR policies and procedures, and research protocols. The Clinical Trial Specialist I will assist in the management of subjects on clinical trials and coordinating activities associated with clinical trials under the mentorship and guidance of a Clinical Trial Specialist II. ESSENTIAL FUNCTIONS: Manage and execute the day-to-day operations of complex Phase I-IV clinical research protocols in compliance with applicable GCP/ICH guidelines and other regulatory requirements Manage and lead cross-functional study teams, including vendors; liaise with other functional areas (preclinical development, pharmaceutical sciences, safety, and regulatory affairs) in order to accurately coordinate clinical study activity. Provides second check for patient eligibility to clinical trial, following review by research nurse, including a second check of inclusion/exclusion requirements and eligibility criteria Attend and oversee Site Initiation Visits Coordinate and attend regular monitoring visits and closeout visits Maintains informed consents records of each patient for the duration of a study Maintains and files all relevant study documents throughout lifetime of a trial Provides regular and concise updates on study timelines, patient statuses, and trial details to study teams, Principal Investigator, and study sponsor. Meets data management deadlines set by internal and external teams Acts as a point of contact for Research Data Coordinator, and assists with and reviews data entry where necessary Protects the rights, safety, and welfare of patients Strives to maintain harmonious relationships with clinic personnel, clients, and administrative staff Reviews newly activated protocols, amendments, notices, suspensions, and terminations Maintains required certification in Good Clinical Practice and Good Documentation Practice Serves as a liaison to multiple Tennessee Oncology departments, providers, and other personnel Serves as a liaison between GHCR and external clients and sponsors 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 Proactively identifies trial-related issues and provides recommendations for resolution Executes job responsibilities with the understanding of how output would affect, and impact other areas related to own job area/team with occasional guidance KNOWLEDGE, SKILLS & ABILITIES: Ability to independently handle multiple priorities in a fast-paced environment Ability to comprehend complex clinical trial protocols Microsoft Office product knowledge (Word, Excel, PowerPoint, SharePoint and OneNote) EDUCATION & EXPERIENCE: Bachelor's Degree or equivalent combination of education and experience required One year of experience working in clinical trials required
$64k-102k yearly est. Auto-Apply 8d ago
Clinical Research Coordinator
Campbell Clinic 4.2
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. 15d ago