Sr. Clinical Research Coordinator (Pasadena, CA)

Profound Research•Southern California, CA

1d•Onsite

About The Position

Profound Research partners with community physicians to offer clinical trials as a therapeutic option for their patients, providing infrastructure, regulatory compliance, and administrative operations so physicians can focus on patient care. The Senior Clinical Research Coordinator leads and coordinates assigned clinical trials, maintains site compliance, and supports patient recruitment, study execution, regulatory documentation, participant visits, data collection, and study monitoring. The role also mentors and trains staff and communicates with study participants, coworkers, leadership, sponsors, CROs, and vendors. This position is performed on-site at a clinical or office facility in Pasadena, California, and may require travel between company sites, meetings, or partner locations.

Requirements

Bachelor of Science/Arts in Life Sciences or a related discipline and 4 years of experience as a Clinical Research Coordinator; or an associate degree and 6 or more years of experience as a Clinical Research Coordinator; or high school graduation and/or a technical degree and 8 or more years of experience as a Clinical Research Coordinator.
Experience performing clinical assessments, including obtaining vital signs, EKGs, and blood draws, and processing and shipping laboratory specimens.
Excellent attention to detail, organization, and communication 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, applicable laws and regulations, policies, and procedures.
Maintain working knowledge of 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 deviation management and reporting, and 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 team members follow good documentation practices for study data and 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.