Clinical Research Coordinator jobs at Henry Ford Village

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.

The Senior Clinical Research Coordinator (SCRC) is responsible for the facilitation and coordination of daily clinical trial activities. USRC has a research Partnership with the principal investigator (PI) and their physician practice. The local oversight and direction for activities related to the conduct of the clinical research is directed by the PI. The SCRC will work collaboratively with the principal investigator (PI), the clinical site, sponsor(s), clinical research organization(s) (CROs), institutional review boards (IRBs), and study participants to ensure Execution of the clinical trial in accordance with the Study Protocol, the Food and Drug Administration (FDA), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and applicable state and local regulations. The SCRC will assist the PI in protecting the rights, safety and welfare of all study participants. Essential Duties and Responsibilities include the following. Other duties and tasks may be assigned. Coordinate all aspects of participant care from screening through study completion as defined by the protocol and PI delegation. Ensure and document that the informed consent process has occurred properly according to the Code of Federal Regulations (45 CFR part 46). Maintain and update each study participant's source records, including collection of medical history, assessment of eligibility and documentation of all study related procedures and relevant information. Promptly report adverse events, protocol deviations and unanticipated problems involving risk to human subjects or others to the PI, the Sponsor, the IRB and in accordance with the Federal Code of Regulations (21 CFR 312). Ensure thorough, individualized, protocol-based study subject education on all study processes including but not limited to informed consent, study participation obligations, appropriate use of investigational product(IP), IP side effects and safety, communication with study staff and research rights. Provide timely and accurate exchange of participant information with the PI and research team as it pertains to study conduct and patient safety. Adhere to the Health Insurance Portability and Accountability Act (HIPAA Privacy Rule) and protect participant confidentiality at all times. Dispense, administer and instruct participants on proper use of the investigational product (IP) in accordance with the protocol, coordinator's scope of practice and at the direction of the PI. Engage and collaborate with the USRC clinical team. Provide study specific training, oversee trial implementation, and ensure compliance with the study protocol by our clinical partners. Perform accurate and timely data collection, source documentation, and entry into the USRC databases and sponsor Case Report Forms (CRFs)/ interactive web response systems (IWRS). Address queries and sponsor requests in a timely manner. Coordinate long-term storage of research records in accordance with contractual requirements. Timely preparation for, accommodation of and attendance during site initiation, monitoring visits, audit visits or regulatory authority inspections. Maintains records of all reports as well as the site's response. Responsible for the preparation and ongoing maintenance of Essential Documents (The Trial Master File). This includes those documents that will allow for the evaluation of the clinical trial and demonstrate compliance of the sponsor and PI with the study protocol and GCP. (Including but not limited to: Form FDA 1572, financial disclosures, laboratory certifications, protocol, investigator brochure, institutional review board (IRB) related documents, IND reports delegation of authority (DOA), study specific enrollment logs, monitoring reports. Assists in the coordination of efforts of internal and external resources (industry partners, clinical research organizations) to ensure efficient trial selection, proper patient recruitment, achieving target enrollment goals and trial plan execution. Fosters a patient-care culture that emphasizes patient safety and quality in all aspects. Responsible for the patient stipend automated payment process including registration into the system and processing payments per the USRC policy and ongoing maintenance of payments during the trial. Adheres to the USRC Research quality assurance program guidelines. Travel to Investigator Meetings or similar research related meetings is required. Travel may be required between dialysis facilities or nephrology practices within the community. Maintains a working knowledge of current clinical research practice standards and regulatory requirements. For example, but not limited to; (FDA Federal Code of Regulations Good Clinical Practice (GCP), Health Insurance Portability and Accountability Act (HIPPA), International Air and Transportation Association (IATA) - Shipping of Dangerous Goods. Maintains their industry standard licensures and certifications. May provide training and oversight of Clinical Research Coordinators and/or Research Assistants. Actively promotes GUEST customer service standards; develop effective relationships at all levels of the organization. Participate in team concepts and promote a team effort; perform duties in accordance with company policies and procedures. Participate in staff meetings as required. Regular and reliable attendance is required for the job.

Site: Mass General Brigham Incorporated Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. Job Summary General Summary/Overview Statement: The Clinical Research Regulatory Coordinator I (CRRCI) works under general supervision to ensure the regulatory requirements for clinical trials are met. This position involves working with clinical teams, Institutional Review Boards (IRB), clinical trial sponsors and federal regulatory agencies. The CRRCI will be trained on the institutional and federal regulations governing clinical research. This position does not involve patient contact. Principal Duties and Responsibilities: The following regulatory duties will be performed under general supervision by the Clinical Research Manager: · Maintain and organize study specific regulatory binders · Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB · Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study · Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required · Submit Data and Safety Monitoring Reports · Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process · Collect, complete, and submit essential regulatory documents to various regulatory entities · Participate in monitoring visits and file all monitoring visit correspondence · Ensure appropriate documentation of delegation and training for all study staff members · Maintain screening and enrollment logs Skills/Abilities/Competencies Required · Careful attention to detail · Good organizational skills · Ability to follow directions · Good communication skills · Computer literacy · Working knowledge of clinical research protocols Qualifications Education: Bachelor's Degree Related Field of Study required Can this role accept experience in lieu of a degree? Yes Licenses and Credentials: n/a Experience: Knowledge, Skills and Abilities: - Careful attention to detail. - Good organizational skills. - Ability to follow directions. - Computer literacy. - Working knowledge of clinical research protocols. Additional Job Details (if applicable) Working Conditions: · Duties will be performed remotely Remote Type Remote Work Location 101 Merrimac Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $19.76 - $28.44/Hourly Grade 5 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: Mass General Brigham Incorporated is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.

Job Description The START Center for Cancer Research (“START”) is the world's largest early phase site network, fully dedicated to oncology clinical research. Throughout our history, START has provided hope to cancer patients in global community practices by offering access to cutting edge trials throughout the US and Europe. Today, with over 1,300 studies completed, and with research facilities in the United States and in Spain, Portugal, and Ireland, START's mission is to accelerate the development of new anticancer drugs that will improve the quality of life and survival for patients with cancer and lead to its eventual cure. To date, over 43 therapies conducted at START locations have obtained FDA/EMA approval. Incredibly, while Academic Medical Centers (AMCs) conduct 80% of cancer trials, such trials reach only 20% of the patient population - leaving the majority of patients who are treated in community practices and hospitals without access to a clinical trial when their care journey calls for one. START serves the many - by bringing cancer trials to physicians and their patients in community hospitals and practices when hope is needed most. START represents the world's largest roster of Principal Investigators (PIs) across its eight clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world. As an example, in San Antonio, where START was founded, START treated the first patient ever with Keytruda - the most effective cancer drug in medical history. We are hiring a motivated Clinical Research Coordinator (CRC) will work under the guidance of senior research staff to support the daily activities of early phase oncology clinical trials. The CRC ensures the accurate and timely conduct of clinical research, adhering to protocols, regulatory requirements, and patient safety standards. This role involves direct patient interaction, data collection, and maintaining compliance with Good Clinical Practice (GCP). The Clinical Research Coordinator will be assigned multiple protocols at any time for which they will oversee the aspects of assigned protocols with planning and coordinating patient participation in the trial. Also, this role is responsible for implementation as well as completion of protocol specific requirements, providing accurate, up to date information to all team members involved with any aspect of carrying out protocol specific requirements. Essential Responsibilities Communicate on a regular basis with Study Sponsor's, CRO's, staff, etc. regarding questions, concerns, as well as status of the protocol. Monitor the overall day-to-day conduct of assigned studies in accordance with the specified protocol requirements, Standard Operating Procedures, and Good Clinical Practice to ensure integrity regarding all aspects of the study. Create/review forms created or revised for assigned trials to assure protocol compliance. Maintain files using standardized study document labeling and filing procedures. Implement initial protocol and amendments, training staff who will be involved in patient treatment and management. Maintain an up-to-date contact list. Assist with patient screening and determination of eligibility. Facilitate the informed consent process ensuring that consent is appropriately completed. Prepare and manage source documents according to standard operating procedures. Recognize deviations to the protocol and will work with leadership and staff to address corrective actions to prevent deviations. Assist data coordinator team with case report form completion and query resolution. Work with the Principal Investigator to complete and submit Serious Adverse Event reports. Perform protocol specific closeout related activities in conjunction with the data coordinator. Provide documentation for all deviations whether related to the protocol or a SOP. Ensure that all team members involved understand and adhere to assigned protocols. Required Education and Experience: High School Diploma or GED. 2 years of clinical research experience. Basic understanding of oncology clinical trials, particularly Phase 1 studies. Strong attention to detail and accuracy in data collection and documentation. Ability to manage multiple tasks and meet deadlines in a fast-paced environment. Excellent organizational and time-management skills. Strong communication skills, both written and verbal. Ability to interact professionally with patients, study staff, and external stakeholders. Working knowledge of GCP and regulatory requirements. Proficient in Microsoft Office Suite and clinical trial management software. Preferred Education and Experience: Experience working in an oncology setting. Physical & Travel Requirements: Approximately 80% of time is spent sitting. Very fast-paced and ever-changing healthcare environment. Demanding deadlines and time frames. Constant demand for updating knowledge. Works closely with physicians and ancillary personnel in caring for and treating oncology/hematology patients. Best-in-Class Benefits and Perks We value our employees' time and efforts. Our commitment to your success is enhanced by a competitive compensation, depending on experience, and an extensive benefits package including: Comprehensive health coverage: Medical, dental, and vision insurance provided Robust retirement planning: 401(k) plan available with employer matching Financial security: Life and disability insurance for added protection Flexible financial options: Health savings and flexible spending accounts offered Well-being and work-life balance: Paid time off, flexible schedule, and remote work choices provided Plus, we work to maintain the best environment for our employees, where people can learn and grow with the company. We strive to provide a collaborative, creative environment where everyone feels encouraged to contribute to our processes, decisions, planning, and culture. More about The START Center for Cancer Research Deeply rooted in community oncology centers globally, The START Center for Cancer Research provides access to specialized preclinical and early-phase clinical trials of novel anti-cancer agents. START clinical trial sites have conducted more than a thousand early-phase clinical trials, including for 43 therapies that were approved by the FDA. START represents the world's largest roster of Principal Investigators (PIs) across its eight clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world. Learn more at STARTresearch.com. Ready to be part of a team changing the future of cancer treatment? Join us in our mission to conquer cancer, one clinical trial at a time. Your expertise and dedication can help us bring hope and healing to patients worldwide. Please submit your application online. We are an equal opportunity employer that welcomes and encourages diversity in the workplace. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.

Site: Mass General Brigham Incorporated Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. Job Summary General Summary/Overview Statement: The Clinical Research Regulatory Coordinator I (CRRCI) works under general supervision to ensure the regulatory requirements for clinical trials are met. This position involves working with clinical teams, Institutional Review Boards (IRB), clinical trial sponsors and federal regulatory agencies. The CRRCI will be trained on the institutional and federal regulations governing clinical research. This position does not involve patient contact. Principal Duties and Responsibilities: The following regulatory duties will be performed under general supervision by the Clinical Research Manager: * Maintain and organize study specific regulatory binders * Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB * Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study * Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required * Submit Data and Safety Monitoring Reports * Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process * Collect, complete, and submit essential regulatory documents to various regulatory entities * Participate in monitoring visits and file all monitoring visit correspondence * Ensure appropriate documentation of delegation and training for all study staff members * Maintain screening and enrollment logs Skills/Abilities/Competencies Required * Careful attention to detail * Good organizational skills * Ability to follow directions * Good communication skills * Computer literacy * Working knowledge of clinical research protocols Qualifications Education: Bachelor's Degree Related Field of Study required Can this role accept experience in lieu of a degree? Yes Licenses and Credentials: n/a Experience: Knowledge, Skills and Abilities: * Careful attention to detail. * Good organizational skills. * Ability to follow directions. * Computer literacy. * Working knowledge of clinical research protocols. Additional Job Details (if applicable) Working Conditions: * Duties will be performed remotely Remote Type Remote Work Location 101 Merrimac Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $19.76 - $28.44/Hourly Grade 5 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: Mass General Brigham Incorporated is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.

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.

This position may be filled at the coordinator level 1 or level 2, based on experience/qualifications and requires the incumbent to reside in Central Oregon: Level 1 Pay range: $25.18 - $37.77 per hour. Level 2 Pay range: $27.20 - $40.79 per hour. St. Charles Health System is a leading healthcare provider in Central Oregon, offering a comprehensive range of services to meet the needs of our community. We are committed to providing high-quality, compassionate care to all patients, regardless of their ability to pay. Our values of compassion, excellence, integrity, teamwork, and stewardship guide our work and shape our culture. What We Offer: Competitive Salary Comprehensive benefits including Medical, Dental, Vision for you and your immediate family 403b with up to 6% match on Retirement Contributions Generous Earned Time Off Growth Opportunities within Healthcare ST. CHARLES HEALTH SYSTEM JOB DESCRIPTION TITLE: Clinical Research Coordinator I REPORTS TO POSITION: Research Manager DEPARTMENT: Research DATE LAST REVIEWED: November 15, 2024 OUR VISION: Creating America's healthiest community, together OUR MISSION: In the spirit of love and compassion, better health, better care, better value OUR VALUES: Accountability, Caring and Teamwork DEPARTMENTAL SUMMARY: St. Charles Research Department conducts clinical trials for promising new treatments and therapies in a wide variety of medical fields, including cancer treatment and prevention, cardiovascular disease and supportive care. POSITION OVERVIEW: The Clinical Research Coordinator I is responsible for conducting clinical trials in compliance with FDA regulation, ICH Guidelines and applicable industry standards. The Clinical Research Coordinator 1 will oversee up to ten clinical trials as the main research coordinator. This position does not directly manage other caregivers, however may be asked to review and provide feedback on the work of other caregivers. ESSENTIAL FUNCTIONS AND DUTIES: Maintains surveillance system to identify potential subjects for study eligibility, prescreen patients, and assists physicians in determining eligibility. Obtains informed consent according to GCP and ICH guidelines. Performs study procedures and assessments following protocol specific guidelines. Assures research is conducted in an ethical and safe manner according to FDA, ICH and St. Charles Health System guidelines. Adheres to St. Charles Health System's compliance plan. Attends IRB meetings as requested by the IRB. Supports the processing of study alerts, protocol revisions, amendments, accrual suspension notices, informed consent modifications, product information and advertisement, and related memoranda. Supports the modification of template informed consent forms for local application in compliance with federal guidelines for patients in lay language at appropriate reading level Prepares for and participates in required sponsor and regulatory audits. Attend Investigator meetings as required to assure seamless study start-up. Assists with subject education and informed consent process, including tissue and genetics consent when indicated. Surveys for re-consent and obtains from eligible subjects. Educates patients regarding protocol diagnostic tests and assists with appointments. Process tissue/blood specimens and prepare it for shipment. Manages treatment and follow-up schedules to assure protocol compliance. Attends subject clinic visits and interacts with subjects and staff as appropriate to assist in protocol adherence. Track study drug usage per protocol and oversee study drug supply. Maintains subject research records including long-term follow up and reporting. Participates in institutional research activities (committee meetings, Tumor Boards, Grand Rounds, other conferences, etc.) that are relevant to the Position. Keeps current with new developments in research methodologies. Participates in quality assurance program for St. Charles Health System and affiliated research partners. Supports the vision, mission and values of the organization in all respects. Supports Value Improvement Practice (VIP- Lean) principles of continuous improvement with energy and enthusiasm, functioning as a champion of change. Provides and maintains a safe environment for caregivers, patients and guests. Conducts all activities with the highest standards of professionalism and confidentiality. Complies with all applicable laws, regulations, policies and procedures, supporting the organization's corporate integrity efforts by acting in an ethical and appropriate manner, reporting known or suspected violation of applicable rules, and cooperating fully with all organizational investigations and proceedings. Delivers customer service and/or patient care in a manner that promotes goodwill, is timely, efficient and accurate May perform additional duties of similar complexity within the organization, as required or assigned. EDUCATION: Required: Bachelor of Science degree, or combination of college level education and Research experience to perform the full scope of position duties. Preferred: Bachelor of Science degree in related field. LICENSURE/CERTIFICATION/REGISTRATION Required: Association of Clinical Research Professional (ACRP) or Society of Clinical research Associates (SOCRA) certification or must obtain within 2 years of full time employment. Current American Heart Association (AHA) Basic Life Support for Healthcare Provider certification. Preferred: N/A EXPERIENCE: Required: None Required. Preferred: Experience as a Clinical Research Coordinator. Experience dealing with multidisciplinary teams. Basic Clinical task knowledge. ADDITIONAL POSITION INFORMATION: N/A Schedule Weekly Hours: 40 Caregiver Type: Regular Shift: First Shift (United States of America) Is Exempt Position? No Job Family: COORDINATOR CLERICAL Scheduled Days of the Week: Monday-Friday Shift Start & End Time: Variable

**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** 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 + 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. 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** _156953_ **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_

**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: + Recruits, orients, and supervises research administration staff or independently manages the most complex research administration activities associated with the conduct of clinical trials. + Manages a large or multiple smaller clinical research projects. + Manages clinical trials related information systems. + Supervises the implementation of and adherence to study protocols. + Monitors expenditures and adherence to study budgets and resolves CAS issues. + Educates research staff on established policies, processes and procedures. + 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. + Plans, identifies, and handles study related equipment and facilities needs. + Provides leadership and expertise in identifying and completing research grants, study materials, brochures and correspondence. + Develops and submits grant proposals. + Leads or chairs committees or task forces to address and resolve significant issues. + Performs related approved responsibilities as required. MINIMUM QUALIFICATIONS: + High School Diploma or GED and nine years of clinical research experience. + Or two years of college in a scientific, health related, or business administration program and seven years clinical research experience + Or licensed as a Practical Nurse (LPN) and six years clinical research experience + Or bachelor's degree in a scientific, health related or business administration program and five years of clinical research experience + Or master's degree, MD or PhD in a scientific, health related, or business administration program and two years 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 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** _150982_ **Job Type** _Regular Full-Time_ **Division** _School Of Medicine_ **Department** _SOM: Medicine: Cardiology_ **Job Category** _Clinical Research_ **Campus Location (For Posting) : Location** _US-GA-Atlanta_ **_Location : Name_** _Emory University Hospital_ **Remote Work Classification** _No Remote_ **Health and Safety Information** _Position involves clinical patient contact, Working with human blood, body fluids, tissues, or other potentially infectious materials_

**Discover Your Career at Emory University** Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the excellence of our academic community. **Description** The Clinical Research Coordinator II handles administrative activities generally associated with the conduct of clinical trials. The School of Medicine's Hematology Department is looking for a Clinical Research Coordinator to join the team. This position involves directing the Winship leukemia program's biospecimen collection efforts, including actively consenting patients and collecting blood, bone marrow aspirate, and other tissue samples for patients with malignancies treated by the leukemia group. Additionally, it involves maintenance of the leukemia group retrospective database focused on evaluation of patient outcomes. Sample collection and biobanking will be done by interfacing closely with the Winship Discovery team. Experience with patient consent, sample acquisition, the REDCap database platform, and blood cancer patients are all valued assets in applicants interested in this position 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** _152600_ **Job Type** _Regular Full-Time_ **Division** _School Of Medicine_ **Department** _SOM: HMO: Hematology_ **Job Category** _Clinical Research_ **Campus Location (For Posting) : Location** _US-GA-Atlanta_ **_Location : Name_** _Emory Clinic Bldg B_ **Remote Work Classification** _No Remote_ **Health and Safety Information** _Position involves clinical patient contact, Working with human blood, body fluids, tissues, or other potentially infectious materials_

**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. + Employees in this classification may be required to work with, take specific precautions against and/or be immunized against potentially hazardous agents. + Transports and processes biological specimens (training provided). + May perform some supervisory duties. + Performs emergency CPR. + Performs related approved responsibilities as required. 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. Must have transportation and be able to work at Emory University Hospital (primary site) and/or Emory University Hospital Midtown. 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** _157509_ **Job Type** _Regular Full-Time_ **Division** _School Of Medicine_ **Department** _SOM: Anesthesiology: Admin_ **Job Category** _Clinical Research_ **Campus Location (For Posting) : Location** _US-GA-Atlanta_ **_Location : Name_** _Emory University Hospital_ **Remote Work Classification** _N/A or Other_ **Health and Safety Information** _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. **NOTE:** Phlebotomy is not designated as a responsibility within the Winship position. _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** _147290_ **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: + 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** This position will oversee all study activities related to a clinical trial investigating the use of Fecal Microbiota Transplant (FMT) as a novel biotherapeutic to prevent infections caused by multidrug-resistant organisms (MDROs). The trial is being conducted at Emory University Hospital and Emory Midtown Hospital and will require periodic travel to study sites in the Atlanta area. This role is part of the PEACH II Program (*************************************************************************************************** , a CDC-funded initiative focused on preventing healthcare-associated infections caused by MDROs. The Clinical Research Coordinator will lead all study activities including: + Screening/consenting eligible research participants + Collecting patient swabs and biological specimens + Managing IRB submissions + Reviewing medical charts for relevant clinical data + Overseeing data entry and quality checks + Supervising the overall implementation of and adhere to the study protocol 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. 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 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** _153520_ **Job Type** _Regular Full-Time_ **Division** _School Of Medicine_ **Department** _SOM: Medicine: Infectious Dis_ **Job Category** _Clinical Research_ **Campus Location (For Posting) : Location** _US-GA-Atlanta_ **_Location : Name_** _Emory Campus-Clifton Corridor_ **Remote Work Classification** _Primarily On Campus_ **Health and Safety Information** _Not Applicable_

**Discover Your Career at Emory University** Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the excellence of our academic community. **Description** The Clinical Research Coordinator II handles administrative activities generally associated with the conduct of clinical trials. This position is for a projects manager to support research programming at Emory-Grady focused on HIV and women's health. A core emphasis will be on assessing the use and implementation of long-acting (LA) HIV treatment options across a variety of care settings. The research portfolio comprises a variety of study types (e.g., clinical/translational, implementation science); data instruments (e.g., human specimens, medical chart abstractions, surveys, interviews, etc.); and sponsors (e.g., CDC/NIH, industry, professional organizations/society, internal/CFAR), etc. The projects manager will be responsible for leading administrative aspects (i.e., regulatory, finances) and grow into supervision of other team members. They will meet with the PI weekly and lead team meetings (that occur on a weekly, biweekly, or monthly basis depending on the project stage). They should be familiarized with the process of primary quantitative and qualitative data collection, and in some instances data analysis, so that they can assist firsthand initially and eventually train/ support/ mentor other team members to execute these. As their interests and capacity permit, they will have the opportunity to contribute to the dissemination of research findings through abstract presentations at scientific conferences and/or community forums and assist with the development/ writing of manuscripts. KEY RESPONSIBILITIES: + Manages research project databases, develops flow sheets and other study related documents, and completes source documents/case report forms. + Provides guidance to less experienced staff. + Interfaces with research participants, determines eligibility and consents study participants according to protocol. + Approves orders for supplies and equipment maintenance. + Assists in developing recruitment strategies and conducting screenings for study participants including interviews and questionnaires. + Supervises collection of study specimens and processing. + Establishes case packages for study procedures, monitors scheduling of procedures and charges, coordinates other services as needed. + Ensures compliance with research protocols, reviews case report forms and audits for accuracy with source documents, attends monitoring meetings with sponsors. + Prepares regulatory submissions. + With appropriate credentialing and training may perform phlebotomy or diagnostics. + Performs related approved responsibilities as required. MINIMUM QUALIFICATIONS: + High School Diploma or GED and five years of clinical research experience. + Or two years of college in a scientific, health related, or business administration program and three years clinical research experience. + Or a licensed as a practical nurse (LPN) and two years clinical research experience. + Or a Bachelor's degree in a scientific, health related, or business administration related program and one year of clinical research experience. + Or a Master's degree, MD or PhD in a scientific, health related or business administration program. This position is intended to support clinical research and all clinical training requirements must be tracked and monitored through Emory Healthcare under the credentialing category of Clinical Researcher. NOTE: Position 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** _156956_ **Job Type** _Regular Full-Time_ **Division** _School Of Medicine_ **Department** _SOM: Medicine: Infectious Dis_ **Job Category** _Clinical Research_ **Campus Location (For Posting) : Location** _US-GA-Atlanta_ **_Location : Name_** _Grady Hospital_ **Remote Work Classification** _Primarily On Campus_ **Health and Safety Information** _Not Applicable_

Ann & Robert H. Lurie Children's Hospital of Chicago provides superior pediatric care in a setting that offers the latest benefits and innovations in medical technology, research and family-friendly design. As the largest pediatric provider in the region with a 140-year legacy of excellence, kids and their families are at the center of all we do. Ann & Robert H. Lurie Children's Hospital of Chicago is ranked in all 10 specialties by the U.S. News & World Report. Location Outpatient Services at 1440 N Dayton Job Description Coordinates all behavioral research activities with moderate supervision. Adheres to the service values and principles as well as the principles of research ethics. The balance between patient-facing and administrative data tasks varies according to the specific requirements of each research program. Essential Job Functions: * Manages research projects, including study start-up, protocol coordination, monitoring, and close-out activities. * Maintains strict adherence to study protocols and regulatory standards throughout all phases of the study. * Manages study regulatory activities by preparing and maintaining all regulatory documents and regulatory agencies, including protocols, informed consent documents, recruitment materials, initial submissions, modifications, and renewals. * Maintains comprehensive study documentation such as regulatory binders and correspondence. * Coordinates the conduct of behavioral research projects with various departments, adheres to standard operating procedures (SOPs) to ensure adherence to research protocols and regulatory standards, and track deadlines for grants and deliverables. * Identifies and recruits eligible study subjects, manage the informed consent/assent process, coordinate the reimbursement of study participants, and serve as the primary liaison for participant inquiries. * Arranges and conducts research visits, including delivering behavioral interventions, such as administering surveys, facilitating interviews, and leading focus groups. * Abstracts and enters data from medical records onto protocol-specific case report forms and electronic systems, record data on source documents and CRFs, and conduct statistical analysis under PI supervision. * Conducts quality assurance activities by adhering to research protocols and applicable regulations (OHRP, FDA, GCP), performing QA/QC checks for database validity, and ensuring ongoing data monitoring to maintain high standards of research integrity. * Attends research meetings and actively participate in educational conferences to promote the ethical conduct of research and stay informed about best practices. * Participates in the preparation and presentation of research findings through abstract and poster development and assists in the writing and editing manuscripts. * Other job functions as assigned. Knowledge, Skills, and Abilities: * Bachelor's degree and one year research experience required. A combination of education and/or experience may be considered in lieu of the degree when the experience is directly related to the duties of the job. * Proficient organizational skills with ability to manage multiple studies. Proficient verbal and written communications skills. * Proficient knowledge of FDA, HSR, and GCP Guidelines. * Proficient analytical skills with the ability to recognize quantitative and qualitative research methods and remain agile and adaptable to various technological systems. * Proficient entry level leadership skills. * Recognizes the need to prioritize tasks, problem solve, and work with others. * Assists to foster an inclusive environment where all team members feel valued and respect Education Bachelor's Degree (Required) Pay Range $49,920.00-$81,619.20 Salary At Lurie Children's, we are committed to competitive and fair compensation aligned with market rates and internal equity, reflecting individual contributions, experience, and expertise. The pay range for this job indicates minimum and maximum targets for the position. Ranges are regularly reviewed to stay aligned with market conditions. In addition to base salary, Lurie Children's offer a comprehensive rewards package that may include differentials for some hourly employees, leadership incentives for select roles, health and retirement benefits, and wellbeing programs. For more details on other compensation, consult your recruiter or click the following link to learn more about our benefits. Benefit Statement For full time and part time employees who work 20 or more hours per week we offer a generous benefits package that includes: Medical, dental and vision insurance Employer paid group term life and disability Employer contribution toward Health Savings Account Flexible Spending Accounts Paid Time Off (PTO), Paid Holidays and Paid Parental Leave 403(b) with a 5% employer match Various voluntary benefits: * Supplemental Life, AD&D and Disability * Critical Illness, Accident and Hospital Indemnity coverage * Tuition assistance * Student loan servicing and support * Adoption benefits * Backup Childcare and Eldercare * Employee Assistance Program, and other specialized behavioral health services and resources for employees and family members * Discount on services at Lurie Children's facilities * Discount purchasing program There's a Place for You with Us At Lurie Children's, we embrace and celebrate building a team with a variety of backgrounds, skills, and viewpoints - recognizing that different life experiences strengthen our workplace and the care we provide to the Chicago community and beyond. We treat everyone fairly, appreciate differences, and make meaningful connections that foster belonging. This is a place where you can be your best, so we can give our best to the patients and families who trust us with their care. Lurie Children's and its affiliates are equal employment opportunity employers. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin, ancestry, age, disability, marital status, pregnancy, protected veteran status, order of protection status, protected genetic information, or any other characteristic protected by law. Support email: ***********************************

Henry Ford Cancer offers a large number of clinical trials, which can offer new or developing treatments to patients before they are widely available. They also provide the opportunity to advance medical knowledge, prevent diseases and increase quality of life. Henry Ford researchers place a strong emphasis on clinical research. That means that most of our work investigates how research questions affect patient care directly. However, our oncology researchers also conduct lab or bench research (studies performed in the laboratory, sometimes at the cellular level), investigating new treatments or cell behaviors. GENERAL SUMMARY: Under minimal supervision the Research Study Coordinator II: * Coordinates research projects within guides of regulatory compliance and/or Code of Federal Regulation. * Provides technical support to Principal Investigators. Duties include but not limited to: * Interacting with both internal and external customers at all levels and oversight of recruitment and coordinating day-to-day operations of the study. * Direct contact with potential and enrolled study participants expected. * Provides other support as required. * May work on multiple studies at any given time. EXPERIENCE REQUIRED: * One (1) year of research project coordination experience. CERTIFICATIONS/LICENSURES REQUIRED: * SOCRA or ACRP and IATA certification preferred. Additional Information * Organization: Henry Ford Medical Group * Department: Cancer Clinical & Trans Resear * Shift: Day Job * Union Code: Not Applicable