Position: Professional Research Coordinator
Classification: Exempt, 40 hours/week
Salary Range: $47,895-$58,585
Reports To: Principal Investigator and/or Supervisor
Position supports the organization’s medical/health science research programs, specifically oncology clinical trials. Executes day-to-day activities of clinical trials and successfully implements study design. Duties include the following aspects of clinical trials: preparation of trial documents and submission to regulatory boards for study approval and site initiation; subject recruitment, enrollment and retention; and appropriate data and specimen collection and management. May help manage fiscal negotiations under management oversight.
Essential Duties and Responsibilities:
Completes and Maintains Regulatory Submissions
Serves as primary point of contact at the clinical trial site with clinical services and provider, the investigational pharmacy, facilities, information technology, and other services required for successful completion of the studies.
Develops and submits regulatory packages to regulatory bodies including PRMS, VA RDC, SRS and study-specific IRBs including COMIRB, NCI CIRB, and other external IRBs across study lifecycle. Ensures accurate, timely reporting of relevant research-related study events (AEs, UAPs, PDs, e.g.) to the Institutional Review Board of note, study sponsor, and required oversight agencies. Responsible for escalating issues/concerns to all relevant stakeholders including adverse participant safety events, and other necessary communications. Works with VA and non-VA study monitors and oversight staff to ensure full compliance.
Maintains Investigator Site Files consisting of all records and materials pertaining to the clinical study, including participant files and related correspondence and regulatory documents. Prepares documentation and any requested VA progress reports for Institutional Review Board and Office of Research & Development staff. Develops and gives presentations/inservices on clinical trial performance and study results to local site staff, study Coordinating Center staff, and ORD staff as requested. Liaises with local Office of Communications to manage public relations activities and initiatives through VACO. Actively engages in initiatives generated by local site and VACO.
Recruits Candidates for Clinical Trials
Screens and evaluates candidates for clinical studies. Screens and assesses candidates for projects of limited complexity. Uses objective ratings techniques (inclusion/exclusion criteria) to identify potential candidates for participation in study. Recruits participants, providing information on study objectives and constraints, and ensuring ethical recruitment of all candidates. Randomizes candidates.
Performs study scheduling; tracks patient participation; administers patient interviews and prepares study assessments; interviews human subjects participating in studies; takes and records vital signs and performs basic physical exam metrology; obtains and processes study-specific laboratory specimens; coordinates diagnostic and non-diagnostic procedures. Engages with study participants to promote study retention and participant compliance. Records data derived from participant study visits, chart review, and external source documents to maintain robust datasets, within guidelines of the study protocol and full regulatory compliance.
Additional Responsibilities (commensurate with experience and programmatic needs)
Arranges teleconferences and prepares research meeting agendas and/or minutes; tracks workloads across multiple projects; develops SOPs for clinical trial management; contributes to process improvement efforts; develops documents required by VA Office of Research Development, VA Medical Center, and Research & Development committee for research grants and investigator-initiated research protocols, under direction of Supervisor; ensures timely and accurate completion of documents and all required/applicable approvals are secured prior to initiation of research activities; Prepares study documents including project planning information, manuals, recruitment materials, stakeholder communications and data collection materials.
· Job Knowledge: understands the position’s critical role in bringing state of the art cancer treatments to Veterans
· Time management: ensures internal and external deadlines are met
· Communication: excellent written and verbal communication with study team, subjects, and external stakeholders
· Focus: shows attention to detail in subject management and documentation
· Independent: Thrives working with position-appropriate responsibility and independence
· Life-long learner: Patient and enjoys learning new skills independently and from others
· Collaborative: must be willing to assist teammates in achieving programmatic goals
· Organized: must be able to work on several projects simultaneously.
Required Education and/or Experience:
· BA or BS in health-related fields or equivalent
· Computer proficiency required with excellence using Microsoft 360 applications (Word/Outlook/Excel/PowerPoint) preferred
· Phlebotomy preferred
· Experience working with veterans, patients with cancer, and in a health care setting preferred
· Experience with CPRS/VINCI/JLV preferred
· Experience utilizing electronic database (i.e. Medidata Rave, RedCap, OnCore) preferred
· Prior experience in areas of data entry, management grant submissions, budget management and data analysis preferred
This job operates in a business-casual office environment. The noise level in the work environment is usually low to moderate. This role routinely uses standard office equipment. Work is performed in typical healthcare and research settings including traditional office settings, hospital, and clinical research laboratory. The environment involves risks or discomforts that require normal safety precautions typical of such places as offices, hospital, and biomedical research laboratories.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
While performing the duties of this job, the employee is occasionally required to stand, walk, sit, use hands and fingers to handle or feel objects, tools or controls. Reach with hands and arms, climb stairs, talk or hear. The employee must occasionally lift or move office products and supplies up to 30 pounds.
Reasonable accommodations in the work environment may be made to enable individuals with disabilities to perform the essential functions.
Travel and/or Work Remotely
Position may involve some travel for training, collaboration with University of Colorado Cancer Center, site visits, attending conferences, and other meetings may be required.
Supervisory Responsibility: None or commensurate with experience and programmatic needs.
For all Full-Time Positions
Benefits for you and your family:
· 403(b) – employee match up to 5% eligibility from your first day
· Dental insurance
· Vision insurance
· Employee assistance program
· Flexible spending account
· Dependent Care account
· Health insurance
· Health savings account
· Paid time off
For all Full-Time and Part-Time Positions
DRI paid benefits after 30 days:
· Short Term Disability
· Long Term Disability
· Basic Life Insurance
FOR ALL DRI POSITIONS
Work Authorization/Security Clearance (if applicable)
· Candidate must be able to be federally badged via a WOC (without compensation) Letter as administered by the VA and to include any background tests or screenings as required by the VA.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.