IP Coordinator

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Colorado Retina Associates is looking for a IP Coordinator Unmasked!

Colorado Retina Associates is the premier retina practice of the Rocky Mountain region.  Come join a team that strives to provide advanced care and cutting-edge therapies for our patients.  Just as we aim to have top notch patient care, we aim to take great care of our team members by providing competitive salary & benefits, continuing education and advancement programs, and an opportunity to work with the top-ranked retina specialists in the US with state-of-the-art equipment and retina treatment methods.

JOB TYPE/COMPENSATION:

• Full Time
  
• Base Wage: $50,000.00 - $68,215.00 (based on education and experience)

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.

Position Summary:

This position will be responsible for support of the research department by performing duties related to the randomization, preparation, and administration of investigational product (IP). This position requires excellent organization skills and attention to detail. The IP Coordinator will function in an unmasked role on every protocol requiring an unmasked coordinator.  Detailed record keeping and reporting to unmasked physicians, monitors and Research Management is also required.

Role and Responsibilities:

IP Coordinator:

•      Protocol compliance when performing procedures and assisting physicians with IP administration.
•      Ordering and tracking of clinical supplies related to the protocols.
•      Detailed record keeping of IP accountability.
•      Ensures all IP is store at appropriate temperature.
•      Ensures all shipments are documented and recorded per sponsor requirements.
•      Ensures all IP is returned to Sponsor according to specifications.
•      Follows randomization procedures for the protocol and ensures accuracy in dispensing.
•      Works closely with unmasked investigators to follow procedures for administration and mixing of IP.
•      Follows CRA SOP regarding IP transport.

Performance of Protocol Related Procedures:

•      Performance of ECG’s
•      Phlebotomy
•      Labeling, Processing and shipping of specimens in accordance to protocol specifications
•      Documentation and record keeping for study related procedures.
•      Scheduling of subjects for visits
•      Scheduling of outside procedures related to the protocol (example: MRI’s)

Protocol Conduct and Management:

•      HIPAA compliant at all times, including but not limited to, patient confidentiality and restricted access to research data. Under no circumstances may any study related documentation be taken home.
•      Data collection and entry (paper format) under the direction of research coordinators.
•      Understanding and working knowledge of protocol to ensure protocol procedures and visits are completed and in compliance with sponsor requirements.

 Research Reporting:

•      May assist research coordinators with tracking referrals and documenting status.
•      Tracking all research visits and entering into NextGen immediately upon completion of visit.
•      Attend Research Department meetings.
•      Checking emails, phone messages and written correspondence and responding to sponsors, investigators, team members or subjects within 24 hours.
•      Complete the following logs as required:

Temperature logs (daily)

Maintain site signature logs and delegation of duty as directed by research coordinator

•      Subject drug accountability logs per sponsor requirements.

Personal and Professional Conduct:

•      Ensure subject safety at all times by reporting any adverse events to research coordinator or unmasked physician as mandated per protocol 
•      Adheres to dress code and is respectful of time and attendance.
•      Maintains CRA confidentiality with our Sponsors and does not discuss any protocols being conducted other than the one being conducted with that Sponsor.
•      Logs off computer when stepping away from desk.
•      Keeps all protocol related materials locked and secured at all times.
•      Other job duties as assigned

Education and Experience:

• High School Diploma / GED
• Medical Assistant/Technician with experience in Ophthalmology OR
• One (1) or more years’ clinical research experience
•  

Preferred Skills/Experience:

• Computer Skills, including MS Word, Excel

• Excellent verbal and written communication
• Customer service oriented
• Working knowledge of Medical terminology
• Excellent organizational skills and detail oriented.
•  

Certificates & Licenses:

• ICH GCP Training / Certificate preferred but not required
• CCRC/CCRA/CPI preferred but not required
•  

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Ability to safely and successfully perform the essential job functions consistent with the ADA, FMLA and other federal, state, and local standards, including meeting qualitative and/or quantitative productivity standards.
• Ability to maintain regular, punctual attendance consistent with the state and local standards.
• Ability to occasionally stand; walk; sit; use hands/fingers to handle, or feel, and reach with hands and arms.
• Ability to occasionally lift and/or move up to 25 pounds.
• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
• Must be able to talk, listen and speak clearly in person and on the telephone.
• Work Environment:
  • Work is occasionally performed in emergency and stressful situations. The noise level in the work environment is usually quiet in office settings and moderate in other situations. While performing the responsibilities of the job, these work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job.

The Americans with Disabilities Act requires that reasonable accommodation be provided to qualified individuals to help them to perform the required duties and tasks of the position.  Please inform us at the time you apply for a position if you will need any specific accommodations.

Colorado Retina will provide the following compensation and benefits:

• Base Salary: $50,000.00 - $$62,013.95 (based on education and experience)
• Medical, Dental, and Vision Insurance
• Retirement Safe Harbor/Profit Sharing Plan
• Legal, Life, Accident, Disability, and Hospitalization Insurance
• Pet Insurance and other incentives