The Company Profound enables community physicians to offer clinical research as a therapeutic option to their patients. We provide all the infrastructure, non-clinical services, and administrative heavy lifting. The physicians practice medicine, we do everything else, and patients get access to the newest therapies available. Mission, Vision, Values o Mission: Improving Lives by Providing Advanced Therapeutic Options
o Vision: Creating the Absolute Best Patient-Physician Experience in Clinical Research. o Values: o Compassion: We value the patient-physician relationship above all else and are committed to a service-oriented approach to all interactions. o Urgency: We work hard and practice selflessness, acting swiftly and decisively to meet the needs of our patients, partners, and colleagues. o Solution Oriented: We are relentlessly positive, and we communicate directly to efficiently identify and implement effective solutions. o 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 Role: Senior Clinical Research Coordinator
Company: Profound Research
Locations: Colorado Springs, Colorado
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.
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\nPhysical Requirements · Prolonged periods of sitting at a desk and working on a computer, standing and walking. · Must be able to lift 25 pounds at times. · Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. · Talking: Expressing or exchanging ideas by means of the spoken word; those activities where detailed or important spoken instructions must be conveyed to other workers accurately, loudly, or quickly. · Hearing: Perceiving the nature of sounds at normal speaking levels with or without correction and having the ability to receive detailed information through oral communication and making fine discriminations in sound. · The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes.