Research Coordinator jobs at Dartmouth-Hitchcock - 71 jobs

NATIONAL LEADERS IN PEDIATRIC CARE Ranked among the top 10 pediatric hospitals in the nation, Children's Hospital Los Angeles (CHLA) provides the best care for kids in California. Here world-class experts in medicine, education and research work together to deliver family-centered care half a million times each year. From primary to complex critical care, more than 350 programs and services are offered, each one specially designed for children. The CHLA of the future is brighter than can be imagined. Investments in technology, research and innovation will create care that is personal, convenient and empowering. Our scientists will work with clinical experts to take laboratory discoveries and create treatments that are a perfect match for every patient. And together, CHLA team members will turn health care into health transformation. Join a hospital where the work you do will matter-to you, to your colleagues, and above all, to our patients and families. The work will be challenging, but always rewarding. It's Work That Matters. Overview This position is 100% remote. CHLA does require a primary residence in CA prior to start date. Schedule: M-F Purpose Statement/Position Summary: Under supervision, supports the efficiency of the Human Subjects Protection Program in the areas of protocol reviews, liaison with the Institutional Review Board, and simple to moderately complex correspondence. Minimum Qualifications/Work Experience: 1+ years IRB experience. Education/Licensure/Certification: Bachelor's degree in a scientific or business discipline or an equivalent combination of relevant education and work experience. Pay Scale Information USD $70,304.00 - USD $104,832.00 CHLA values the contribution each Team Member brings to our organization. Final determination of a successful candidate's starting pay will vary based on a number of factors, including, but not limited to education and experience within the job or the industry. The pay scale listed for this position is generally for candidates that meet the specified qualifications and requirements listed on this specific job description. Additional pay may be determined for those candidates that exceed these specified qualifications and requirements. We provide a competitive compensation package that recognizes your experience, credentials, and education alongside a robust benefits program to meet your needs. CHLA looks forward to introducing you to our world-class organization where we create hope and build healthier futures. Children's Hospital Los Angeles (CHLA) is a leader in pediatric and adolescent health both here and across the globe. As a premier Magnet teaching hospital, you'll find an environment that's alive with learning, rooted in care and compassion, and home to thought leadership and unwavering support. CHLA is dedicated to creating hope and building healthier futures - for our patients, as well as for you and your career! CHLA has been affiliated with the Keck School of Medicine of the University of Southern California since 1932. At Children's Hospital Los Angeles, our work matters. And so do each and every one of our valued team members. CHLA is an Equal Employment Opportunity employer. We consider qualified applicants for all positions without regard to race, color, religion, creed, national origin, sex, gender identity, age, physical or mental disability, sexual orientation, marital status, veteran or military status, genetic information or any other legally protected basis under federal, state or local laws, regulations or ordinances. We will also consider for employment qualified applicants with criminal history, in a manner consistent with the requirements of state and local laws, including the LA City Fair Chance Ordinance and SF Fair Chance Ordinance. Qualified Applicants with disabilities are entitled to reasonable accommodation under the California Fair Employment and Housing Act and the Americans with Disabilities Act. Please contact CHLA Human Resources if you need assistance completing the application process. Our various experiences, perspectives and backgrounds allow us to better serve our patients and create a strong community at CHLA. TSRI - Human Research Protection Program

Centerstone is among the nation's leading nonprofit behavioral health systems with thousands of employees dedicated to delivering care that changes people's lives. A dynamic, well-established organization, we offer rewarding opportunities to serve all ages in a variety of settings. Come talk to us about joining the Centerstone team! JOB DESCRIPTION: SUMMARY OF POSITION Centerstone's Institute works to support the organization's mission of delivering care that changes people's lives by generating knowledge that transforms behavioral healthcare and translating that knowledge meaningfully into behavioral healthcare practice. Our main goal is closing the research-to-practice gap so our clients can receive excellent behavioral healthcare and achieve their best outcomes. We bring technology, innovation, and multidisciplinary approaches to the forefront in all we do. We aim to set standards for the mental health care field as a whole. As a Research Associate at Centerstone's Institute, you will provide a wide array of support for evaluation projects, including Data Collection and Data Management, Research/Evaluation Planning, Data Reporting and Dissemination, and other tasks related to program evaluation. You will work closely with the Lead Evaluator and clinical program staff to achieve program goals and objectives and address any barriers to achieving these goals. The ideal candidate will demonstrate effective communication skills, the capacity to work effectively independently, and within a functional team, while managing responsibilities and prioritizing tasks in an environment with overlapping activities and competing priorities. ESSENTIAL DUTIES & RESPONSIBILITIES Research/Evaluation Planning and Organizing Contribute to the planning, implementation, and maintenance of evaluation and research projects Assist with the recruitment and tracking of evaluation participants Conduct surveys, interviews and engage in other primary and secondary data collection Support the evaluation team in the development of surveys, questionnaires, reports and presentations Data Collection, management, and analysis Collect and submit all project data as required by funding agencies (e.g., adhere to follow-up data collection schedules, conduct phone calls/text communication, maintain databases, and complete data entry within specific time requirements) as directed by the Lead Evaluator Assist with coding and organizing data for analysis and interpretation Use hardware and software for data management, data analysis, document creation, and system maintenance, that may include (but not be limited to) Microsoft Outlook, Excel, PowerPoint, Access, SPSS, REDCap, SPARS, Atlas ti Data Reporting and Dissemination Communicate clearly and effectively with staff, supervisors, and others of diverse social, cultural, economic, and educational backgrounds Maintain accurate records, coordinate multiple tasks, and ensure comprehensive documentation of operations Assist the Lead Evaluator, evaluation staff, and clinical personnel in the effective dissemination and utilization of evaluation information Assist with the creation of data visualization graphics and narrative interpretation When able, attend and present program findings at conferences Organizational Development Participate in Program Evaluation Departmental initiatives and meetings, Institute, and Centerstone as a whole, including attendance at Town Halls, Table Topics, Employee Resource Groups, and other developmental or educational activities as directed by the Lead Evaluator or supervisor KNOWLEDGE, SKILLS & ABILITIES Ability to effectively work remotely and maintain a professional demeanor Able to communicate clearly and effectively with staff, supervisors and others. Possesses organizational skills to maintain records and coordinate other tasks. Skilled in speaking and writing to persons of various social, cultural, economic and educational backgrounds. Familiarity with behavioral sciences Competent in the use of personal computers and software (i.e. Excel, Access, SPSS, Atlas ti). Able to perform basic qualitative and/or quantitative data analysis. Assists in quality improvement activities. Capacity to work both independently as well as within a team,. Capacity and interest in learning how to apply social science research methods to the field of evaluation, which aims to improve the performance or efficiency of individuals, groups, programs, policies, government and others, capacity to manage responsibilities and prioritize tasks in an environment with many activities and competing priorities. QUALIFICATIONS Education Level · Bachelor's degree preferred · Associate's degree OR equivalent combination of four (4) years of post-secondary education, training, and experience in social sciences, mental health, or experience providing customer service or technical support will be accepted in lieu of the Associate's degree. Years of Experience Minimum of 1 year of progressive experience in program evaluation or research, and superior performance on an evaluation or research project is preferred. Certification/Licensure Possess a valid driver's license, current auto insurance and willing/able to travel locally PHYSICAL REQUIREMENTS Standing - 10% Sitting - 90% Squatting - Occasional Kneeling - Occasional Bending - Occasional Driving - Occasional Lifting - Occasional DISCLAIMER The duties and responsibilities described in this document are not a comprehensive list and additional tasks may be assigned to the employee from time to time, or the scope of the job may change as necessitated by business demands. Time Type: Full time Pay Range: $15.00--$21.00 Delivering care that changes people's lives starts with our employees. Below are just some of the great benefits Centerstone employees enjoy: Medical, dental, and vision health coverage Flexible Spending and Health Savings Accounts 403b retirement plan with company match Paid time off and ten paid holidays AD&D Insurance, Life Insurance, and Long Term Disability (company paid) Employee Resource Groups Continuing education opportunities Employee Assistance Program Centerstone is an equal opportunity employer. Employment at Centerstone is based solely on a person's merit and qualifications directly related to professional competence. We treat all clients and colleagues with dignity and respect. At Centerstone, we use our values as a guide for what we do. Respect, Expertise, Integrity and Empowerment are at the heart of every interaction at Centerstone, and particularly rooted in our Culture. Our approach to culture is to create an environment that encourages, supports and celebrates the voices and experiences of our employees. We are committed to a culture of empowerment, respect, integrity and expertise that powers our innovation and connects us to each other, our clients and the communities we serve. Centerstone is also committed to a strong culture of quality and safety, celebrating role-models who champion best practices for quality, clinical risk, and patient safety.

We've made a lot of progress since opening the doors in 1942, but one thing has never changed - our commitment to serve, heal, lead, educate, and innovate. We believe that every award earned, every record broken and every patient helped is because of the dedicated employees who fill our hallways. At Ochsner, whether you work with patients every day or support those who do, you are making a difference and that matters. Come make a difference at Ochsner Health and discover your future today! This job evaluates, initiates, and maintains activities related to the conduct of clinical trials with the assistance and guidance of departmental staff. Communicates with external funding agencies and sponsors, other departments, departmental staff, and patients to ensure the understanding of the requirements of conducting and participating in clinical trials. Organizes and manages all patient care requirements of the company with the direction and approval of other research staff. 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 qualified individuals with disabilities to perform the essential duties. This is a summary of the primary duties and responsibilities of the job and position. It is not intended to be a comprehensive or all-inclusive listing of duties and responsibilities. Contents are subject to change at the company's discretion. Education Required - High school diploma or equivalent. Work Experience Required - 1 year of relevant research or clinical experience, OR Bachelor's degree in life science or related field. Certifications Required - Current Basic Life Support (BLS) certification from the American Heart Association within 60 days of hire. Exceptions will be granted for those in fully remote status. Knowledge Skills and Abilities (KSAs) Knowledge of medical and clinical research terminology and processes. Familiarity with ICH guidelines for ethical conduct of research. Ability to follow the investigational plan in execution of study visits. Strong organizational and time management skills and ability to multi-task and pay close attention to detail. Knowledge of the requirements and regulations associated with the conduct of clinical trials and other related research activity. Proficiency in using computers, software, and web-based applications, including working knowledge of Epic. Effective verbal and written communication skills. Organizational and time management skills and ability pay close attention to detail. Ability to travel throughout and between facilities and work a flexible work schedule. Job Duties Assists in recruiting study participants and screening study participants for eligibility on the telephone, in the clinic, and other settings as required. Coordinates and oversees patient (study participant) activity as it relates to the conduct of research and clinical trials including informed consent under direction and supervision of more senior research staff. Arranges necessary tests and procedures in accordance with protocol requirements and reports results to the investigator. Performs clinical laboratory activities as required per protocol. Develops and maintains all required documentation as it relates to the conduct of assigned clinical trials and associated patient care. Completes data entry into sponsor-specific data entry systems and/or supports data coordinator, including query resolution. Conducts daily work and clinical trial activity in accordance with Good Clinical Practice Guidelines. Adapts behavior to the specific patient population, including but not limited to respect for privacy, method of introduction to the patient, adapting explanation of services or procedures to be performed, requesting permissions and communication style. Performs other related duties as assigned. The above statements describe the general nature and level of work only. They are not an exhaustive list of all required responsibilities, duties, and skills. Other duties may be added, or this description amended at any time. Remains knowledgeable on current federal, state, and local laws, accreditation standards or regulatory agency requirements that apply to the assigned area of responsibility and ensures compliance with all such laws, regulations, and standards. This employer maintains and complies with its Compliance & Privacy Program and Standards of Conduct, including the immediate reporting of any known or suspected unethical or questionable behaviors or conduct; patient/employee safety, patient privacy, and/or other compliance-related concerns. The employer is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Physical and Environmental Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Medium Work - Exerting 20 to 50 pounds of force occasionally, and/or 10 to 25 pounds of force frequently, and/or greater than negligible up to 10 pounds of force constantly to move objects. (Constantly: activity or condition exists 2/3 or more of the time) to move objects. Physical demand requirements are in excess of those for Sedentary Work. Even though the weight lifted may be only a negligible amount, a job should be rated Light Work: (1) when it requires walking or standing to a significant degree; or (2) when it requires sitting most of the time but entails pushing and/or pulling of arm or leg controls; and/or (3) when the job requires working at a production rate pace entailing the constant pushing and/or pulling of materials even though the weight of those materials is negligible. NOTE: The constant stress and strain of maintaining a production rate pace, especially in an industrial setting, can be and is physically demanding of a worker even though the amount of force exerted is negligible. Duties performed routinely require exposure to blood, body fluid and tissue. The incumbent works in a patient care area; works in an area where patients enter; works directly with patients; and/or works with specimens that could contain communicable diseases. The incumbent has an occupational risk for exposure to all communicable diseases. Because the incumbent works within a healthcare setting, there may be occupational risk for exposure to hazardous medications or hazardous waste within the environment through receipt, transport, storage, preparation, dispensing, administration, cleaning and/or disposal of contaminated waste. The risk level of exposure may increase depending on the essential job duties of the role. Are you ready to make a difference? Apply Today! Ochsner Health does not consider an individual an applicant until they have formally applied to the open position on this careers website. Please refer to the job description to determine whether the position you are interested in is remote or on-site. Individuals who reside in and will work from the following areas are not eligible for remote work position: Colorado, California, Hawaii, Illinois, Maryland, Massachusetts, Minnesota, New Jersey, New York, Vermont, Washington, and Washington D.C. Ochsner Health endeavors to make our site accessible to all users. If you would like to contact us regarding the accessibility of our website, or if you need an accommodation to complete the application process, please contact our HR Employee Solution Center at ************ (select option 1) or ******************* . This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. Ochsner is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to any legally protected class, including protected veterans and individuals with disabilities.

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.

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

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.

SHIFT: Day (United States of America) Clinical Research Coordinator III Seeking Breakthrough Makers Children's Hospital of Philadelphia (CHOP) offers countless ways to change lives. Our diverse community of more than 20,000 Breakthrough Makers will inspire you to pursue passions, develop expertise, and drive innovation. At CHOP, your experience is valued; your voice is heard; and your contributions make a difference for patients and families. Join us as we build on our promise to advance pediatric care-and your career. CHOP does not discriminate on the basis of race, color, sex, national origin, religion, or any other legally protected categories in any employment, training, or vendor decisions or programs. CHOP recognizes the critical importance of a workforce rich in varied backgrounds and experiences and engages in ongoing efforts to achieve that through equally varied and non-discriminatory means. A Brief Overview This role will primarily work on mRNA clinical trials for two metabolic disorders, methylmalonic acidemia and propionic acidemia. These trials provide mRNA infusions to participants, currently on an every 2 week schedule. You will independently manage communication with potentially eligible participants, enrollment, coordination of study procedures, and regulatory submissions for protocol amendments and other updates. You will have primary responsibility for the methylmalonic acidemia clinical trials and will work closely with the team covering propionic acidemia clinical trials, both providing and receiving support as needed depending on enrollment numbers on each study. What you will do Applies in depth knowledge of clinical research and independently coordinates the activities of 1 or more large-scale, complex multi-center / multi-institutional studies Provides oversight in the preparation, management and monitoring of study budgets Accountable for study oversight at one or more sites/institutions May be responsible for conducting monitoring activities at one or more sites/institutions Prepares study sites for internal/external regulatory audits (sponsor, FDA, NIH, etc) Facilitates and/or leads research/project team meetings Educates and mentors internal and external clinical staff, research teams and other coordinators; provides resources, and consulting on difficult protocols or projects Independent of the PI assesses and critiques protocol feasibility and provides recommendations May support 1 or more PI sponsored INDs or IDEs Liaises between Research billing (CTFM) and the research team Participate in the informed consent process of study subjects Scheduling, facilitating and/or leading research/project team meetings Screen, recruit and enroll patients/research participants Report adverse events Comply with Institutional policies, standard operating procedures (SOPs) and guidelines Must comply with federal, state, and sponsor policies Education Qualifications Bachelor's Degree - Required Master's Degree in a related field - Preferred Experience Qualifications At least four (4) years of clinical/research coordination experience - Required At least five (5) years of clinical/research coordination experience - Preferred Skills and Abilities Intermediate knowledge of IRB and human subject protection Basic proficiency in data management systems/tools Excellent verbal and written communications skills Excellent time management skills Solid analytical skills Ability to collaborate with stakeholders at all levels To carry out its mission, CHOP is committed to supporting the health of our patients, families, workforce, and global community. As a condition of employment, CHOP employees who work in patient care buildings or who have patient facing responsibilities must receive an annual influenza vaccine. Learn more. EEO / VEVRAA Federal Contractor | Tobacco Statement SALARY RANGE: $61,360.00 - $78,230.00 Annually Salary ranges are shown for full-time jobs. If you're working part-time, your pay will be adjusted accordingly. ------------------- At CHOP, we are committed to fair and transparent pay practices. Factors such as skills and experience could result in an offer above the salary range noted in this job posting. Click here for more information regarding CHOP's Compensation and Benefits.

**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_

**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** **About Winship Cancer Institute of Emory University** Dedicated to discovering cures for cancer and inspiring hope, Winship Cancer Institute of Emory University is Georgia's only National Cancer Institute-designated Comprehensive Cancer Center, a prestigious distinction given to the top tier of cancer centers nationwide for making breakthroughs against cancer. Winship is researching, developing, teaching, and providing novel and highly effective ways to prevent, detect, diagnose, treat, and survive cancer. Cancer care at Winship includes leading cancer specialists collaborating across disciplines to tailor treatment plans to each patient's needs and type of cancer; innovative therapies and clinical trials; comprehensive patient and family support services; and a personalized care experience aimed at easing the burden of cancer. Winship is Where Science Becomes Hope . For more information, visit winshipcancer.emory.edu. **Winship is seeking qualified candidates for the Clinical Research Coordinator II position.** **Position details are as follows:** 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. **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** _157432_ **Job Type** _Regular Full-Time_ **Division** _Exec.V.P. for Health Affairs_ **Department** _Winship Clinical Trials_ **Job Category** _Clinical Research_ **Campus Location (For Posting) : Location** _US-GA-Atlanta_ **_Location : Name_** _Emory Clinic Bldg C_ **Remote Work Classification** _Primarily On Campus_ **Health and Safety Information** _Position involves clinical patient contact, Working with human blood, body fluids, tissues, or other potentially infectious materials_

**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** **About Winship Cancer Institute of Emory University** Dedicated to discovering cures for cancer and inspiring hope, Winship Cancer Institute of Emory University is Georgia's only National Cancer Institute-designated Comprehensive Cancer Center, a prestigious distinction given to the top tier of cancer centers nationwide for making breakthroughs against cancer. Winship is researching, developing, teaching, and providing novel and highly effective ways to prevent, detect, diagnose, treat, and survive cancer. Cancer care at Winship includes leading cancer specialists collaborating across disciplines to tailor treatment plans to each patient's needs and type of cancer; innovative therapies and clinical trials; comprehensive patient and family support services; and a personalized care experience aimed at easing the burden of cancer. Winship is Where Science Becomes Hope . For more information, visit winshipcancer.emory.edu. **Winship is seeking qualified candidates for the Clinical Research Coordinator III position.** **Position details are as follows:** KEY RESPONSIBILITIES: + Independently manages significant and key aspects of a large clinical trial or all aspects of one or more small trials, or research projects. + Trains and provides guidance to less experienced staff. + Oversees data management for research projects. + Interfaces with research participants and resolves issues related to study protocols. + Authorizes purchases for supplies and equipment maintenance. + Determines effective strategies for promoting/recruiting research participants and retaining participants in long term clinical trials. + Periodically audits operations including laboratory procedures to ensure compliance with applicable regulations; provides leadership in identifying and implementing corrective actions/processes. + Monitors IRB submissions and responds to requests and questions. + Interfaces with study sponsors, monitors and reports SAEs; resolves study queries. + Provides leadership in determining, recommending, and implementing improvements to policies/processes. + Assists in developing grant proposals and protocols. + With appropriate credentialing and training may perform phlebotomy, specimens collection or diagnostics. + May perform some supervisory duties. + Performs related approved responsibilities as required. MINIMUM QUALIFICATIONS: + High School Diploma or GED and seven years of clinical research experience. + Or two years of college in a scientific, health related or business administration program and five years of clinical research experience + Or licensed as a Practical Nurse (LPN) and four years of clinical research experience + Or bachelor's degree in a scientific, health related or business administration program and three years clinical research experience + Or master's degree, MD or PhD in a scientific, health related or business administration program and one year of clinical research experience Certified Research Administrator (CRA) or Clinical Research Coordinator (CRC) preferred. 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. **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** _158378_ **Job Type** _Regular Full-Time_ **Division** _Exec.V.P. for Health Affairs_ **Department** _Winship Clinical Trials_ **Job Category** _Clinical Research_ **Campus Location (For Posting) : Location** _US-GA-Atlanta_ **_Location : Name_** _Emory Clinic Bldg C_ **Remote Work Classification** _Primarily On Campus_ **Health and Safety Information** _Position involves clinical patient contact, Working with human blood, body fluids, tissues, or other potentially infectious materials_

**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: + Assists in the coordination and implementation of clinical research studies, including participant recruitment, enrollment, and follow-up in accordance with study protocols and regulatory requirements. + Reviews medical records and conducts participant screenings to assess eligibility; obtains informed consent and administers study questionnaires or quality-of-life assessments as required. + Collects, processes, and prepares biospecimens for shipment in compliance with study and institutional standards; may perform phlebotomy and related specimen handling procedures. + Maintains accurate and complete study documentation, including source documents, case report forms, and data entry into approved databases. + Coordinates study-related activities such as scheduling study visits, preparing case packages, ordering supplies, and maintaining study equipment. + Participates in study meetings and contributes to ongoing communication with the principal investigator and study team to ensure timelines and objectives are met. + Assists with quality assurance procedures and supports the preparation and tracking of regulatory submissions. + Assists with screening participants, coordinating data and specimen collection at participating Emory hospitals, and supporting collaboration for timely biospecimen processing. + Performs other related duties as assigned to support the success of the research program. + This position requires flexibility to accommodate the unique demands of research involving pregnant participants and delivery-based biospecimen collection. Because deliveries can occur at any time, the coordinator may be required to work during evenings, weekends, or overnight hours to ensure timely collection and processing of samples within strict protocol timelines. + A shifted schedule and participation in an on-call rotation may be implemented as needed to maintain continuous study coverage. + Coordinators are expected to demonstrate initiative and accountability for study-related responsibilities, maintain a high level of productivity and attention to detail, and communicate proactively with study leadership regarding project progress and scheduling needs. 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 tasksaregenerallyrequired tobe performed in-person at an Emory University location. Remote workfrom homedayoptions may be grantedatdepartmentdiscretion.Emory reserves the right to changeremote workstatus 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** _156871_ **Job Type** _Regular Full-Time_ **Division** _School Of Medicine_ **Department** _SOM: GYN OB: Research_ **Job Category** _Clinical Research_ **Campus Location (For Posting) : Location** _US-GA-Atlanta_ **_Location : Name_** _Woodruff_ **Remote Work Classification** _Primarily On Campus_ **Health and Safety Information** _Not Applicable, Position involves clinical patient contact, Working in a laboratory, Working with human blood, body fluids, tissues, or other potentially infectious materials_

**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** KEY RESPONSIBILITIES: + Independently manages significant and key aspects of a large clinical trial or all aspects of one or more small trials, or research projects. + Trains and provides guidance to less experienced staff. + Oversees data management for research projects. + Interfaces with research participants and resolves issues related to study protocols. + Authorizes purchases for supplies and equipment maintenance. + Determines effective strategies for promoting/recruiting research participants and retaining participants in long term clinical trials. + Periodically audits operations including laboratory procedures to ensure compliance with applicable regulations; provides leadership in identifying and implementing corrective actions/processes. + Monitors IRB submissions and responds to requests and questions. + Interfaces with study sponsors, monitors and reports SAEs; resolves study queries. + Provides leadership in determining, recommending, and implementing improvements to policies/processes. + Assists in developing grant proposals and protocols. + With appropriate credentialing and training may perform phlebotomy, specimens collection or diagnostics. + May perform some supervisory duties. + Performs related approved responsibilities as required. MINIMUM QUALIFICATIONS: + High School Diploma or GED and seven years of clinical research experience. + Or two years of college in a scientific, health related or business administration program and five years of clinical research experience + Or licensed as a Practical Nurse (LPN) and four years of clinical research experience + Or bachelor's degree in a scientific, health related or business administration program and three years clinical research experience PREFERRED QUALIFICATIONS: + Master's degree, MD or PhD in a scientific, health related or business administration program and one year of clinical research experience Certified Research Administrator (CRA) or Clinical Research Coordinator (CRC) preferred. _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** _157526_ **Job Type** _Regular Full-Time_ **Division** _School Of Medicine_ **Department** _SOM: Peds: BMT_ **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** _Working in a laboratory_

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

We've made a lot of progress since opening the doors in 1942, but one thing has never changed - our commitment to serve, heal, lead, educate, and innovate. We believe that every award earned, every record broken and every patient helped is because of the dedicated employees who fill our hallways. At Ochsner, whether you work with patients every day or support those who do, you are making a difference and that matters. Come make a difference at Ochsner Health and discover your future today! This job evaluates, initiates, and maintains all activities related to the conduct of clinical trials. Communicates with external funding agencies and sponsors, other departments, departmental staff, and patients to ensure the understanding of the requirements of conducting and participating in clinical trials. Organizes and manages all patient care requirements of the company. Coordinates trials that are more complex and/or a greater number of trials than the associate level. 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 qualified individuals with disabilities to perform the essential duties. This is a summary of the primary duties and responsibilities of the job and position. It is not intended to be a comprehensive or all-inclusive listing of duties and responsibilities. Contents are subject to change at the company's discretion. Education Required - High school diploma or equivalent. Work Experience Required - 3 years of relevant research experience in a clinical setting, OR 2 years of relevant research experience in a clinical setting with ACRP or SOCRA certification. Certifications Current Basic Life Support (BLS) certification from the American Heart Association within 60 days of hire. Exceptions will be granted for those in fully remote status. Knowledge Skills and Abilities (KSAs) Knowledge of medical and clinical research terminology and processes. Working knowledge of ICH guidelines for ethical conduct of research. Strong critical thinking skills. Ability to follow and provide critical feedback on the investigational plan Ability to develop study related budgets, contracts, and patient consent documents. Working knowledge of the requirements and regulations associated with the conduct of clinical trials and other related research activity. Proficiency in using computers, software, and web-based applications, including working knowledge of Epic. Effective verbal and written communication skills and ability to present information clearly and professionally to varying levels of individuals throughout the patient care process. Strong organizational and time management skills and ability to multi-task, pay close attention to detail, and learn new techniques. Ability to travel throughout and between facilities and work a flexible work schedule, including on-call, weekend, and night shifts. Job Duties Organizes strategies for recruiting study participants and screening study participants for eligibility on the telephone, in the clinic, and other settings as required. Coordinates and oversees patient (study participant) activity as it relates to the conduct of research and clinical trials, serving as a liaison for both patient and Principal Investigator (PI). Serves as primary point of contact for patient to report and triage adverse events and independently conducts informed consent. Arranges necessary tests and procedures in accordance with protocol requirements and reports results to the investigator. Performs clinical laboratory activities as required per protocol and maintains study supplies and equipment. Maintains close communication with study sponsor representatives including but not limited to site initiation, maintenance, and close out of studies. Develops and maintains all required documentation as it relates to the conduct of assigned clinical trials and associated patient care. Completes data entry into sponsor-specific data entry systems and/or supports data coordinator, including query resolution and transcribes information across various internal and external electronic data systems. Conducts daily work and clinical trial activity in accordance with Good Clinical Practice Guidelines. Adapts behavior to the specific patient population, including but not limited to respect for privacy, method of introduction to the patient, adapting explanation of services or procedures to be performed, requesting permissions and communication style. Performs other related duties as assigned. The above statements describe the general nature and level of work only. They are not an exhaustive list of all required responsibilities, duties, and skills. Other duties may be added, or this description amended at any time. Remains knowledgeable on current federal, state, and local laws, accreditation standards or regulatory agency requirements that apply to the assigned area of responsibility and ensures compliance with all such laws, regulations, and standards. This employer maintains and complies with its Compliance & Privacy Program and Standards of Conduct, including the immediate reporting of any known or suspected unethical or questionable behaviors or conduct; patient/employee safety, patient privacy, and/or other compliance-related concerns. The employer is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Physical and Environmental Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Medium Work - Exerting 20 to 50 pounds of force occasionally, and/or 10 to 25 pounds of force frequently, and/or greater than negligible up to 10 pounds of force constantly to move objects. (Constantly: activity or condition exists 2/3 or more of the time) to move objects. Physical demand requirements are in excess of those for Sedentary Work. Even though the weight lifted may be only a negligible amount, a job should be rated Light Work: (1) when it requires walking or standing to a significant degree; or (2) when it requires sitting most of the time but entails pushing and/or pulling of arm or leg controls; and/or (3) when the job requires working at a production rate pace entailing the constant pushing and/or pulling of materials even though the weight of those materials is negligible. NOTE: The constant stress and strain of maintaining a production rate pace, especially in an industrial setting, can be and is physically demanding of a worker even though the amount of force exerted is negligible. Duties performed routinely require exposure to blood, body fluid and tissue. The incumbent works in a patient care area; works in an area where patients enter; works directly with patients; and/or works with specimens that could contain communicable diseases. The incumbent has an occupational risk for exposure to all communicable diseases. Because the incumbent works within a healthcare setting, there may be occupational risk for exposure to hazardous medications or hazardous waste within the environment through receipt, transport, storage, preparation, dispensing, administration, cleaning and/or disposal of contaminated waste. The risk level of exposure may increase depending on the essential job duties of the role. Are you ready to make a difference? Apply Today! Ochsner Health does not consider an individual an applicant until they have formally applied to the open position on this careers website. Please refer to the job description to determine whether the position you are interested in is remote or on-site. Individuals who reside in and will work from the following areas are not eligible for remote work position: Colorado, California, Hawaii, Illinois, Maryland, Massachusetts, Minnesota, New Jersey, New York, Vermont, Washington, and Washington D.C. Ochsner Health endeavors to make our site accessible to all users. If you would like to contact us regarding the accessibility of our website, or if you need an accommodation to complete the application process, please contact our HR Employee Solution Center at ************ (select option 1) or ******************* . This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. Ochsner is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to any legally protected class, including protected veterans and individuals with disabilities.

**We've made a lot of progress since opening the doors in 1942, but one thing has never changed - our commitment to serve, heal, lead, educate,** **and innovate. We believe** **that every award earned, every record broken and every patient helped is because of the dedicated employees who fill our hallways.** **At Ochsner, whether you work with patients** **every day** **or support those who do, you are making a difference and that matters. Come make a difference at Ochsner Health and discover your future today!** This job evaluates, initiates, and maintains all activities related to the conduct of clinical trials. Communicates with external funding agencies and sponsors, other departments, departmental staff, and patients to ensure the understanding of the requirements of conducting and participating in clinical trials. Organizes and manages all patient care requirements of the company. Coordinates trials that are more complex and/or a greater number of trials than the associate level. 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 qualified individuals with disabilities to perform the essential duties. This is a summary of the primary duties and responsibilities of the job and position. It is not intended to be a comprehensive or all-inclusive listing of duties and responsibilities. Contents are subject to change at the company's discretion. **Education** Required - High school diploma or equivalent. **Work Experience** Required - 3 years of relevant research experience in a clinical setting, OR 2 years of relevant research experience in a clinical setting with ACRP or SOCRA certification. **Certifications** Current Basic Life Support (BLS) certification from the American Heart Association within 60 days of hire. Exceptions will be granted for those in fully remote status. **Knowledge Skills and Abilities (KSAs)** + Knowledge of medical and clinical research terminology and processes. + Working knowledge of ICH guidelines for ethical conduct of research. + Strong critical thinking skills. + Ability to follow and provide critical feedback on the investigational plan + Ability to develop study related budgets, contracts, and patient consent documents. + Working knowledge of the requirements and regulations associated with the conduct of clinical trials and other related research activity. + Proficiency in using computers, software, and web-based applications, including working knowledge of Epic. + Effective verbal and written communication skills and ability to present information clearly and professionally to varying levels of individuals throughout the patient care process. + Strong organizational and time management skills and ability to multi-task, pay close attention to detail, and learn new techniques. + Ability to travel throughout and between facilities and work a flexible work schedule, including on-call, weekend, and night shifts. **Job Duties** + Organizes strategies for recruiting study participants and screening study participants for eligibility on the telephone, in the clinic, and other settings as required. + Coordinates and oversees patient (study participant) activity as it relates to the conduct of research and clinical trials, serving as a liaison for both patient and Principal Investigator (PI). + Serves as primary point of contact for patient to report and triage adverse events and independently conducts informed consent. + Arranges necessary tests and procedures in accordance with protocol requirements and reports results to the investigator. + Performs clinical laboratory activities as required per protocol and maintains study supplies and equipment. + Maintains close communication with study sponsor representatives including but not limited to site initiation, maintenance, and close out of studies. + Develops and maintains all required documentation as it relates to the conduct of assigned clinical trials and associated patient care. + Completes data entry into sponsor-specific data entry systems and/or supports data coordinator, including query resolution and transcribes information across various internal and external electronic data systems. + Conducts daily work and clinical trial activity in accordance with Good Clinical Practice Guidelines. + Adapts behavior to the specific patient population, including but not limited to respect for privacy, method of introduction to the patient, adapting explanation of services or procedures to be performed, requesting permissions and communication style. + Performs other related duties as assigned. The above statements describe the general nature and level of work only. They are not an exhaustive list of all required responsibilities, duties, and skills. Other duties may be added, or this description amended at any time. Remains knowledgeable on current federal, state, and local laws, accreditation standards or regulatory agency requirements that apply to the assigned area of responsibility and ensures compliance with all such laws, regulations, and standards. This employer maintains and complies with its Compliance & Privacy Program and Standards of Conduct, including the immediate reporting of any known or suspected unethical or questionable behaviors or conduct; patient/employee safety, patient privacy, and/or other compliance-related concerns. The employer is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. **Physical and Environmental Demands** The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Medium Work - Exerting 20 to 50 pounds of force occasionally, and/or 10 to 25 pounds of force frequently, and/or greater than negligible up to 10 pounds of force constantly to move objects. (Constantly: activity or condition exists 2/3 or more of the time) to move objects. Physical demand requirements are in excess of those for Sedentary Work. Even though the weight lifted may be only a negligible amount, a job should be rated Light Work: (1) when it requires walking or standing to a significant degree; or (2) when it requires sitting most of the time but entails pushing and/or pulling of arm or leg controls; and/or (3) when the job requires working at a production rate pace entailing the constant pushing and/or pulling of materials even though the weight of those materials is negligible. NOTE: The constant stress and strain of maintaining a production rate pace, especially in an industrial setting, can be and is physically demanding of a worker even though the amount of force exerted is negligible. Duties performed routinely require exposure to blood, body fluid and tissue. The incumbent works in a patient care area; works in an area where patients enter; works directly with patients; and/or works with specimens that could contain communicable diseases. The incumbent has an occupational risk for exposure to all communicable diseases. Because the incumbent works within a healthcare setting, there may be occupational risk for exposure to hazardous medications or hazardous waste within the environment through receipt, transport, storage, preparation, dispensing, administration, cleaning and/or disposal of contaminated waste. The risk level of exposure may increase depending on the essential job duties of the role. **Are you ready to make a difference? Apply Today!** **_Ochsner Health does not consider an individual an applicant until they have formally applied to the open position on this careers website._** **_Please refer to the job description to determine whether the position you are interested in is remote or on-site._** _Individuals who reside in and will work from the following areas are not eligible for remote work position: Colorado, California, Hawaii, Illinois, Maryland,Massachusetts, Minnesota, New Jersey, New York, Vermont, Washington, and Washington D.C._ **_Ochsner Health endeavors to make our site accessible to all users. If you would like to contact us regarding the accessibility of our website, or if you need an accommodation to complete the application process, please contact our HR Employee Solution Center at ************ (select option 1) or_** **_*******************_** **_. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications._** Ochsner is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to any legally protected class, including protected veterans and individuals with disabilities.

**We've made a lot of progress since opening the doors in 1942, but one thing has never changed - our commitment to serve, heal, lead, educate,** **and innovate. We believe** **that every award earned, every record broken and every patient helped is because of the dedicated employees who fill our hallways.** **At Ochsner, whether you work with patients** **every day** **or support those who do, you are making a difference and that matters. Come make a difference at Ochsner Health and discover your future today!** This job evaluates, initiates, and maintains all activities related to the conduct of clinical trials. Communicates with external funding agencies and sponsors, other departments, departmental staff, and patients to ensure the understanding of the requirements of conducting and participating in clinical trials. Organizes and manages all patient care requirements of the company. Coordinates trials that are more complex and/or a greater number of trials than the associate level. 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 qualified individuals with disabilities to perform the essential duties. This is a summary of the primary duties and responsibilities of the job and position. It is not intended to be a comprehensive or all-inclusive listing of duties and responsibilities. Contents are subject to change at the company's discretion. **Education** Required - High school diploma or equivalent. **Work Experience** Required - 3 years of relevant research experience in a clinical setting, OR 2 years of relevant research experience in a clinical setting with ACRP or SOCRA certification. **Certifications** Current Basic Life Support (BLS) certification from the American Heart Association within 60 days of hire. Exceptions will be granted for those in fully remote status. **Knowledge Skills and Abilities (KSAs)** + Knowledge of medical and clinical research terminology and processes. + Working knowledge of ICH guidelines for ethical conduct of research. + Strong critical thinking skills. + Ability to follow and provide critical feedback on the investigational plan + Ability to develop study related budgets, contracts, and patient consent documents. + Working knowledge of the requirements and regulations associated with the conduct of clinical trials and other related research activity. + Proficiency in using computers, software, and web-based applications, including working knowledge of Epic. + Effective verbal and written communication skills and ability to present information clearly and professionally to varying levels of individuals throughout the patient care process. + Strong organizational and time management skills and ability to multi-task, pay close attention to detail, and learn new techniques. + Ability to travel throughout and between facilities and work a flexible work schedule, including on-call, weekend, and night shifts. **Job Duties** + Organizes strategies for recruiting study participants and screening study participants for eligibility on the telephone, in the clinic, and other settings as required. + Coordinates and oversees patient (study participant) activity as it relates to the conduct of research and clinical trials, serving as a liaison for both patient and Principal Investigator (PI). + Serves as primary point of contact for patient to report and triage adverse events and independently conducts informed consent. + Arranges necessary tests and procedures in accordance with protocol requirements and reports results to the investigator. + Performs clinical laboratory activities as required per protocol and maintains study supplies and equipment. + Maintains close communication with study sponsor representatives including but not limited to site initiation, maintenance, and close out of studies. + Develops and maintains all required documentation as it relates to the conduct of assigned clinical trials and associated patient care. + Completes data entry into sponsor-specific data entry systems and/or supports data coordinator, including query resolution and transcribes information across various internal and external electronic data systems. + Conducts daily work and clinical trial activity in accordance with Good Clinical Practice Guidelines. + Adapts behavior to the specific patient population, including but not limited to respect for privacy, method of introduction to the patient, adapting explanation of services or procedures to be performed, requesting permissions and communication style. + Performs other related duties as assigned. The above statements describe the general nature and level of work only. They are not an exhaustive list of all required responsibilities, duties, and skills. Other duties may be added, or this description amended at any time. Remains knowledgeable on current federal, state, and local laws, accreditation standards or regulatory agency requirements that apply to the assigned area of responsibility and ensures compliance with all such laws, regulations, and standards. This employer maintains and complies with its Compliance & Privacy Program and Standards of Conduct, including the immediate reporting of any known or suspected unethical or questionable behaviors or conduct; patient/employee safety, patient privacy, and/or other compliance-related concerns. The employer is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. **Physical and Environmental Demands** The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Medium Work - Exerting 20 to 50 pounds of force occasionally, and/or 10 to 25 pounds of force frequently, and/or greater than negligible up to 10 pounds of force constantly to move objects. (Constantly: activity or condition exists 2/3 or more of the time) to move objects. Physical demand requirements are in excess of those for Sedentary Work. Even though the weight lifted may be only a negligible amount, a job should be rated Light Work: (1) when it requires walking or standing to a significant degree; or (2) when it requires sitting most of the time but entails pushing and/or pulling of arm or leg controls; and/or (3) when the job requires working at a production rate pace entailing the constant pushing and/or pulling of materials even though the weight of those materials is negligible. NOTE: The constant stress and strain of maintaining a production rate pace, especially in an industrial setting, can be and is physically demanding of a worker even though the amount of force exerted is negligible. Duties performed routinely require exposure to blood, body fluid and tissue. The incumbent works in a patient care area; works in an area where patients enter; works directly with patients; and/or works with specimens that could contain communicable diseases. The incumbent has an occupational risk for exposure to all communicable diseases. Because the incumbent works within a healthcare setting, there may be occupational risk for exposure to hazardous medications or hazardous waste within the environment through receipt, transport, storage, preparation, dispensing, administration, cleaning and/or disposal of contaminated waste. The risk level of exposure may increase depending on the essential job duties of the role. **Are you ready to make a difference? Apply Today!** **_Ochsner Health does not consider an individual an applicant until they have formally applied to the open position on this careers website._** **_Please refer to the job description to determine whether the position you are interested in is remote or on-site._** _Individuals who reside in and will work from the following areas are not eligible for remote work position: Colorado, California, Hawaii, Illinois, Maryland,Massachusetts, Minnesota, New Jersey, New York, Vermont, Washington, and Washington D.C._ **_Ochsner Health endeavors to make our site accessible to all users. If you would like to contact us regarding the accessibility of our website, or if you need an accommodation to complete the application process, please contact our HR Employee Solution Center at ************ (select option 1) or_** **_*******************_** **_. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications._** Ochsner is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to any legally protected class, including protected veterans and individuals with disabilities.

Clinical Research Coordinator II performs a full range of clinical research duties at a skilled level and has a working knowledge of the clinical research process and the regulations that govern it. The expectation is to perform progressively more complex and comprehensive clinical research duties with an increasing level of independence, working closely with the Principal Investigator (PI). The Clinical Research Coordinator II works under the supervision of and at the direction of the PI or their designee. They cannot perform any tasks that state or local law require a license to perform. Responsibilities Research Operations - Occasionally requiring tasks outside of defined operating hours May arrange and/or schedule required tests and other appointments. Understands and supports all of aspects of the study operations (including subject management/regulatory) with oversight from the investigator or their designee. Primarily supports subject management, such as data entry in the Clinical Trial Management System(CTMS), scanning informed consents into EMR, and supporting data entry needs of the study. May carry out study visit tasks such as administering Quality of Life (QoL) questionnaires under supervision of investigator. May interview study participants about medical history, medications, adverse events, demographics, and quality of life issues depending on complexity with review by PI with collection of source data directly informed by medical records. May communicate with participants throughout the course of the study. May provide education and support to study participants and their families. Prepares and submits regulatory documents to study sponsors and applicable regulatory agencies. Maintains study and regulatory documentation. May manage study tasks primarily related to working with Institutional Review Boards (IRBs) and study sponsors as well as Dartmouth-Hitchcock Medical Center (DHMC) regulatory committees. Ethics & Participant Safety Applies and implements Good Clinical Practice (GCP)/Human Subjects Protection (HSP) practices.Maintains familiarity with the ethical conduct of research and safeguards needed when conducting research. May assist in the design of studies so they include specific safeguards to ensure ethical conduct and protect vulnerable populations.May develop or assist with the development of documents related to safety and security.May communicate with research participants regarding the difference between clinical activities and research activities, and the risks and benefits of study participation. Data and Informatics Utilizes the Electronic Data Capture (EDC) systems, technologies, and software necessary for study operations Scores tests, enter data, and completes Case Report Forms (CRFs, eCRFs) accurately and according to protocol. Develops or assists with the development of data collection documents and instruments and procedures for data quality assurance.Monitors for and identifies potential issues related to data capture, collection or management and suggests solutions. Investigates incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data.Adheres to processes and runs queries, summaries and reports to monitor the quality of data.May be responsible for recognizing trends related to data quality and escalating as appropriate.Uses required processes, policies and systems to ensure data security. Leadership and Professionalism Understands and employs the professional guidelines and code of ethics related to the conduct of clinical research and Dartmouth-Hitchcock (D-H) and project specific training requirements. May travel to investigator meetings or protocol specific training. May participate in new employee mentoring/training under the guidance of a supervisor or senior team member. Site and Study Management Organizes and manages clinical trials and research studies.Conducts protocol reviews to assess the feasibility of potential studies. Seeks out new research opportunities.Participates in study site selection activities.Collaborates with study investigators to develop recruitment and screening procedures.Designs and develops recruitment documentation.Composes informed consent forms and protocol abstracts. Maintains other study documents and study management tools.May participate in manuscript/abstract development. Communication and Team Science Serves as a liaison between principal investigators, regulatory agencies, D-H stakeholders and study participants to resolve problems. Identifies and recognizes the respective roles of team members.Understands and upholds the importance of an interdisciplinary team and the value each member can bring to clinical studies. Performs other duties as required or assigned. Qualifications * Bachelors and 2 years of relevant research experience OR equivalent years of experience * Ability to travel as required * SOCRA/ACRP Certification or eligible for certification preferred Required Licensure/Certifications * BLS certification within 30 days of hire date. * Human Subject Protection, Responsible Conduct of Research and Good Clinical Practice certificates required within 30 days of hire.

Full-time Description Soleo Health is seeking a Clinical Review Coordinator to support our Specialty Infusion Pharmacy and work Remotely (USA) . Join us in Simplifying Complex Care! Must be able to work 8:30am-5pm Eastern Time Zone Monday-Friday. Soleo Health Perks: Competitive Wages Flexible schedules 401(k) with a match Referral Bonus Paid Time Off Annual Merit Based Increases No Weekends or Holidays Affordable Medical, Dental, and Vision Insurance Plans Company Paid Disability and Basic Life Insurance HSA and FSA (including dependent care) options Education Assistant Program The Position: The Clinical Review Coordinator works closely with all departments to research and provide accurate and timely clinical review on complex, patient cases to ensure that approval is secured and to mitigate risk of technical and clinical denials. The Clinical Review Coordinator attempts to resolve denials by utilizing nationally recognized criteria for appeal submission. Responsibilities include: Completes prior authorization reviews in a timely manner through their clinical expertise evaluating patient clinicals and payer clinical criteria to determine if the service meets medical necessity of the payer Reviews and comprehends patient progress notes, lab reports, infusion summaries, imaging reports, and plan of care. Identifies appropriate medical documentation that satisfies payer medical policy criteria. Request additional clinical information when needed to render a decision and/or determine next steps Assists with creation of clinical support packets to be used for the initial prior authorization and/or subsequent appeals In cases of authorization denials, constructs and documents a succinct and fact-based clinical case to support appeal utilizing appropriate medical necessity criteria and other pertinent clinical facts. Creates and maintains, a library of clinical support resources to include templates for appeals, journal articles, other reference tools that can be used to support medical necessity. When existing resources are unavailable search for supporting clinical evidence to support appeals. Provides program support by staying current on the top payer covered services, medical necessity requirements and formulary details. Also, must be proficient in locating payer resources related to medical policies. Assist with post service insurance denials & appeals Participates in outcome programs including but not limited to data entry, reporting functions, and patient calls with necessary to complete denial support tasks Provides inter-departmental training to increase teams' knowledge for top disease states and specialty drugs, clinical requirements, and prior authorization & appeal best practices Schedule: Must be able to work Remote, 8:30am-5pm Eastern Time Zone Monday-Friday Must have experience with denial support, clinical reviews, and appeals for Infusions Requirements Bachelor's degree in healthcare field or 3 years in a qualified position Preferred experience with patients with specialty infusion needs and challenges Excellent communication skills (written, oral, and presentation), excellent customer service and interpersonal skills Flexible communication style, highly motivated team player with excellent listening skills Able to handle stress to meet identified program objectives and manages time effectively Self-starter that takes responsibility, is comfortable with accountability and results oriented Competent in the use of Word, Excel, and Power Point Must be able to communicate effectively with all levels of organization within Soleo Health. Must enthusiastically support Soleo Health's philosophy and goals. About Us:Soleo Health is an innovative national provider of complex specialty pharmacy and infusion services, administered in the home or at alternate sites of care. Our goal is to attract and retain the best and brightest as our employees are our greatest asset. Experience the Soleo Health Difference! Soleo's Core Values: Improve patients' lives every day Be passionate in everything you do Encourage unlimited ideas and creative thinking Make decisions as if you own the company Do the right thing Have fun! Soleo Health is committed to diversity, equity, and inclusion. We recognize that establishing and maintaining a diverse, equitable, and inclusive workplace is the foundation of business success and innovation. We are dedicated to hiring diverse talent and to ensuring that everyone is treated with respect and provided an equal opportunity to thrive. Our commitment to these values is evidenced by our diverse executive team, policies, and workplace culture. Soleo Health is an Equal Opportunity Employer, celebrating diversity and committed to creating an inclusive environment for all employees. Soleo Health does not discriminate in employment on the basis of race, color, religion, sex, pregnancy, gender identity, national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an organization, parental status, military service or other non-merit factor. Keywords: Now Hiring, Hiring Now, Immediately Hiring, Hiring Immediately, Clinical Review Coordinator, Infusion Clinical Review Coordinator, Patient Access, Patient Access Clinical Review Coordinator, Denial Support Clinical Review Coordinator, Appeals Clinical Review Coordinator, Home Infusion, Specialty Infusion Salary Description $68,000 - $85,000 per year

The Clinical Appeals Coordinator is responsible for supporting Concord Hospital with claim appeal activities within the Revenue Integrity department. This involves a timely and accurate review of medical records in response to claim denials received from third party payers, Recovery Audit Contractors (RAC), Medicare Administrative Contractors (MAC), as well as medical necessity denials from other governmental and non-governmental payers and auditors. The Clinical Appeals Coordinator will evaluate opportunities for education and provide feedback to physicians the RCC Committee, and other relevant departments. Additionally, this person will serve as a clinical resource to the entire Revenue Management division. Education Bachelor's degree in Nursing from an accredited Nursing program. Certification, Registration & Licensure Experience Minimum of five years' experience in utilization review and/or auditing in an acute-care hospital setting. Medicare audit and appeal background strongly desired. Must have solid understanding of Medicare levels of care (inpatient/observation). Experience applying Milliman and/or Interqual guidelines required. Familiarity with medical coding, reimbursement, and insurance practices required. Must possess excellent interpersonal, communication, and motivational skills, including the ability to communicate clearly and concisely, both orally and in writing. Ability to work collaboratively with individuals at all levels throughout the organization required. Strong facilitation and presentation skills required. Must use independent judgment in reviewing records to determine appropriate appeal action. Must be able to compose a persuasive appeal using clinical data, regulatory guidelines, evidence-based standards, and applicable legal statute. Strong organizational and time management skills required. Must be able to independently prioritize work. Strong critical-thinking and problem solving skills required. Must be flexible and comfortable in an environment with frequent changing demands and requirements. Strong computer skills required including MS Word and Excel. Responsibilities Performs audits on all assigned clinical denials. Constructs all necessary appeals with payers for reconsideration of denied charges and/or services. Identifies root cause of denials and provides education to Care Managers, Providers and Charge Departments as appropriate. Acts as a clinical resource to Patient Financial Services and other Concord Hospital departments for payment/charge issues and other clinical inquiries that may or may not be related to audits and appeals. Takes responsibility for individual performance goals. Performs other duties as assigned. Concord Hospital is an Equal Employment Opportunity employer. It is our policy to provide equal opportunity to all employees and applicants and to prohibit any discrimination because of race, color, religion, sex, sexual orientation, gender, gender identity, national origin, age, marital status, genetic information, disability or protected veteran status. Know Your Rights: Workplace Discrimination is Illegal Applicants to and employees of this company are protected under federal law from discrimination on several bases. Follow the link above to find out more. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, you may contact Human Resources at ************.