Regional Clin Research Assoc

Job Summary Description: The Regional Clinical Research Associate (Monitor) provides monitoring expertise to clinical study teams (CSTs). The Monitor maintains a positive relationship with the investigator and site personnel to ensure the execution of a clinical trial in a timely, efficient and effective manner. The Monitor also ensures that the site staff conducts the study according to the Clinical Study Protocol (CSP) and in compliance with regulatory requirements and AstraZeneca Pharmaceuticals policies. The Monitor is deployed to a geographic area and is responsible for assisting the CST in the design, execution and reporting of clinical studies.

Major Responsibilities
Clinical Study Design
Reviews Case Report Forms (CRFs) and ensures they are filled out properly, completely, accurately and consistently
Contributes to the CRF design
Participates in the selection of investigators
Assists in the execution of investigator contracts
Prepares study start-up documents including 1572s, CVs, signed CSP and amendments, investigator study files, enrollment logs, etc.
Prepares site specific logs and investigator study files
Provides feedback to the CST on issues pertaining to the completion of the CRFs and input into future enhancements to the standard CRF modules
Participates in planning and preparation of Investigator Meetings
Assists in the development of patient recruitment strategy

Clinical Study Execution
Assists in providing clinical-related progress of project schedule to CST
Develops ability to independently conduct pre-study, initiation, monitoring and closeout visits
Maintains positive and cooperative relationship in day-to-day interactions and communications with investigators and study sites
Completes site visit reports, site correspondence, telephone logs, and other relevant documents
Ensures site staff is adequately informed of protocol and study procedures
Prepares site for audit activities
Maintains and archives study administrative files at study site
Oversees collection and review of regulatory documents
Ensures clinical supplies are properly stored and accounted for, and any necessary blinding is maintained
Ensures on-site personnel understand and comply with the CSP, GCPs and AstraZeneca Pharmaceuticals Standard Operating Procedures (SOPs)
Ensures IRB communications and regulatory documents stay current
Ensures CST understands and complies with adverse event reporting requirements
Ensures patient safety is maintained and informed consent procedures are carried out properly
Prepares and presents, with guidance, at Investigator Meetings, training sessions and internal meetings
Reports Serious adverse Events (SAEs) and reconciles on-site and in-house reports
Participates in data management processes including the collection and cleaning of data, and the identification and resolution of data queries
Implements, tracks and reports patient recruitment and retention at investigational sites
Provides information for input into Clinical Trial Management System (IMPACT)
Ensures lab certification, test equipment calibration, and pertinent normal laboratory values are maintained
Conducts Source Data Verification (SDV)
Maintains site monitoring visit schedule
Ensure IRB certification is current and all IRB documentation is in order
Proactively identifies study-related issues and provides recommendations for resolution

Clinical Study Reporting
Completes the final reconciliation of clinical drug supply and assists study team in the final reconciliation of the adverse event database and retrieving any additional study file documents
Reviews CRFs, CSPs and informed consent forms
Documents and distributes visit findings in trip reports


Responsibilities

Minimum Requirements
Bachelor degree in biological science or health-care related field
3 years of relevant experience in industry (strongly preferred), or health-care related field, or equivalent overall experience in combination with exceptional performance
Minimum of two years experience in monitoring clinical research programs with the pharmaceutical industry
Strong interpersonal and presentation skills
Good oral and written communication skills
Detail-oriented
Demonstrated effectiveness working independently, collaboratively with peers and in cross-functional teams
Knowledge of multiple therapeutic areas
Ability to travel
Valid Driver?s License with clean driving record
Good credit report

Preferred Background
Knowledge of the clinical study process, GCP/ICH guidelines
Familiarity with medical terminology
Experience with ordering and managing clinical supplies