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CRA III/IV

California All, CA

Job Type: Clinical Job Number: JN -122019-26126 Region: California All

Job Description

Assists the Clinical Research Director or designee with the planning, execution and completion of clinical studies within agreed upon timeframes and budget and in compliance with the currently approved protocol, ICH and GCP regulations as well as Standard Operating Procedures (SOPs)

May be responsible for more than one study

Some or all of the responsibilities may be delegated to a Contract Research Organization (CRO)

Duties & Responsibilities:

Provide input into the development of protocols and amendments

Prepare study specific informed consent form (ICF) template

Develop study conduct plans and templates where applicable (e.g. Monitoring Plan, Source Document Verification Plan, CRF Completion Guidelines, etc.)

Develop study specific tools for the sites and monitors

Develop patient education materials if needed

Coordinate development of potential investigator list for a given study

Coordinate feasibility assessments including the development of questionnaires, collection of responses and summarization of results

Co-monitors with contract/CRO monitoring staff as needed to evaluate site/monitor adherence to protocols, review study progress, evaluate performance, provide monitoring support when needed, etc.

May conduct monitoring visits (study qualification, study initiation, interim monitoring and close-out visits) as needed, prepare reports as per the Monitoring Plan and ensure timely resolution of issues

Participate in clinical vendor selection process when appropriate

Assist with the planning and execution of investigator/study coordinator/monitor meetings

Develop protocol specific CRFs and any other tools used to collect data (e.g. patient diaries)

Ensure clinical and non-clinical supplies are available for shipment when required. Responsible for ensuring authorized sites always have supplies on hand during the treatment phase of the study

Participates in the selection and oversight of contract Clinical Research Associates (CRAs)

Reviews reports and ensures timely resolution of issues

Initiate grant payment process ensuring checks are mailed to sites in a timely manner

Track protocol violations and deviations ensuring appropriate documentation is available

Ensure SAEs are processed and closed in a timely manner and sites have followed their site-specific reporting requirements

Ensure also that SAE data is consistent with CRF data

Lead CRA team meetings, answers CRA study-related questions

Develop regular site newsletters

Ensure timely collection/review of case report forms and resolution of queries

Participate in the clinical review of study data; create and/or resolve data queries as needed

Attend clinical team meetings and provide updates as needed (e.g. status of site selection, site visits, site/CRA issues, etc.)

Create frequently asked questions (FAQs)

Create protocol-specific close-out checklist for monitors and sites

Coordinate evaluation of site performance ensuring results are recorded in the investigator database

May require up to 50% travel both domestically and internationally

Requirements:

Requires a Bachelor s degree, R.N., or B.S.N. degree or equivalent

Minimum of 5-10+ years of clinical research and monitoring experience

Ophthalmology experience is required

Able to work independently; receives little to no instructions on routine work; general instructions on new assignments

Strong interpersonal skills are required

Requires excellent written and verbal communication skills

Able to multi-task and prioritize appropriately

Positive, team-oriented attitude

Requires computer literacy in several software packages, especially Microsoft Office applications and database software


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