Profound Research

Clinical trial site network for community physicians

Senior Clinical Research Coordinator

Clinical Research OperationsConfirmed live in the last 24 hours

Full-timePasadena, CA, USANo salary listed

About the Job

Requirements

A bachelor’s degree in life sciences or a related discipline and four years of experience as a Clinical Research Coordinator, or an associate degree and six or more years of experience as a Clinical Research Coordinator, or a high school diploma and/or technical degree and eight or more years of experience as a Clinical Research Coordinator.
Successful completion of Good Clinical Practice (GCP) certification and Certified Clinical Research Coordinator (CCRC) certification is preferred.
Experience performing clinical assessments, including obtaining vital signs, electrocardiograms (EKGs), drawing blood, and processing and shipping laboratory specimens.
Ability to communicate clearly verbally and in writing, read and interpret detailed materials, navigate a clinical facility, and transport supplies or work materials as needed.
Ability to wear personal protective equipment (PPE) in accordance with facility protocols when required.

Responsibilities

Maintain site compliance for all clinical trial activities in accordance with research protocols and standards, applicable laws, regulations, policies, and procedural requirements.
Maintain working knowledge of current Food and Drug Administration (FDA) regulations, International Council for Harmonisation Good Clinical Practice (ICH-GCP) guidelines, organizational standard operating procedures (SOPs), guidance documents, and assigned study protocols.
Complete required Profound Research training, including ICH-GCP and International Air Transport Association (IATA) certifications, in a timely manner.
Lead, implement, and coordinate assigned clinical trial duties, including 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, monitoring visits, and follow-up.
Ensure regulatory documents are created, collected, and submitted to sponsors and institutional review boards (IRBs) as required by the protocol, GCP/ICH regulations, and IRB requirements.
Create patient recruitment and study execution strategies and implement them to meet timelines and recruitment expectations.
Ensure all team members apply good documentation practices when collecting, maintaining, and correcting study data and required clinical trial records, including source documentation, case report forms, queries, drug dispensation records, and regulatory forms.
Communicate professionally with coworkers, leadership, study subjects, sponsors, contract research organizations (CROs), and vendors.
Mentor and train staff in clinical trial conduct, protocol requirements, communication, and trial management skills.
Collect and account for supplies from sponsors, including laboratory kits, ancillary supplies, and investigational products.
Perform other duties as assigned.
Perform the role on-site at a clinical or office facility, involving prolonged periods of sitting, standing, or walking.
Travel between company sites, meetings, or partner locations when required.

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.

Physical Requirements & Work Environment

This role is performed on-site at a clinical or office facility and requires prolonged periods of sitting, standing, or walking throughout the work environment
Requires the ability to communicate clearly in verbal and written forms and to read and interpret detailed materials
Must be able to navigate a clinical facility, including areas with limited space, and transport supplies or work materials as needed
May be required to wear personal protective equipment (PPE) in accordance with facility protocols
Travel between company sites, meetings, or partner locations may be required
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the role

Why Join Profound Research?

Meaningful Impact: Every role at Profound contributes to advancing medical knowledge and expanding therapeutic options for patients – the work we do here matters
Professional Growth: We invest in our people through comprehensive training, certification support, and ongoing education to help you grow in your role and your career
Leadership & Advancement: Profound is a place where initiative is recognized. We actively support internal growth and create pathways for people to take on greater responsibility over time
Collaborative Culture: You’ll work alongside a team of dedicated professionals who are passionate about clinical research and committed to doing it well
Full Benefits Package: Competitive compensation, health insurance, PTO, retirement plan, and professional development support
Diverse Clinical Exposure: Work across multiple therapeutic areas and study phases, building a breadth of experience that’s rare in a single organization

About the Company

Profound Research

Clinical trial site network for community physicians

Profound Research is a clinical research organization that operates a nationwide network of trial sites, partnering with community physicians to bring pharmaceutical and biotech studies into everyday medical practices. It recruits and enrolls patients from a combined database of more than 1.25 million people, coordinates site operations and investigator oversight, and runs studies across more than 15 therapeutic areas on behalf of trial sponsors. Its network spans 22 sites across four geographies, with over 1,000 providers, 110-plus active investigators, and more than 130 clinical trials conducted to date. What sets Profound Research apart is its model of embedding research infrastructure within existing community practices, giving physicians and their patients access to experimental treatments without leaving their local care setting. The goal is to expand patient access to new treatments while helping sponsors conduct trials through a community-based site network.

Company size: Not listed
Company stage: Not listed
Total funding: Not listed
Headquarters: Not listed
Founded: Not listed

Recently Posted Jobs

Explore more opportunities at Profound Research

See more jobs