Clinical Research SURVENT Project Coordinator

University of Colorado•Aurora, CO

1d•$58,705 - $78,665•Onsite

About The Position

As an important member of the research team, the Clinical Research SURVENT Project Coordinator works with industry-sponsored, co-operative group and/or investigator-initiated clinical trials in accordance with the trial protocols, FDA Regulations, and ICH/GCP Guidelines. This position is accountable for meeting study-specific goals and timelines, while also performing and assisting with clinical tasks related to study-specific tests, procedures, and treatments as assigned based on appropriate licensure and/or completion of competency documentation and team needs. The Project Coordinator communicates appropriately and effectively with study subjects, investigators, and other team members and has outstanding customer service skills and accepts responsibility in maintaining relationships that are equally respectful to all. This position is responsible for the implementation and coordination of clinical trials and investigator-initiated studies conducted by Dr. Sachin Wani and colleagues at the University of Colorado.

Requirements

Bachelor’s degree in any field.
Two (2) years clinical research or related experience.
An advanced degree (Masters or PhD) 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 meet minimum qualifications at the time of hire.
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.
Knowledge of basic human anatomy, physiology, and medical terminology.
Ability to interpret and master complex research protocol information.
Exceptional organizational skills.
Demonstrated interpersonal skills.
Ability to maintain professionalism and confidentiality in all interactions.
Contribute to a collaborative research environment that promotes scientific excellence and respect for all individuals.
Advanced proficiency with excel and other Microsoft Office programs.

Nice To Haves

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).
Experience with project management, financial coordination and regulatory oversight.

Responsibilities

Assist with and oversee the day-to-day operations of clinical trials and studies.
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.
Serve as the primary operational contact for participating sites involved in the SURVENT study.
Provide training and onboarding for site investigators and research staff on study protocols, procedures, and study documentation.
Provide guidance and respond to questions regarding biospecimen collection, processing, storage, and shipment requirements.
Collect information to determine feasibility, recruitment and retention strategies. Employ, evaluate and assist with the implementation of innovative solutions to maximize recruitment and retention.
Serve as a resource and participate in study initiation and close out duties.
Other duties as assigned.