Research Coordinator - Clinical (Project Management)

Colorado Retina has an exciting opportunity for a Full-Time Research Coordinator - On-Call not required!
Colorado Retina is a thirteen physician, sub-specialty eye care practice providing medical and surgical care of vitreoretinal eye disease. We provide comprehensive treatment for age-related macular degeneration (AMD), diabetic retinopathy, retinal vascular disease, retinal detachments, ocular tumors, uveitis/inflammatory eye disease, inherited retinal degenerations and numerous other vitreoretinal conditions.

We are proud to be the largest retina practice in the Rocky Mountain region with the ability to collaborate as a team for highly complex cases. We provide five service locations in the Denver Metro area: East Denver (Central Park), Cherry Creek, Lakewood, Lafayette, Parker, and Summit County.
Colorado Retina Associates is complying with the Covid-19 Vaccine Mandate. Colorado Retina requires employees to be vaccinated as a condition of employment, subject to accommodation. All candidates, upon hire, will be required to provide proof of vaccination or have a valid accommodation.

SUMMARY OF RESPONSIBILITIES:
The research coordinator is primarily responsible for coordinating research patient visits according to both the ICH-GCP guidelines and the IRB-approved study protocol and/or manual of procedures. Day-to-day activities may include all or some of the essential functions listed below, depending upon individual experience / knowledge and the needs of the organization which are subject to change from time to time.

ROLES and RESPONSIBILITIES:
Role and Responsibilities:

Facilitates and coordinates daily clinical trial activities, playing a critical role in study conduct.
Administers sponsor-required questionnaires (e.g., VFQ)
Works with team members responsible for ordering study supplies to ensure adequate inventory.
Creates, manages, and maintains source documents for each trial.
Attends teleconferences and Investigator Meetings as requested by the research director.
Reviews and comprehends all study protocols, including proceedings, timelines, inclusion/exclusion criteria, confidentiality, and privacy protections.
Collaborates with the study and clinical team to recruit eligible candidates and screens subjects for eligibility.
Efficiently completes all delegated study tasks (e.g., scribing, questionnaires, IOP, etc.)
Collects updated medical history, adverse events, and serious adverse events for reporting to the sponsor and IRB within the required timeframe.
Conducts/involves in the informed consent process/discussion with research participants.
Acts as a secondary reviewer to ensure accurate implementation of amended consent forms and procedures.
Collects protocol-required data and enters information into the electronic data capture (EDC) system within specified timeframes.
Oversees data accuracy and resolves queries issued within the required timeframe.
Collects and reports ALL Adverse Events and Serious Adverse Events.
Ensures acknowledgment and review of ALL SUSAR/Safety Reports.
Coordinates monitor site visits, assisting with preparation of documentation.
Works with the monitor to make corrections as needed to meet requirements and deadlines.
Manages and maintains all regulatory information about the study, including protocol, investigator brochure, IRB documents, Investigator disclosures, CVs, training documentation, and reporting instructions.
Ensure protocol compliance during procedures, assist physicians with IP administration, and follow randomization procedures accurately.
Order, track, and maintain detailed records of clinical supplies related to protocols.
Ensure proper storage temperature and maintain storage logs as necessary.
Document and record all shipments, returns, and destruction per sponsor requirements.
Work closely with study team to ensure proper IP transport, administration, missing, and administration.
Obtain and maintain any applicable additional/required sponsor training and/or certifications.
Coordinates monitor site visits and assists with preparation of site visit documentation.
Manages and maintains all regulatory information about the study including the protocol, investigator brochure, IRB documents, Investigator disclosures, CVs, training documentation, instructions on reporting requirements for the IRB and the sponsor.
Understand and maintain and working knowledge of protocol to ensure protocol procedures and visits are completed and in compliance with sponsor requirements.

EDUCATION and EXPERIENCE:
Level I
Education:

College degree preferred or significant relevant experience

Ophthalmic experience preferred

Experience / Knowledge / Skills:

1-3 years prior research experience (i.e., as a research assistant)

Effective oral and written communication

Delivers safe and appropriate care to patients in addition to the requirements outlined by study protocols

Certifications / Training:

ICH GCP Training / Certificate

IATA Certification

PREFERRED SKILLS/EXPERIENCE:

Efficiently and accurately interviews patients and documents histories

Demonstrates working knowledge of eye anatomy, disease, symptoms, and ocular medications
Accurately performs labs, ECG, tonometry, pupil exam, data entry, and other specified duties
Possesses excellent organizational skills to independently manage workflow
Pays meticulous attention to detail
Takes initiative and possesses the insight and energy to prioritize quickly
Demonstrates high-level critical thinking skills
Cooperates with supervisory staff, physicians, peers, external customers, and patients in a positive, energetic, and professional manner
Demonstrates excellence in communication skills, both personal and written, as well as organizational and time-management skills
Demonstrates ability to effectively convey ideas and information and able to creatively generate ideas with excellent follow through

COMPENSATION:
Base Salary: $48,000 - $76,401.19 (based on education and experience, Level I)
We do not take evening, weekend, or holiday on-call!
Our benefits include

Competitive salary
Safe harbor/profit sharing plan
full medical, dental, and vision insurance
Pet insurance
Legal, life, accident, disability, and hospitalization insurance