Clinical Research Assistant

2 weeks ago

Modesto, United States Medix™ Full time

Position Summary

The research assistant is primarily responsible for assisting in research patient visits according to ICH-GCP

guidelines and according to 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.

Job Description


Level I

Minimum Qualifications:

• Education:

o High School diploma or the equivalent, with significant relevant experience

o College degree preferred

o Ophthalmic experience preferred

• Experience / Knowledge / Skills:

o Effective oral and written communication

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

study protocols

Duties:

• Coordinate and schedule subject visits within study/subject specific windows per protocol

guidelines.

• Prepare visit-specific documentation and charts for Clinical Research Coordinator

• Observe Coordinator in patient care and management

• Assist Coordinator in monitoring subject flow and assist in subject care and management

• Observe, assist, collect and record all necessary data for follow up (e.g. adverse events, concomitant

medications, etc.) study visits (Phase 2 & 3; NO Gene Therapy)

• Transcribe subject study information from source documents to the Electronic Case Report Forms

• Administer all mandatory questionnaires to study subjects

• Set up, prepare subject, and conduct electrocardiograms (ECG) on subjects as required per study

protocol

• Promptly request all necessary medical records for Serious Adverse Event Reporting

• Process and ship laboratory biological samples for analysis

• Perform intraocular pressure checks after injections

• Perform trial frame refraction and ETDRS visual acuity testing (For ISTs only, at selected sites)

• Inform subjects and obtain written re-consents in regard to ICF’s

• Perform other duties as assigned

• Obtain any applicable additional/required sponsor training and/or certifications


Level II

Minimum Qualifications:

• Experience / Knowledge / Skills:

o RA Level I >3 months – 1 year

• Prior annual review or promotion assessment exceeds expectations and shows proficiency in the job

requirements

Duties:

All duties included in RA Level I in addition to:

• Assist Coordinator in CTMS management

• Review and resolve data management queries as needed

• Inform subjects and obtain written consent in regard to ICF’s (on selected studies)

• Observe and assist scribe in ocular exams for doctors and confirm appropriate treatment per protocol

• Submit images to CRCs as needed


Level III

Minimum Qualifications:

• Experience / Knowledge / Skills:

o RA Level II > 6months - 1 year

• Prior annual review or promotion assessment exceeds expectations and shows proficiency in the job

requirements


Duties:

All duties included in RA Level II in addition to:

• Assist and perform unmasked duties for ISTs and Phase 1 studies, including maintaining IP and

shipping logs

• Perform Serious Adverse Event reporting, initial & follow up reporting, including the prompt

request of all necessary medical records, review of medical records and updated reporting

• Train and understand all aspects of regulatory compliance

• Assist Coordinator in regulatory management, including training and monitoring visits

• Transcribe and perform query resolution regarding subject study information from source

documents to the Electronic Case Report Forms

Minimum Demonstrated Skills/Qualifications:

• 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

• Possesses 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

• Abounds in organizational and time-management skills

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