Clinical Research Coordinator (Kirkland)

Company DescriptionData Point Clinical LLC is a trusted clinical research partner, dedicated to delivering high-quality data through precise study execution and strong patient engagement. Collaborating with sponsors and CROs, we focus on enhancing operational efficiency, improving recruitment outcomes, and ensuring seamless trial execution. Our experienced, senior-led team emphasizes accuracy, speed, and exceptional patient experience. We are committed to accelerating the development of new therapies while adhering to the highest standards of compliance and care.Position SummaryThe Clinical Research Coordinator (CRC) plays a central role in the planning, implementation, and management of clinical research studies. This position is responsible for ensuring the ethical conduct of research, maintaining regulatory compliance, and providing high-quality patient care throughout the research process. The CRC serves as a key liaison between study participants, investigators, sponsors, and regulatory agencies.Key ResponsibilitiesStudy Coordination & OperationsCoordinate and manage day-to-day clinical trial activities in accordance with study protocols, GCP guidelines, and applicable regulations (FDA, ICH, IRB)Screen and enroll eligible study participants; obtain and document informed consentSchedule and conduct study visits, procedures, and assessments per protocol requirementsCollect, process, and ship biological specimens including blood draws (phlebotomy required)Perform and document study-related procedures such as vital signs, ECGs, and questionnaire administrationMaintain accurate and complete source documentation and case report forms (CRFs/eCRFs)Additional responsibilities may applyRegulatory & Compliance (in collaboration with Regulatory Staff)Partner with the regulatory team on IRB submissions, amendments, renewals, and adverse event reportingAssist with maintaining and organizing the Investigator Site File (ISF) and regulatory bindersIdentify and communicate protocol deviations to the PI and regulatory staff in a timely mannerSupport monitoring visits, audits, and sponsor/CRO site visits alongside the regulatory teamMaintain working knowledge of applicable GCP guidelines, FDA regulations, and institutional policiesAdditional responsibilities may applyPatient Care & SafetyPerform phlebotomy and specimen collection following established safety and quality proceduresMonitor participants for adverse events (AEs) or serious adverse events (SAEs) and report findings to the PI and sponsor per protocolProvide participant education and ongoing study-related support throughout the trialCoordinate with clinical staff to ensure continuity of participant careAdditional responsibilities may applyData Management & ReportingEnter study data accurately and in a timely manner into electronic data capture (EDC) systemsResolve data queries from sponsors, monitors, and data managersAssist with preparation of study reports, presentations, and publications as neededTrack enrollment metrics, visit completion, and study milestonesAdditional responsibilities may applyCommunication & CollaborationAct as the primary point of contact for study sponsors, CROs, and external collaboratorsCommunicate study updates to the research team, investigators, and institutional departmentsParticipate in research team meetings, investigator meetings, and training sessionsMentor and provide guidance to junior research staff as appropriateQualificationsEducationAssociate degree or higher in a health-related field required; Bachelor's degree preferredCoursework or training in clinical research, life sciences, nursing, or a related disciplineExperienceMinimum 2 years of clinical research coordination or directly related clinical experience requiredDemonstrated experience with informed consent processes and human subjects researchExperience with EDC systems and clinical trial management software preferredFamiliarity with FDA regulations, ICH-GCP guidelines, and IRB submission processesRequired Licensure (One of the following must be active and in good standing)Medical Assistant-Phlebotomist (MA-P) LicensePhlebotomy Technician License/CertificationRegistered Nurse (RN) LicenseSkills & CompetenciesProficient phlebotomy skills with demonstrated ability to perform venipuncture and capillary collectionStrong organizational skills with meticulous attention to detail and accuracyExcellent written and verbal communication skillsAbility to work independently and manage multiple protocols simultaneouslyProficiency in Microsoft Office Suite (Word, Excel, Outlook) and database softwareDemonstrated ability to maintain strict confidentiality and handle sensitive information with discretionWorking ConditionsClinical and office environment; standard research facility settingsMay require occasional evening or weekend hours to accommodate study visit schedulesExposure to biological specimens; adherence to universal precautions and safety protocols requiredAbility to stand, sit, and perform physical tasks associated with clinical procedures for extended periodsPreferred QualificationsSociety of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) certification (CCRC, CRC, or equivalent)Bilingual language skills are a plusPrior experience with sponsor-initiated or investigator-initiated trialsBenefitsPaid Time Off (PTO)Qualified Small Employer Health Reimbursement Arrangement (QSEHRA)This job description is intended to convey information essential to understanding the scope of the position and is not an exhaustive list of skills, efforts, duties, or responsibilities associated with it. Job duties may be modified at any time.