Clinical Research Coordinator (CRC)
hace 1 mes
Pearland
Job Description Clinical Research Coordinator (CRC) LINQ Research, LLC Location: Pearland, TX -0 Onsite Job Type: Full-Time Schedule: Monday-Friday, 8:00 AM-5:00 PM Department: Clinical Research Reports To: Site Manager FLSA Status: Exempt About LINQ Research LINQ Research is a growing, fast-paced clinical research site with approximately 20 employees. We specialize in chronic disease studies and pride ourselves on being nimble, collaborative, and patient focused. Our team values accountability, ownership, strong execution, and high-quality patient care. We are seeking an experienced Clinical Research Coordinator (CRC) to join our Clinical Research team. This position is ideal for a CRC who has previously taken ownership of clinical studies, interfaced directly with study monitors and sponsors, and can confidently manage patient visits, data integrity, investigational product accountability, and study activities with minimal oversight. Position Overview The Clinical Research Coordinator plays a critical role in the successful execution of clinical research studies by managing study activities from activation through closeout and ensuring protocol requirements, patient safety, data integrity, and regulatory requirements are consistently maintained. The CRC will work closely with the Site Manager, Principal Investigator, Investigators, Recruitment, Regulatory, sponsors, CROs, and study monitors and will serve as a primary point of contact for study participants, sponsors, and monitors. The ideal candidate is highly accountable, detail-oriented, organized, patient-focused, and comfortable managing multiple studies in a fast-paced environment while working independently with minimal oversight. Our Therapeutic Areas currently consists of: • Heart Failure, • COPD, • Asthma, • Gastroenterology (GI), • Chronic Kidney Disease (CKD) Key Responsibilities Clinical Research & Study Management • Manage assigned clinical research studies from study activation through closeout., • Conduct study activities in accordance with the protocol, ICH-GCP guidelines, company SOPs, and applicable regulations., • Obtain informed consent from study participants in accordance with ICH-GCP, protocol requirements, and site SOPs., • Schedule and coordinate study visits and ensure visit requirements are completed within protocol-defined windows., • Coordinate with recruitment and regulatory teams to support enrollment, compliance, and study execution goals., • Maintain accurate and complete study documentation throughout the study lifecycle., • Independently manage assigned studies with minimal oversight., • Communicate study status, outstanding actions, and potential issues to the Site Manager and Principal Investigator., • Participate in study team meetings and support timely resolution of study-related action items. Patient Visits & Clinical Procedures • Conduct and coordinate patient study visits according to protocol requirements., • Perform clinical study procedures, including:, • Vital signs, • ECGs, • Blood draws and phlebotomy, • Other protocol-required clinical assessments and procedures within the employee's training and scope of responsibility, • Provide professional, patient-focused communication throughout the study visit process., • Monitor participant compliance with study requirements and communicate concerns to the appropriate study personnel., • Maintain accurate and timely documentation of patient visits and study procedures. Laboratory & Specimen Management • Collect, process, label, store, and ship laboratory specimens in accordance with protocol and laboratory requirements., • Ensure specimens are handled within required processing and shipping timelines., • Maintain accurate laboratory documentation and tracking records., • Identify and promptly communicate specimen-related issues or deviations. Investigational Product (IP) Management • Dispense investigational product in accordance with protocol requirements and site procedures., • Maintain accurate investigational product accountability records., • Coordinate investigational product storage, dispensing, reconciliation, and return activities as applicable., • Identify and escalate investigational product discrepancies or issues., • Ensure investigational product activities remain audit-ready and compliant with study requirements. Data Management & EDC • Complete Case Report Forms (CRFs) and perform timely data entry into electronic data capture (EDC) systems., • Maintain accurate, complete, and consistent clinical research data., • Enter and review study data within required timelines., • Respond to sponsor and monitor data queries and ensure appropriate resolution., • Maintain source documentation that supports data entered into EDC systems., • Identify discrepancies between source documentation and EDC data and resolve them appropriately., • Maintain data integrity and ensure documentation is inspection-ready. Source Documentation & Electronic Systems • Maintain accurate source documentation in electronic source systems., • Utilize electronic source and clinical research platforms, including RealTime eSource and/or REDCap., • Ensure source documentation is complete, accurate, contemporaneous, and consistent with protocol and ICH-GCP requirements., • Maintain appropriate study records throughout the study lifecycle., • Ensure documentation is readily available for monitoring visits, audits, and inspections. Monitoring Visits & Sponsor/CRO Communication • Interface directly with study monitors, sponsors, and CRO representatives., • Prepare for and host monitoring visits independently., • Ensure required study documentation is available and organized for monitoring visits., • Respond to monitor requests and follow up on outstanding action items., • Address data queries and documentation findings within required timelines., • Communicate study issues, deviations, and corrective actions to appropriate study leadership., • Support sponsor audits, quality reviews, and regulatory inspections as applicable. Study Technology & Scheduling Systems • Utilize clinical research and scheduling software to support study execution., • Utilize Setmore for study participant scheduling and visit coordination., • Support Clario eCOA/eTablet systems as required by applicable protocols., • Troubleshoot or escalate technology-related issues that may affect study execution or participant visits., • Maintain proficiency with required study-specific systems and platforms. Collaboration • Collaborate closely with the Site Manager, Principal Investigator, Investigators, Recruitment, Regulatory, and other internal departments., • Communicate effectively with sponsors, CROs, CRAs, study monitors, laboratories, vendors, and other external partners., • Coordinate study activities across departments to ensure enrollment, compliance, and study timelines are maintained., • Provide timely updates regarding study progress, patient visits, data queries, monitoring findings, and outstanding action items., • Foster professional and effective relationships with patients, study teams, sponsors, monitors, and internal stakeholders. Required Qualifications • 3–5 years of Clinical Research Coordinator experience., • Experience working on at least 3 different clinical studies., • Demonstrated experience independently managing at least one clinical study from activation through closeout., • Strong working knowledge of EDC systems and electronic source platforms., • Regular phlebotomy and blood draw experience required., • Experience conducting patient study visits and protocol-required clinical procedures., • Experience with informed consent processes and ICH-GCP requirements., • Experience responding to data queries and maintaining audit-ready documentation., • Experience preparing for and hosting monitoring visits with minimal or no direct supervision., • Proficiency with computer systems, including document editing, printing, data systems, and Microsoft Office applications., • Excellent organizational, time management, communication, and problem-solving skills., • Strong attention to detail and commitment to data integrity., • Ability to manage multiple studies, patients, priorities, and deadlines simultaneously., • Comfortable working independently with minimal oversight., • Comfortable working in a small, fast-paced, team-oriented organization., • Must have reliable, independent transportation and the ability to drive independently. Preferred Qualifications • At least one year of experience conducting studies in one or more of the following therapeutic areas:, • Heart Failure, • COPD, • Asthma, • Gastroenterology (GI), • Chronic Kidney Disease (CKD), • Experience with Clario eCOA/eTablet, particularly within COPD or Asthma studies., • Experience with RealTime eSource and/or REDCap., • Experience with multiple EDC systems., • Experience managing multiple clinical studies simultaneously., • Experience working within a research site, SMO, healthcare, or CRO environment., • Experience independently managing studies from activation through closeout., • Experience preparing for and hosting sponsor monitoring visits., • Experience resolving data queries and maintaining inspection-ready documentation. What Success Looks Like In this role, success means: • Patient visits are conducted accurately, professionally, and within protocol-required timelines., • Study activities are completed in accordance with protocols, ICH-GCP, company SOPs, and applicable requirements., • Study data is accurate, complete, timely, and consistently maintained., • Source documentation and EDC records remain current, complete, and audit-ready., • Data queries are proactively addressed and resolved within required timelines., • Investigational product accountability is accurate and maintained throughout the study., • Laboratory specimens are properly collected, processed, documented, and shipped., • Monitoring visits are prepared for and conducted effectively with minimal supervision., • Study action items, deviations, and outstanding issues are identified and resolved promptly., • Patients receive professional, compassionate, and consistent support throughout their participation., • Study teams, sponsors, and monitors receive timely and effective communication., • Assigned studies progress successfully from activation through closeout. Work Environment & Physical Requirements This is an onsite position within a clinical research and clinical care setting. The role requires prolonged periods of standing, sitting, walking, and computer use, as well as frequent interaction with study participants and clinical research personnel. The position requires the ability to perform regular phlebotomy and clinical research procedures, move throughout office and clinical areas, and use standard office and clinical equipment. Occasional lifting and carrying of up to 25 pounds may be required. Travel Minimal local travel between research sites and company locations may be required. Reliable independent transportation is required. Occasional attendance at sponsor meetings, training sessions, or professional development activities may also be required. Schedule This is a full-time, exempt position with standard business hours generally Monday through Friday, 8:00 AM–5:00 PM. Additional hours may occasionally be required to accommodate patient visits, study deadlines, monitoring visits, or business needs. Interview Process Our interview process includes: • Phone screen, • Face-to-face interview, • Second-round practical skills assessment Benefits • Dental insurance, • Health insurance, • Paid time off, • Parental leave, • Vision insurance Equal Employment Opportunity LINQ Research is an Equal Opportunity Employer and provides equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, national origin, age, disability, genetic information, veteran status, or any other protected status under applicable law. This job posting describes the general nature and level of work performed in this position and is not intended to be an exhaustive list of all duties, responsibilities, or qualifications. Management reserves the right to modify, assign, or remove duties as business needs dictate.
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