Clinical Research Associate I

Job Detail

• Job Title:

  Clinical Research Associate I

• Department:

  10520-Neag Cancer Center (SOM)

• Location:

  Farmington

• FTE%:

  1

• Shift

• Search #:

  2025-1126

• Closing Date:

  04/10/2025

• Recruiter:

  Rucker, Pamela S.

Additional Links:

• This position is Benefit eligible; click here for an overview of available benefits.
• This position is covered by the UHP Bargaining Unit; click here to review the current UHP Contract.
• This position is in salary group UHP-10; click here to review the current UHP Pay Plan

Excellence, Teamwork, Leadership and Innovation. These are the values that define UConn Health, and we are looking for team members that share these same values. Our top rated organization is looking to add a Clinical Research Associate 1 in the Neag Comprehensive Cancer Center Clinical Trials Office to our growing team. If you have a background in this field, as well as a passion for customer and patient experience, we want to hear from you.

SUPERVISION RECEIVED:

Works under the limited supervision of an employee or a higher rank.

SUPERVISION EXERCISED:

Leads clinical research assistants and technicians, clerical or other staff members of lower rank as assigned.

COMPREHENSIVE BENEFITS OFFERED:

• Industry-leading health insurance options and affordability

• Generous vacation and sick-time plans

• Multi-channel retirement options (pension and match options)

• Tuition waiver and reimbursement for employees and qualified family members

• Quick commute access from I-84, Rte 9 and surrounding areas

• State of the art facility and campus environments

• Progressive leadership and educational development programs available

SCHEDULE: Full time, 40 hours per week, 8:00 a.m. to 4:30 p.m., flexibility required to accommodate research needs and may include weekends and holidays, 30 minute unpaid meal break.

EXAMPLES OF DUTIES:

• Coordinates activities related to research subjects according to study protocols

• Screens and evaluates subjects for research protocols.

• Verifies that subject eligibility requirements have been properly documented and supported by source documents.

• Develops study tools and checklists Collaborates with IT / EPIC teams to activate studies within the EMR

• Obtains informed consent according to local and federal requirements. Documents and reports adverse events and serious adverse events to sponsors, IRBs, and funding agencies, as needed

• Documents and assists in the reporting of protocol deviations to the IRB

• Completes case report forms.

• Actively participates in meetings with study team, Principal Investigators and sponsors

• Actively participates in site initiation visits, audits, monitoring visits, and close out visits.

• Assists with storage, preparation, and shipping of research specimens.

• Prepares submissions to the IRB and as needed, the Institutional Biosafety Committee (IBC), including but not limited to initial applications, amendments, continuing reviews, and safety reporting.

• Creates and maintains regulatory files for each study.

• Oversees the maintenance and delegation of authority logs and documentation of training of key personnel on assigned studies.

• Assists in the development and revisions to Protocol and Informed Consent Documents

• Ensures end of study requirements have been obtained and all protocol specific documents are present for study terminations

• Performs other duties as assigned.

MINIMUM QUALIFICATIONS REQUIRED

KNOWLEDGE, SKILL AND ABILITY:

• Considerable knowledge of clinical research protocols, principles and procedures

• Considerable knowledge of clinical trials and other clinical research methods such as screening, interviewing, reviewing case report forms, reviewing medical records

• Considerable knowledge of experimental design, mathematics, statistics, computer applications and procedures and computerized databases

• Considerable knowledge of a science such as biology or psychology

• Oral and written communication skills

• Managerial, interpersonal and organizational skills

• Ability to identify, produce, organize, analyze, evaluate and interpret data

• Knowledge of regulatory procedures (e.g. informed consent, IRB applications, FDA regulations) involved with clinical research

• Ability to work as a member of a project team and independently

• Supervisory ability

EXPERIENCE AND TRAINING :

GENERAL EXPERIENCE:

Master's Degree in basic science or clinical sciences, plus two (2) years of clinical research experience.

SUBSTITUTIONS ALLOWED:

• Bachelor's Degree in basic science or clinical sciences and three (3) years of clinical research experience or

• Certification as a Clinical Research Coordinator (CCRC) by SOCRA or equivalent with ten (10) years of appropriate practical clinical research experience. If not certified at the time of hire must take and pass the certification within one (1) year of employment.

PREFERRED REQUIREMENTS:

• At least one (1) year clinical research coordinator experience in interventional and non-interventional oncology trials.

• At least two (2) years experience managing regulatory/IRB clinical research activities in oncology trials

• Experience working with UConn Health IRB and Centralized IRB systems

GENERAL GUIDELINES

• Proactively manages, coordinates and delivers comprehensive oncology care in accordance with the IRB approved protocol, local and Federal requirements and accepted standards of care.

• Must be competent, knowledgeable, and capable of independent decision-making, multitasking and assisting personnel.

• Must maintain current working knowledge of DHHS, FDA, OHRP, NIH, GCP, and HIPAA regulations, laws and policies, and oncology principles, as they presently exist, as they change, or as modified.

• Understands and adheres to UConn Health Compliance Standards as they appear in policy, Code of Conduct and Conflict of Interest policy.

Why UConn Health

UConn Health is a vibrant, integrated academic medical center that is entering an era of unprecedented growth in all three areas of its mission: academics, research, and clinical care. A commitment to human health and well-being has been of utmost importance to UConn Health since the founding of the University of Connecticut schools of Medicine and Dental Medicine in 1961. Based on a strong foundation of groundbreaking research, first-rate education, and quality clinical care, we have expanded our medical missions over the decades. In just over 50 years, UConn Health has evolved to encompass more research endeavors, to provide more ways to access our superior care, and to innovate both practical medicine and our methods of educating the practitioners of tomorrow.