Overview
Clinical Research Associate IIThe Clinical Research Associate (CRA) II is responsible for monitoring clinical study sites either onsite at investigative sites or remotely to ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH GCP, and all applicable regulatory requirements. The CRA will conduct monitoring visits and activities in accordance with Emmes SOPs, applicable regulations, and ICH GCP.
Responsibilities
- Under supervision of the project CRA staff oversight lead, example, Clinical Study Manager, Lead CRA, Project Manager, etc., independently schedules and conducts remote and on-site monitoring visits such as qualification pre study visits, site initiation visits, interim routine monitoring visits, closeout visits, and for cause visits.
- As part of the site visits, independently conducts Informed Consent ICF review, source data verification source document review, review for compliance with required reporting tracking of adverse events and protocol deviations, investigator site file review, laboratory tour and specimen storage assessment, pharmacy Investigational Product IP Investigational Device ID storage location tour and storage condition assessment, IP ID accountability, facilities tours, and other activities per the site monitoring plan under minimal direction from the project CRA staff oversight lead.
- Documents observations and monitoring activities in a site visit report at the conclusion of the visit.
- Facilitates and oversees Action Item resolution post visit.
- Helps to ensure that clinical sites are conducting the study in compliance with protocol clinical investigational plan, SOPs, ICH GCP, and other applicable regulations.
- Provides training and retraining to site staff including protocol, GCP GDP, and other training under direction from the project CRA staff oversight lead.
- Identifies areas requiring follow up and improvement at each clinical study site and reports findings to project CRA staff oversight lead.
- Ensures all visits are conducted according to country regulations, ICH GCP, and company standard operating procedures
- Serves as point of contact for study site personnel to answer questions and resolve studyrelated issues under the direction of the project CRA staff oversight lead.
- May assist with the development and or review of study related materials including protocols, informed consent forms, monitoring plan, monitoring documents, etc.
- Prepares for and attends project team meetings and provides updates on project status and site specific performance
- Works collaboratively and effectively in a project team environment including internal and external colleagues to meet project objectives and timelines.
- Participates in Investigator Meetings or other client meetings as needed.
- Assists with filing and archiving of study documents.
- Assists in preparing sites for audits and may provide support and cooperation during audits inspections including translation to Auditor if needed.
- May assist with coordination of clinical study supplies.
- May assist with submission of applications notifications to Institutional Review Board IRB Ethics Committee EC Regulatory Authority.
- May assist with site recruitment oversight activities such as developing focused patient recruitment strategies and action plans.
- Performs site management activities as required
- Performs other duties as assigned
- Complies with all policies and standards
Qualifications
- Bachelor's Degree Scientific discipline preferred or equivalent work experience Required
- 1-3 years 1-2 years of relevant monitoring experience (on-site and remote) Required
- Proficient with MS Office Suite High
- Excellent computer and organizational skills High
- High level of attention to detail required High
- Ability to work on varying projects and exercise critical thinking High
- self starter who can work remotely and a team player who can work cross functionally with some oversight High
- Knowledgeable in clinical research operations, including interpretation and implementation of country regulations and ICH guidelines, as required per their role as a CRA High
- Excellent organizational, interpersonal, and communication skills both oral and written High
- Demonstrated problem solving skills, self motivated, and adaptable to a dynamic environment High
- Knowledgeable in prioritization, problem solving, organization, critical thinking, decisionmaking, time management, and planning activities High
- Ability to collaborate with internal and external colleagues and work well in a team oriented setting High
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