Clinical research associate jobs in Auburn, AL

A Clinical Research Associate II (CRA-II) plays a key role in monitoring and ensuring the integrity of clinical studies that evaluate the safety, performance, and effectiveness of medical devices and related products. This position supports the clinical operations function by ensuring compliance with applicable regulatory requirements and study protocols. By safeguarding data quality and patient safety, the CRA-II enables the organization to bring innovative healthcare solutions to market efficiently and ethically. The role adds value by bridging scientific research with operational excellence, ensuring studies are executed on time and to the highest quality standards Responsibilities Key Accountabilities Conduct site qualification, initiation, monitoring, and close-out visits to ensure compliance with study protocols and regulatory requirements. Serve as the primary point of contact between the sponsor and investigator sites, fostering effective communication and issue resolution. Verify that investigator sites have adequate resources, qualified staff, and investigational products throughout the study lifecycle. Ensure adherence to Good Clinical Practice (GCP), company SOPs, and applicable regulatory guidelines for all assigned studies. Monitor data integrity by reviewing source documents, case report forms, and ensuring accurate and complete trial records. Identify, document, and communicate protocol deviations, non-compliance, and safety issues promptly. Assist in managing study timelines, budgets, and deliverables, escalating risks. Prepare and maintain essential clinical trial documentation, including protocols, agreements, study reports, and site communications. Assist with reagent inventory management - ordering, storage and dispostion of investigation products and study supplies Uses the English language effectively in both written and verbal communication to convey complex clinical concepts with clarity and precision. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions. Networking/Key relationships Work closely and collaboratively with members of clinical affairs (Clinical Project Leader, Senior CRA,CRA,Statistician) Interface regularly with crossfunctional teams (R&D,Regulatory) as well as other functions across the organization as needed Qualifications Minimum Knowledge & Experience required for the position: Bachelor's degree in life sciences or related field (Medical Technology, Biology.) Minimum of 3 years clinical research experience in coordinating or monitoring Medical Device (IVD) Trials or working with a CRO Strong understanding of GCP guidelines, International Conference on Harmonization (ICH) and regulatory requirements (FDA,IVDR) Excellent understanding of clinical trial design Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement. Skills & Capabilities: Demonstrates strong regulatory knowledge to maintain compliance across global studies. Executes effective site monitoring and management, ensuring adherence to study protocols and timely issue resolution. Maintains meticulous attention to detail in documentation, source data verification, and reporting to support high-quality outcomes. Communicates clearly and professionally with investigators, sponsors, and cross-functional teams to foster collaboration and alignment. Manages multiple projects and timelines efficiently, prioritizing tasks to meet study milestones and regulatory deadlines. Adapts quickly to change, responding to evolving protocols, site needs, and regulatory updates with flexibility and composure. Travel requirements: Will vary by project. Travel requirement could be approx. 20%

A Clinical Research Associate II (CRA-II) plays a key role in monitoring and ensuring the integrity of clinical studies that evaluate the safety, performance, and effectiveness of medical devices and related products. This position supports the clinical operations function by ensuring compliance with applicable regulatory requirements and study protocols. By safeguarding data quality and patient safety, the CRA-II enables the organization to bring innovative healthcare solutions to market efficiently and ethically. The role adds value by bridging scientific research with operational excellence, ensuring studies are executed on time and to the highest quality standards Responsibilities Key Accountabilities Conduct site qualification, initiation, monitoring, and close-out visits to ensure compliance with study protocols and regulatory requirements. Serve as the primary point of contact between the sponsor and investigator sites, fostering effective communication and issue resolution. Verify that investigator sites have adequate resources, qualified staff, and investigational products throughout the study lifecycle. Ensure adherence to Good Clinical Practice (GCP), company SOPs, and applicable regulatory guidelines for all assigned studies. Monitor data integrity by reviewing source documents, case report forms, and ensuring accurate and complete trial records. Identify, document, and communicate protocol deviations, non-compliance, and safety issues promptly. Assist in managing study timelines, budgets, and deliverables, escalating risks. Prepare and maintain essential clinical trial documentation, including protocols, agreements, study reports, and site communications. Assist with reagent inventory management - ordering, storage and dispostion of investigation products and study supplies Uses the English language effectively in both written and verbal communication to convey complex clinical concepts with clarity and precision. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions. Networking/Key relationships Work closely and collaboratively with members of clinical affairs (Clinical Project Leader, Senior CRA,CRA,Statistician) Interface regularly with crossfunctional teams (R&D,Regulatory) as well as other functions across the organization as needed Qualifications Minimum Knowledge & Experience required for the position: Bachelor's degree in life sciences or related field (Medical Technology, Biology.) Minimum of 3 years clinical research experience in coordinating or monitoring Medical Device (IVD) Trials or working with a CRO Strong understanding of GCP guidelines, International Conference on Harmonization (ICH) and regulatory requirements (FDA,IVDR) Excellent understanding of clinical trial design Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement. Skills & Capabilities: Demonstrates strong regulatory knowledge to maintain compliance across global studies. Executes effective site monitoring and management, ensuring adherence to study protocols and timely issue resolution. Maintains meticulous attention to detail in documentation, source data verification, and reporting to support high-quality outcomes. Communicates clearly and professionally with investigators, sponsors, and cross-functional teams to foster collaboration and alignment. Manages multiple projects and timelines efficiently, prioritizing tasks to meet study milestones and regulatory deadlines. Adapts quickly to change, responding to evolving protocols, site needs, and regulatory updates with flexibility and composure. Travel requirements: Will vary by project. Travel requirement could be approx. 20%

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 and 401K

Details Information Requisition Number S4591P Home Org Name Office of Research Compliance Division Name VP for Research and Economic Dev Position Title Research Compliance Administrator (Pooled Posting) Job Class Code HC80 Appointment Status Full-time Part-time FTE Limited Term No Limited Term Length Job Summary This is a pooled posting. This posting will remain open for an extended period of time and selected applicants will be contacted as future staffing needs arise. Auburn University's Office of the Sr. Vice President of Research and Economic Development is accepting applications for the position of Research Compliance Administrator. This position contributes to the daily activities of the Research Compliance Program(s) within the Office of Research Compliance (ORC), which includes the Animal Care and Use Program, the Human Research Protection Program, and the Biological Safety Program. This role ensures adherence to federal and state regulations, sponsor-specific requirements, and institutional policies, and its efforts are essential in maintaining the integrity and ethical standards of our research initiatives. Essential Functions * Organizes, coordinates, and executes daily activities of the research compliance programs to ensure adherence to regulatory, contractual, and policy requirements. * Reviews and assists with research protocols, guiding investigators, faculty, and staff through the protocol submission process to ensure compliance. * Provides subject-matter advice and oversight on non-compliance assessments, inquiries, investigations, audits, and inspections, including preparing necessary reports and follow-ups. * Develops, reviews, and revises compliance policies, procedures, and guidelines, enhancing institutional and departmental strategies. Establishes goals and objectives to identify successful program indicators. * Supports accreditation efforts by preparing and submitting annual/interim reports, coordinating re-accreditation materials, and ensuring compliance with accreditation standards. * Develops and implements educational programs to promote compliance and responsible conduct of research, including conducting training sessions, seminars, and workshops. * Remains current on regulatory requirements and organizational demands by attending workshops and seminars and disseminates relevant information as needed. * Performs additional duties as assigned to support the overall mission of the research compliance programs. Why Work at Auburn? * Life-Changing Impact: Our work changes lives through research, instruction, and outreach, making a lasting impact on our students, our communities, and the world. * Culture of Excellence: We are committed to leveraging our strengths, resources, collaboration, and innovation as a top employer in higher education. * We're Here for You: Auburn offers generous benefits, educational opportunities, and a culture of support and work/life balance. * Sweet Home Alabama: The Auburn/Opelika area offers southern charm, vibrant downtown scenes, top-ranked schools, and easy access to Atlanta, Birmingham, and the Gulf of Mexico beaches. * A Place for Everyone: Auburn is committed to fostering an environment where all faculty, staff, and students are welcomed, valued, respected, and engaged. Ready to lead and shape the future of higher education? Apply today! War Eagle! Minimum Qualifications Minimum Qualifications * Bachelor's degree- No specific discipline * 4 years of Contracts and grants, compliance, research, research administration, or other related experience. Minimum Skills, License, and Certifications Minimum Skills and Abilities Strong organizational, administrative, communication, and interpersonal skills. | Proficient computer skills with Internet and MS Office (Outlook, Word, Excel etc.). Minimum Technology Skills Minimum License and Certifications Desired Qualifications Desired Qualifications * Higher Education experience * Master's degree * Knowledge of federal regulations, state laws, and institutional policies and procedures related to animal care and use, human subject research protection, or biological hazards required based on program assignment. Posting Detail Information Salary Range $49,220-$83,680 Job Category Research Working Hours if Non-Traditional City position is located in: Auburn State position is located: AL List any hazardous conditions or physical demands required by this position Posting Date 07/16/2025 Closing Date Equal Opportunity Compliance Statement It is our policy to provide equal employment and education opportunities for all individuals without regard to race, color, national origin, religion, sex, sexual orientation, gender identity, gender expression, pregnancy, age, disability, protected veteran status, genetic information, or any other classification protected by applicable law. Please visit their website to learn more. Special Instructions to Applicants Quick Link for Internal Postings ******************************************* Documents Needed to Apply Required Documents * Resume * Cover Letter Optional Documents Supplemental Questions Required fields are indicated with an asterisk (*). * * Please tell us how you first heard about this opportunity. (Open Ended Question) * * Please select the answer that best describes your current employment relationship with Auburn University: * Current full-time Auburn or AUM employee within probationary period * Current full-time Auburn or AUM employee outside of probationary period * Current part-time Auburn or AUM employee * Not an Auburn or AUM employee * * Do you have a Bachelor's degree from an accredited institution? * Yes * No * * Do you have 4 years of contracts and grants, compliance, research, research administration, or other related experience? * Yes * No

About N-Power MedicineN-Power Medicine aims to establish a new paradigm in drug development by reinventing the ‘how' and transforming clinical trials through better integration with clinical practice, ensuring broader participation by physicians and patients. We are building an exceptional multi-disciplinary team with diverse expertise spanning healthcare, engineering, technology and regulatory, and with people who share our core value of Empowering Community through generosity, curiosity and humility. We are working with urgency to bring better therapies to patients faster. Position OverviewYou will be a part of the rapidly changing clinical oncology environment with the opportunity to impact the future of clinical research and improve patients' lives while growing professionally at a dynamic, fast-growing, start-up organization. As the Senior Digital Health Specialist, you will work at a clinical site in Tuscaloosa and/or Anniston, Alabama. This role would act as a site liaison between NPM staff and the network partner to address any issues or concerns in real time. The ideal candidate has extensive clinical oncology research experience or research experience in a healthcare setting. You are an expert in your understanding of clinical workflow, patient data systems and clinical research in an oncology setting. In collaboration with the Digital Health Specialist Manager, you will be vital to the successful implementation and operations with Network Partners and serve as point of contact for local N-Power Medicine staff. We are looking for individuals who are motivated and ambitious professionals who desire to positively influence and innovate upon the quality of care for patients diagnosed with cancer. Role Objectives and Responsibilities -Serve as the Company's trusted face to the clinical practice, providing clinical support while advancing research data collection.-Act as the point of contact for network partners and N-Power Medicine staff supporting the site to address queries and issues in a timely manner.-Participate directly in the implementation at the site and all aspects of a site start-up. -Support the hiring and onboarding of new N-Power Medicine staff including, new hire interviews, new hire training, onsite shadowing, etc.-Perform quality assurance activities as required, identify opportunities for retraining of Digital Health Staff.-Assist in developing training, work instructions and standard operating procedures, and other materials.-Manage queries regarding missing, aberrant, or potential outlier data for studies and projects - escalate to the healthcare provider and Digital Health staff as necessary for resolution.-Obtain informed consent for N-Power Medicine's clinical trials. -Assist and participate in the site clinical trial initiation and clinical trial(s) activities as assigned.-Ensure adherence to study protocols, data completeness and patient consent.-Lead patient recruitment strategies where appropriate as site liaison and network partner research department. -Foster collaborative relationships by effectively communicating with clinical site staff, internal stakeholders, and N-Power Medicine.-Attend, participate and take action in required meetings.-Build and maintain relationships at the clinical site, becoming part of the functional team of practitioners.-Ensure quality and integrity of the Kaleido Registry and clinical trials data, protocol compliance and confidentiality with N-Power Medicine's and site's policies, standard operating procedures (SOPs), and Good Clinical Practice (GCP).-Collect practice insights regarding Kaleido Registry workflows and maintain site performance metrics for internal and site reporting. -Provide proactive input and user experiences including software- escalate issues while offering solutions based upon your expert knowledge and experience. -Solicit feedback from users of new technology and contribute to implementation for clinical care and clinical trials. -Additional duties and responsibilities as required. Education, Experience, Behavioral Competencies, & Skills-5+ years of experience in oncology clinical research and/or oncology ambulatory care -Bachelor's degree, focused in health science or related field -Clinical supervisory or management experience preferred-Certified Clinical Research Coordinator, Associate or Professional (CCRC, CCRA or CCRP) preferred-Bilingual in Spanish (or other language) is preferred-In depth knowledge of clinical trials, study-specific operating procedures and patient consent forms-Strong desire to drive a paradigm change in clinical research conduct and improve patients' lives-Compassionate focused patient care-Coach and encourages other team members, contributing to a positive team environment-Self-starter, able to work independently, prioritize actively, seek input, and problem solve in complex and fast-evolving environments-Results oriented focused on delivering the goals set-forth-Attention to detail and strong organizational skills-Exceptional oral and written communication skills with a proven ability to lead through effective interpersonal interactions at all organizational levels-Critical thinking and proven problem-solving skills-Work hours are dependent on local Network Partner Clinics (typically M-F, 8-5pm)-Generous, curious and humble. Travel Requirements Daily travel between network partner sites may be required Pay InformationThe expected salary range for this position is $118,000 and $177,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. N-Power Medicine (NPM) offers equity at hire as well as a discretionary annual bonus which may be available based on Company performance. This position is eligible for company benefits. More About Us:We are a mission-driven, well-funded, rapidly growing company, eager to attract passionate professionals offering a highly attractive compensation package with a balanced and flexible work environment, competitive industry benefits as well as a 401K plan and other great company “perks.” We are an Equal Opportunity Employer and value diversity at our company. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. Covid-19 Policy - The Company is committed to providing and maintaining a safe workplace, and to safeguard the health and well-being of our employees, families, visitors, and the community. While vaccination remains one of the most important tools in advancing the health and safety of employees and promoting the efficiency of workplaces, we are now in a different phase of our response when these measures are no longer necessary. We currently do not have mandatory COVID-19 vaccination requirements for our employees and contractors, as the COVID-19 public health emergency has ended. However, there are certain N-Power Medicine employees and contractors who, based on their role, will be required to continue to follow our 2021 COVID-19 vaccination and other requirements as mandated by N-Power Medicine's partners they serve. We reserve the right to modify or amend our corporate policy at any time. Applicants must be currently authorized to work in the U.S. on a full-time basis. The Company will not sponsor applicants for work visas. Please note that state-specific background checks and screenings may be required for this role. Employment is contingent upon successfully passing all applicable screenings. Notice on fraudulent job offers: Only positions posted on ****************************************** site are legitimate. Please be mindful of recruitment fraud and job scams. We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

Scheduled Hours40The Cruchaga Lab, the NeuroGenomics and Informatics (NGI) Center, at WashU Medicine is recruiting a Clinical Research Study Assistant. We are seeking an experienced, self-motivated, self-driven person to work as a part of vibrant group in a fast-paced environment. This person will work in a collegial environment and join a multidisciplinary, diverse team in a well-established, well-funded research group, currently 30+ dynamic members, to explore the frontiers of neurodegenerative diseases. The NGI generates and analyzes Whole-Genome and high-throughput multi-dimensional omics data to study neurodegenerative diseases of the central nervous system. The goal of our research is to use genomic and multi-omic approaches to understand the biology neurodegenerative diseases. Under the direction of the Research Coordinators or PI, they will participate in moderately complex clinical research study activities. The Clinical Research Study Assistant will be responsible for multiple study's biospecimens including, but not limited to: blood, plasma, serum, and brain. They will perform a variety of duties including the oversight, organization and handling of these biospecimen samples for these multiple studies. They will ship samples and be responsible for an accurate manifest. They will be trained on the lab's database system to maintain the order of the samples. They will be responsible for assembling outgoing biospecimen kits for multiple studies. As needed, they will draw blood from research participants at our various clinics. They will work with the research coordinators for any other responsibilities that may be needed.Job Description Primary Duties & Responsibilities: Assists clinical research coordinators with management of clinical trials, by creating outgoing biospecimen kits for blood collection and recording data appropriately. Assists clinical research coordinators by receiving biospecimen samples from off-campus clinics, evaluating condition of samples, entering into the database, and reporting any issues to the coordinators. Assists with study sample tracking of home locations and shipping outgoing samples, as needed. Assists with general supply/equipment orders, material shipments to collaborators, maintenance and cleaning. Complies with established safety procedures and maintains required documentation on laboratory and specimen conditions. Working knowledge of computer programs and systems such as Excel and Word, as well as Filemaker Pro and/or Freezerworks. Assists current phlebotomists with blood drawing duties as needed. Assists with other duties as assigned by research team. 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: High school diploma or equivalent high school certification or combination of education and/or experience. Certifications/Professional Licenses: The list below may include all acceptable certifications, professional licenses and issuers. More than one credential, certification or professional license may be required depending on the role.Basic Life Support - American Heart Association, Basic Life Support - American Red Cross Work Experience: Administrative Or Research (2 Years) Skills: Not Applicable Driver's License: A driver's license is not required for this position.More About This Job For more information about the NeuroGenomics and Informatics Center, please visit our website at this link. Required Qualifications: Basic Life Support certification must be obtained within one month of hire date Basic Life Support certification (Online Basic Life Support certifications, those without a skills assessment component, are not sufficient to meet the Basic Life Support requirements). Preferred Qualifications Education: Associate degree Certifications/Professional Licenses: No additional certification/professional licenses unless stated elsewhere in the job posting. Work Experience: Customer Service (1 Year) Skills: Clinical Trials, Data Entry, Data Management, FileMaker Pro, Freezerworks (Software), Interpersonal Communication, Oral Communications, Ordering Supplies, Organizing, Safety Protocols, Sample Collection, Written CommunicationGradeC07-HSalary Range$19.21 - $28.85 / 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 Statement Personal Up to 22 days of vacation, 10 recognized holidays, and sick time. Competitive health insurance packages with priority appointments and lower copays/coinsurance. Take advantage of our free Metro transit U-Pass for eligible employees. WashU provides eligible employees with a defined contribution (403(b)) Retirement Savings Plan, which combines employee contributions and university contributions starting at 7%. Wellness Wellness challenges, annual health screenings, mental health resources, mindfulness programs and courses, employee assistance program (EAP), financial resources, access to dietitians, and more! Family We offer 4 weeks of caregiver leave to bond with your new child. Family care resources are also available for your continued childcare needs. Need adult care? We've got you covered. WashU covers the cost of tuition for you and your family, including dependent undergraduate-level college tuition up to 100% at WashU and 40% elsewhere after seven years with us. For policies, detailed benefits, and eligibility, please visit: ****************************** 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.

Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit ******************* How This Role Makes a Difference The Clinical Research Coordinator's primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. How You'll Make An Impact * Patient Coordination * Prioritize activities with specific regard to protocol timelines * Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials. * Maintain effective relationships with study participants and other care Access Research personnel. * Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management. * Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives. * Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate) * Prescreen study candidates * Obtain informed consent per Care Access Research SOP . * Complete visit procedures in accordance with protocol. * Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc. * Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion. * Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff. * Documentation * Record data legibly and enter in real time on paper or e-source documents * Accurately record study medication inventory, medication dispensation, and patient compliance. * Resolve data management queries and correct source data within sponsor provided timelines * Assist regulatory personnel with completion and filing of regulatory documents. * Assist in the creation and review of source documents. * Patient Recruitment * Assist with planning and creation of appropriate recruitment materials. * Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database. * Actively work with recruitment team in calling and recruiting subjects * Review and assess protocol (including amendments) for clarity, logistical feasibility * Ensure that all training and study requirements are met prior to trial conduct * Communicate clearly verbally and in writing * Attend Investigator meetings as required * Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) The Expertise Required * Ability to understand and follow institutional SOPs. * Excellent working knowledge of medical and research terminology * Excellent working knowledge of federal regulations, good clinical practices (GCP) * Ability to communicate and work effectively with a diverse team of professionals. * Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail * Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel. * Critical thinker and problem solver * Friendly, outgoing personality; maintain a positive attitude under pressure. * High level of self-motivation and energy * Excellent professional writing and communication skills * Ability to work independently in a fast-paced environment with minimal supervision. Certifications/Licenses, Education, and Experience: * Bachelor's Degree preferred, or equivalent combination of education, training and experience. * A minimum of 3 years prior Clinical Research Coordinator experience required * Prefer 1 year of experience as a Care Access Research Clinical Research Coordinator * Recent phlebotomy experience required * Licenses: * California based roles require National phlebotomy certification by an organization approved by the California Department of Public Health * Louisiana based roles require National phlebotomy certification by an organization approved by the Louisiana State Board of Medical Examiners * Washington based roles require National phlebotomy certification by an organization approved by the Washington State Department of Health * Nevada based roles require Laboratory Assistant certification by the Division of Public and Behavioral Health How We Work Together * Location: This is an on-site position with regional commute requirements, located in Dalton, Georgia * Travel: This role requires up to 10% travel requirements further explained below. Length of travel will depend upon study requirements, staff needs, and company initiatives. * Type of travel required: Regional (within 100 miles) * Physical demands associated with this position Include: The ability to use keyboards and other computer equipment. * Walking - 20% * Standing - 20% * Sitting - 20% * Lifting - 20% * Up to 25lbs * Over 25lbs Overhead * Driving - 20% The expected salary range for this role is $60,000 - $90,000 USD per year for full time team members. Benefits & Perks (US Full Time Employees) * Paid Time Off (PTO) and Company Paid Holidays * 100% Employer paid medical, dental, and vision insurance plan options * Health Savings Account and Flexible Spending Accounts * Bi-weekly HSA employer contribution * Company paid Short-Term Disability and Long-Term Disability * 401(k) Retirement Plan, with Company Match Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************

Research Coordinator Reports to: Chief Medical Officer We are seeking a detail-oriented, highly organized Research Coordinator with broad medical knowledge to support and manage clinical research activities. The ideal candidate will play a pivotal role in the planning, implementation, and coordination of research studies. This position requires strong analytical skills, a working knowledge of medical terminology, and the ability to interact effectively with investigators, sponsors, and study participants. Key Responsibilities: Coordinate and oversee day-to-day operations of multiple research studies in compliance with study protocols and regulatory requirements. Screen, recruit, and consent study participants; ensure proper documentation and eligibility assessment. Meet with site managers and providers to explain study eligibility Collect, process, and manage clinical and research data accurately and in a timely manner. Maintain and organize essential regulatory documents, case report forms, and study files. Monitor study progress, perform regular audits, and ensure data integrity and protocol compliance. Act as a liaison between investigators and research staff. Coordinate study visits, procedures, and follow-up schedules for participants. Assist with writing reports, abstracts, and manuscripts for publication or presentation. Train new staff or students in research procedures and compliance standards. Qualifications: Required: Travel to Cahaba's rural clinics in Perry, Wilcox counties is required Based in-person in Centreville Broad Clinical knowledge required Ability to manage multiple priorities in a fast-paced environment. Strong organizational, interpersonal, and communication skills. Demonstrates a high level of initiative and independence in daily tasks Cahaba Medical Care is an Equal Opportunity Employer.

Gastro Health is seeking a Full-Time Clinical Research Coordinator to join our team! Gastro Health is a great place to work and advance in your career. You'll find a collaborative team of coworkers and providers, as well as consistent hours. This role offers: A great work/life balance No weekends or evenings - Monday thru Friday Paid holidays and paid time off Rapidity growing team with opportunities for advancement Competitive compensation Benefits package Duties you will be responsible for: General Administrative Coordinates with Principal Investigator, local site, and Central Hub to help ensure that clinical research and related activities are performed in accordance with federal regulations and sponsoring agency policies and procedures. Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training. Assists Principal Investigator to assure that all key personnel or persons ‘engaged' in the research project have met training requirements in accordance with federal regulations and university and sponsoring agency policies and procedures. Cooperates with compliance and monitoring efforts related to sponsored program administration and respond to any audit findings and implement approved recommendations. Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by FDA and sponsors. Protocol Preparation & Review Attends investigator meetings as required or requested by the PI. Collaborates with the Regulatory Specialist to prepare IRB and any other regulatory submission documents as required by the protocol. Prepares other study materials as requested necessary. These study materials include, but are not limited to, the informed consent document, source documents, enrollment logs, and drug/device accountability logs. Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials. Conduct of Research Reviews and comprehends the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections. Assists PI in communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log. Develops and implement recruitment strategies in accordance with HRPO (IRB) requirements and approvals. Conducts or participates in the informed consent process and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed. Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant's eligibility or exclusion. Registers each participant in CTMS to ensure billing of study procedures to the appropriate funding source. Coordinates participant tests and procedures. Collects data as required by the protocol. Assures timely completion of Source Documents. Maintains study timelines. Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol and/or Gastro Health Research Policy on Investigational Drug/Device Accountability. Completes study documentation and maintains study files in accordance with sponsor requirements and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms. Retains all study records in accordance with sponsor requirements and Gastro Health Research policies and procedures. Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study. Works with the PI to manage the day to day activities of the study including problem solving, communication and protocol management. Project Closeout Assists the Principal Investigator and Regulatory Specialist in submission of accurate and timely closeout documents to applicable federal agencies, and the sponsoring agency in accordance with federal regulations and sponsoring agency policies and procedures. Arranges secure storage of study documents that will be maintained according to Gastro Health Research policy or for the contracted length of time, whichever is longer. Minimum Requirements Clinical research experience preferred Previous phlebotomy skills High School Diploma Interested in learning more? Click here to learn more about the location. Gastro Health is the one of the largest gastroenterology multi-specialty groups in the United States, with over 130+ locations throughout the country. Our team is composed of the finest gastroenterologists, pediatric gastroenterologists, colorectal surgeons, and allied health professionals. We are always looking for individuals that share our mission to provide outstanding medical care and an exceptional healthcare experience. We offer a comprehensive benefits package to our eligible employees. Gastro Health is proud to be an Equal Opportunity Employer. We do not discriminate based on race, color, gender, disability, protected veteran, military status, religion, age, creed, national origin, gender identity, sexual orientation, marital status, genetic information, or any other basis prohibited by local, state, or federal law. We thank you for your interest in joining our growing Gastro Health team!

Clinical Research Coordinator (LOCATED in Atlanta, GA) MUST be able to relocate on your own to the Atlanta, GA area (no relocation offered) Manage and coordinate oncology clinical research trials, including patient recruitment, protocol development, and data management. Oversee oncology trials and research projects Develop research protocols and grant proposals Perform patient evaluations and administer medications Train and supervise staff Ensure compliance with regulations through audits Manage financial accounts and authorize purchases Develop strategies for participant recruitment and retention Interface with study sponsors and resolve queries Monitor IRB submissions and respond to requests Qualifications MUST be able to relocate on your own to the Atlanta, GA area (no relocation offered) MUST have Clinical Research Coordinator (CRC) experience 3+ years of solid CRC experience in oncology or interventional drug trials in other therapeutic areas Two years of college in a scientific, health related, or business administration program AND 3 years of clinical research experience OR High School Diploma or GED AND3+ years of clinical research experience Pay and Benefits The pay range for this position is $28.00 - $30.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: * Medical, dental & vision * Critical Illness, Accident, and Hospital * 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available * Life Insurance (Voluntary Life & AD&D for the employee and dependents) * Short and long-term disability * Health Spending Account (HSA) * Transportation benefits * Employee Assistance Program * Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Birmingham,AL. Application Deadline This position is anticipated to close on May 2, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

: Headquartered in Birmingham, No Resistance is a clinical trial site management organization that performs clinical trials in urgent care centers throughout the north and southeast. We focus on sample collection and testing trials for lab device manufacturers with the purpose of collecting data to support the device's 510(k) or emergency use approval by the FDA. Notably, the trials we have participated in have directly led to the FDA EUA approval of three separate COVID-19 PCR testing platforms. No clinical trial experience is required. No Resistance will train the right candidate(s). Hours are Monday-Friday 8:30 am to 5:00 pm with no weekend requirements. Job Description: No Resistance is seeking motivated individuals to join our team! In this role, you'll play a pivotal part in the implementation and execution of clinical research projects, ensuring the successful attainment of quality, safety, regulatory, and financial objectives. Job Duties: Maintaining regulatory binders, inventory of study-specific and clinical supplies. Recruiting, and enrolling study subjects. Obtaining informed consent. Collecting nasal swab samples. Testing samples on investigational laboratory PCR analyzers. Data collection and entry. Query resolution. Assuring protocol compliance and efficient workflow including organizing clinical work areas, tracking and ordering study supplies and shipping materials, checking and replacing expired items, etc. Key Success Factors: Ability to work independently. Desire to work in a clinical environment with direct patient contact. Genuine interest in research. Timely in all communications. Superior attention to detail. While not a requirement, senior pre-medical students who hope to gain experience in clinical research or recent graduates who have a "gap" year before they start medical school are encouraged to apply. This position offers an exceptional opportunity to earn a competitive income while gaining invaluable experience highly regarded by medical school admission committees. Job Type: Full-time Pay: $25.00 per hour Expected hours: 40 per week Benefits: 401(k) Dental Insurance Health Insurance Paid time off Vision Insurance Schedule: Monday to Friday Work Location: In person You must be local to the area!

M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance. Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data. Due to our continued growth, we are hiring for a contract Clinical Research Coordinator at Wake Research, an M3 company. This is an on-site position. A Clinical Research Coordinator (contract/PRN) supports site-based trial execution by ensuring compliance with ICH/GCP, FDA regulations, sponsor requirements, and site SOPs. Responsibilities include coordinating with the PI and site team, managing study documentation, conducting informed consent, performing delegated procedures (e.g., vitals, EKGs, phlebotomy), and supporting participant visits and data entry. Working hours and responsibilites can vary depending on the associated trial. Essential services to be performed: Completes all site course requirements, including but not limited to, GCP, IATA, OSHA, site SOP review, and study related courses. Cooperates with site management and monitoring efforts to ensure protocol adherence. Reports instances of non-compliance, external inspections/audits immediately to site management. Coordinates with site management/PI to help ensure that clinical research protocol and related activities are performed in accordance with ICH/GCP, federal regulations, Research site SOPs and sponsoring agency policies and procedures. Reviews and adheres to assigned protocol, e.g., study procedures, timelines, and inclusion/ exclusion criteria. Establishes and maintains study files, including but not limited to regulatory binders, source documents and other materials. Assists with regulatory duties as they relate to coordination of clinical trials, to include, but not limited to: Providing appropriate study training tools for study team members with appropriate documentation, maintenance and completion of Delegation of Authority Log, sponsor and vendor communication documents, IP/device documentation, etc. In accordance with site's informed consent SOP, conducts and participates in the informed consent process with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms. Involves investigator with informed consent process as necessary Assures that amended consent forms are appropriately implemented and signed. Performs study-related procedures that have been delegated by PI according to study protocol (i.e. vital signs, EKG, phlebotomy, pulmonary function testing, urine pregnancy and drug testing, processing blood, or any other procedures required per protocol or ordered by study investigator) and documents appropriately on source documents. Obtains/reviews participant's medical history, concomitant medication history and inclusion/exclusion criteria review. Assists with timely completion of case report forms, if appropriately delegated/trained. Maintains adequate inventory of all study supplies. When handling investigational drugs/devices, follows the protocol for Investigational Drug/Device Accountability. Assists fellow co-workers with studies as time and ability permits. Qualifications Knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs. Successful completion of the GCP certification. Phlebotomy and EKG experience. +2 years of CRC experience is preferred. Additional Information About M3: M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we've seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems. Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements. Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA. Benefits: A career opportunity with M3 Wake Research offers competitive wages, and benefits such as: 401(k), 401(k) matching Dental insurance Disability insurance Employee assistance program Flexible spending account Health insurance Life insurance Paid time off Vision insurance *M3 reserves the right to change this job description to meet the business needs of the organization #LI-Onsite #LI-LB1

M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance. Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data. Due to our continued growth, we are hiring for a contract Clinical Research Coordinator at Wake Research, an M3 company. This is an on-site position. A Clinical Research Coordinator (contract/PRN) supports site-based trial execution by ensuring compliance with ICH/GCP, FDA regulations, sponsor requirements, and site SOPs. Responsibilities include coordinating with the PI and site team, managing study documentation, conducting informed consent, performing delegated procedures (e.g., vitals, EKGs, phlebotomy), and supporting participant visits and data entry. Working hours and responsibilites can vary depending on the associated trial. Essential services to be performed: Completes all site course requirements, including but not limited to, GCP, IATA, OSHA, site SOP review, and study related courses. Cooperates with site management and monitoring efforts to ensure protocol adherence. Reports instances of non-compliance, external inspections/audits immediately to site management. Coordinates with site management/PI to help ensure that clinical research protocol and related activities are performed in accordance with ICH/GCP, federal regulations, Research site SOPs and sponsoring agency policies and procedures. Reviews and adheres to assigned protocol, e.g., study procedures, timelines, and inclusion/ exclusion criteria. Establishes and maintains study files, including but not limited to regulatory binders, source documents and other materials. Assists with regulatory duties as they relate to coordination of clinical trials, to include, but not limited to: Providing appropriate study training tools for study team members with appropriate documentation, maintenance and completion of Delegation of Authority Log, sponsor and vendor communication documents, IP/device documentation, etc. In accordance with site's informed consent SOP, conducts and participates in the informed consent process with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms. Involves investigator with informed consent process as necessary Assures that amended consent forms are appropriately implemented and signed. Performs study-related procedures that have been delegated by PI according to study protocol (i.e. vital signs, EKG, phlebotomy, pulmonary function testing, urine pregnancy and drug testing, processing blood, or any other procedures required per protocol or ordered by study investigator) and documents appropriately on source documents. Obtains/reviews participant's medical history, concomitant medication history and inclusion/exclusion criteria review. Assists with timely completion of case report forms, if appropriately delegated/trained. Maintains adequate inventory of all study supplies. When handling investigational drugs/devices, follows the protocol for Investigational Drug/Device Accountability. Assists fellow co-workers with studies as time and ability permits. Qualifications Knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs. Successful completion of the GCP certification. Phlebotomy and EKG experience. +2 years of CRC experience is preferred. Additional Information About M3: M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we've seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems. Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements. Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA. Benefits: A career opportunity with M3 Wake Research offers competitive wages, and benefits such as: 401(k), 401(k) matching Dental insurance Disability insurance Employee assistance program Flexible spending account Health insurance Life insurance Paid time off Vision insurance *M3 reserves the right to change this job description to meet the business needs of the organization #LI-Onsite #LI-LB1

M3 Wake Research, an M3USA Company, is an integrated network of premier investigational sites meeting the clinical research needs of global biopharmaceutical, biotechnology, medical device, pharmaceutical and clinical research organizations (CROs). With close to 30 owned and managed research sites across the country, M3 Wake Research is one of the largest independent, multi-site clinical research companies in the US. M3 Wake Research continues to grow through acquisitions and uncompromising commitment to careful planning and execution in accordance with regulatory compliance. Conducting studies since 1984, M3 Wake Research owns a proprietary patient database of potential clinical trial participants across the US. As of today, our board-certified physicians have completed more than 7,000+ successful clinical trials, while consistently exceeding sponsor expectations for integrity, timeliness, subject enrollment, human protection, and expeditious delivery of accurate evaluable data. Due to our continued growth, we are hiring for a contract Clinical Research Coordinator at Wake Research, an M3 company. This is an on-site position. A Clinical Research Coordinator (contract/PRN) supports site-based trial execution by ensuring compliance with ICH/GCP, FDA regulations, sponsor requirements, and site SOPs. Responsibilities include coordinating with the PI and site team, managing study documentation, conducting informed consent, performing delegated procedures (e.g., vitals, EKGs, phlebotomy), and supporting participant visits and data entry. Working hours and responsibilites can vary depending on the associated trial. Essential services to be performed: * Completes all site course requirements, including but not limited to, GCP, IATA, OSHA, site SOP review, and study related courses. * Cooperates with site management and monitoring efforts to ensure protocol adherence. Reports instances of non-compliance, external inspections/audits immediately to site management. * Coordinates with site management/PI to help ensure that clinical research protocol and related activities are performed in accordance with ICH/GCP, federal regulations, Research site SOPs and sponsoring agency policies and procedures. * Reviews and adheres to assigned protocol, e.g., study procedures, timelines, and inclusion/ exclusion criteria. * Establishes and maintains study files, including but not limited to regulatory binders, source documents and other materials. * Assists with regulatory duties as they relate to coordination of clinical trials, to include, but not limited to: Providing appropriate study training tools for study team members with appropriate documentation, maintenance and completion of Delegation of Authority Log, sponsor and vendor communication documents, IP/device documentation, etc. * In accordance with site's informed consent SOP, conducts and participates in the informed consent process with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms. Involves investigator with informed consent process as necessary Assures that amended consent forms are appropriately implemented and signed. * Performs study-related procedures that have been delegated by PI according to study protocol (i.e. vital signs, EKG, phlebotomy, pulmonary function testing, urine pregnancy and drug testing, processing blood, or any other procedures required per protocol or ordered by study investigator) and documents appropriately on source documents. * Obtains/reviews participant's medical history, concomitant medication history and inclusion/exclusion criteria review. * Assists with timely completion of case report forms, if appropriately delegated/trained. * Maintains adequate inventory of all study supplies. When handling investigational drugs/devices, follows the protocol for Investigational Drug/Device Accountability. * Assists fellow co-workers with studies as time and ability permits. Qualifications * Knowledge of FDA regulations, ICH-Good Clinical Practices (GCP) and ISOs. * Successful completion of the GCP certification. * Phlebotomy and EKG experience. * +2 years of CRC experience is preferred. Additional Information About M3: M3 USA is at the forefront of healthcare innovation, offering digital solutions across healthcare, life sciences, pharmaceuticals, and more. Since our inception in 2000, we've seen remarkable growth, fueled by our mission to utilize the internet for a healthier world and more efficient healthcare systems. Our success is anchored in our trusted digital platforms that engage physician communities globally, facilitating impactful medical education, precise job placement, and insightful market research. M3 USA prides itself on a dynamic and innovative work environment where every team member contributes to global health advancements. Joining M3 USA means being part of a dedicated team striving to make a significant difference in healthcare. We provide a unique opportunity for you to be at the cutting edge of healthcare innovation, shaping the future in a meaningful career. Embrace the chance to drive change with M3 USA. Benefits: A career opportunity with M3 Wake Research offers competitive wages, and benefits such as: * 401(k), 401(k) matching * Dental insurance * Disability insurance * Employee assistance program * Flexible spending account * Health insurance * Life insurance * Paid time off * Vision insurance * M3 reserves the right to change this job description to meet the business needs of the organization #LI-Onsite #LI-LB1

Our clinical research company is looking to hire a qualified candidate for the full-time position of Clinical Research Coordinator II. The ideal candidate will possess 3+ years of clinical research coordination experience, and have a strong desire to work directly with patients. Who We Are ObjectiveHealth is a clinical research company that uses proprietary technology to: * Increase patient access to research trials within our communities, * Provide physicians with enhanced care options for current patients, and * Deliver superior clinical research enrollment metrics to Pharma sponsors All with the goal of Improving Patient Outcomes at the Point of Care. We want you to join us in doing just that. Who You Are * A lover of patient interaction and skilled at providing patient care * A team player with a bias for action and an attitude that takes personal responsibility * Skilled in all aspects required for conducting an IRB approved clinical trial protocol: identification, screening, randomization, and enrollment of patients, conducting clinic visits, etc. * Skilled at performing and assisting with direct patient care activities: consenting patients, physical assessments, blood draws, medication administration, ECG, etc. * Possess an acute attention to detail for clean data entry, regulatory compliance, productive site visits, efficient study set-up and maintenance, and strict protocol adherence * An expert communicator with the goal of fostering relationships between the research team, PIs, Sponsors, Monitors, and others * A strong advocate for Company values, mission, and initiatives * Not easily distracted: You have the ability to stay focused while running different protocols, resolving and submitting IRB responses and audit findings, tracking AE and SAE events, and maintaining eSource material for assigned studies * Energized by the idea of playing a role in the future of new therapy development in the areas of Gastroenterology, Urology, Dermatology, and/or Oncology What Success Looks Like for This Role * Taking ownership of assigned studies and patients * Communicating promptly and effectively with leadership and coworkers when you have a question or see something that needs correction * Showing up on time, every time * Ensuring strict compliance to the laws, regulations, and requirements of all applicable governing bodies * Learning and using the technologies we provide to increase efficiency in your day-to-day activities * Embodying our core values of Compassion, Integrity, Collaboration, Innovation, Velocity, and Dedication What We Offer Competitive compensation, 401(k) with Company match, a clear career pathway for advancement within the Company, Short- and Long-Term Disability, Health Savings and Flexible Spending Accounts, Health, Dental and Vision insurance Plans, Generous PTO, Adoption Assistance, Paid Holidays, and a wide selection of other voluntary benefits. Requirements This job requires legal authorization to work in the US. We are not currently accepting work visas. ObjectiveHealth is an EEO Employer and an E-Verify participant.

Schedule: Shift May Vary The Clinical Response Coordinator (CRC) is an integral role within the organ donation process at Legacy of Hope (LoH). The CRC will be responsible for performing on-site visits to donor hospitals within their coverage area. They, in conjunction with the administrator on call, will determine initial suitability of potential organ and tissue donors. This will be done by communicating and interacting with hospital and physician staff in collaborative and professional ways. The CRC will evaluate specific case dynamics and determine which information is clinically significant and should be communicated to the hospital teams and Legacy of Hope staff who are off-site. They will also assess available clinical data found in medical record or bedside assessment to determine initial medical suitability for donation. The CRC will encourage implementation of catastrophic brain injury guidelines as appropriate based upon their clinical judgement. In situations when needed, the CRC will also be expected to identify and support the needs of the potential donor family and offer them information about donation opportunities (organ and tissue). After authorization is obtained, the CRC will coordinate the transport of blood for serological testing and tissue typing to the appropriate laboratories. They will also initiate individualized case donor management, after brain death is declared, to ensure donor stability while coordinating arrival of procurement transplant coordinator (PTC) or critical care transport (CCT) to donor's location. Donor management could include ordering and interpreting labs, ensuring appropriate fluid maintenance, and implementing vasoactive and hemodynamic supportive medications as required by the donor's status. They will obtain required information from the hospital medical record to be transferred with patients from the donor hospital location to the donor recovery center as appropriate. The Clinical Response Coordinator will also be able to perform specific partner services activities as directed by their supervisor. Those responsibilities may include but not be limited to: rounding through units to build relationships, presenting information/outcomes to hospital staff members in both formal and informal settings, and participating in education about donor suitability, brain death testing, specific donation processes, etc. This position requires 12-15 days of 24-hour call per month. Position Requirements: EDUCATION AND EXPERIENCE: Required: Associate's degree in a medical or related field and one (1) year of experience in nursing, as an EMT, Paramedic, Respiratory Therapist, Social Worker, or experience in the donation industry required. Work experience may substitute for education requirement. Preferred: Hospital experience, crisis intervention, and/or grief support. . LICENSE, CERTIFICATION AND/OR REGISTRATION: Required: Valid driver's license and ability to be insured. Preferred: Currently licensed/certified as a Nurse, Emergency Medical Technician (EMT), Paramedic, Respiratory Therapist, Social Worker, or related. TRAITS & SKILLS: Must be self-directed / self-motivated; must have good communication and interpersonal skills. Must be able to: (1) perform a variety of duties often changing from one task to another of a different nature without loss of efficiency or composure; (2) accept responsibility for the direction, control and planning of an one's own work; (3) work independently and on a flexible schedule; (4) recognize the rights and responsibilities of patient confidentiality; (5) convey empathy and compassion to those experiencing pain, physical or emotional distress and/or grief; (6) relate to others in a manner which creates a sense of teamwork and cooperation; (7) communicate effectively with people from every socioeconomic, cultural and educational background; (8) exhibit flexibility and cope effectively in an ever-changing, fast-paced healthcare environment; (9) perform effectively when confronted with emergency, critical, unusual or dangerous situations; (10) demonstrate the quality work ethic of doing the right thing the right way; and (11) maintain a customer focus and strive to satisfy the customer's perceived needs. UA Health Services Foundation (UAHSF) is proud to be an AA/EOE/M/F/Vet/Disabled employer.

At ScionHealth, we empower our caregivers to do what they do best. We value every voice by caring deeply for every patient and each other. We show courage by running toward the challenge and we lean into new ideas by embracing curiosity and question asking. Together, we create our culture by living our values in our day-to-day interactions with our patients and teammates. Job Summary The RN Coordinator/Specialist - Emergency Department is responsible for coordinating patient care, supporting clinical operations, and ensuring compliance with regulatory and quality standards within the Emergency Department. This role collaborates with nursing staff, physicians, and ancillary departments to provide effective, timely, and high-quality emergency care. The RN Coordinator/Specialist serves as a clinical resource, facilitates care transitions, and contributes to performance improvement initiatives. Essential Functions * Coordinate emergency patient care delivery to ensure timely evaluation, treatment, and safe transition of care. * Collaborate with interdisciplinary teams to assess, plan, implement, and evaluate patient care interventions. * Serve as a clinical resource and mentor to emergency department nursing and support staff. * Conduct daily rounding to assess care quality, patient needs, and support nursing workflows. * Assist with patient and family education, discharge planning, and community resource coordination. * Participate in quality and safety initiatives, including audits, case reviews, and process improvements. * Support regulatory readiness and compliance with EMTALA, Joint Commission, CMS, and state-specific standards. * Communicate effectively with physicians, EMS, ancillary departments, and hospital leadership. * Ensure accurate and timely documentation in the electronic medical record (EMR). Knowledge/Skills/Abilities/Expectations * Strong clinical judgment and emergency care competencies. * Ability to work in a high-acuity, fast-paced environment. * Skilled in conflict resolution, triage prioritization, and interdisciplinary collaboration. * Proficient in EMR systems and Microsoft Office applications. * Commitment to patient-centered care and continuous quality improvement. Qualifications Education * Associate Degree in Nursing (ADN) required. * Bachelor of Science in Nursing (BSN) or Master's in Nursing, Healthcare Management, or Administration preferred. Licenses/Certifications * Current RN licensure in the state of practice or compact state required. * Basic Life Support (BLS) certification required within time frame required by facility policy. * Advanced Cardiovascular Life Support (ACLS) and Pediatric Advanced. * Life Support (PALS) preferred or as required by facility policy. Experience * Minimum of 2 years of acute care nursing experience in an emergency department required. * Experience in care coordination, quality improvement, or clinical leadership preferred.

About Us: Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. Hourly Rate: 19.00 -$21.00/hr (Depending on education, experience, and skillset) Schedule: 08:00 am - 4:30 PM - Monday - Friday Job Summary: Provides direct support to Clinical Research Coordinators in the completion of protocol-specific study goals while observing strict adherence to ICH, GCP, protocol, and site guidelines and policies. Essential Responsibilities and Duties: Creating and maintaining patient charts for all assigned studies. Preparing participant visits based on CRCs schedule, ensuring all source documents, assessments, lab kits and other visit materials are available and accurate. Filing of lab results, EKG results, and other communication in designated patient charts. Maintaining inventory of study specific supplies including lab kits, assessments and participant facing materials. Timely completion of data entry and query resolution for all CRFs, based on sponsor specific timelines and deadlines established in contract or other communication. Assisting Coordinators in assessments, including but not limited to, blood pressure, urine collection. Communicating with study participants, caregivers, third party vendors and laboratories as needed. Assisting Coordinators with scheduling, copying, faxing, and other clerical tasks. Aiding Coordinators in the facilitation of study monitoring visits. Completion of daily responsibilities delegated by CRC as they pertain to the study and/or participants. Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive. Education/Experience/Skills: Interest in and knowledge of specific study indications. Excellent computer skills and advanced knowledge of electronic equipment (i.e., e-mail, computer, fax machine, copier, etc.). Skilled in organization and record maintenance. Phlebotomy experience preferred. Experience working with patients. Skilled in developing and maintaining effective working relationships with supervisors and co- workers. Strong personal initiative and attention to detail. Ability to react calmly and effectively in emergency situations. Ability to interpret, adapt and apply guidelines and procedures. Ability to clearly communicate both orally and verbally in both English and Spanish. Working Conditions Indoor, Office environment. Essential physical requirements include sitting, typing, standing, and walking. Lightly active position, occasional lifting of up to 20 pounds. Reporting to work, as scheduled, is essential. CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.

Department: Operations Employment Type: Full Time Reporting To: Adrienne Hilliard Description 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 Research Assistant (RA) provides support to the Clinical Research Coordinators (CRCs), Site Manager, Principal and Sub Investigators, and other site staff in compliance with GCP, ICH, HIPAA, FDA Regulations and SOPs. The RA performs clinical, lab, and administrative tasks as needed for the successful operation of the clinical research site. Key Responsibilities Essential Job Duties: In collaboration with other members of the clinical research site team, assists with the execution of assigned studies, and support functions as needed. Responsibilities may include but are not limited to: * Under the direction of the Site Manager/Director and the Principal/Sub Investigators, assists the CRCs and other site staff in their responsibilities by conducting the following according to study protocol: * Assists with the basic screening of patients for study enrollment; * Assists with patient follow-up visits; * Documents in source clinic charts; * Enters data in EDC and answers queries; * Obtains vital signs and ECGs; * May perform blood draws; * Perform basic lab procedures per protocol, such as: blood specimen collection, centrifuge operation, storing and shipping of lab specimens, accountability of specimens and notification of courier for specimen pick-up; * Request and track medical record requests; * Enters data in EDC and answers queries; * Assists the CRC with updating and maintaining logs and filing in charts, and with chart filing; and * Schedules subjects for study visits, conducts appointment reminders, and reschedules visits if needed; * Ensures study related reports and patient results are reviewed by the Research Coordinator and/or investigator in a timely manner. * Assists the CRC and/or Manager with study recruitment, patient enrollment, and tracking as needed; * Maintains strict confidentiality of patients, employees, customers and company information at all times and adheres to HIPAA Guidelines; and * Perform all other duties as requested or assigned. Skills, Knowledge and Expertise Minimum Qualifications: A High School diploma and 1 year of administrative / clinical experience is required. 1 year or more years of clinical research or clinical experience is 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 skills and attention to detail. * 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.