Posted 7 days ago
Sr. Clinical Research Coordinator (Carlsbad, CA)
CarlsbadOn-siteFull-time
AI Summary
Senior Clinical Research Coordinator at Profound Research manages clinical trial operations, ensures regulatory compliance, and coordinates site activities for community physician partners.
About this role
About Profound Research
Profound Research partners with community physicians to offer clinical trials as a therapeutic option for their patients. We handle all infrastructure, regulatory compliance, and administrative operations so physicians can focus on patient care. Our model gives patients access to the newest therapies while maintaining the trusted patient-physician relationship.
Our Mission: Improving Lives by Providing Advanced Therapeutic Options
Our Vision: Creating the Absolute Best Patient-Physician Experience in Clinical Research
Our Values:
- Compassion: We prioritize the patient-physician relationship, ensuring every interaction is service-oriented and patient-centered.
- Urgency:We work hard and practice selflessness, acting swiftly and decisively to meet the needs of our patients, partners, and colleagues.
- Solution Orientation:We embrace challenges with a positive mindset, communicate directly, and identify and implement effective solutions with efficiency.
- Excellence:We insist on excellence, holding ourselves accountable and empowering each other to deliver best-in-class service while maintaining the highest ethical and scientific standards.
Role: Senior Clinical Research Coordinator
Company: Profound Research
Role & Responsibilities:
-Maintain site compliance for all clinical trial activities in accordance with established research protocols and standards in compliance with all applicable laws, regulations, policies, and procedural requirements.
-Maintain working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s).
-Complete all relevant Profound Research required training, including but not limited to ICH-GCP certification and IATA certification in a timely manner.
-Lead, implement and coordinate duties for assigned clinical trials including but not limited to study start up, vendor management, subject recruitment, source document review and completion, protocol training, collection of regulatory documents, participant visits, timely data collection and documentation, management and reporting of adverse events, serious adverse events, and deviations, and monitoring visits and follow up.
-Ensure the creation, collection, and submission of regulatory documents to Sponsors and IRBs as required per protocol, GCP/ICH regulations, and IRB requirements.
-Create patient recruitment and study execution strategies are implemented so that timelines and recruitment expectations are met.
-Ensure good documentation practices are applied by all team members when collecting, maintaining, and correcting study data and required records of clinical trial activity including but not limited to source documentation, case report forms, queries, drug dispensation records, and regulatory forms.
-Communicate effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors.
-Mentor and train staff in the conduct of clinical trials, protocol requirements, communication, and trial management skills
-Collect and account for supplies from sponsors such as lab kits, ancillary supplies, and investigational products.
-Other duties as assigned.
Requirements & Skills:
-BS/BA in Life Sciences or related discipline and 4 years as a Clinical Research Coordinator OR
-Associate degree and 6+ years as a Clinical Research Coordinator OR
-High School Graduate and/or technical degree and 8+ years as a Clinical Research Coordinator
-Successful completion of GCP certification and Certified Clinical Research Coordinator (CCRC) certification preferred.
-Experience performing clinical assessments, including but not limited to obtaining vital signs, EKGs, blood draws, processing/shipping lab specimens.
-Excellent attention to detail, organization, and communication with varied stakeholders.
Skills
Adverse Event ReportingBlood DrawsCase Report FormsCCRC CertificationClinical Trial ManagementDrug Dispensation RecordsEKGsFDA RegulationsGCP CertificationIATA CertificationICH-GCPIRBLab Specimen ProcessingRegulatory Document SubmissionSOPSource Document ReviewSubject RecruitmentVital Signs
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