Assistant Administrator/Research Specialist

Job Details

Job Location
Lakewood Clinic - Lakewood, CO

Position Type
Full Time

Education Level
4 Year Degree

Salary Range
$80000.00 - $85000.00 Salary/year

Travel Percentage
Up to 25%

Job Category
Research

Description

Are you interested in making a difference in patient care? Learn about our unique culture of respect, growth, innovation, the best patient care, and how we give back to the community.

At United Urology Group, our employees are at the heart of our mission and have incredible opportunities to impact our patients' lives with their urologic care.

• We foster a culture that thrives on compassion, teamwork, integrity, and diversity, all of which start with our staff!
• We deliver a cohesive approach to urologic care that provides patients with access to experienced specialists, a superb team of healthcare professionals, and the most advanced technology for patient treatments and therapies.
• We offer competitive salaries and a great work/life balance: enjoy your weekends!
• UUG offers outstanding benefits, including tuition reimbursement, health, dental, and vision insurance, corporate discounts, and much more!

United Urology Group is regarded as the leading urology network in the country. Our Affiliates include Chesapeake Urology, Arizona Urology-Phoenix & Scottsdale, Arizona Urology-Tucson, Colorado Urology, and Tennessee Urology.

Position Summary:

The Assistant Administrator/Research Specialist is responsible for screening, enrolling, and following study subjects for Phase I, II, III, and IV clinical trials, ensuring protocol compliance and close monitoring while the subjects are on study. This position handles more complex clinical trials and functions in a leadership capacity to resolve Site/sponsor-related issues for the site and assists the research administration in supporting Good Clinical Practice (GCP).

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 of more complex clinical trials.
• 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/CRO visits in accordance with internal SOP.
• When applicable, prepare study charts, binders, and supplies for offsite storage in conjunction with the Regulatory department.
• Ensure maintenance and calibration of site study required equipment and logs of temperature compliance for related equipment.

Enrollment of Study Subjects

• Review the study design and inclusion/exclusion criteria with the PI/SI and, if necessary, 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, and follow-up procedures with the potential study subjects.
• Ensure the current approved informed consent is signed and the process documented before subjects are screened and enrolled.
• Inform and document notification of the subject's Primary Care Physician of trial participation if approved by the subject.
• Perform delegated Protocol specific tasks as assigned on the Delegation of Authority Log.
• Ensure that the randomization procedures are followed and documented as required per protocol and GCP.
• Document protocol exemptions and deviations, as appropriate. Ensure deviations are accurately uploaded into the site's clinical trial management system (CTMS).
• Ensure all procedures and documentation of subject participation are kept in accordance with FDA regulations, ICH guidance, and internal SOPs.

Follow-Up Procedures

• Schedule subjects for follow-up visits and any protocol-required assessments; collect subjects' responses to therapy and interview subjects for adverse events and changes to concomitant medications. Ensure that an EMR review is made during the subjects' visit for any notable medical/medication changes from the last research visit.
• Review laboratory data and communicate abnormal values to the PI/SI and, as 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 to ensure timely and accurate study drug distribution when applicable.
• Administer study drug therapy as needed and maintain the study drug dispensing log if a pharmacist is not involved in the study.
• Record all Adverse Events as outlined in protocol and review them with the PI/SI.
• Report all serious adverse events to the principal investigator, sponsor, and IRB as outlined in the protocol and site SOP. If necessary, contact the subject's primary care physician or specialist.

Administrative/Clerical

• Complete CDA, feasibility, and study start-up process for new trials.
• Reporting all Deviations/Adverse/SAE within Sponsor/IRB's timeframe and in accordance with site SOP.
• Follow SOPs/GCPs/HIPAA 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, and study-related communications.
• 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 of the report.
• File appropriate regulatory or Sponsor communications in CTMS and/or Regulatory Binder.
• Perform Regulatory tasks assigned by Regulatory Specialist.
• Create and maintain Master Subject Log, Visit Log, and/or CTMS, as appropriate.
• Attend Sponsor/CRO Investigator Meetings.
• At the request of the Administrator, works to resolve Site/sponsor-related issues made by other team members on unassigned trials.
• Provides an annual GCP and good source documentation-focused training session for all site coordinators/research assistants and an onboarding session for new hires.

Project Coordination

• Oversees and coordinates research projects from inception to completion, including CDA assignment (for all CURA research coordinators) and execution, to ensure faster implementation of study start-up and site activation.
• Assist in planning and executing internal monitoring of research protocols.

Mentorship and Training

• Assist the Administrator in mentoring new hires (research coordinators and assistants), providing guidance and support as needed.
• Conduct focused training sessions and workshops for all site coordinators and research assistants.
• Provide onboarding to new hires, including investigators, throughout the practice.

Communication and Liaison

• Liaison with team members, sponsors, and the administrative team to facilitate communication that aligns with departmental goals.

Subject Recruitment

• Develop and implement effective recruitment strategies to identify and enroll eligible subjects for clinical trials.
• Collaborate with investigators and site coordinators to ensure recruitment goals are met.
• Monitor recruitment progress and adjust strategies as necessary to maintain a steady flow of participants.

Daily Support

• Serve as the daily "Go To" for all coordinators, addressing issues related to monitoring, equipment needs, ordering site supplies, protocol design, and everyday challenges (e.g., Investigators, sponsors, and subjects).

Administrative Coverage

• Provide coverage for the Administrator when she is out of the office.

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

Qualifications:

• Bachelor's degree preferably in science or related field or equivalent level of education and/or experience required.
• Prior Five (5) + clinical research experience.
• Maintained certification of professional accreditation (CCRC/IATA/GCP/Protecting Human Subjects).

Knowledge, Competencies & Skills:

• Exceptional customer service skills.
• Strong attention to detail, a willingness to learn & the ability to stay organized.
• Ability to perform clinical assessments.
• Exceptional knowledge of FDA clinical trial phases I-IV.
• Exceptional knowledge of GCP set forth by the ICH.
• Exceptional knowledge of medical terminology
• Exceptional knowledge of clinical research-related terminology.
• Strong understanding of regulatory requirements.
• Strong communication skills, both verbal & written.
• Proficient computer software and database skills.
• Comfortable working in a fast-paced environment.
• Very comfortable asking examining questions to patients, if applicable.
• Must demonstrate a caring, compassionate, and patient attitude.
• Maintain HIPAA compliance.
• Multitasking and proactive problem-solving.

Direct Reports:

• N/A.

Travel:

• Must have the ability & willingness to travel to other sites as necessary within a geographic region.
• There will be out of state travel required for meetings and/or conferences.
• Travel can, at times, include weekend days.

Physical Requirements for the Job:

• Regularly required to sit and stand for extended periods.
• Involves standing, sitting, walking, bending, stooping, and twisting.
• Requires full range of body motion, including manual and finger dexterity and eye-hand coordination.
• Occasionally lifts and carries items weighing up to 25 lbs.

Equal Opportunity Employer: United Urology Group and its affiliate practices are an equal opportunity employer. We do not discriminate based on race, color, religion, age, sex, national origin, disability, veteran status, or sexual orientation.

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

Actual compensation offered to candidates is based on work experience, education, and skill level.