Posted in Other 30+ days ago.
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Type: Full Time
Location: Denver, Colorado
Job Code: 03058-5171
SUMMARY OF KEY RESPONSIBILITIES: Primary responsibility is to screen, enroll and follow study subjects, ensuring protocol compliance and close monitoring while the subjects are on study. Responsible for all data collection, source documentation, and recording of adverse events.
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.
* Uses the protocol as the only tool to screen, treat, and follow patients.
* Completes and documents screening/eligibility accurately.
* Completes and documents the informed consent process accurately and has all parties sign/date as required, including HIPAA Authorization.
* Accurately completes and submits on-study forms within two weeks of enrollment.
* Ensures that patient documentation is completed at each clinic visit while in screening.
* Ensures that all medications are approved prior to initiating treatment or when changing medication regimens, such as crossover studies.
* Accurately calculates and documents BSA, Creatinine Clearance, Urine Protein:Creatinine ratio, and any other calculations or conversions required per protocol.
* Ensure that follow-up appointments, scans, or related procedures are scheduled correctly according to protocol requirements.
* Documents appropriately when patients are removed from protocol.
* Ensures reconsent of patients at the next scheduled visit, following availability of updated ICF, and documents process appropriately.
* Attends monthly staff meetings, if required, and participates in start-up training for new studies.
* Maintains patient confidentiality according to ethical and legal requirements.
* Medical and research terminology
* FDA Code of Federal Regulations and GCP
* Sarah Cannon organizational policies, standard operating procedures and systems
* Clinical research processes
* Verbal and written communication skills
* Analytical, problem-solving, and multi-tasking skills
* Organizational skills
* Computer skills
* Public presentation skills
* Interpersonal skills
* Work independently in a fast-paced environment with minimal supervision
* Manage multiple ongoing priorities and projects
* Communicate and work effectively with a diverse team of professionals
Associate Degree Required
Bachelor Degree Preferred
EXPERIENCE: * Oncology experience, preferably heme/onc and/or transplant
* Experience in a clinical research setting
CERTIFICATION OR LICENSE:
RN license required
Research certification (ACRP or CCRP) preferred
Last Edited: 06/20/2018
Diversity is valued and actively promoted in the workforce at all levels. We strive to celebrate cultural and other differences and consider them strengths of the organization.
We are committed to:
Providing an inclusive work environment where everyone is treated with fairness, dignity and respect.
Recruiting and retaining a diverse staff reflective of the patients and communities we serve.
Equal employment opportunities are provided to all employees and applicants for employment without regard to race, color, religion, gender, national origin, citizenship, age, disability, sexual orientation, genetic information, gender identity, protected veteran status, or any other legally protected category in accordance to applicable federal, state, or local laws.
The policy applies to all terms and conditions of employment including, but not limited to, hiring, placement, promotion, termination, layoff, transfer, leaves or absence, compensation and training.