Open Rank Clinical Research Coordinator (Intermediate – Senior)

University of Colorado•Aurora, CO

7d•Onsite

About The Position

As an important member of the research team, the Clinical Research Services Professional 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. This position communicates appropriately and effectively with study subjects, investigators, and other team members and has outstanding customer service skills, a high standard of professionalism, 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. For this position specifically, we are seeking a member to join Dr. Wani and his research team at the University of Colorado Anschutz Medical Campus. The successful candidate will be a part of a team that includes supportive research personnel (regulatory, budget, coordinators) and medical personnel, all led by the principal investigator and the GI division research leadership. The candidate will participate in clinical research projects including studies examining esophageal diseases and therapeutic endoscopy. The position requires an ability to work independently but collaboratively, have attention to detail, and be able to maintain organized protocol documentation and data. Furthermore, the Clinical Science Professional will have the opportunity to manage and lead teams. The studies we conduct require in-person and telephone interactions with participants/patients/staff; thus, we are seeking a candidate who is a “people person” and can interact well with others.

Requirements

Intermediate Level: Bachelor’s degree in any field. One (1) year of clinical research or related experience.
Senior Level: Bachelor’s degree in any field. Two (2) years of clinical research or related experience.
Substitution: 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.
Applicants must be legally authorized to work in the United States without requiring sponsorship.
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.
Demonstrate exceptional organizational skills.
Demonstrated interpersonal skills.
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

Coordinate day-to-day operations of clinical research studies, independently managing study activities in accordance with study protocols, institutional requirements, FDA regulations, and ICH/GCP guidelines.
Serve as a primary coordinator for assigned clinical trials and research studies, managing study activities from initiation through active enrollment, follow-up, and study closeout.
Coordinate participant recruitment and study visits, including pre-screening and screening, eligibility review, informed consent, participant education, scheduling, and protocol-required procedures and assessments.
Maintain regulatory and study documentation to ensure research activities and records are accurate, complete, timely, and compliant with applicable regulatory, institutional, protocol, and sponsor requirements.
Manage clinical research data and study quality, including source documentation, data collection and entry, case report forms, data queries, monitoring activities, and resolution of data discrepancies.
Collaborate with investigators, sponsors, monitors, research participants, and multidisciplinary clinical and research teams to facilitate study activities, address operational issues, and meet study goals and timelines.
Support research operations and continuous improvement by developing study-specific workflows and tools, assisting with study start-up and close-out, identifying opportunities to improve processes, and providing guidance or training to junior research staff.