Clinical Research Associate (Central US, Medical Device) - Novella Clinical
Participatesin the preparation and execution of Medical Device clinical trials. Oversees theprogress of clinical investigations by conducting site evaluation, initiation, interim and close out visits tosites. Monitors clinical trials in accordance with Good Clinical Practices andprocedures set forth by Novella and sponsors. Works closely with the ClinicalTrial Manager (CTM) and/or Lead CRA to ensure all monitoring activities areconducted according to study requirements.
ESSENTIAL JOB FUNCTIONS,DUTIES AND RESPONSIBILITIES:
- Participatesin the investigator recruitment process. Performs site evaluation visits ofpotential investigators. May collaborate with the Investigative Strategy and Site Coordination (ISSC) department to evaluatethe capability of the site to successfully manage and conduct the clinicalstudy.
- Collaborateswith the ISSC department to coordinate activities with the site in preparationfor the initiation of the study. Obtainsregulatory documentation for successful implementation, monitoring, andevaluation of clinical trials. Works with ISSC and site staff to obtainregulatory (IRB/IEC) approval of study specific documents
- Performsstudy initiation activities, reviewing with the site personnel the protocol,regulatory issues, study procedures, and provides training on eCRF completionand the use of the EDC system, monitoring activities and study close-outactivities.
- Assistsin resolving any issues to ensure compliance with site file audits inconjunction with the ISSC department.
- Assuresadherence to Good Clinical Practices, investigator integrity, and compliancewith all study procedures through on-site monitoring visits including anongoing site file review. Performs validation of source documentation asrequired by sponsor. Prepares monitoring reports, confirmation and follow-upletters per the timelines defined in Novella SOPs by using approved Novella/sponsortemplates and reports.
- Documentsaccountability, stability and storage conditions of clinical trial materials asrequired by sponsor. Performs investigational product inventory. Ensures return of unused materials todesignated location or verifies destruction as required.
- Reviewsthe quality and integrity of the patient clinical data through (1) in housereview of electronic CRF data and (2) on-site source verification. Works withsites to resolve data queries.
- Servesas primary contact between Novella and investigator; coordinates allcorrespondence; ensures timely transmission of clinical data with the studysite and technical reporting, as requested.
- Authorizedto request site audits due to data integrity concerns.
- AttendsInvestigator and study-related meetings, as required.
- Attendscompany, departmental, and external meetings, as required.
- Conductsclose-out visits per the study specific Clinical Monitoring Plan includingfinal investigational product reconciliation and disposition, site study filereconciliation, data query resolution through database lock and resolution ofoutstanding action items.
- Ensureinternal and study-related trainings and any metrics are completed per Novella and/or studytimelines; CTMS should be current at all times with the pertinent siteupdates/contacts.
KNOWLEDGE, SKILLS ANDABILITIES:
- Knowledgeof clinical research and medical device process as well as medical terminology.
- Twelvemonths experience in clinical research and coordinating clinical trials required; experience in a clinicalsetting is a plus; monitoring experience is preferred.
- Mustpossess at least 1 year of medical device experience.
- Strongwritten and verbal communication skills to express complex ideas to studypersonnel at research and clinical institutions.
- Goodorganizational and interpersonal skills.
- Abilityto reason independently and recommend specific solutions in clinical settings.
- Understandelectronic data capture including basic data processing functions.
- Understandcurrent GCP/ICH guidelines applicable to the conduct of clinical research.
- Ableto qualify for a major credit card.
- Validdriver’s license; ability to rent automobile.
- Willingnessand ability to travel domestically, as required.
EEO Minorities/Females/Protected Veterans/Disabled
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