Job Description
Job Description
The research coordinator is responsible for coordinating research patient visits according to 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.
Compensation:
$19 hourly
Responsibilities:
- Coordinate and schedule subject visits within study/subject-specific windows per protocol guidelines
- Prepare visit-specific documentation and charts for the Clinical Research Coordinator
- Observe Coordinator in patient care and management
- Assist the 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 subjects, and conduct electrocardiograms (ECG) on subjects as required per the 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 certification
Qualifications:
- Possess high energy, and have a positive, professional attitude
- Strong communication skills with a team-player approach
- Critical time management skills
- Certifications/Trainings
- ICH GCP Training/Certificate
- IATA Certification
- Adhere to ongoing training and education
- Demonstrate effectiveness by showing courtesy, diligence, integrity, and teamwork
- Other functions may be assigned, and management retains the right to add or change the duties at any time
About Company
- Benefits: Paid Time Off + Holidays, Medical Insurance, Vision, Dental, 401(k), Life Insurance
- Travel within 120 miles is required (company-provided transportation, day trips only), which can mean early mornings and long days
- Schedule varies depending on the assigned role and/or assigned physician
- Physical Demands and Abilities: Ability to stand and walk for long periods, ability to lift more than 30 lbs