Research Coordinator

Colorado Urology Associates; Denver (CO); Presencial; USD 37.000 - 44.000; Jornada completa

Descripción de la vacante

Colorado Urology Associates seeks a Research Coordinator to screen, enroll, and track subjects across Phase I–IV trials, ensuring protocol compliance and ongoing safety. You will work with investigators and staff to manage recruitment, documentation, and study logistics in a fast-paced clinical setting.

The role requires at least two years in clinical research, familiarity with FDA/ICH guidelines, HIPAA, and strong communication skills.

Formación

• Minimum High School Diploma or GED.
• Minimum of two years of clinical research experience.
• Certification of accreditation (CCRC/IATA/CPR/NIH/CITI) required and will be verified.

Responsabilidades

• Screen, enroll, and follow study subjects for Phase I–IV clinical trials.
• Ensure protocol compliance and close monitoring of subjects.
• Coordinate with Principal Investigator and sponsor/CRO per SOP.

Conocimientos

Customer service

Attention to detail

Clinical assessments

GCP knowledge

HIPAA compliance

Multitasking

Typing speed

Educación

High school diploma or GED

Certifications: CCRC, IATA, CPR, NIH, CITI

Descripción del empleo

Why Join Us?

At Colorado Urology, we believe our people are the foundation of our success. When you join our team, you become part of an organization committed to exceptional patient care, clinical excellence, innovation, and continuous growth. We foster a collaborative and supportive culture where employees are valued, empowered, and encouraged to make a meaningful impact every day. Whether you’re just starting your career or looking to take the next step professionally, you’ll find opportunities to learn, grow, and thrive while helping improve the lives of the patients and communities we serve.

We offer competitive compensation and a healthy work-life balance, allowing you to enjoy your evenings and weekends. Employees also enjoy an outstanding benefits package, including health, dental, and vision insurance, tuition reimbursement, employee assistance programs, corporate discounts, paid time off, and much more. At Colorado Urology, you’ll find more than a job, you’ll find a rewarding career with purpose.

Job Description

The Research Coordinator will screen, enroll,and follow study subjects for Phase I, II, III,and IV clinical trials,ensuring protocol compliance and close monitoring while the subjects are on study.

Primary Duties & Responsibilities

Conducting Clinical Trials

• Review with the Principal Investigator (PI) the inclusion/exclusion criteria, overall structure, and requirements of each protocol and ensure logistics for site implementation.
• Review the protocol and the informed consent form for accuracy and clarity.
• Develop and implement strategies for subject recruitment and ongoing communications with all physicians, research staff, and office staff.
• Complete new trial feasibilities upon review with potential Investigator and submit to Sponsor/CRO. Complete and submit CDA to Sponsor/CRO in accordance with site Standard Operating Procedures (SOP).
• Schedule site Sponsor visits in accordance with internal SOP.
• Prepare study charts, binders,and supplies for offsite storage in conjunction withtheRegulatory Specialist, when applicable.
• Ensure maintenance and calibration of site study required equipment.

Enrollment of Study Subjects

• Review the study design and inclusion/exclusion criteria with the PI/SI, and if needed the Sponsor to ensure understanding.
• Review, verify,and record/collect all relevant documentation in the subject’s medical record needed to confirm study eligibility.
• Review the protocol, informed consent form, andfollow-upprocedures with the potential study subjects.
• Ensure the current approved informed consent is signed before subjects are screened and enrolled.
• Inform and document notification ofthesubject’sPrimary Care Physician of trial participation if approved by the subject.
• Perform delegated Protocol specific tasks as assigned by Principal Investigator.
• Ensure that the randomization procedures are followed and documented per protocol guidelines.
• Document protocol exemptions and deviations, as appropriate. Ensure duplication of each for filing inthesubject source and withtheregulatory specialist.
• Ensure all procedures and documentation of subject participationarekept in accordance with FDA regulations, ICH guidance,and internal SOP.

Follow-Up Procedures

• Schedule subjects forfollow-upvisits,collectsubjects’responsesto therapy,and interviewsubjectsfor adverse events and changes to concomitant medications. Ensuring that a review of EMR is made during thesubjectvisit for any notable medical/medication changes fromthelast research visit.
• Review laboratory data and communicate abnormal values to the PI/SIandas needed, primary care provider or specialist if additional medical attention is needed.
• Assess and document subject compliance and accountability with Investigational Product(IP). Document re-education when appropriate.
• Communicate with research staff toensuretimely and accurate study drug distribution when applicable.
• Administer study drug therapy as needed andmaintainthe study drug dispensing log if a pharmacist is not involved.
• Record all Adverse Events outlined in protocol and reviewthemwith the PI/SI.
• Report all Serious Adverse Events to the principal investigator, sponsor, and IRB as outlined in the protocol and site SOP. If need be,contactthesubject’s primary care physician or specialist.

Administrative/Clerical

• Reporting all Deviations/Adverse/SAEwithin Sponsor/IRB’s timeframe and in accordance with site SOP.
• FollowSOPs/GCPs/HIPPA according to the site, sponsor, ICH,and FDA.
• Maintenance of accurate and complete documentation,including but not limited to signed informed consent forms, source documentation, drug dispensing logs, subject logs, andstudy-relatedcommunications.
• Follow up and document outstanding action items on Monitoring reports, ensure PI/SI oversight,and that the site Regulatory Specialist receives reviewed/corrected/signed copy ofthereport.
• File appropriate regulatory or Sponsor communications withthesite Regulatory Specialist.
• Create and maintain Master Subject Log and VisitLog.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities required of the employee for this job. Duties, responsibilities, and activities may change at any time,with or without notice.

Qualifications

• Minimum High School Diploma or GED required.
• Minimum of two (2) yearsofclinical research experience.
• Maintained certification of accreditation (CCRC/IATA/CPR/NIH/CITI)required and will be verified prior to employment.

Knowledge, Competencies & Skills

• Exceptionalcustomer service skills.
• Strong attentionto detail,awillingnessto learn& theability to stay organized.
• Ability to perform clinical assessments.
• Strong understanding of FDA clinical trial phases I-IV.
• Strong understanding of GCP set forth by the ICH.
• Proficient knowledge of medical terminology.
• Proficient knowledge ofResearch-relatedTerminology.
• Strong communication skills, both verbal & written.
• Proficient computer software and database skills.
• Comfortable working in a fast-paced environment.
• Very comfortable asking probing questions to patients, if applicable.
• Must demonstrate a caring, compassionate, and patientattitude.
• Maintain HIPAA compliance.
• Multitasking and proactiveproblem-solving.
• Ability to type a minimum of 40 words per minute.

Job Type

Full-Time

Pay Range

$27.00 - $32.00 per hour

Actual compensation offered to candidates is based on work experience, education, skill level, and geographic location. Compensation may vary depending on the state or region in which the position is located, in accordance with applicable laws.

Equal Opportunity Employer

Our Practice is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, age, sex, national origin, disability, veteranstatus, or sexual orientation.

The successful candidate(s) for any UUG position will be subject to a pre-employment background check.