HCA, Hospital Corporation of America Clinical Research Coordinator in Denver, Colorado

Summary of Key Responsibilities:The Clinical Research Coordinator, Blood Cancer/BMT is responsible for overall clinical operations of the facility’s blood cancer research program including enrollment, regulatory, quality, and site operations.

Duties and Responsibilities: Duties include but are not limited to: * Supports enrolling patients onto clinical trials through recruitment, screening, enrollment, treatment, and follow-up of eligible participants according to protocol requirements. * Reviews the study design and inclusion/exclusion criteria with physician and patient * Ensures the protection of study patients by verifying informed consent procedures and adhering to protocol requirements * Collects, completes, and enters data into study specific case report forms (CRFs) or electronic data capture systems within study required timelines * Ensures the integrity of the data submitted on case report forms or other data collection tools by careful source document review; monitors data for missing or implausible data * Ensures that adequate and accurate records are maintained for inspecting * Creates study specific tools for source documentation when not provided by sponsor * Generates and tracks drug shipments, lab kits, and other supplies as needed * Reports and follows up on serious adverse events as per the protocol and regulations * Implements study-specific communications * Responsible for accurate and complete documentation of protocol requirements according to site work instructions/SOPs * Tracks and reports adverse events, serious adverse events, protocol waivers, and deviations * Communicates all protocol-related issues to appropriate study colleagues and stakeholders * Maintains accurate and complete records, including regulatory documents, signed informed consent forms, source documentation, drug dispensing logs, screening and enrollment logs, and study communications * Coordinates regular site research meetings * Attends study-specific on-site meetings/visits, investigator meetings, conference calls, and other coordinator meetings, as required. * Ensure GCP, SOP, and protocol training and compliance of all team members * Problem solves clinical situations along with research staff as they arise * Assists in tracking of and reporting of quarterly goals for research program * Works closely with monitors, study teams and site staff to ensure quality study data * Supports strategic and tactical plans for site growth * Communicates site status through a weekly activity report to appropriate site/management colleagues * Represents the company vision to site colleagues and affiliated organizations

Knowledge: * Medical and research terminology * FDA Code of Federal Regulations and GCP * Sarah Cannon organizational policies, standard operating procedures and systems * Clinical research processes Skills: * Verbal and written communication skills * Analytical, problem-solving, and multi-tasking skills * Organizational skills * Computer skills * Public presentation skills

Abilities: * Interpersonal skills * Work independently in a fast-paced environment with minimal supervision at off-site facilities * Manage multiple ongoing priorities and projects * Communicate and work effectively with a diverse team of professionals

Education: Associate Degree Required Bachelor Degree Preferred

Experience: * At least one year of oncology experience, preferably heme/onc and/or transplant * At least one year of experience in a clinical research setting * At least one year of experience managing blood cancer and/or BMT clinical trials preferred

Certification or License: Research certification (ACRP or CCRP) RN or LPN preferred

Job: *Supervisors Team Leaders & Coordinators

Title: Clinical Research Coordinator

Location: Colorado-Denver-Denver Drug Development Unit

Requisition ID: 03058-5173