Clinical Research Associate Ii- Pain Experience Preferred
Kendle International (Cincinnati, Ohio)

This job posting has expired.

You may wish to try a search for Clinical Research Associate II- Pain experience preferred

Or visit the FlipDog home page
 

job ID: 4649

Position Title: Clinical Research Associate II- Pain experience preferred

Working Location: Regional Home Based

Employment Status: Full-Time Regular

Required Experience: 2 years

Required Education: Associates Degree

Required Travel: 0


Job Summary:
Completes project activities associated with monitoring functions of Phase I-IV clinical research studies while developing an understanding of the drug development process, Good Clinical Practices, and relevant regulations. Provide clinical and technical support for CRA I and administrative staff. Performs management of study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs) and Project Specific Operating Procedures (PSOPs).

May assume the role of a Lead CRA on projects by providing direction and guidance to the project team, coordinating all monitoring activities and communicating the status of these activities to the study Project Leader.

Core Responsibilities:
• Performs clinical trial initiation, monitoring and close out activities while adhering to all applicable regulatory and Standard Operating Procedures (SOPs) and Project Specific Operating Procedures (PSOPs).
• Completes study start-up activities.
• Develops and implements innovative approaches for site selection, and pre-study activities to identify and evaluate potential investigators
• Completes site evaluation and reports to Lead CRA / Project Leader as appropriate.
• Completes submission of documents to the Ethics Committees, when required.
• Collects, reviews and tracks regulatory documents when required.
• Manage and track investigator grants with study sites when required
• Assists with the development of study specific monitoring plan, annotated CRFs, monitoring conventions, tracking forms, and other study related documents.
• Participates in study specific training.
• Actively participates in the preparation and coordination of investigator meetings and attends when required.
• Completes pre-study visits with study site staff.
• Provides status updates of pre-study and initiation activities to Lead CRA / Project Leader.
• Completes initiation visits with study staff through training, reviewing regulatory requirements, collecting outstanding documents, reviewing patient screening/randomization procedures, reviewing SAE reporting requirements, and reviewing drug storage and accountability procedures.
• Develops patient enrollment strategies with the project team and study sites.
• Completes monitoring visits to ensure the integrity of clinical data and appropriate follow up procedures, including source document verification and SAE reporting in accordance with the project plan.
• Ensures proper storage, dispensation, and accountability of all Investigational Product(s) and trial-related materials.
• Manages study site activities and provides ongoing updates of site status to Lead CRA / Project Leader.
• Completes in-house monitoring activities as appropriate, such as updating in-house site files, and completing visit reports.
• Maintains tracking records for assigned sites such as tracking of status and source document review per patient.
• Completes study site closeout visits.
• Conducts and assists with Project specific administrative activities as a member of the project team.
• Provides study site evaluation through consultation with senior staff and if appropriate ensure site registration in investigator database.
• Participates in feasibility activities and reports outcome to appropriate manager.
• Responsible for representation of Kendle in a professional manner.
• Continues to increases knowledge of drug development process, therapeutic areas, Good Clinical Practices, and any applicable local regulatory requirements.
• If appropriate, maintains home-office set-up to include computer, fax/copier printer, appropriate filing system, adequate telephone lines, and voice mail system when applicable.
• If appropriate, maintain appropriate lines of communication and use of mail and delivery services if applicable
• Accurately completes Kendle administrative activities in a timely manner.
• When applicable provides clinical and technical support for CRA I and administrative staff as a mentor.
• Other duties and assignments as requested for the overall performance of the OU and company.


Skills & Attributes:
Education: AA, RN, BS/BA or equivalent with at least 1.5 years clinical trial monitoring experience or experience as follows:

2 years of previously related health care or clinical research experience (e.g. study coordinator) and 1.5 years of clinical trial monitoring experience.

Previous practical experience in conducting clinical pharmaceutical research studies in a hospital setting, pharmaceutical company, or CRO preferred. Experience or education indicates a sound basic knowledge of medical and pharmaceutical terminology.

Position requires:
Excellent verbal and written communication skills. Excellent organizational, record retention, time management, decision making, customer service, and interpersonal skills. Good command of written and spoken English language.

Ability to travel domestically and internationally as required and process visit reports and expense reports effectively. If applicable, ability to obtain credit cards for the purpose of paying expenses while traveling. Ability to work independently. Proficient in the use of computer and software systems. Ability to understand basic and complex medical details. Understanding of basic data processing functions preferred. Knowledge of GCP and all applicable regulatory requirements preferred. complex medical details. Understanding of basic data processing functions preferred. Knowledge of GCP and all applicable regulatory requirements preferred.

~BSP~
~CB~
.