Clinical Research Coordinator jobs at Medix

**Seeking a Clinical Research Coordinator in Greenville, NC** Job Title: Research Coordinator Position Type : Full-Time Reports To: Clinical Trials Supervisor Pay: $60,000-75,000 (Depending on experience) Position Summary The research coordinator is primarily responsible for coordinating research patient visits according to both the International Council for Harmonisation Good Clinical Practice (ICH-GCP) guidelines and the Institutional Review Board (IRB)-approved study protocol and/or manual of procedures. Day-to-day activities may include all or some of the essential functions listed below, depending upon individual experience / knowledge and the needs of the organization which are subject to change from time to time. Duties: • Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study • Administer sponsor required questionnaires (i.e. Visual Function Questionnaire [VFQ]) • Works with team member responsible for ordering study supplies (lab kits, shippers, etc.) to ensure adequate inventory is on hand • Ensures study staff is properly trained on study-related information (i.e. protocol, Informed Consent Form [ICF], manuals, etc.) and that the training is documented • Creates, manages, and maintains source documents for each trial • Attends teleconferences and Investigator Meetings as requested by research director • Reviews and comprehends all study protocols, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections • Works with other members of the study team and clinical team to recruit eligible candidates to meet enrollment goals

Milwaukee, WI (Preferred; US-based candidates) Hybrid Role (Onsite preferred; remote/hybrid flexibility after onboarding) Duration: ASAP through June 30, 2026 (Extension possible) ABOUT THE ROLE Medasource is seeking two Research Project Coordinators to support clinical and operational research within a leading global medical device and healthcare technology organization. Based in Milwaukee, WI, with remote or hybrid options available after initial training, these roles are responsible for driving study execution, maintaining high-quality documentation, and coordinating research operations across patient-monitoring, acute-care, and maternal-infant-care technology portfolios. You will support multiple ongoing clinical studies and evidence-generation initiatives, focusing on meeting coordination, study documentation, QMS support, site engagement, and overall research operations. This is an excellent opportunity for experienced research coordinators or project specialists looking to advance their impact in a regulated med-tech environment, with flexibility for hybrid or remote work following successful onboarding. WHAT YOU'LL DO Participate in recurring study meetings; capture detailed minutes, decisions, and action items Track follow-up activities and ensure timely closure with cross-functional teams Help maintain project timelines, trackers, dashboards, and study artifacts Manage study documents, deliverables, trackers, and vendor invoices Support Quality Management System (QMS) documentation practices and version control Maintain organized electronic study files and ensure audit-ready documentation Engage with research sites to support timelines, data requests, and study logistics Track study milestones, enrollment, and operational metrics Coordinate with internal partners across Clinical, Quality, Regulatory, and Product teams Assist with protocol updates, controlled document management, and evidence-generation tasks Support research operations and process initiatives across the team as needed WHAT YOU BRING 3+ years experience in clinical research, medical device research, med-tech, or regulated healthcare settings Working knowledge of Good Clinical Practice (GCP) and Quality Management System (QMS) documentation (ISO 13485 or similar) Strong skills in meeting facilitation, action tracking, and structured communication Excellent written and verbal communication abilities Proficiency in MS Teams, SharePoint/OneDrive, and Excel-based trackers Ability to work independently after onboarding Experience supporting multi-site clinical studies (preferred) Familiarity with protocol management, controlled documentation, or ClinicalTrials.gov submissions (preferred) Exposure to medical device research, post-market clinical follow-up, or evidence generation (preferred) Understanding of patient monitoring, maternal-infant care, or acute-care device environments (preferred) Preference for candidates based in the United States working standard US business hours WHAT'S IN IT FOR YOU Opportunity to advance your impact in a regulated med-tech environment Hybrid or remote work flexibility after successful onboarding Collaborative, cross-functional team environment Exposure to global medical device and healthcare technology research Potential for contract extension beyond June 2026

The Clinical Trial Documentation Coordinator plays a vital role within the Clinical Operations team, providing seasoned administrative and logistical support across a variety of clinical trial activities. This role is responsible for ensuring studies are well-organized, audit-ready, and progressing smoothly by flexibly managing documentation, image and data tracking, payments, device logistics, and meeting coordination. As a core and consistent member of the team, the Clinical Coordinator is regarded as a peer among fellow coordinators and a reliable contributor to study success. Responsibilities: Clinical Documentation & Site Support Manage essential clinical documentation, including IRB approvals, informed consent forms, agreements, and regulatory files. Track and update CVs and credentials for study site personnel. Serve as a primary contact for clinical sites regarding documentation needs and visit scheduling. Maintain organized, audit-ready study files within electronic systems. Image & Data Management Coordinate the collection, processing, and tracking of clinical images and related data from sites and core labs. Troubleshoot and resolve data submission issues with sites and vendors to ensure completeness and timeliness. Ensure image data quality and compliance by maintaining accurate records in the EDC system. Payments & Financial Tracking Process payments to study sites, vendors, core labs, and data management groups. Maintain and update payment tracking databases; provide accrual information to the Finance team. Communicate regularly with vendors and sites to support timely and accurate financial transactions. Device & Logistics Coordination Manage logistics for study device shipments, returns, and related documentation. Track device inventory, usage, and return status. Collaborate with Operations to facilitate purchase orders and coordinate shipping logistics. Meeting & Training Support Assist with planning and coordinating investigator meetings, site coordinator trainings, and study committee meetings (in-person and virtual). Support travel arrangements and meeting logistics as needed. Prepare training materials, track participant attendance, and monitor related expenses. General Team Support Assemble and maintain study materials, binders, and equipment supplies. Provide backup support to fellow Clinical Coordinators during periods of high workload. Participate in continuous improvement efforts and team-wide initiatives. Qualifications: Associate or Bachelor's degree required; degree in life sciences, healthcare, or a related field preferred. 3-5 years of experience in clinical research, clinical trials, or a regulated healthcare setting. Strong understanding of clinical documentation requirements and trial operations. Proficient in Microsoft Office (Excel, Word, PowerPoint, Outlook); experience with EDC systems or clinical databases is highly preferred. Exceptional organizational skills with the ability to handle multiple priorities in a dynamic environment. High attention to detail, accuracy, and follow-through. Excellent communication skills and the ability to foster productive relationships with internal teams, clinical sites, and vendors. Demonstrated dedication to a coordinator-level role and a commitment to team stability and performance. Salary of $60,000 to $80,000 + 5 to 7 % bonus

Title: Clinical Engineering Project Manager Duration: 3-4 months Precise. Reliable. Powerful. Join a team as innovative as the technology we manage. Are you a Clinical Engineer or lead biomedical/imaging equipment technology professional who has strong project management experience/training? Here's your opportunity to use analytic skills to manage and make recommendations for equipment replacement planning and forecasting. What You'll Do Coordinate the implementation of a defined, short-term project or sub-set of projects (less than one year) within set organizational procedures and standards. Responsible for meeting sub-set objectives within quality, time, and budget targets, and for managing associated risks. Typical knowledge and experience of the technical area being managed and an awareness of the business issues. What You Bring Background in clinical engineering with medical devices and project management, specific to equipment replacement planning & forecasting and contracts analysis; Clinical Engineering degree or equivalent experience, 3-5 years in a healthcare setting. This position will manage the capital process of medical equipment from start to finish. Experience providing analysis, consultation, and research to establish project timelines and deliverables; Participated in cross functional project teams to determine the most appropriate equipment service, purchases, and agreements; Experience in managing projects, being well organized, self-motivated, and have excellent communication skills.

Clinical Research Spec Mounds View, MN- Local Onsite Lafayette, CO- Onsite Duration: 24 months+ (2 years) Shift: 1shift CST/MST Pay Range $40-$43/Hr on w2 Top 3 things required in a candidate's experience: Site management experience (site or sponsor) Knowledge/experience with CTMS/EDC/TMF Experience with Good Clinical Practice (GCP) Education Required: Bachelor Degree (prefer degree in engineering, life sciences, or related medical/scientific field) Years' Experience Required: Minimum 2 years experience Work Hours: Yes, 40 hours/week Work Location: Local to either of the MN locations or the CO location On-site Requirement: Yes, Full time on-site Must Have • Experience with CTMS and patient data and site management systems (i.e. Veeva Vault, RAD Rave, Oracle) • Experience with Microsoft Office Applications Responsibilities may include the following and other duties may be assigned: Oversees, designs, plans and develops clinical evaluation research studies. Prepares and authors protocols and patient record forms. Conducts registered and nonregistered clinical studies of products that have been determined to satisfy a medical need and/or offer a commercial potential. Oversees and interpret results of clinical investigations in preparation for new drug device or consumer application. Oversees and resolves operational aspects of clinical trials in conjunction with project teams and in accordance with standard operating procedures (SOP), good clinical practice (GCP) and specific country regulations, and may prepare clinical trial budgets. May be responsible for clinical supply operations, site and vendor selection. Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience.

Clinical Studies Regional Research Manager Schedule: Schedule: Full-time; flexible schedule with M/W/F and T/Th/Sat coverage as needed. Typical hours are 7:30 AM - 3:30 PM, with occasional early-morning study visits (as early as 4:30 AM). Travel: ~20% (mostly local) Overview: We're seeking a motivated and compassionate Clinical Studies Regional Research Manager to lead research operations across Las Vegas and surrounding areas. This role oversees regional clinical study execution, supports site expansion, and manages a team of ~8. Ideal for a proactive leader passionate about driving high-quality, compliant clinical research. Key Responsibilities: Oversee regional research sites, ensuring proper staffing, vendor support, and study execution. Expand research operations by identifying new dialysis units and physician clinics for study participation. Partner with practice managers and field teams to assess site feasibility. Collaborate cross-functionally to improve processes, resolve issues, and plan future initiatives. Ensure GCP compliance and adherence to protocols, policies, and industry standards. Build and maintain relationships with physicians and act as liaison with sponsors. Conduct site selection visits and support study placement. Lead, coach, and develop the regional research team. Qualifications: Bachelor's degree strongly preferred. 4+ years of clinical research experience. 4+ years of management/leadership experience. Strong communication, organization, and multi-project management skills. Ability to handle confidential information with discretion. Ability to travel up to 20-25% (mostly local) and work occasional Saturdays. Must-Have Skills: Proven ability to lead and motivate a team of ~8. Strong budgeting and real-time operational decision-making skills. Hands-on QC experience and a commitment to clean, compliant operations.

Clinical Trial Coordination Coordinate and manage all aspects of assigned clinical trials from site initiation to close-out. Conduct study visits, including obtaining informed consent, performing protocol-required procedures, and collecting source data using eSource systems. Ensure timely and accurate entry of study data into electronic case report forms (eCRFs). Technology & Documentation Utilize eSource, eConsent, eISF, and other clinical trial software platforms to maintain complete, accurate, and regulatory-compliant study records. Support site readiness and compliance Regulatory Compliance Maintain up-to-date regulatory documents and study binders (electronic and/or paper as required). Assist with preparation for sponsor, CRO, or regulatory audits. Patient Engagement & Safety Recruit, screen, and enroll study participants according to protocol inclusion/exclusion criteria. Ensure ongoing patient safety by monitoring for adverse events and reporting per protocol. Execute phlebotomy Collaboration & Support Serve as the primary point of contact for sponsors, CROs, monitors, and other site staff. Support training and mentoring of new CRC staff as assigned.

The Clinical Research Coordinator II (CRC II) is responsible for the day-to-day conduct and oversight of assigned clinical trials, including both administrative and regulatory functions. This role requires effective communication and collaboration with sponsors, monitors, CROs, principal investigators (PIs), and site management. The CRC II also serves as a resource for CRC Is, providing guidance on site SOPs, study protocols, and regulatory compliance. The ideal candidate demonstrates professionalism, ethical integrity, and strong problem-solving skills when addressing challenges. Reports to: Site Manager Key Responsibilities Manage daily operations and participant enrollment for assigned clinical trials in accordance with study protocols, with a focus on meeting or exceeding recruitment goals. Partner with the recruitment team and site leadership to develop and implement effective recruitment strategies. Educate patients and/or caregivers about study procedures, expectations, and potential risks or benefits. Monitor study progress to ensure adherence to protocols, GCP, and all applicable local, federal, and institutional regulations. Maintain accurate and complete e-regulatory binders and study documentation. Follow site policies, SOPs, and controlled documents; provide mentorship and support to CRC Is as needed. Schedule and coordinate study visits and monitoring activities per study timelines and sponsor requirements. Complete real-time source documentation during patient visits, ensuring accuracy and compliance with good documentation practices. Enter data into electronic data capture (EDC) systems within one business day; address data queries within 48 hours. Monitor and maintain inventory of study and laboratory supplies. Attend investigator meetings, site initiation visits, and other sponsor meetings; share updates and key information with site staff. Maintain thorough and organized study files, including case report forms and investigational product accountability records. Perform protocol-specific procedures such as vital signs, ECGs, and specimen collection. Communicate lab results, adverse events, and other findings promptly to investigators and document accordingly. Manage specimen handling, labeling, storage, and shipment in compliance with protocol requirements. Dispense investigational products or devices as authorized, ensuring accurate dosing and documentation. Identify, document, and resolve protocol deviations or unanticipated events. Maintain accurate investigational product (IP) accountability and ensure secure storage. Keep study master logs up to date, including informed consent, enrollment, delegation, and training logs. Participate in quality assurance and regulatory audits as needed. Review and track all safety reports, ensuring timely PI review and documentation. Uphold confidentiality of participant PHI and sponsor data at all times. Perform other duties as assigned. Skills and Qualifications Prior experience serving as lead CRC on multiple clinical trials strongly preferred. Ability to work independently and collaboratively within a team environment. Strong mentoring and training capabilities. Excellent written and verbal communication skills. Proficiency in English (reading, writing, speaking). Strong knowledge of medical terminology. Occasional travel may be required to support or train at other research sites. Education and Experience High school diploma or GED required; some college preferred. Minimum 2-5 years of clinical research experience required. Phlebotomy certification required, if applicable by state law. Physical Requirements Prolonged periods of sitting and computer use. Must be able to lift up to 15 pounds occasionally.

Clinical Research Coordinator in Los Angeles, CA (91402) We are seeking a detail-oriented Clinical Research Coordinator to oversee and support all phases of clinical trials involving investigational drugs and medical devices. This role is responsible for ensuring smooth trial operations from initiation through closeout, while upholding the highest standards of compliance, data quality, and patient care. The ideal candidate will be proactive, organized, and knowledgeable in regulatory guidelines governing clinical research. Responsibilities: Manage all aspects of study coordination including participant recruitment, informed consent, visit scheduling, and protocol compliance. Guide participants through clinical trial procedures, ensuring adherence to study timelines and ethical standards. Maintain thorough and accurate records of study visits, observations, test results, and patient-reported outcomes in source documents and sponsor databases. Monitor and track investigational product inventory, laboratory supplies, and other study materials, ensuring availability and proper documentation. Collaborate closely with investigators, study teams, sponsors, and regulatory personnel to support ongoing communication and issue resolution. Prepare and submit timely reports, including adverse event and serious adverse event documentation, in accordance with sponsor and regulatory requirements. Ensure proper handling of confidential information and maintain HIPAA compliance at all times. Participate in site selection visits, sponsor monitoring visits, and audit preparation activities. Stay current with evolving industry regulations and standards through training sessions, webinars, and professional development opportunities. Represent the research site in a professional and respectful manner in all internal and external interactions. Qualifications: Bachelor's degree preferred, but equivalent experience will be considered. At least 2 years of experience as a Clinical Research Coordinator Must have Oncology Experience Strong understanding of GCP, ICH guidelines, and IRB processes. Excellent organizational skills, attention to detail, and ability to manage multiple studies simultaneously. Strong communication and interpersonal skills to interact with diverse teams and patient populations. Additional Details: Title: Clinical Research Coordinator Location: Los Angeles, CA (91402) Employment: Direct Hire Hours: Monday-Friday; 8AM-5PM; Onsite 5 Days a Week Pay: $70,000-$79,000 Annual Salary (Dependent on background and years of experience)

Job Title: Clinical Research Coordinator Schedule: Full-time; flexible schedule with M/W/F and T/Th/Sat coverage as needed. Typical hours are 7:30 AM - 3:30 PM, with occasional early-morning study visits (as early as 4:30 AM). Overview We are seeking a dedicated Clinical Research Coordinator to support all phases of clinical trials, from patient enrollment through study closeout. In this role, you will work closely with the Principal Investigator (PI) and cross-functional research teams to ensure high-quality study execution, strong patient support, and compliance with all regulatory requirements. This position is ideal for someone who thrives in a patient-focused environment. You will primarily support one site, allowing you to develop strong and meaningful relationships with the PI, study team, and patient population. Key Responsibilities Coordinate all aspects of clinical trials, including enrollment, study conduct, and closeout activities. Perform protocol-specific research procedures and support the PI throughout study execution. Serve as a liaison between investigators, sponsors, monitors, and internal study team members. Meet or exceed enrollment goals while ensuring high-quality, accurate, and timely data entry. Maintain strict compliance with Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all regulatory requirements. Foster a patient-centered environment, especially for rare disease populations with limited sample sizes. Support studies, including occasional early morning patient visits. Nice-to-Have Skills Prior experience in a clinical research setting. Phlebotomy experience is a plus. Strong organizational and multi-tasking abilities. Excellent communication and relationship-building skills. Soft Skills & Expectations Patient-focused, empathetic approach to clinical research. Strong interpersonal skills and the ability to collaborate effectively with diverse teams. Reliable follow-through and commitment to timely communication.

Clinical Research Coordinator Schedule: Full-time (40 hours/week) | Part-time (30 hours/week during training for entry-level candidates) Compensation: Competitive salary + performance-based incentives Overview We are seeking a motivated and detail-oriented Clinical Research Coordinator to join our growing research team. This role is responsible for coordinating and supporting all aspects of assigned clinical trials to ensure compliance with study protocols, regulatory requirements, and ethical standards. Key Responsibilities Study Coordination Manage the day-to-day operations of assigned clinical research studies. Ensure adherence to study protocols, ICH/GCP guidelines, and institutional policies. Assist in study start-up activities and maintain ongoing regulatory compliance. Participant Management Screen, recruit, and enroll participants according to inclusion/exclusion criteria. Obtain informed consent and maintain ongoing communication with study participants. Coordinate and conduct study visits, including vital signs, EKGs, lab draws, and patient questionnaires. Data Collection & Documentation Accurately record and manage clinical data in electronic or paper case report forms (CRFs). Ensure timely entry of data, documentation of deviations, and reporting of adverse events. Maintain complete and accurate study records in compliance with sponsor and regulatory requirements. Regulatory Compliance Prepare and maintain study regulatory documents, including IRB submissions and renewals. Participate in internal and external study audits to ensure compliance with Good Clinical Practice (GCP). Collaboration & Communication Serve as a key liaison between investigators, sponsors, monitors, and study participants. Coordinate study logistics and scheduling to ensure efficient workflow. Foster positive working relationships within a multidisciplinary team. Qualifications Required: Degree in a health-related field (e.g., Medical Assistant, LPN, Nursing, Biology, Public Health, or related discipline). Minimum of 2 years of clinical research experience (full-time role). Entry-level candidates with no prior research experience may be hired at 30 hours/week during training, with the opportunity to transition to full-time once fully trained. Proficiency in Microsoft Office Suite (Word, OneNote, Excel). Preferred: Strong organizational and time-management skills. Excellent interpersonal and written communication skills. High attention to detail and commitment to data integrity. Ability to maintain confidentiality and manage sensitive information. Problem-solving ability and adaptability in a dynamic research environment. Why Join Us? Competitive pay with performance-based incentives. Comprehensive health and wellness benefits. Opportunities for career growth and continuing education. Collaborative and inclusive work culture in a rapidly growing organization.

The Clinical Research Coordinator conducts and manages multiple clinical trials from start up through study close out in accordance with the study protocol, GCP, and the site's SOPs. Responsibilities Duties/Responsibilities: Conduct and manage clinical trials in accordance with the study protocol, GCP, ICH Guidelines and the site's SOPs Implement and coordinate assigned clinical trials including start up, vendor management,subject recruitment, source development review, scheduling subjects, protocol training,collection of regulatory documents, conducting visits, ensuring data is entered in a timely manner and all queries are resolved, managing and reporting adverse events, serious adverse events, and deviations, implementing new protocol amendments, providing all close out reports. Apply project management concepts to manage risk and improve quality in the conduct of a clinical research study Develop, coordinate, and implement research and administrative strategies to successfully manage assigned protocols. Communicate effectively and professionally with coworkers, leadership, study subjects,sponsors, CROs, and vendors. Apply good documentation practices when collecting and correcting data, transferring data to sponsor/CRO data capture systems and resolving queries Maintain confidentiality of patient protected health information, sponsor confidential information and the site's confidential information Verify and escalate patient safety concerns by ensuring all adverse events, serious adverse events, and adverse events of special interest are followed and reported in accordance with the protocol and the site's SOPs. Ensure all data is entered into the sponsor's data portal and all queries are resolved in a timely manner Ensure staff are delegated and trained appropriately and documented Create, collect and submit regulatory documents to Sponsors and IRBs as required per protocol, GCP/ICH regulations and IRB requirements. Evaluate potential subjects for participation in clinical trials including phone and in person prescreens. Create and execute recruitment strategies defined by Clinical Research Team Understand key timelines, endpoints, required vendors, and patient population for each assigned protocol. Understand product development life cycle and significance of protocol design including critical data points Understand the disease process or condition under study Collaborate with Clinical Research Team to develop Quality Control strategy for reviewing one's work on an ongoing basis and in preparation for monitor visits. Perform clinical duties (e.g., drug preparation and administration, fibroscan, phlebotomy, ECG,lab processing) within scope Other duties as assigned Qualifications Education/Experience: Bachelor's degree and 2 years relevant experience in the life science industry OR Associate's degree with 4 years relevant experience in the life science industry OR High School Graduate and/or technical degree with minimum of 6 years relevant experience in the life science industry AND 1 year Clinical Research Coordinator experience Required Skills: Demonstrated knowledge of medical terminology Proficient in the use of the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone. Proficient ability to work in a fast-paced environment Proficient verbal, written, and organizational skills Proficient interpersonal and communication skills Proficient ability to work as a team player Proficient ability to read, write, and speak English Proficient ability to multi-task Proficient ability to follow written guidelines Proficient ability to work independently, plan and prioritize with minimal guidance Proficient ability to be flexible/adapt as daily schedule may change rapidly Must be detail oriented Demonstrated problem solving and strategic decision making ability. Proficient in accepting individual responsibility for actions taken and demonstrating professionalism when judged, critiqued and/or praised. Demonstrated leadership ability Required Physical Abilities: Sit or stand for long periods of time Travel locally and nationally Communicate in person and by a telephone Limited walking required Limited to lifting up to 30 pounds

The Clinical Research Coordinator (CRC) manages and coordinates clinical research studies, ensuring they are conducted efficiently, ethically, and in compliance with regulatory requirements. The role involves working with principal investigators, research staff, and study participants to oversee all aspects of trials, including recruitment, data management, regulatory compliance, and monitoring participant progress. Screens and recruits' subjects. Communicates with subjects and medical group providers, including the Principal Investigator and any Sub-Investigators. Collects, labels, stores, and ships specimens collected from subjects in connection with a clinical research trial. Enters patient and research data in systems designated by the company. Monitors study activities to ensure compliance with study protocols and with applicable federal, state, and local regulatory and site requirements. Oversees subject enrollment to ensure that informed consent is properly obtained and documented. Records adverse events and side effect data and confers with Investigators regarding reporting of events to oversight agencies. Prepares study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports. Doses and administers study drugs and/or implements study methodologies.

Performs study subject visits by, among other things; Screening and recruiting subjects; Dosing and administering study drugs and/or implementing study methodologies; Accounting for study drugs; Communicating with subjects and medical group providers, including the Principal Investigator and any Sub-Investigators; Collecting, labeling, storing, and shipping specimens collected from subjects in connection with a clinical research trial; Entering patient and research data in systems designated by the Company; and Maintaining patient charts and resolving research queries. Follows Good Clinical Practice Works cooperatively with others Monitors study activities to ensure compliance with study protocols and with applicable federal, state, and local regulatory and Site requirements and policies; Maintains required records of study activity including case report forms, drug dispensation records, and regulatory forms; Tracks enrollment status of subjects and documents dropout information, such as dropout causes and subject contact efforts and communicates this information as directed; Assesses eligibility of potential subjectsthrough methods such as screeninginterviews, reviews of medical records,and discussions with physicians and other healthcare professionals; Oversees subject enrollment to ensure that informed consentis properly obtainedand documented; Records adverse events and side effect data and confers with Investigators regarding the reporting of events to oversight agencies; Prepares for or participates in quality assurance audits conducted by study sponsors, federal agencies, or designated review groups; Creates source documents as assigned, such as regarding protocols, memos, patient participation; Prepares study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports; Reviews proposed study protocols to evaluate factorssuch as sample collection processes, data management plans,and potential subjectrisks; Instructs research staff in scientific and procedural aspectsof studies including standards of care, informed consentprocedures, or documentation procedures; Collaborateswith Investigators and Company Management to prepare presentations or reports of clinical studyprocedures, results, and conclusions; Communicateswith laboratories or investigators regarding laboratory findings; Reviews scientific literature, participates in continuing education activities, and/or attends conferences and seminars to maintain knowledge of clinical research; Orders drugs or devices necessary for study completion; Documents findings and events in the Company's research CTMS platform and in other binders and platforms as directed; Occasional travel to Company sites, Investigator meetings, and/or Company meetings; and Performs other duties as assigned, including duties routinely performed by the Company's Research Assistants.

Job Title: Clinical Research Coordinator - Bilingual (EN/ES) Schedule: Full-time; flexible schedule with M/W/F and T/Th/Sat coverage as needed. Typical hours are 7:30 AM - 3:30 PM, with occasional early-morning study visits (as early as 4:30 AM). Overview We are seeking a dedicated Clinical Research Coordinator to support all phases of clinical trials, from patient enrollment through study closeout. In this role, you will work closely with the Principal Investigator (PI) and cross-functional research teams to ensure high-quality study execution, strong patient support, and compliance with all regulatory requirements. This position is ideal for someone who thrives in a patient-focused environment. You will primarily support one site, allowing you to develop strong and meaningful relationships with the PI, study team, and patient population. Key Responsibilities Coordinate all aspects of clinical trials, including enrollment, study conduct, and closeout activities. Perform protocol-specific research procedures and support the PI throughout study execution. Serve as a liaison between investigators, sponsors, monitors, and internal study team members. Meet or exceed enrollment goals while ensuring high-quality, accurate, and timely data entry. Maintain strict compliance with Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all regulatory requirements. Foster a patient-centered environment, especially for rare disease populations with limited sample sizes. Support studies, including occasional early morning patient visits. Nice-to-Have Skills Prior experience in a clinical research setting. Phlebotomy experience is a plus. Strong organizational and multi-tasking abilities. Excellent communication and relationship-building skills. Must be bilingual in both English and Spanish. Soft Skills & Expectations Patient-focused, empathetic approach to clinical research. Strong interpersonal skills and the ability to collaborate effectively with diverse teams. Reliable follow-through and commitment to timely communication.

Clinical Research Coordinator (CRC) Key responsibilities typically include: Screening and recruiting study participants, verifying eligibility per protocol. Conducting informed consent discussions and ensuring ethical treatment of participants. Coordinating study visits, executing protocol-specified procedures (labs, vitals, diaries, adverse event monitoring, etc.). Monitoring adverse events (AEs) and serious adverse events (SAEs), ensuring timely reporting to sponsors/IRBs. Entering data into electronic systems (EDC/CTMS), maintaining source documentation, case report forms (CRFs) and regulatory files. Interacting with sponsors/CROs, coordinating with study monitors, handling queries and managing trial logistics. Ensuring compliance with Good Clinical Practice (GCP), institutional policies and regulatory requirements. Often serving as the participant-facing point of contact and maintaining excellent communication and engagement with subjects and site staff. Why the role matters: The CRC ensures that the research is conducted ethically, safely, according to protocol, and produces high-quality data. They maintain the interface between participants, clinical staff, sponsors/CROs and regulatory oversight - which is critical for successful trial execution. Because they manage many moving parts (visits, documentation, labs, data, adverse events), strong organisational, communication and multitasking skills are essential.

**Seeking a Clinical Research Coordinator in Worcester, MA** -MUST be able to perform phlebotomy! We are a growing integrated research organization dedicated to bringing innovative care to patients across the U.S. The CRC is responsible for the day-to-day operations of clinical trials at the site which include coordinating participant visits, recruiting and retaining trial participants, and performing tasks as delegated, required to complete a study according to the protocol and ICH-GCP guidelines. Key Responsibilities Under the direction of the Senior Director of Clinical Research and the Principal/Sub Investigator(s): o Coordinates with Principal Investigator and local site to ensure that clinical research trials and activities are performed in accordance with the study protocol, FDA, GCP, ICH Guidelines and SOPs. o Adhere to clinical trial protocols and coordinate and perform assigned clinical trial activities including, but not limited to: o Participant pre-screening, recruitment and scheduling o Complete protocol and trial system training o Maintenance of regulatory documents o Conducts or participates in the informed consent process and discussions with trial participants, including answering any questions related to the study. o Conducting participant visits o Ability to perform basic lab and clinical procedures per protocol, such as: o blood specimen collection (phlebotomy) o blood pressure o vitals o EKGs o centrifuge operation o storing and shipping of lab specimens o accountability of specimens and notification of courier for specimen pick-up o Entering data in the EDC and resolving all queries o Updating and maintaining trial logs and participant charts o Conducting monitoring visits and resolving issues as needed in a timely manner o Managing and reporting of AEs, SAEs, and deviations o Maintains adequate inventory of study supplies Qualifications o College degree (health sciences) preferred or significant relevant experience o At least 2 years of CRC experience in a direct patient care role o Knowledge of Good Clinical Practice (GCP), IATA and FDA regulations pertaining to clinical trials o Fluent in written and spoken English o Ability to complete clinical procedures including phlebotomy, vitals, height, weight, ECGs

**Seeking a FULL TIME Clinical Research Coordinator for a brand new site in La Vergne, TN. Phlebotomy skills are a MUST!** What You'll Do Clinical Trial Coordination Coordinate and manage all aspects of assigned Phase 2-4 clinical trials from site initiation to close-out. Conduct study visits, including obtaining informed consent, performing protocol-required procedures, and collecting source data using eSource systems. Ensure timely and accurate entry of study data into electronic case report forms (eCRFs). Technology & Documentation Utilize eSource, eConsent, eISF, and other clinical trial software platforms to maintain complete, accurate, and regulatory-compliant study records. Support site readiness and compliance with 21 CFR Part 11, ICH GCP, and sponsor SOPs. Regulatory Compliance Maintain up-to-date regulatory documents and study binders (electronic and/or paper as required). Assist with preparation for sponsor, CRO, or regulatory audits. Patient Engagement & Safety Recruit, screen, and enroll study participants according to protocol inclusion/exclusion criteria. Ensure ongoing patient safety by monitoring for adverse events and reporting per protocol. Collaboration & Support Serve as the primary point of contact for sponsors, CROs, monitors, and other site staff. Support training and mentoring of new CRC staff as assigned. Provide on-site support at additional study locations when required (occasional travel). Occasional travel may be required for audits, site visits, or team meetings.? What We Offer Competitive compensation Medical, dental, and vision insurance Generous PTO and paid holidays Flexible scheduling options Professional development and continuing education support A mission-driven team that values respect, inclusion, and innovation Ready to Make an Impact? Mission with Meaning: Be part of a purpose-led team committed to health equity and real-world impact. Startup Energy, Proven Expertise: Work fast, adapt quickly, and help build something new; guided by seasoned visionary?professionals who've seen what needs to change. People First Culture: We care deeply about our patients, participants, and each other. Collaboration, transparency, and bold, straight-talking are core to how we work. Invested in Your Growth: We don't just hire for today; we're building the leaders and change makers of tomorrow.? 3-5 Must Have Skills/Qualifications What You Bring Strong interpersonal skills for effective collaboration with patients, investigators, and sponsors. Excellent organizational skills, attention to detail, and ability to prioritize multiple studies. Proficient in Microsoft Office Suite and clinical trial management systems (CTMS). Experience with eSource, eConsent, and electronic ISF systems strongly preferred. Minimum 3 years of experience coordinating Phase 2-4 clinical trials in a site, SMO, or academic research setting. Certified Clinical Research Coordinator (CCRC) a plus. Knowledge of GCP, FDA regulations, and clinical trial conduct.

Screens potential patients for protocol eligibility. Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on protocol. Coordinates patient care in compliance with protocol requirements. May disburse investigational drug and provide patient teaching regarding administration. Maintains investigational drug accountability. -In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings. Responsible for accurate and timely data collection, documentation, entry, and reporting. Schedules and participates in monitoring and auditing activities. Maintains regulatory documents in accordance with USOR SOP and applicable regulations. Participates in required training and education programs. Responsible for education of clinic staff regarding clinical research. May collaborate with Research Site Leader in the study selection process. Additional responsibilities may include working directly with other (non-USOR) research bases and/or sponsors. Identify quality and performance improvement opportunities and collaborates with staff in the development of action plans to improve quality. May be responsible for compiling and reporting protocol activity, accrual data, and research financial information to practice administration and physicians. May oversee the preparation of orders by physicians to assure that protocol compliance is maintained. Communicates with physician regarding study requirements, need for dose modification, and adverse event reporting. Provides a safe environment for patients, families, and clinical staff at all times through compliance with all federal, state, and professional regulatory standards as issued through OSHA and the CDC. Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Qualifications Associate's degree in a clinical or scientific related discipline required, Bachelor's degree preferred. Minimum five years of experience in a clinical or scientific related discipline required, preferably in oncology. SoCRA or ACRP certification preferred. OR Graduate from an accredited program for nursing education (BSN preferred). Minimum 3 years of nursing experience, preferably in oncology. Experience in clinical research preferred. Current licensure as a registered nurse in state of practice. Current BLCS or ACLS certification required. OCN, SoCRA or ACRP certification preferred. We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO), and the California Fair Chance Act (CFCA). This position is subject to a background check based on its job duties, which may include patient care, working with vulnerable populations, access to financial and confidential information, driving, working with heavy machinery, or working in a warehouse or laboratory environment. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.