Research Services Intermediate – Senior Professional

University of Colorado•Aurora, CO

5d•$54,302 - $74,673•Onsite

About The Position

The Department of Ophthalmology has an opening for 1.0 FTE clinical intermediate – senior professional to support our Cornea division. The successful candidate will coordinate clinical studies, assists with adherence to IRB/regulatory requirements, enroll and correspond with study participants, act as liaison to industry sponsors of research studies, clinical research organizations, the Federal Drug Administration, and other participating centers, maintain study databases and files, create and monitor study budgets and generate and process invoices. Provide ophthalmic assistance to the Cornea division faculty, fellow and rotating resident, providing ancillary screening and testing as necessary.

Requirements

Bachelor's degree from an accredited institution and 1 year of professional experience in clinical research (Intermediate Professional)
Bachelor's degree from an accredited institution and 2 years of professional experience in clinical research (Senior Professional)
A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor’s degree on a year for year basis.
Applicants must meet minimum qualifications at the time of hire.
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 medical terminology
Ability to interpret and master complex research protocol information
Applicants must be legally authorized to work in the United States without requiring sponsorship. We are unable to provide work visa sponsorship and employment authorization for this position now or in the future.

Nice To Haves

Bachelor’s degree in science or health related field (Intermediate Professional)
Two (2) years of clinical research or related experience (Intermediate Professional)
Experience with electronic data capture systems (e.g. EMR or EHR and data management systems) (Intermediate Professional)
Qualified Ophthalmic Technician. Completion of two year training program in Ophthalmic Technology from an AMA and JCAHPO approved school AND two years of clinical and /or laboratory experience conducting preliminary screening and vision testing including specialized tests such as refractometry and visual fields OR an equivalent combination of training and experience (Intermediate Professional)
Preferred experience in coordinating clinical trials. (Intermediate Professional)
Previous experience in Ophthalmology desirable. (Intermediate Professional)
Bachelor’s degree in science or health related field (Senior Professional)
Three (3) years of clinical research or related experience (Senior Professional)
Experience with electronic data capture systems (e.g. EMR or EHR and data management systems) (Senior Professional)
Qualified Ophthalmic Technician. Completion of two year training program in Ophthalmic Technology from an AMA and JCAHPO approved school AND two years of clinical and /or laboratory experience conducting preliminary screening and vision testing including specialized tests such as refractometry and visual fields OR an equivalent combination of training and experience (Senior Professional)
Preferred experience in coordinating clinical trials. (Senior Professional)
Previous experience in Ophthalmology desirable. (Senior Professional)

Responsibilities

Assist with and oversee the day to day operations of clinical trials and studies
Obtain study subject’s medical history and current medication information, reviews research protocol inclusion/exclusion criteria, and confirms eligibility of subject to participate in clinical trial
Perform informed consent process or ensures that the informed consent process has occurred, is properly documented, and that informed consent form documents are filed as required
Interview prospective subjects for a variety of research clinical trials. Educate potential subjects on the details of the studies through phone contacts and personal interviews
Schedule subject participation in research clinical trial, coordinating availability of necessary space, and clinical research support (e.g., physician, nurse practitioner, laboratory, radiology, pharmacy)
Collect, code, and analyze data obtained from research in an accurate and timely manner
Adhere to research regulatory standards
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
Participate in subject recruitment efforts, including communicating with patients expressing an interest and all pre-screening/screening activities
Ensure that the necessary supplies and equipment for studies are in stock and in working order
Independently master study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studies
Independently perform study related processes, procedures, and assessments as defined in study protocol and in compliance with regulating bodies
Assist Team Leads, Supervisors and/or management with creation and implementation of processes and procedures and quality improvement initiatives
Act as a Primary Coordinator on multiple trials/studies
Assist and train junior team members
Assist with developing or develops protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs). Maintains subject level documentation and prepares documents, equipment and/or supplies
Assist with identifying issues related to operational efficiency and shares results with leadership
Collect information to determine feasibility, recruitment and retention strategies. Employ, evaluate and assist with the implementation of innovative solutions to maximize recruitment and retention
Serve as a resource and participate in study initiation and close out duties