Clinical Research Associate II/SR CRA (East)
Premier Research - Raleigh, NC

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Conducts monitoring activities of assigned clinical trials in compliance with the protocol, ICH-GCP/ISO14155 and all applicable local laws and regulations, company policies and quality standards. Performs management of study site activities to ensure the collection of accurate clinical data within given timelines. May be responsible for multiple studies and must work independently with team support. Position can be regional or office based.

Manages all aspects of a clinical trial at all assigned clinical sites to ensure patient safety, adherence to appropriate safety regulations and data integrity

Scientifically monitors clinical studies, which includes the review of case report forms (CRFs) and source documentation to ensure adherence to the protocol and consistency and scientific validity of the data

Provides full support including technical and scientific guidance to study site personnel to ensure consistency in interpretation and exchange of scientific information in clinical trials

Manages query resolution process with sites and Premier Research Data Management

Assists project team with assessing project feasibility and recruitment, as applicable

Prepares for and conducts on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites

Maintains/reviews regulatory documents, as required

Prepares for and attends project launch meetings

Assists the project team in the tracking of enrollment rates and receipt and review of completed CRFs, as required

May be involved in the preparation of documentation for submission to IRB/IECs and CAs as well as coordination of submission with appropriate site staff and /or Project Manager/Clinical Manager

Prepares Visit Reports and contributes information for Status Reports for sponsors

Maintains project tracking system of subjects and site information as applicable

Assists in the preparation and development of materials for Investigators’ Meeting; participates in Investigators’ Meeting as designated by Project Manager

Manages investigative sites via telephone calls between visits

Ensures adherence to study timeline and budget

Performs additional duties and assignments as requested

Willingness to travel up to 70%, as required (additional travel is possible based on project requirements and availability)

Participates in company required training programmes

Valid driver’s license

Required Skills

Demonstrates a strong working knowledge of clinical research processes, Good Clinical Practices, International Committee on Harmonization Guidelines, federal regulations and applicable local laws pertaining to clinical research investigations

Demonstrates, understands and complies with Premier Research’s policies and procedures

Exhibits a solid knowledge base of medical terminology, clinical pharmacology and pathophysiology

Fluent written and verbal English language skills

Attention to detail and a methodical approach to work

Ability to organise and takes initiative when indicated

Ability to handle and prioritize multiple assignments in a fast-paced work environment

Ability to identify issues proactively, identify resolutions and follow through to completion

Ability to communicate and negotiate at all levels

Ability to effectively interact with a variety of individuals including internal and external customers

Ability to work independently as well as part of a project team

Maintain awareness of developments in the field of clinical research by reading relevant literature, attending clinical meetings, etc.

Proficient in the required computer skills including the ability to work with Microsoft Word, Excel, Outlook and ability to attain knowledge of other programmes as needed

Recognised undergraduate degree in a clinical, science or related field or R.N. or equivalent work experience is required; a degree in Pharmacy, Biology, Chemistry, Psychology, Nursing or a related discipline is preferred

A minimum of two (2) years clinical research experience as a monitor OR

One (1) year as a monitor plus minimum of two (2) years direct clinical research experience as a coordinator (e.g., study, data, compliance) OR

One (1) year as a monitor plus a minimum of two (2) years experience at an RN level in critical care or in-patient hospital setting

Working knowledge of ICH-GCP/ISO14155 and relevant SOPs, as required

Working knowledge of FDA, European Regulatory and EC procedures, as applicable

Required Experience

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