Senior Research Project Coordinator

About the role

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.

Responsibilities

• Aid in 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.
• Perform study related processes, procedures, and assessments as defined in study protocol and in compliance with regulating bodies.
• Develop or develop protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs).
• Organize and coordinate a multi-site in-person investigator meeting, including agenda development, logistics, and communication with participating investigators and stakeholders.
• Coordinate and track regulatory submissions and documentation, including site regulatory packets, amendments, and required study updates.
• Prepare and execute subcontracts and site agreements in collaboration with institutional administrative offices.
• Process and track site invoices and payments to ensure timely reimbursement to participating sites.

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.

Qualifications

• 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.

Skills

• Knowledge and understanding of federal regulations and Good Clinical Practice (GCP).
• Effective communication skills, both in writing and orally.
• Establishing and maintaining effective working relationships with employees at all levels throughout the institution.
• Outstanding customer service skills.
• Knowledge of basic human anatomy, physiology, and medical terminology.
• Exceptional organizational skills.
• Demonstrated interpersonal skills.
• Professionalism and confidentiality in all interactions.
• Collaborative research environment that promotes scientific excellence and respect for all individuals.
• Advanced proficiency with excel and other Microsoft Office programs.

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: 15/year.
• Tuition Benefit: Employees have access to this benefit on all CU campuses.
• ECO Pass: Reduced rate RTD Bus and light rail service.

Why work for the University?

The University of Colorado offers an excellent benefits package including:

• 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: 15/year.
• Tuition Benefit: Employees have access to this benefit on all CU campuses.
• ECO Pass: Reduced rate RTD Bus and light rail service.