Clinical Research Coordinator (open rank) - LCPC / CPS Team jobs in United States
University of Colorado
- Clinical Research Coordinator (open rank) - LCPC / CPS Team
- $50K/yr - $50K/yr
- 0–2 years exp
Responsibilities
- The position will require understanding workflows and requirements for performing studies at both UCHealth and the Rocky Mountain Regional VA Medical Center
- Assist with and oversee the day-to-day operations of cancer prevention and survivorship research studies and clinical trials
- Independently abstracts and records all research subject data pertaining to the research protocol onto protocol-specific Case Report Forms (CRFs) and into clinical trials database in an accurate and timely fashion
- Obtain study subject’s medical history and current medication information, reviews research protocol inclusion/exclusion criteria, and confirms eligibility of subject to participate in clinical trial
- Perform informed consent process or ensures that the informed consent process has occurred, is properly documented, and that informed consent form documents are filed as required
- Interview prospective subjects for a variety of research clinical trials and educate potential subjects on the details of the studies through phone contacts and personal interviews
- Schedule subject participation in research clinical trial, coordinating availability of necessary space, and clinical research support (e.g., physician, nurse practitioner, laboratory, radiology, pharmacy)
- Collaborates with hospital staff to ensure tests and procedures, required by research protocols, are performed and documented (e.g., vital signs, phlebotomy, specimen processing, electrocardiograms (EKGs), research drug administration, and protocol-specific tests and procedures); follow-up with appropriate persons on missing or discrepant data
- Perform data entry for all assigned studies and subjects
- Meets with Monitors to respond to any question of data validity and corrects/revises data as appropriate; responds to queries from Sponsor
- Adhere to research regulatory standards
- Maintain detailed records of studies to ensure compliance with requirements of the Food and Drug Administration (FDA), study protocols, department, hospital/clinical standard operating procedures and other regulatory guidelines
- Assists with Sponsor, Data Safety Monitoring, and Food and Drug Administration (FDA) audits and responses
- As delegated by supervisor or manager, may participate in subject recruitment efforts, including communicating with patients expressing an interest and all pre-screening/screening activities
- Ensure that the necessary supplies and equipment for studies are in stock and in working order
- May assist with tracking protocol training and delegation of authority logs
- Schedules, coordinates, and prepares for Sponsor Monitor Visits and audits in collaboration with Regulatory personnel, Primary CRC and other research team members
- Independently master study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studies
- Independently perform study related processes, procedures, and assessments as defined in study protocol and in compliance with regulating bodies
- Assist Team Leads, Supervisors and/or management with creation and implementation of processes and procedures and quality improvement initiatives
- Act as a Primary Coordinator on multiple trials/studies
- Assist and train junior team members
- Assist with developing or develops protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs). Maintains subject level documentation and prepares documents, equipment and/or supplies
- Assist with identifying issues related to operational efficiency and shares results with leadership
- Employ, evaluate and assist with the implementation of innovative solutions to maximize recruitment and retention, efficiency and productivity within team
- Serve as a resource and participate in study initiation and close out duties
- May assist manager in review of study feasibility and site qualification/selection activities
Preferred
- Bachelor's degree in science or health related field
- Three (3) years of clinical research or related experience
- Experience with electronic data capture systems (e.g., EMR or EHR and data management systems)
- Additional certification (one of the following):
- CCRC – Certified Clinical Research Coordinator
- CCRP – Certified Clinical Research Professional
- CCRA – Certified Clinical Research Associate
Benefits
- Medical: Multiple plan options
- Dental: Multiple plan options
- Additional Insurance: Disability, Life, Vision
- Retirement 401(a) Plan: Employer contributes 10% of your gross pay
- Paid Time Off: Accruals over the year
- Vacation Days: 22/year (maximum accrual 352 hours)
- Sick Days: 15/year (unlimited maximum accrual)
- Holiday Days: 10/year
- Tuition Benefit: Employees have access to this benefit on all CU campuses
- ECO Pass: Reduced rate RTD Bus and light rail service
- You may be eligible to work a hybrid schedule after six months of employment. This benefit must be approved by your supervisor.
- Glassdoor
- 3.6
- University of Colorado offers higher education and serving as the catalysts in business, arts, health, and community growth.
- Denver, Colorado, USA
- https://www.cu.edu
- Late Stage
- Total Funding
- $0.5M
- Key Investors
- US Department of Energy
- "US Department of Commerce, Economic Development Administation"
- 2023-07-27
- Grant
- 2023-01-26
- 2021-04-06
- Grant· $0.5M
- Leadership Team
- Richard Schulick
- Professor and Chair of Surgery
Qualifications
- Bachelor's degree in any field
- A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis
- One (1) year clinical research experience or one (1) year of clinical (or related) experience
- Two (2) years' clinical research experience and/or one (1) year of clinical research experience and one (1) year of clinical (or related) experience
- An advanced degree (Masters or Doctorate) may be substituted for experience on a year for year basis if the degree is in a field of study directly related to the work assignment
- Applicants must be legally authorized to work in the United States without requiring sponsorship. We are unable to provide work visa sponsorship or employment authorization for this position now or in the future
- Knowledge and understanding of federal regulations and Good Clinical Practice (GCP)
- Ability to communicate effectively, both in writing and orally
- Ability to establish and maintain effective working relationships with employees at all levels throughout the institution
- Outstanding customer service skills
- Demonstrated commitment and leadership ability to advance diversity and inclusion
- Knowledge of basic human anatomy, physiology medical terminology
- Ability to interpret and master complex research protocol information
- Bachelor's degree in science or health related field
- Three (3) years of clinical research or related experience
- Experience with electronic data capture systems (e.g., EMR or EHR and data management systems)
- Additional certification (one of the following):
- CCRC – Certified Clinical Research Coordinator
- CCRP – Certified Clinical Research Professional
- CCRA – Certified Clinical Research Associate
- A combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year for year basis
- Two (2) years’ clinical research experience and/or one (1) year of clinical research experience and one (1) year of clinical (or related) experience
- An advanced degree (Masters or Doctorate) may be substituted for experience on a year for year basis if the degree is in a field of study directly related to the work assignment.
Required skills
- Clinical Practice (GCP), Clinical Research, Clinical Research Certifications CCRA, Clinical Research Certifications CCRC, Clinical Research Certifications CCRP, Electronic Data Capture Systems, Federal Regulations, Human Anatomy, Medical Terminology, Physiology
Preferred skills
- Additional certification (one of the following):, Bachelor's degree in science or health related field, CCRA – Certified Clinical Research Associate, CCRC – Certified Clinical Research Coordinator, CCRP – Certified Clinical Research Professional, Three (3) years of clinical research or related experience
