Clinical Research Associate (East Coast Oncology / Hematology) - Novella Clinical
Novella Clinical is seeking candidates on the East Coast.
Candidates must have 2 years of Hematology/ Oncology monitoring experience.
Participatesin the preparation and execution of Phase I-IV clinical trials. Oversees theprogress of clinical investigations by conducting pre-study, initiation,interim and close out visits to sites. Monitors clinical trials inaccordance with Good Clinical Practices and procedures set forth by Novella andsponsors. Works closely with the Clinical Trial Manager to ensure allmonitoring activities are conducted according to study requirements.
ESSENTIALJOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
- Participatesin the investigator recruitment process. Performs initial qualification visitsof potential investigators. Evaluates the capability of the site tosuccessfully manage and conduct the clinical study, both clinically andtechnically
- Assists inthe preparation and review of protocols, eCRFs, study manuals, and other studydocuments as requested by Clinical Trial Manager
- Works withthe Study Start-up Group to coordinate activities with the site in preparationfor the initiation of studies. Obtains and reviews regulatory documentation forsuccessful implementation, monitoring, and evaluation of clinical trials. Workswith Study Start-up Group and site staff to obtain regulatory (IRB/IEC)approval of study specific documents
- Performs studyinitiation activities, reviewing with the site personnel the protocol,regulatory issues, study procedures, and provides training on completion of theeCRF; monitoring activities and study close-out activities
- Trains sitestaff on the EDC system and verifies site computer system
- Conductsperiodic site file audits to ensure compliance with GCPs and Novella standardoperating procedures
- Assuresadherence to Good Clinical Practices, investigator integrity, and compliancewith all study procedures through on-site monitoring visits. Performsvalidation of source documentation as required by sponsor. Prepares monitoringreports and letters in a timely manner using approved Novella/sponsor forms andreports
- Documentsaccountability, stability and storage conditions of clinical trial materials asrequired by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifiesdestruction as required
- Reviews thequality and integrity of the clinical data through (1) in house review ofelectronic CRF data and (2) on-site source verification. Works with sites toresolve data queries
- Serves asprimary contact between Novella and investigator; coordinates allcorrespondence; ensures timely transmission of clinical data with the studysite and technical reporting, as requested
- Assistswith, attends, and may present at Investigator Meetings for assigned studies
- Performsstudy close-out visits
- Serves asmentor for more junior CRAs as well as new CRAs to the project
- May conductfield training and assessment of CRA Is and CRA IIs
- Authorizedto request site audits for reasons of validity
- Performsother duties as requested
KNOWLEDGE,SKILLS AND ABILITIES:
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.
- 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
- Requires an ability to work independently, prioritize, and work within a matrix team
- Computer literacy and knowledge of electronic data capture preferred.
- Must be able to travel domestically and internationally 50-75%.
EEO Minorities/Females/Protected Veterans/Disabled
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