Sobre esta vaga de Clinical Research Coordinator (Detroit, MI) na Profoundresearch
Profoundresearch · Presencial · Detroit, MI
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.
Why this Role Exists
The Clinical Research Coordinator will manage all clinical trial activities under supervision in compliance with all applicable laws, regulations, and procedures of study protocol while maintaining company mission, vision and values.
Responsibilities
-Conduct and manage all clinical trial activities in accordance with established research protocols and standards in compliance with all applicable laws, regulations, policies, and procedural requirements.
-Complete all relevant Profound Research required training, including but not limited to ICH-GCP certification and IATA certification in a timely manner.
-Mentor and train staff in the conduct of clinical trials, protocol requirements, communication and trial management skills.
-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 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.
-Collect and account for supplies from sponsors such as lab kits, ancillary supplies, and investigational products.
-Other duties as assigned.
Requirements
-Bachelor’s degree and 2 years relevant experience in the life science industry OR
-Associate’s degree with 4 years relevant experience in the life science industry OR
-High School Graduate and/or technical degree with minimum of 6 years relevant experience in the life science industry AND 1 year
-Clinical Research Coordinator experience
-Successful completion of GCP certification and Certified Clinical Research Coordinator (CCRC) certification within 6 months of being in the role
-Experience performing clinical assessments, including but not limited to obtaining vital signs, EKGs, blood draws, processing/shipping lab specimens
-Proficient ability to work independently, plan and prioritize with minimal guidance
-Excellent attention to detail, organization, and communication with varied stakeholders
-Ability to work as a team player with the ability to adapt to changing schedules and assignments
Travel Requirements
Daily commute to site(s)
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
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