Clinical Research Associate jobs in Smyrna, GA

This is a zero-hourly position (PRN) and individual will work on an as-needed basis. Flexibility is essential due to the needs of the research participants and lab. Position provides skilled, thorough, physical therapy assessments for research participants with musculoskeletal pain conditions. Responsibilities include participant recruitment, screening, scheduling, measurement, data processing and analysis support. Works with Principal Investigator (PI) to execute responsibilities within a team framework of exchange and open communication in a clinically-oriented research laboratory.Job Description Primary Duties & Responsibilities: Communicates effectively with multiple personnel across a variety of recruitment sites to ensure timely participant recruitment. Performs participant screening, scheduling for laboratory and treatment visits, and regular follow-up communication to maintain participant retention. Provides clinical assessments of research participants according to study protocols, which may include assessments of pain, neurological function, strength, motor control, sensation, functional activities (e.g., walking), functional limitations, disability, quality of life and other areas. Operates equipment to measure movement including research-grade movement sensors and other equipment as needed for data collection. Works with PI, Clinical Research Coordinator and Clinical Research Assistants to ensure proper creation, processing and maintenance of data files in a database and proper coding/storage of data to comply with HIPAA and WUSM HRPO regulations. Assist with processing and basic analyses of data according to study protocols and as discussed with the PI and the research team. Competently uses a variety of software for successful participant recruitment and retention, data collection, processing, and analysis. Develops and implements documentation records and procedures including methods for managing data collection. Works effectively and efficiently with a team that includes the PI, Clinical Research Coordinator, Clinical Research Assistants, graduate students and others on interdisciplinary research projects. Acts as a resource to community therapists and to participants seeking therapeutic resources within the community. Follows up laboratory visits with phone calls to participants and participants' families when required. Working Conditions: Job Location/Working Conditions Normal lab/office environment Patient care setting Requires protective devices Physical Effort Occasional lifting 25-50 lbs. Frequent lifting 25lbs. or more Ability to lift ten pounds from floor to waist, carry ten pounds for short distances Push and pull occasionally with moderate force Ability to coordinate hand movements to write, type, manipulate folders, and client body parts Equipment Therapy equipment Lab equipment Office equipment Clinical/diagnostic equipment The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel so classified. Management reserves the right to revise or amend duties at any time.Required Qualifications Education: Bachelor's degree Certifications: The list below may include all acceptable certifications and issuers. More than one credential or certification may be required depending on the role.Basic Life Support - American Heart Association, Basic Life Support - American Red Cross, Occupational Therapist - Illinois Department of Financial and Professional Regulation, Occupational Therapist - Missouri Division of Professional Registration, Physical Therapist - Illinois Department of Financial and Professional Regulation, Physical Therapist - Missouri Division of Professional Registration Work Experience: Clinical Or Research (5 Years) Skills: Not Applicable Driver's License: A driver's license is not required for this position.More About This Job Required Qualifications: Basic Life Support certification (Online BLS certifications, those without a skills assessment component, are not sufficient to meet the BLS requirements). Currently licensed or eligible for licensure in the state of Missouri as a Physical Therapist. Preferred Qualifications Education: No additional education beyond what is stated in the Required Qualifications section. Certifications: No additional certification beyond what is stated in the Required Qualifications section. Work Experience: No additional work experience beyond what is stated in the Required Qualifications section. Skills: Adaptability, Compliance Requirements, Computer Literacy, Confidentiality, Critical Thinking, Customer Service, Data Collection Methods, Detail-Oriented, High Accuracy, Human Subjects Research, Interpersonal Communication, Laboratory Research, Multitasking, Organizing, Orthopaedic Physical Therapy, Patient Counseling, Patient Screening, Prioritization, Professional Etiquette, Research Databases, Research Recruitment, Scheduling, Scientific Reasoning, Teamwork, Working IndependentlyGradeR12-H Salary Range $32.53 - $55.29 / HourlyThe salary range reflects base salaries paid for positions in a given job grade across the University. Individual rates within the range will be determined by factors including one's qualifications and performance, equity with others in the department, market rates for positions within the same grade and department budget.Questions For frequently asked questions about the application process, please refer to our External Applicant FAQ. Accommodation If you are unable to use our online application system and would like an accommodation, please email **************************** or call the dedicated accommodation inquiry number at ************ and leave a voicemail with the nature of your request. All qualified individuals must be able to perform the essential functions of the position satisfactorily and, if requested, reasonable accommodations will be made to enable employees with disabilities to perform the essential functions of their job, absent undue hardship.Pre-Employment ScreeningAll external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. The screenings will include criminal background check and, as applicable for the position, other background checks, drug screen, an employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. All offers are contingent upon successful completion of required screening.Benefits StatementPlease visit our website at ****************************** to review our benefit eligibility criteria along with any applicable benefits.EEO StatementWashington University in St. Louis is committed to the principles and practices of equal employment opportunity and especially encourages applications by those from underrepresented groups. It is the University's policy to provide equal opportunity and access to persons in all job titles without regard to race, ethnicity, color, national origin, age, religion, sex, sexual orientation, gender identity or expression, disability, protected veteran status, or genetic information.Washington University is dedicated to building a community of individuals who are committed to contributing to an inclusive environment - fostering respect for all and welcoming individuals from diverse backgrounds, experiences and perspectives. Individuals with a commitment to these values are encouraged to apply.

As a Clinical Research Associate you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. What You Will Be Doing: * Serve as the primary point of contact between investigational sites and the sponsor * Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out * Ensure site compliance with ICH-GCP, SOPs, and regulations * Maintain up-to-date documentation in CTMS and eTMF systems * Support and track site staff training and maintain compliance records * Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting * Support subject recruitment and retention efforts at the site level * Oversee drug accountability and ensure proper storage, return, or destruction * Resolve data queries and drive timely, high-quality data entry * Document site progress and escalate risks or issues to the clinical team * Assist in tracking site budgets and ensuring timely site payments (as applicable) * Collaborate with cross-functional partners including CTAs, LTMs, and CTMs You are: * A graduate with a Bachelor's degree in Life Sciences or equivalent, or a qualified RN * Eligible to work in United States without visa sponsorship * A clinical research professional with 2+ years of on-site monitoring experience in the pharmaceutical or CRO industry * Experienced across multiple therapeutic areas, ideally including Oncology (Prostate Cancer, and Lung Cancer) and Hematology * Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF * A clear communicator, problem-solver, and collaborative team player * Willing and able to travel up to 50% for on-site monitoring visits across Southeast region, preference given to candidates residing near major HUB airports in the southeast region to support efficient regional travel What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: * Various annual leave entitlements * A range of health insurance offerings to suit you and your family's needs * Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead * Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being * Life assurance * Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: ************************************ At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. ***************************************************** Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons' most difficult challenges in treating patients with aortic diseases. Artivion has over 1,400 employees worldwide with sales representation in over 100 countries. The Company has manufacturing facilities located in Atlanta, Georgia, Austin, Texas and Hechingen, Germany. Additionally, it has sales and distribution offices in various countries throughout Europe, Asia, and South America. For additional information about Artivion, visit our website, ***************** Position Objective: To independently manage and monitor all aspects of clinical trials at investigative sites, ensuring data accuracy and compliance with protocols, ICH-GCP guidelines, and applicable regulations, while demonstrating a deeper understanding of clinical research processes. Responsibilities * Manage 10-15 study sites (class 2 - 3 products) from start-up to closure. * Manages clinical monitoring visits individually and in some cases, may conduct site visits. * Completes onsite and remote monitoring activities * Build and maintain strong relationships with study sites, including principal investigators and site staff. Provide support, training, and guidance to site personnel as needed. Communicate effectively to address queries, provide updates, and facilitate resolution of issues. * Serve as the primary point of contact between the sponsor, investigational sites, and other stakeholders involved in the clinical trial. * Prepare and review on-site files and records, case report forms, and source documents for completeness, accuracy, consistency, and compliance. * Ability to develop and implement clinical research monitoring plans. * Knowledge of all regulations and guidelines pertaining to the conduct of clinical trials on human subjects. * Ensuring adherence to applicable regulatory requirements and guidelines from relevant authorities. (ISO 14155 GCP, MDR, EU, FDA, and/or Local Regulations etc.) * Prepare site visit reports and correspondence for all visits conducted in accordance with the study. * Follows-up with site to gauge progress on any action items and assess needs to reinforce completion of those action items. * Makes updates in applicable tracking systems. * Participates in study initiation. * Coordinates site activities from site start-up. * Conducts Site Selection Visits & Site Initiation Visits. * Participates in site selection. * Verifies that the investigator and research staff follow the approved protocol and all GCP procedures. * Oversee the execution of clinical trial protocol. * Participate in the execution of the overall clinical study. * Coordinate, conduct and evaluate research related activity. * Recognize problems, trends and react to resolve issues quickly and to bring effective resolution. * Participate in quality assurance activities to ensure compliance with company standards, industry regulations, and best practices. This may involve participating audits / inspections, training sessions, and process improvements such as CAPA execution. * Ensures appropriate transmission of clinical case data to the data management centers; reviews case report queries and problems and clarifies and/or obtains changes to data as appropriate. * Review queries and assist in the resolution of Data Clarification Forms (DCFs). * Assists in the termination of clinical studies by identifying items and issues for review and/or follow-up. * Coordinate and implement site close-out activities and generate site close-out report. * Conduct site Close Out Visits. * Assist in the supervision of clinical studies in cooperation with Clinical Research Associates III, IV, Data Managers ,Project Managers and other Clinical Affairs team members. Qualifications: * BA/BS/BSc in a scientific or healthcare related field. (MSc, a plus) * Minimum of 2 years of on site monitoring experience. * In-depth knowledge of monitoring, ICH-GCP guidelines and FDA regulations. * Ability to work independently with strong strategic thinking skills. * Able and willing to travel * Able and willing to work from a designated and appropriate home office. * Possession of a full driver's license Preferred Experience: * Cardiology and/or Cardiovascular therapeutic area experience * Experience on medical device clinical studies and ISO14155 knowledge

Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons' most difficult challenges in treating patients with aortic diseases. Artivion has over 1,400 employees worldwide with sales representation in over 100 countries. The Company has manufacturing facilities located in Atlanta, Georgia, Austin, Texas and Hechingen, Germany. Additionally, it has sales and distribution offices in various countries throughout Europe, Asia, and South America. For additional information about Artivion, visit our website, www.artivion.com. Position Objective: To independently manage and monitor all aspects of clinical trials at investigative sites, ensuring data accuracy and compliance with protocols, ICH-GCP guidelines, and applicable regulations, while demonstrating a deeper understanding of clinical research processes. Responsibilities Manage 10-15 study sites (class 2 - 3 products) from start-up to closure. Manages clinical monitoring visits individually and in some cases, may conduct site visits. Completes onsite and remote monitoring activities Build and maintain strong relationships with study sites, including principal investigators and site staff. Provide support, training, and guidance to site personnel as needed. Communicate effectively to address queries, provide updates, and facilitate resolution of issues. Serve as the primary point of contact between the sponsor, investigational sites, and other stakeholders involved in the clinical trial. Prepare and review on-site files and records, case report forms, and source documents for completeness, accuracy, consistency, and compliance. Ability to develop and implement clinical research monitoring plans. Knowledge of all regulations and guidelines pertaining to the conduct of clinical trials on human subjects. Ensuring adherence to applicable regulatory requirements and guidelines from relevant authorities. (ISO 14155 GCP, MDR, EU, FDA, and/or Local Regulations etc.) Prepare site visit reports and correspondence for all visits conducted in accordance with the study. Follows-up with site to gauge progress on any action items and assess needs to reinforce completion of those action items. Makes updates in applicable tracking systems. Participates in study initiation. Coordinates site activities from site start-up. Conducts Site Selection Visits & Site Initiation Visits. Participates in site selection. Verifies that the investigator and research staff follow the approved protocol and all GCP procedures. Oversee the execution of clinical trial protocol. Participate in the execution of the overall clinical study. Coordinate, conduct and evaluate research related activity. Recognize problems, trends and react to resolve issues quickly and to bring effective resolution. Participate in quality assurance activities to ensure compliance with company standards, industry regulations, and best practices. This may involve participating audits / inspections, training sessions, and process improvements such as CAPA execution. Ensures appropriate transmission of clinical case data to the data management centers; reviews case report queries and problems and clarifies and/or obtains changes to data as appropriate. Review queries and assist in the resolution of Data Clarification Forms (DCFs). Assists in the termination of clinical studies by identifying items and issues for review and/or follow-up. Coordinate and implement site close-out activities and generate site close-out report. Conduct site Close Out Visits. Assist in the supervision of clinical studies in cooperation with Clinical Research Associates III, IV, Data Managers ,Project Managers and other Clinical Affairs team members. Qualifications: BA/BS/BSc in a scientific or healthcare related field. (MSc, a plus) Minimum of 2 years of on site monitoring experience. In-depth knowledge of monitoring, ICH-GCP guidelines and FDA regulations. Ability to work independently with strong strategic thinking skills. Able and willing to travel Able and willing to work from a designated and appropriate home office. Possession of a full driver's license Preferred Experience: Cardiology and/or Cardiovascular therapeutic area experience Experience on medical device clinical studies and ISO14155 knowledge

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

As a Clinical Research Associate you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Responsibilities What You Will Be Doing: Serve as the primary point of contact between investigational sites and the sponsor Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out Ensure site compliance with ICH-GCP, SOPs, and regulations Maintain up-to-date documentation in CTMS and eTMF systems Support and track site staff training and maintain compliance records Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting Support subject recruitment and retention efforts at the site level Oversee drug accountability and ensure proper storage, return, or destruction Resolve data queries and drive timely, high-quality data entry Document site progress and escalate risks or issues to the clinical team Assist in tracking site budgets and ensuring timely site payments (as applicable) Collaborate with cross-functional partners including CTAs, LTMs, and CTMs Qualifications You are: A graduate with a Bachelor's degree in Life Sciences or equivalent, or a qualified RN Eligible to work in United States without visa sponsorship A clinical research professional with 2+ years of on-site monitoring experience in the pharmaceutical or CRO industry Experienced across multiple therapeutic areas, ideally including Oncology (Prostate Cancer, and Lung Cancer) and Hematology Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF A clear communicator, problem-solver, and collaborative team player Willing and able to travel up to 50% for on-site monitoring visits across Southeast region, preference given to candidates residing near major HUB airports in the southeast region to support efficient regional travel What ICON can offer you: Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family's needs Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: ************************************ At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. ***************************************************** Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

Senior CRA Responsibilities include: * All aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, writing of clinical trial reports, conduct of pre-study and initiation visits, liaise with vendors and other duties * All aspects of site and registry management as prescribed in the project plans * Organize and make presentations at Investigator Meetings * Report, write narratives and follow-up on serious adverse events * Review progress of projects and initiate appropriate actions to achieve target objectives * You may serve as lead monitor for a protocol or project and assist in establishing monitoring plans if required * Participate in the development of protocols and Case Report Forms as assigned * Interact with internal work groups to evaluate needs, resources and timelines Qualifications * 5+ years of clinical research monitoring experience (including pre-study, initiation, routine monitoring and close-out visits) preferably in a CRO or Pharma environment * Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines * Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of Seas * Good knowledge of ICH Guidelines and GCP, monitoring procedures and understanding of the clinical trial process * Good planning, organization and problem solving abilities * Good communication and interpersonal skills Additional Information All your information will be kept confidential according to EEO guidelines.

Senior Clinical Research Associate (home based) (Level dependent on experience) To help support the unique job functions of our CRAs, we have a dedicated training department that offers ongoing therapeutic training sessions from our world-class medical directors, and an experienced and supportive management team that is there to offer continual guidance. Additionally, all CRAs are able keep their hotel points and airline miles and are offered a home office allowance. Maintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each department can provide an update on a study or milestone that they have achieved. Each employee also has the opportunity join one of our CTI Cares committees that not only help support our culture, but also focus on our various philanthropic efforts. What You'll Do Manages investigative site activity for multiple protocols / indications and provides ongoing updates of site status to Project Manager / sponsor. Creates and implements subject enrollment strategies for assigned investigative sites. Conducts study site visits (pre-study, initiation, monitoring, and close-out) and completes site visit deliverables within given timelines in the Monitoring Plan. Ensures proper storage, dispensation, and accountability of all investigational product(s) and trial-related material. Maintains tracking records for assigned sites including tracking of subject status, subject case report form (CRF) retrieval / source document review (SCV), regulatory documents, and investigational product. Participates in development of CRFs and other study related documents What You Bring Bachelor's or Master's Degree in allied health fields, such as nursing, pharmacy, or health / natural science, or RN with Associate's Degree or 3-year Nursing Diploma with at least 2 years of clinical nursing experience Why CTI? At CTI, we recognize that our people are what make our company successful. Our work moves medicine forward. For that reason, we treat our team members with the respect they deserve, and our numbers show it: We support career progression - We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward We value education and training - We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training department We value our people - We have never had a layoff in our three decade history and we guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked. We support a work-life balance and the importance of time with family by offering generous vacation time, a hybrid work from home schedule, and paid parental leave. Our culture is unparalleled - We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry We think globally and act locally - With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work. Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world. We are looking toward the future - We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROs Our work makes a difference - We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market

Title: Clinical Pharmacy Research Manager Hybrid : This role requires associates to be in-office 1 - 2 days per week, fostering collaboration and connectivity, while providing flexibility to support productivity and work-life balance. This approach combines structured office engagement with the autonomy of virtual work, promoting a dynamic and adaptable workplace. Alternate locations may be considered. Please note that per our policy on hybrid/virtual work, candidates not within a reasonable commuting distance from the posting location(s) will not be considered for employment, unless an accommodation is granted as required by law. The Clinical Pharmacy Research Manager is responsible for implementing strategic plans and objectives for complex Clinical Research initiatives that may cross departmental, divisional, or health plan lines. How you will make an impact: Primary duties may include, but are not limited to: * Leads projects. * Provides technical oversight, problem identification and resolution, and identification of information needs and technologies. * Ensures regulatory and/or accreditation compliance as applicable. * Manages collaborative teams to ensure project objectives are achieved. * Secures or coordinates the resources (people, material, data and support) for staff to effectively accomplish operational needs and strategic initiatives. * May represent the department on committees, task forces and work groups. Minimum Requirements: * Requires a BA/BS in business, public health, nursing, epidemiology biostatistics, or related field and minimum of 5 years direct health care experience involving analyses of health care data or healthcare products; or any combination of education and experience, which would provide an equivalent background. Job Level: Non-Management Exempt Workshift: Job Family: BSP > Program/Project Please be advised that Elevance Health only accepts resumes for compensation from agencies that have a signed agreement with Elevance Health. Any unsolicited resumes, including those submitted to hiring managers, are deemed to be the property of Elevance Health. Who We Are Elevance Health is a health company dedicated to improving lives and communities - and making healthcare simpler. We are a Fortune 25 company with a longstanding history in the healthcare industry, looking for leaders at all levels of the organization who are passionate about making an impact on our members and the communities we serve. How We Work At Elevance Health, we are creating a culture that is designed to advance our strategy but will also lead to personal and professional growth for our associates. Our values and behaviors are the root of our culture. They are how we achieve our strategy, power our business outcomes and drive our shared success - for our consumers, our associates, our communities and our business. We offer a range of market-competitive total rewards that include merit increases, paid holidays, Paid Time Off, and incentive bonus programs (unless covered by a collective bargaining agreement), medical, dental, vision, short and long term disability benefits, 401(k) +match, stock purchase plan, life insurance, wellness programs and financial education resources, to name a few. Elevance Health operates in a Hybrid Workforce Strategy. Unless specified as primarily virtual by the hiring manager, associates are required to work at an Elevance Health location at least once per week, and potentially several times per week. Specific requirements and expectations for time onsite will be discussed as part of the hiring process. The health of our associates and communities is a top priority for Elevance Health. We require all new candidates in certain patient/member-facing roles to become vaccinated against COVID-19 and Influenza. If you are not vaccinated, your offer will be rescinded unless you provide an acceptable explanation. Elevance Health will also follow all relevant federal, state and local laws. Elevance Health is an Equal Employment Opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, citizenship status, color, creed, disability, ethnicity, genetic information, gender (including gender identity and gender expression), marital status, national origin, race, religion, sex, sexual orientation, veteran status or any other status or condition protected by applicable federal, state, or local laws. Applicants who require accommodation to participate in the job application process may contact ******************************************** for assistance. Qualified applicants with arrest or conviction records will be considered for employment in accordance with all federal, state, and local laws, including, but not limited to, the Los Angeles County Fair Chance Ordinance and the California Fair Chance Act.

Note: If you are CURRENTLY employed at Children's and/or have an active badge or network access, STOP here. Submit your application via Workday using the Career App (Find Jobs). Work Shift Day Work Day(s) Monday-Friday Shift Start Time 8:00 AM Shift End Time 4:30 AM Worker Sub-Type Regular Children's is one of the nation's leading children's hospitals. No matter the role, every member of our team is an essential part of our mission to make kids better today and healthier tomorrow. We're committed to putting you first, and that commitment is at the heart of our company culture: People first. Children always. Find your next career opportunity and make a difference doing what you love at Children's. Job Description Develops, implements, and supports the research process by assisting investigators in study design, completion of the approval process, and management of data specific to the subspecialty of involvement. Proactively supports the efforts that ensure delivery of safe patient care and services and promotes a safe environment at Children's Healthcare of Atlanta. Experience * One year of research experience. May substitute required experience with equivalent years of education beyond the minimum education requirement Preferred Qualifications * Bachelor's degree in Health or Biological Sciences Education * Bachelor's degree in a scientific, health related, or business administration related program or relevant experience in lieu of education Certification Summary * Basic Life Support (BLS) within 30 days of employment if role requires patient contact * ARUP Handling, Packaging and Shipping Infectious Substances or similar within 30 days of employment if role requires specimen acquisition * Collaborative Institutional Training Initiative (CITI) within 30 days of employment Knowledge, Skills, and Abilities * Working knowledge of state and federal regulatory guidelines related to research * Good computer skills including working knowledge of a PC and Microsoft Office (Word, Access, and Excel) * Self-directed and motivated to work independently toward short- and long-term goals * Good communication, organization, and interpersonal skills * Good working relationships with colleagues, subordinates, and superiors Job Responsibilities Develops, conducts, and facilitates research protocols. * Supports investigators in writing study protocols. * Performs participant screening, enrollment, study activities, and communication. * Coordinates study visits and procedures, including specimen acquisition, transport, documentation, and shipment. * Maintains equipment and supply resources for research studies. * Completes data management activities and ensures data integrity. * Assists in the development and completion of source documents and case report forms. * Participates in sponsor correspondence, monitoring, and study meetings. * Monitors compliance throughout all study activities and engages compliance oversight as needed. * Directs patient interaction to conduct research protocols. * Obtains informed consent by following policy, procedure, and regulatory requirements. * Schedules study-specific visits in conjunction with ancillary departments. * Administers various research surveys in accordance with research study requirements. * Completes research-only testing as required and applicable per study and system requirements, including electrocardiograms. * Performs phlebotomy if trained to do so. * Provides research study education to participants as part of a study protocol. * Completes documentation as needed within the medical record. Manages all regulatory processes related to clinical research activities. * Completes Institutional Review Board preparation, submission, modifications, reporting, and termination activities. * Maintains all licensure, certification, and system education requirements for role. * Maintains all regulatory documents. * Assist with facilitating grants, contracts, and financial tasks for research and clinical trials. * Assist with supporting Principal Investigator in study budgeting, sponsor interactions, routing, feasibility assessments, account management, and reconciliation. * Completes research administrative duties according to Children's policies regarding Epic enrollment, Clinical Trial Management System data entry, patient care invoice accuracy. Participates in education activities to support specific research activities and primary role at Children's Healthcare of Atlanta. * May participate in departmental policy and quality projects. * Completes departmental, system-wide, and study-specific education as required. Children's Healthcare of Atlanta is an equal opportunity employer committed to providing equal employment opportunities to all qualified applicants and employees without regard to race, color, sex, religion, national origin, citizenship, age, veteran status, disability or any other characteristic covered by applicable law. Primary Location Address Job Family Research

The Clinical Project Manager is responsible for working closely with our current clients on various Clinical Trials, Education, Quality Improvement, or other specific clinically driven programs. This person has responsibility for all aspects of managing the planning, deployment, engagement, and delivery of final reports from initial customer contract to project completion. The Project Manager interfaces with life sciences and provider customers and internal teams on all project-related matters, keeping the project on schedule and in scope, anticipating and assessing project issues, aggregating data and analyzing to derive insights, and developing resolutions to meet productivity, quality, and client-satisfaction/retention goals.?This role requires strong communication, customer service, organizational and leadership skills, as well as a great deal of flexibility and devotion to maintaining excellent customer satisfaction. This role also includes the ability to interact with the clinical staff at the client site and must have a strong understanding of clinical data, EMR and other hospital technology systems. ESSENTIAL DUTIES AND RESPONSIBILITIES Manage all aspects of various projects done in conjunction with OncoLens life sciences and provider clients around clinical trials, clinical education and quality improvement. Work with multiple departments and stakeholders internally and client facing, to ensure tasks are completed timely and accurately. Define project scope and objectives, taking projects from original concept through final implementation and reporting which includes proposal and grant writing and editing. Develop detailed work plans, schedules, and status reports. Conduct detailed data aggregation and analysis, project write-up and development of final reports for delivery to client. Act as a single point of contact for projects, interfacing with all areas affected by the project including end users, management, IT, and cross-functional departments, both customer and internal resources. Conduct project meetings and take responsibility for project deliverables, tracking and reviewing all deliverables. Create and maintain regular project status reporting for internal stakeholders and leadership. Recommend and act to direct analysis and solution to problems. Participate in project forecasting, including kick-off dates, launch dates, effort and financials. Provide training for assigned customers as needed, on all aspects/roles of the project. Support management of the client relationship by managing practice relationships and fostering an environment which will lead to client retention and expansion. TRAVEL REQUIREMENTS KEY COMPETENCIES Strong planning and project management skills, ability to execute within established timeline. Strong understanding and love of clinical data and informatics. Strong familiarity with Electronic Medical Record platforms Excellent time management skills, including adhering to work schedules and activities with ability to multi-task. Effective communicator, collaborator, and customer service skills. Strong interpersonal, presentation, and communication skills and comfortable interacting with top pharma, diagnostic, and cancer center hospital leadership and physicians. Ability to manage multiple, simultaneous tasks and deadlines; prioritize effectively and handle shifting priorities smoothly and professionally. Superior problem-solving skills and ability to thrive in an environment of ambiguity and change. EDUCATION AND QUALIFICATIONS An Oncology Nurse with company or commercial experience is ideal. A Bachelors degree in a relevant field required. MPH or related degrees a plus Experience with Quality Improvement Methodologies, Root Cause Analysis, Plan Do Act Study methodologies a plus. 2+ years experience in healthcare data or IT related project management. Familiarity with healthcare information system, systems, formats, and languages such as: HL7 (ADT, ORU, CDA, etc.), FHIR, ICD-O and/or ICD-10. Experience with PACS/DICOM, pathology and radiology integrations a plus. Experience working with Cerner, Athena, Epic and other hospital EMR systems. Experience interfacing with pharma, diagnostics, cancer center clinical, administrative and IT/Data/Informatics teams. Proficiency in MS Word, Excel, Outlook, and PowerPoint required. Strong proficiency in MS Project, or other PM tool and PMP methodology as well as MS Word and Excel PMP certification a plus

Alcanza is a growing multi-site, multi-phase clinical research company with a network of locations in MA, NH, MI, VA, SC, FL, GA, AL, MO, TX and Puerto Rico. We have established a strong presence across Phase I-IV studies and several therapeutic areas including vaccine, neurology, dermatology, psychiatry, and general medicine. Join us as we continue to grow. The Clinical Research Site Manager is responsible for leading the operational performance of the clinical research staff. Provides on-site oversight to help ensure execution and coordination of clinical research activities according to ICH guidelines, GCP, FDA guidelines and follows company policies and procedures. Key Responsibilities Essential Job Duties: * Overall team management and leadership support with a focus on driving study performance, enhancing efficiencies, patient safety and protocol/GCP/regulatory compliance. * Collaborating with other departments (Business Development, Patient Recruitment, Finance, Budgets and Contracts, and Quality) to coordinate delivery expectations, meet expected study milestones (such as site activation targets, enrollment targets, etc.), meet budgets, and delivery quality data to sponsors. * Reviewing the performance dashboards and other clinical trial systems to oversee site and patient activities, ensure proper staff coverage, and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency). * Overseeing resourcing allocations, site assignments and study team members' output and performance, to ensure study deliverables are on track, identifying risks to delivery or quality, and escalating any risks to clinical trial management deliverables (timeline, quality and budget). * Assisting with initial and ongoing trainings regarding protocol specificities, Case Report Form (CRF) completion, Standard Operating Procedures (SOPs), clinical plans and guidelines, and timelines for the study. * Ensuring adherence to standard operating procedures, good clinical practice (GCP), FDA regulations, and company policies and procedures. * Overseeing site staff assigned to the study and routinely assessing study-specific process and training compliance, CMP compliance, and identifies emerging risks. May develop and support execution of corrective action plans at site and study level. * Overseeing people management activities including timecards, absence tracking/approvals, new hire training, interviewing and selection, performance appraisals, job description preparation, employee counseling, career coaching and employment meetings. * Managing assigned site staff, proactively identify and resolve issues, and work to ensure successful site operations. * Collaborating with investigators to ensure patient safety and meeting client goals and timelines. * Employing strategic thinking and problem-solving skills to propose and implement risk mitigations. * Participating and presenting in management or site meetings. * Perform all other duties as required or assigned. Skills, Knowledge and Expertise Minimum Qualifications: Bachelor's degree and a minimum of 2 years of clinical research experience, or an equivalent combination of education and experience, is required. 2+ years' experience as a clinical research coordinator (CRC) is required. 1+ years of management experience in clinical research is highly preferred. Bi-lingual (English / Spanish) proficiency is a plus. Required Skills: * Proficiency with computer applications such as Microsoft applications, email, electronic health records, web applications, and the ability to type proficiently (40+ wpm). * Must possess strong organizational, time management, problem solving, and project management skills to meet project deadlines. * Well-developed written and verbal communication skills. * Well-developed interpersonal and listening skills and the ability to work well independently as well as with co-workers, subjects, managers and external customers. * Ability to effectively handle multiple tasks and adapt to changes in workloads and priorities. * Must be professional, respectful of others, self-motivated, and have a strong work ethic. * Must possess a high degree of integrity and dependability. * Ability to work under minimal supervision, identify problems and implement solutions. * Ability to handle highly sensitive information in a confidential and professional manner, and in compliance with HIPAA guidelines. Benefits * Full-time employees regularly scheduled to work at least 30 hours per week are benefits-eligible, with coverage starting on the first day of the month following date of hire. * Medical, dental, vision, life insurance, short and long-term disability insurance, health savings accounts, supplemental insurances, and a 401k plan with a safe harbor match are offered.

Job Details CBO Office - Atlanta, GA Full Time 4 Year Degree As needed for business requirements. Ancillary ServicesDescription GENERAL SUMMARY OF DUTIES: The Clinical Research Director is responsible for the daily operations and overall success of United Digestive's clinical research department. This includes oversight of central research functions, financial performance, quality assurance, and staff management across all research locations. The director ensures studies are adequately staffed, maintains and develops relationships with pharmaceutical sponsors and investigators, and supports the onboarding of new investigators. A thorough knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements is essential to this role. REPORTS TO: Director of Ancillary Services RESPONSIBILITIES: Duties include but are not limited to: Manages overall clinical research department staff, inclusive of clinical research coordinators, clinical research nurses, and any staff performing research functions including but not limited to patient recruiters, contract / budget specialists, regulatory specialists, and business development personnel Oversight of both Georgia and Florida research activities for United Digestive research department, with expected travel to research sites as necessary Responsible for overall quality of clinical research department, including adherence to ICH-GCP, regulatory requirements, and department SOPs Oversees clinical research department finances working with United Digestive leadership to ensure department hits profitability targets Identifies, analyzes, and resolves daily workflow issues within departments including study-specific challenges Develops relationships with study sponsors and contract research organizations (CROs) to become a preferred site for research services on current and future studies Identifies, pursues, and evaluates potential new study opportunities for both profitability, viability (including proper resourcing), and alignment with investigator interest and company goals Maintains strong relationships with investigators at United Digestive and ensures that research staff is fully supported operationally to ensure the success of research projects Develop new relationships with United Digestive physicians to support the growth of the research program at United Digestive while facilitating referral program Encourages enrollment success by partnering with research staff and utilizing both internal and external recruitment strategies Supports study contracting and budgeting efforts for organizational approval, ensuring ancillary costs are covered and studies will be profitable for the department Works closely with UD finance team to ensure research finances are being appropriately tracked, invoiced, reconciled, and received Oversees the recruiting, hiring, training / development, and evaluation of all clinical research staff Maintains strong relationships and oversight of study sponsors throughout the entire clinical research process, including start up, ongoing monitoring visits, and close out Responsible for maintaining study regulatory compliance and proper site staff training including GCP, IATA, etc. Any other duties and special projects assigned by UD Leadership EDUCATION, SKILLS AND EXPERIENCE: Required: Bachelor's degree in healthcare or related field 7+ years of clinical research experience, preferably at a clinical research site Must have a strong understanding of GCP guidelines and regulatory requirements Experience with clinical research CTMS platforms and workflows Computer literate, ability to operate Microsoft Office applications Preferred: Preferred experience with large healthcare systems Preferred experience with gastrointestinal or metabolic clinical research studies CORE SKILLS AT UNITED DIGESTIVE: Director of Clinical Research have or must be able to: Plan, prioritize, and complete multiple tasks effectively Work under pressure; assess, respond to, and communicate issues in a timely manner Strong problem-solving skills and ability to handle conflict resolution Maintain composure and set professional examples to staff and patients Communicate clearly and present detailed information to a multidisciplinary audience Interpret and apply clinical and non-clinical policies and procedures PHYSICAL/MENTAL/ENVIRONMENTAL DEMANDS Requires sitting and standing associated with a normal office environment; travel as business needs require DRUG FREE WORKPLACE United Digestive is a drug free workplace. All offers of employment are contingent upon passing a pre-employment drug screening. EQUAL OPPORTUNITY EMPLOYER United Digestive is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, gender, color or national origin in its employment practices.

GENERAL SUMMARY OF DUTIES: Responsible for directing and supporting the daily operational and administrative functions of clinical study operations of the in-patient unit with a focus on project and resource management. Ensures the implementation of policies and procedures of the clinic and regulatory agencies are met or exceeded. REPORTS TO: Chief Executive Officer SUPERVISES: Coordinators, Research Assistants, Nurses and PRN staff RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO: Leading the daily clinical operations for all studies to include: Manage the project to those commitments Assigns studies to clinical staff based upon experience and workload. Contributes to the definition of the organization's strategic plan. Maintaining overall protocol timeliness and study enrollment goals. Collaborate with other experts to ensure that studies are conducted efficiently and are completed with the highest quality standards and outcomes. Provides direction to all clinical staff as well as overseeing external vendors including contract research organizations, sponsors, and monitors. Participates and prepares for all study initiations, close-out meetings, monitor visits, and sponsor audits. Acts as liaison between the sponsor, investigator, and study coordinators to address issues relating to protocol compliance. Works with clinical staff and management to ensure enrollment goals are met. Review clinical study documentation in adherence to protocol, ensuring compliance. Participates in the selection and hiring of all study staff. Responsible for and oversees formal training of study staff. All other duties as assigned. KNOWLEDGE, SKILLS & ABILITIES Thorough understanding of clinical research terminology, good clinical practices, regulatory and ethical guidelines, and regulations. Strong leadership, personnel management, and supervisory skills. Strong customer service and client relationship skills. Strong project management skills. Excellent organization and time management skills with a strong ability to prioritize and multi-task across competing demands. Excellent verbal/written communication skills with evidence of effective collaboration across businesses and functions. High-level computer skills. EDUCATION BA/BS is required. Advanced Degree Preferred. EXPERIENCE 5+ years of direct project management required. Management experience in a clinical research setting is preferred. CERTIFICATE/LICENSE - N/A PHYSICAL DEMANDS/WORKING CONDITIONS - Requires prolonged walking, standing, some bending, stooping, and stretching. Requires hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment. Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports. Requires occasional lifting of boxes up to 50 pounds. Work is performed in a medical office environment and includes exposure to blood-borne pathogens and bio-hazardous materials. This role requires the ability to work with a broad range of personalities, situations, and psychiatric disorders; therefore, candidates must possess the ability to resolve conflicts immediately and diffuse potentially escalating events before they occur.

In order to be considered for this role, after clicking "Apply Now" above and being redirected, you must fully complete the application process on the follow-up screen. At PrizePicks, we are the fastest-growing sports company in North America, as recognized by Inc. 5000. As the leading platform for Daily Fantasy Sports, we cover a diverse range of sports leagues, including the NFL, NBA, and Esports titles like League of Legends and Counter-Strike. Our team of over 450 employees thrives in an inclusive culture that values individuals from diverse backgrounds, regardless of their level of sports fandom. Ready to reimagine the DFS industry together? The Insights team at PrizePicks drives research-backed decision-making to enable industry-leading, customer-focused experiences. Our mission is to shape the future of sports and cultural prediction gaming through unmatched insight at the core of every strategic decision. We believe that by deeply understanding sports fans and mobile gamers, we'll build products that define the next era of fantasy sports and gaming. We're looking for a sharp, adaptable researcher who thrives in fast-paced, high-growth environments and wants their work to directly shape products used and loved by millions of people. As a Sr. Staff Researcher, you won't just uncover insights, you'll shape how the business thinks. You'll drive high-impact decisions by helping teams see opportunities differently, challenge assumptions, and reframe product strategy around player behavior. You'll be a thought partner to senior leaders and a force multiplier across product, design, and marketing. You'll partner closely with these teams to explore new game concepts, deepen engagement, and bring more fans into the PrizePicks ecosystem. You'll set the bar for research at PrizePicks, bringing clarity to ambiguous spaces, mentoring others, and helping us move fast without compromising on depth or rigor. You'll be embedded in interdisciplinary teams while also playing a leadership role on the centralized Insights team; raising the bar for what research can do and generating work that has visibility across the entire business. This is a role for a researcher who's not just comfortable driving decisions, but lives for the moment their insight unlocks a new direction. If you're ready to shape the future of gaming through research that doesn't just inform-but drives-bold business decisions, this is your seat at the table. What you'll do: Own end-to-end, multi-modal insight workstreams that blend behavioral analytics with secondary and primary research to uncover growth and engagement opportunities in key strategic areas. Run advanced mixed-method studies, inclusive of large-scale surveys and IDIs to co-creation and ethnography to answer high-stakes, high-visibility product and portfolio questions. Turn research data into strategy, building player models, pricing frameworks, and revenue-weighted recommendations that steer roadmaps and capital allocation. Drive change with leadership, crafting crisp narratives that spotlight player needs and trigger decisive and confident action. Partner daily with Design, Product, and Marketing to test assumptions, refine mechanics, and optimize live operations for major, multi-year product initiatives as well as ad-hoc needs. Mentor researchers and cross-functional teams, elevating craft standards and scaling research infrastructure. Spot the next big bet, translating cultural and market shifts into future-facing product concepts. What you have: 10+ years of consumer/product research (4+ in-house gaming or mobile), owning high-impact, cross-functional projects. Mastery of mixed methods: behavioral data mining, regression & factor analysis, large-scale surveys, in-depth qual, and agile UX testing. Fluency in experimental research design and the ability to pivot methods to match pace and ambiguity. Proven influence at the exec level, turning complex findings into clear business decisions and shipped features. Deep grasp of game design, live-ops economics, and player psychology within sports or gaming ecosystems. Leadership chops: vendor management, mentoring, and driving alignment across multiple collaborators. Exceptional communication skills: You don't just present findings; you shift thinking and inspire action. Strong strategic thinking and storytelling ability, able to zoom out to the 10,000-ft view and connect the dots across data, behavior, and opportunity while understanding the tactical steps required to execute the strategy Confidence to challenge the status quo and advocate for the Player even when it's uncomfortable or contrarian. Bias for action, curiosity, and empathy - you move fast, ask power questions, and always advocate for the player. Where you'll live: While we prefer candidates based in Atlanta, we are open to qualified applicants from anywhere in the U.S. and are willing to consider remote candidates. #LI-Remote Working at PrizePicks: The typical salary range for this position is $160,000 to $210,000. At PrizePicks, we consider your role, level, and where you'll be working when determining our salary ranges. The compensation info you see on our job postings gives you an idea of the starting pay range for the position. Your actual pay within that range will depend on your specific work location, as well as your skills, experience, and education. Your recruiter will be happy to chat more about the specific pay range for your location and how we arrived at it during the hiring process. This application period will remain open for 30 days. We're committed to finding the best candidate, so this date may be adjusted, and any changes will be reflected in this posting. Date Posted: 7/7/2025 Benefits you'll receive: In addition to your great compensation package, full-time employees will be eligible for the following perks: Company-subsidized medical, dental, & vision plans 401(k) plan with company match Annual bonus Flexible PTO to encourage a healthy work/life balance (2 weeks STRONGLY encouraged!) Generous paid leave programs, including 16-week paid parental leave and disability benefits Workplace flexibility and modern work schedules focused on getting the job done, not hours clocked Company-wide in-person events and team outings Lifestyle enhancement program Company equipment provided (Windows & Mac options) Annual performance reviews with opportunities for growth and career development You must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time. PrizePicks is an Equal Opportunity Employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

Internal Job Description **Job Title:** Clinical Research Coordinator **Work Set-Up:** Working On-site **Schedule** : 20 hours per week. **Responsibilities:** + **Phlebotomy** is required, and pediatric experience is also needed. Additionally, community outreach will be part of the role. + Perform a variety of complex clinical procedures on subjects including but not limited to **ECG, sample collection including spirometry, and vital signs.** + Coordinate clinical research studies conducted by a supervising principal investigator. + Update and maintain skills, training, and knowledge of current best nursing practices and topics related to clinical research. + Safeguard the well-being of the subjects and ensure and maintain high standards: + Maintain a safe environment in accordance with Health and Safety policies. + Act as a volunteer advocate. + Address volunteer and visitor concerns proactively and take remedial action as required. + Assist staff, both registered and unregistered, in clinical coordinator practices and the delivery of care to the volunteer. + Report any deviation from normal practice to senior staff. **Support Study Conduct By:** + Reviewing the study protocol, case report form (CRF), other study documents, and electronic data capture systems. + Participating in project meetings with the project team as needed. + Performing clinical set-up and preparation for the study including labeling specimen collection tubes and containers, setting up equipment and documents. + Planning logistical activity for procedures as per protocol. + Generating volunteer instructions. + Identifying and obtaining required supplies and equipment. + Preparing and delivering study-specific training materials, documents, and records. + Troubleshooting study issues. + Participating in huddles to ensure daily tasks assigned to team members are executed to the expected standards. + Assisting with data quality checking and query resolution to ensure that data collected on study volunteers adhere to study protocol and ensuring quality control for content accuracy and completeness. + Recruiting and screening volunteers for inclusion in the study based on pre-determined criteria. + Orienting volunteers to the study and the site including the purpose of the study, procedures, and practical issues such as timelines for visits. + Responsible for the correct administration and custody of study drug according to site standard operating procedures. + Collecting, recording, and reporting clinical data and findings appropriately in case report forms (CRFs). Collaborating closely with the study investigator, informing on relevant adverse events and serious adverse events according to procedures outlined in the protocol. + Cooperating with the study monitor and reserving sufficient time for questions during monitoring. + Following ICH GCP guidelines with regards to all study and patient activities. **Qualifications:** + Equivalent education and experience - High School Diploma and 1 years' relevant work experience in clinical research + At least 1 year experience working in a clinical research setting preferred. + Applicable certifications and licenses as required by company, country, state, and/or other regulatory bodies. + Working knowledge of clinical trials. + Working knowledge of the principles of Good Clinical Practices (GCP). + In-depth knowledge of protocol and study-specific operating procedures, consent forms, and study schedules. + Skill in carrying out required clinical procedures. + Working knowledge of medical terminology. + Ability to pay close attention to detail. + Ability to establish and maintain effective working relationships with coworkers, managers, patients, physicians, and clients. _Please note, this position is not eligible for sponsorship._ \#LI-CES and #LI-DNP #LI-HCP #ONSITE IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at ********************** IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe The potential base pay range for this role is $35.00-$42.00 per hour. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide. To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us. EEO Minorities/Females/Protected Veterans/Disabled

Discover Your Career at Emory University Emory University is a leading research university that fosters excellence and attracts world-class talent to innovate today and prepare leaders for the future. We welcome candidates who can contribute to the excellence of our academic community. Description The Clinical Research Coordinator II handles administrative activities generally associated with the conduct of clinical trials. KEY RESPONSIBILITIES: * Manages research project databases, develops flow sheets and other study related documents, and completes source documents/case report forms. * Provides guidance to less experienced staff. * Interfaces with research participants, determines eligibility and consents study participants according to protocol. * Approves orders for supplies and equipment maintenance. * Assists in developing recruitment strategies and conducting screenings for study participants including interviews and questionnaires. * Supervises collection of study specimens and processing. * Establishes case packages for study procedures, monitors scheduling of procedures and charges, coordinates other services as needed. * Ensures compliance with research protocols, reviews case report forms and audits for accuracy with source documents, attends monitoring meetings with sponsors. * Prepares regulatory submissions. * With appropriate credentialing and training may perform phlebotomy or diagnostics. * Performs related approved responsibilities as required. MINIMUM QUALIFICATIONS: * High School Diploma or GED and five years of clinical research experience. * Or two years of college in a scientific, health related, or business administration program and three years clinical research experience. * Or a licensed as a practical nurse (LPN) and two years clinical research experience. * Or a Bachelor's degree in a scientific, health related, or business administration related program and one year of clinical research experience. * Or a Master's degree, MD or PhD in a scientific, health related or business administration program. This position is intended to support clinical research and all clinical training requirements must be tracked and monitored through Emory Healthcare under the credentialing category of Clinical Researcher. ADDITIONAL INFORMATION: The Research Coordinator will join the Sleep Epidemiology Research Group, led by Dr. Dayna Johnson, and will primarily support the ARISE study-a funded research study focused on sleep measurement and understanding the determinants and health consequences of sleep problems. The coordinator may also contribute to other related studies. This position involves direct participant interaction, data collection, and fieldwork. The ideal candidate will be highly organized, dependable, and comfortable working independently in a research setting. Key Responsibilities: * Recruit, screen, and schedule research participants. * Write protocols. * Conduct research visits in participant homes and at Emory University, including administering questionnaires and collecting physical data. * Complete data collection protocols, including: * Initializing and retrieving air, light, and noise monitoring devices * Providing instructions on the use of sleep monitors and ambulatory blood pressure monitors * Collecting, processing, and mailing saliva samples * Perform blood draws on participants (phlebotomy); formal training will be provided. * Collaborate with a team member to conduct evening and weekend field visits (typically 3-4 hours, twice per month). * Ensure protocol adherence and data quality; review and grade data under the guidance of Dr. Johnson or the project manager. Process participant incentives. * Coordinate and mail study results (sleep and cardiovasc their healthcare providers. * Assist with additional research-related tasks as needed. PREFERRED QUALIFICATIONS: * Master's degree in Public Health or a related field required. * Experience working with health disparity populations is strongly preferred. * Strong attention to detail and ability to follow research protocols. * Familiarity with IRB policies and research ethics. * Reliable transportation and willingness to travel to participant homes (mileage reimbursed). * Availability to work evenings and weekends (required). * Interest in sleep research and community-based health studies. * Willingness to be trained in and perform phlebotomy. 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 emp 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 providing reasonable accommodations to qualified individuals with disabilities upon request. To request this document in an alternate format or to request a reasonable accommodation, please contact the Department of Accessibility Services at ************ (V) | ************ (TDD). Please note that one week's advance notice is preferred.

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

The Research Coordinator is responsible for the comprehensive management and oversight of clinical study programs, ensuring their seamless operation and strict adherence to regulatory standards. Essential Duties and Responsibilities To effectively fulfill this role, the individual must competently perform each essential function, with or without reasonable accommodation. Regulatory Compliance: Ensure studies are conducted in accordance with FDA and OHRP regulations. Review regulatory requirements to implement appropriate methods, practices, and procedures for all research activities. Develop accurate source materials and ensure compliance by site staff. Ensure timely and precise data collection, documentation, entry, and reporting in both sponsor and OMRC databases. Ensure appropriate credentialing and training of the research team as required for all studies and protocols. Maintain regulatory documentation in compliance with sponsor, site requirements, and applicable regulations. Interface with research participants to determine eligibility and secure consent according to protocol. Communication and Collaboration: Communicate and collaborate with the research team, including internal and external parties, sponsors, monitors, PI, and study participants. Participate with the PI and study team to identify and prioritize the development of systems and infrastructure to maintain research quality and compliance. Quality Control and Audits: Ensure compliance with research protocols through ongoing quality control audits. Maintain investigational drug accountability. Distribute investigational drugs and provide patient instructions on administration, including daily temperature monitoring of all investigational products. Monitor and record temperatures of all study products. Administrative Responsibilities: Retrieve and respond to communications from the clinical study email inbox. Prepare and organize patient charts. Order supplies for the study department. Schedule appointments for all study participants. Assist providers with ECG procedures. Process and prepare samples for shipment. Dispose of lab and study supplies in accordance with OSHA guidelines. Ensure all study equipment is operational. Process orders for new studies. File documents as needed. Train on study systems. Attend study initiation visits and investigator meetings. Set up electronic devices for study subjects. Maintain regular and reliable attendance. Perform other duties as assigned. Maintain and confirm all necessary certifications for all study team members. Additional Information Public Facing Role: This position primarily serves external customers, including patients, centers of influence, vendors, and community leaders, as well as review committees. Knowledge, Skills, and Abilities Education: High school diploma or equivalent. Experience: 1-3 years of experience in clinical study operations, preferably in a coordinator role. Certified Clinical Research Coordinator or 3,000 hours of relevant experience. The ideal candidate will be detail-oriented, self-motivated, and capable of executing all duties compliantly. Technology Applications: Proficiency in Microsoft Office applications. Role-Specific Knowledge: Medical terminology HIPAA privacy laws Certifications: CPR Certification is preferred. Physical and Mental Demands Occasionally required to stand, walk, and sit for extended periods. Use hands to finger, handle, or feel objects, tools, or controls. Reach with hands and arms; climb stairs; balance, stoop, kneel, bend, crouch, or crawl. Communicate effectively through talking and hearing. Occasionally lift, push, pull, and/or move up to 20 pounds. Engage in repetitive motion of the upper body due to extended computer use. Specific vision abilities required include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus. Work Environment and Travel Requirements Work in a well-lit, ventilated, and climate-controlled office environment with routine office equipment; some equipment may have moving mechanical parts. Noise level in the work environment is typical for an office and/or medical clinic environment. The role may require occasional weekend and/or overnight travel for investigator meetings. NOTE: This job description may not include all of the duties assigned to the employee and may be updated and modified by the department supervisor, according to the operations at any given time.