Clinical Research Coordinator- Neurology (Detroit, MI)
Profound Research:
Profound Research seeks to drive clinical innovation by partnering with community physicians to offer clinical research as a therapeutic option to their patients. Profound enables providers with the right people and tools to launch clinical research operations, often for the first time, to offer new care pathways to patients. Profound Research is looking to grow its energetic team inspired by changing how patients and providers engage in clinical research.
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 value the patient-physician relationship above all else and are committed to a service-oriented approach to all interactions.
Urgency: We work hard and practice selflessness, acting swiftly and decisively to meet the needs of our patients, partners, and colleagues.
Solution Orientation: We are relentlessly positive, and we communicate directly to efficiently identify and implement effective solutions.
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.
Profound Ethos
o Physicians are the Vanguard
o All Decisions Improve Patient Care
o Never Compromise Quality
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)
Why Join Profound Research?
· Exposure to diverse therapeutic areas and cutting-edge treatments
· Supportive team environment with comprehensive training
· Opportunity to make a direct impact on patient access to innovative therapies
· Professional development in the growing field of clinical research