POSITION TITLE: Senior Clinical Research Associate
REPORTS TO: Director/Associate Director, Clinical Monitoring (US)
CRA Manager (EU)
Participates in the preparation and execution of Phase I-IV clinical trials. Oversees the progress of clinical investigations by conducting pre-study, initiation, interim and close out visits to sites. Monitors clinical trials in accordance with Good Clinical Practices and procedures set forth by Novella and sponsors. Works closely with the Clinical Trial Manager to ensure all monitoring activities are conducted according to study requirements.
ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
· Participates in the investigator recruitment process. Performs initial qualification visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study, both clinically and technically.
· Assists in the preparation and review of protocols, eCRFs, study manuals, and other study documents as requested by Clinical Trial Manager.
· Works with the Study Start-up Group to coordinate activities with the site in preparation for the initiation of studies. Obtains and reviews regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with Study Start-up Group and site staff to obtain regulatory (IRB/IEC) approval of study specific documents.
· Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.
· Trains site staff on the EDC system and verifies site computer system.
· Conducts periodic site file audits to ensure compliance with GCPs and Novella standard operating procedures.
· Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters in a timely manner using approved Novella/sponsor forms and reports.
· Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required.
· Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Works with sites to resolve data queries.
· Serves as primary contact between Novella and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.
· Assists with, attends, and may present at Investigator Meetings for assigned studies.
· Performs study close-out visits.
· Serves as mentor for more junior CRAs as well as new CRAs to the project.
· May conduct field training and assessment of CRA Is and CRA IIs.
· Authorized to request site audits for reasons of validity.
· Performs other duties as requested.
KNOWLEDGE, SKILLS AND ABILILTIES:
· Strong knowledge of clinical research process and medical terminology.
· At least four years experience in monitoring clinical trials preferred.
· Excellent written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions.
· Excellent organizational and interpersonal skills.
· Ability to interact with all levels of staff to coordinate/execute study activities.
· Ability to handle several priorities within multiple, complex clinical trials.
· Ability to reason independently and recommend specific solutions in clinical settings.
· Able to mentor other CRAs on project team and co-monitor as required.
· Understanding of basic data processing functions, including electronic data capture.
· Understanding of current GCP/ICH guidelines applicable to the conduct of clinical research.
· Able to qualify for a major credit card.
· Valid driver’s license; ability to rent automobile.
· Willingness and ability to travel domestically and internationally, as required.
CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:
· Ability to travel domestically and internationally.
· Very limited physical effort required to perform normal job duties.
MINIMUM RECRUITMENT STANDARDS:
· BS/BA (or equivalent) in one of the life sciences with a minimum of 4 years of monitoring experience or equivalent amount of education/experience.
· Must possess excellent verbal and written communication, interpersonal and organizational skills.
· Requires an ability to work independently, prioritize, and work within a matrix team environment.
· Computer literacy and knowledge of electronic data capture preferred.
· Must be able to travel domestically and internationally 50-75%.
This position is exempt from the Fair Labor Standards Act; employees are not eligible for overtime compensation.
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