The Clinical Research Associate may be based at the ProTrials office, or at a client location, or clinical trials site location. This CRA position may consistently involve up to 65% travel. Depending on the Scope of Work defined by the Client, this individual may be involved in some or all of the functions listed below. Other tasks or responsibilities may be assigned as deemed necessary.
EDUCATION AND/OR EXPERIENCE
Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training and 2 years of prior experience as a Clinical Research Associate preferred.
Monitoring clinical studies of investigational and approved products that have been determined to satisfy a medical need and/or offer a commercial benefit. This may include the following site visits: qualification, initiation, interim and close out.
Managing and training of site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion.
Managing, preparing, sending, tracking, and returning investigational supplies at individual sites.
Monitoring and documenting investigational product dispensing, inventory, and reconciliation.
Monitoring and documenting laboratory sample storage and shipment.
Monitoring trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory abnormalities.
Reviewing source data and case report forms for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issues.
Reviewing data queries and listings, and working with the study centers to resolve data discrepancies.
Reviewing regulatory documentation for accuracy and completeness, and supporting study centers with regulatory issues.
Maintaining complete and accurate study files and reviewing files to ensure all appropriate documentation is present.
Maintaining consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials.
Following Good Documentation Practices, complete Visit Reports and site correspondence in accordance with SOPs.
Other tasks or responsibilities as assigned.
Excellent attention to details.
Flexibility with changing priorities.
Excellent organizational skills.
Ability to efficiently perform and prioritize multiple tasks.
Ability to use independent, professional judgment to identify and take initiative to solve logistical problems.
Effective verbal and written communication skills.
Ability to work effectively on a diverse team.
Ability to work efficiently on the computer, including document retrieval, review, and tracking.
Familiarity with medical and pharmaceutical industry, and related terminology and practices.
Appropriate knowledge of FDA regulations and their practical implementation.
Intermediate proficiency in Microsoft Office applications, including Word, Excel and Power Point.
Ability to maintain travel schedules efficiently and effectively.
Ability to travel, including air travel, on notice as short as 24 hours, maintaining efficient and effective travel schedules.
Must have availability of a car in good condition, a valid driver's license, a good driving record, and up-to-date car insurance.