Sr. Clinical Research Coordinator (Pasadena, CA)

Profound Research•Pasadena, CA

3d•Onsite

About The Position

Profound Research partners with community physicians to offer clinical trials as a therapeutic option for their patients. The company provides infrastructure, regulatory compliance, and administrative operations so physicians can focus on patient care, helping patients access new therapies while maintaining the patient-physician relationship. The Senior Clinical Research Coordinator leads and coordinates assigned clinical trials, ensuring site activities comply with study protocols, applicable laws and regulations, organizational procedures, and ethical and scientific standards. The role includes study start-up, vendor management, recruitment, regulatory documentation, participant visits, data collection, safety reporting, and monitoring follow-up. The coordinator also develops recruitment and study-execution strategies, mentors and trains staff, and communicates with study participants, colleagues, sponsors, CROs, vendors, and leadership. This is an on-site role at a clinical or office facility. It requires prolonged sitting, standing, or walking; clear verbal and written communication; reading and interpreting detailed materials; navigating clinical facilities; and transporting supplies or work materials as needed. PPE may be required, and travel between company sites, meetings, or partner locations may be required. Reasonable accommodations may be made for individuals with disabilities.

Requirements

One of the following experience and education combinations: a BS/BA in Life Sciences or a related discipline and 4 years as a Clinical Research Coordinator; an associate degree and 6 or more years as a Clinical Research Coordinator; or a high school diploma and/or technical degree and 8 or more years as a Clinical Research Coordinator.
Experience performing clinical assessments, including obtaining vital signs, conducting EKGs, drawing blood, and processing or shipping lab specimens.
Excellent attention to detail, organization, and communication skills with varied stakeholders.

Nice To Haves

Successful completion of GCP certification.
Certified Clinical Research Coordinator (CCRC) certification.

Responsibilities

Maintain site compliance for clinical trial activities in accordance with research protocols, standards, applicable laws and regulations, policies, and procedures.
Maintain working knowledge of current FDA regulations, ICH-GCP guidelines, organizational SOPs, guidance documents, and assigned study protocols.
Complete required Profound Research training, including ICH-GCP and IATA certification, in a timely manner.
Lead, implement, and coordinate assigned clinical trials, including study start-up, vendor management, subject recruitment, source document review and completion, protocol training, regulatory document collection, participant visits, data collection and documentation, adverse event and serious adverse event management and reporting, deviations, monitoring visits, and follow-up.
Create, collect, and submit regulatory documents to sponsors and IRBs as required by protocols, GCP/ICH regulations, and IRB requirements.
Develop and implement patient recruitment and study-execution strategies to meet timelines and recruitment expectations.
Ensure good documentation practices are followed by team members when collecting, maintaining, and correcting study data and clinical trial records, including source documents, 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 clinical trial conduct, protocol requirements, communication, and trial management skills.
Collect and account for sponsor-provided supplies, including lab kits, ancillary supplies, and investigational products.
Perform other duties as assigned.