Sobre esta vaga de Clinical Research Site Manager (Munster, IN) na Profoundresearch
Profoundresearch · Presencial · Munster, IN
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 & 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).
-Responsible for immediate supervision and performance of the assigned site including conducting performance reviews as well as coaching, counseling, and implementing disciplinary action if needed.
-Responsible for ensuring appropriate training of all staff to ensure compliance and inspection readiness.
-Work closely with Operations and Business Development leadership on feasibility and study placement.
-Accountable for enrollment planning and success at sites across all studies; understand revenue expectations.
-Coordinate as primary CRC on at least one trial of medium to high complexity and serve as a back-up CRC for other study procedures and trials when needed. This includes completing all relevant training in a continued timely manner.
-Share best practices with other Profound site locations with the goal of raising the overall level of operational competencies at Profound.
-Work closely with the Quality Assurance team to ensure quality at the site; create processes and CAPAs to improve trends as needed.
-Identify and build relationships with outside medical practices, pharmacies, and other healthcare professionals/organizations to aid in the patient recruitment process.
-Act as a site liaison and champion by communicating effectively and professionally with coworkers, leadership, study subjects, sponsors, CROs, and vendors.
-Ensure weekly, monthly, and quarterly assigned goals are met for the respective sites.
-In addition to trial specific responsibilities, support in building and implementing a scalable operations infrastructure at new, regional Profound Research sites as needed.
-Other duties as assigned by leadership.
Requirements & Skills:
-Associate degree or BS / BA in Life Sciences or related discipline.
-8+ years prior experience as a clinical research coordinator
-3-5 years of direct line management responsibilities
-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.
-Demonstrated ability to foster concepts of teamwork, cooperation, self- control, and flexibility to get the work done.
-Excellent attention to detail, organization, and communication with varied stakeholders.
-Able to travel regionally and to professional meetings as required.
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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