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Clinical Research Coordinator

$70.49k - $76.81k

Trusted Medical PLLC

W2 Full-Time Clinical Research Coordinator Clinical Research Coordinator – Washington DC Trusted Medical is a value-driven organization dedicated to delivering direct, high-quality healthcare services across 22 states. Our expanding network of clinics and research operations supports active military personnel, Veterans, and the broader community through comprehensive care and cutting‑edge clinical trials. Job Overview We are seeking a full‑time Clinical Research Coordinator (CRC) to join our national clinical trials team. The CRC will support multiple clinical studies, playing a pivotal role in coordinating daily operations and ensuring compliance with regulatory requirements and protocol standards. They will apply their experience to program refinement and improvements for all those accessing and associated with our clinical trials—including registrants, participants, vendors, and key stakeholders. Additionally, they will support our program in leading clinical trials with an innovative approach, creating substantial opportunities for inclusivity and expanding clinic trial accessibility to all. The ideal candidate will demonstrate strong organizational skills, attention to detail, and a compassionate approach to participant engagement. Responsibilities Coordinate daily operations for assigned clinical trials from initiation to closeout. Recruit, screen, and enroll study participants according to protocol eligibility criteria. Obtain and document informed consent in compliance with ICH‑GCP and IRB requirements. Maintain accurate and complete source documentation, case report forms, and logs. Prepare and submit regulatory documents to Institutional Review Boards and sponsors. Schedule and conduct study visits, procedures, and follow‑up appointments. Administer study questionnaires, assessments, and ePROs. Ensure protocol adherence and proactively identify deviations or violations. Manage and track investigational product inventory, storage, dispensing, and return. Monitor participant safety and report adverse events and serious adverse events. Serve as primary contact for study monitors, sponsors, auditors, and regulatory agencies. Facilitate and participate in site selection, initiation, monitoring, and closeout visits. Enter and verify data in electronic data capture systems. Reconcile study data queries and ensure timely resolution of discrepancies. Maintain study files, regulatory binders, and essential documentation per FDA 21 CFR Part 11. Coordinate specimen collection, processing, and shipping to central labs or biorepositories. Support budget development, invoicing, and payment tracking for study‑related procedures. Train and oversee study support staff, interns, or volunteers (if applicable). Prepare for and participate in audits, monitoring visits, and quality assurance reviews. Maintain credentialing, licenses, and required study training documentation. Ensure compliance with HIPAA and data privacy regulations during research activities. Track enrollment targets, retention, and study milestones to ensure timely progress. Support development and updates of standard operating procedures. Communicate study updates to investigators, sponsors, and internal stakeholders. Collaborate with pharmacy, radiology, lab, and clinical teams for protocol‑specific coordination. Participate in feasibility assessments for new research opportunities. Assist in drafting study materials, recruitment tools, and IRB communication. Provide participants with study education, visit reminders, and engagement support. Manage scheduling software, calendars, and workflow tools to maintain operational efficiency. Attend sponsor, CRO, or consortium training meetings onsite or virtually as required. Knowledge and Skills Working knowledge of FDA, ICH‑GCP, and OHRP regulations. Expert understanding of clinical research protocols and informed consent procedures. Proficiency in Microsoft Office Suite and electronic data capture systems. Excellent written and verbal communication skills. Attention to detail with ability to track items to resolution. Ability to work independently and collaboratively across teams. Education/Certification Bachelor’s degree in life sciences, healthcare, or a related field. Clinical Research Coordinator certification (ACRP‑CRC or SOCRA‑CCRC) preferred. Experience Minimum 5 years of experience supporting clinical research. Experience working on multi‑site or national studies. Expertise in regulatory submissions and IRB processes. Experience with NIH, CMS, or FDA‑sponsored studies is highly desired. Technical Skills Proficiency with Microsoft Word, Excel, PowerPoint. Experience with electronic regulatory and EDC platforms. Proficiency in research database tools (e.g., REDCap, Medidata Rave). Additional Information Salary Range: $70,491 – $76,810 base pay. Competitive salary/pay and potential bonus based on key performance indicators. Work Location: Regional based approach. Employee will need to report to an established Trusted Medical clinic. Occasional travel may be required for national study meetings or site activities. Role Reports to: Nurse Executive. Direct Reports: None, but will collaborate with clinic and call center staff daily. All applicants must be U.S. citizens and able to obtain a Public Trust clearance. Trusted Medical participates in the E‑Verify program and is a drug‑free workplace. EEO Statement Trusted Medical is an Equal Opportunity and affirmative action employer. We prohibit discrimination against individuals based on their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other category protected by law. We take affirmative action to employ and advance in employment individuals without regard to protected status. #J-18808-Ljbffr

Vacancy posted 2 days ago
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