In-House Clinical Research Associate – HIRING NOW
Company : Actalent
Country: United States
Location : Rockville, Maryland
Post: Sun, 19 Sep 2021 05:22:39 GMT
Expires: Tue, 19 Oct 2021 23:59:59 GMT
Apply Job : Apply Online
—————————— Job Description ——————————
DESCRIPTION:To monitor clinical study sites to ensure compliance with the clinical trial protocol, to check clinical site activities, to make on-site visits, to reviews Case Report Forms (CRFs) and to communicate with clinical research investigators. * Assists with the development and/or review of study-related materials including case report forms (CRF), protocols, informed consent forms, monitoring plan, etc. * Participates in the identification and recruitment of investigators, and assists in the development of subject recruitment strategies and materials. * Prepares for and conducts site qualification, initiation, interim monitoring, and close-out visits at study sites. * Ensures that all visits are conducted according to FDA regulations, ICH guidelines, and company standard operating procedures. * Ensures adequate reporting/tracking of adverse events, protocol deviations, and subject status. * Identifies areas requiring follow-up and improvement at each clinical study site, and recommend and implement corrective action. * Serves as primary point of contact for study site personnel to answer questions and resolve study-related issues. * Confirms that data recorded on CRF are accurate, complete, and verifiable against source documents. * Oversees collection of regulatory documents required for CTM shipment clearance. Ensures proper maintenance of required essential documents at the site level. Assists with set-up, maintenance, and reconciliation of Trial Master File. * Prepares and attends project team meetings, and provide updates on project status and site-specific performance. * Assists with overseeing CRO’s and other study vendors, including co-monitoring external CRO monitors. * Works collaboratively and effectively in a project team outsourced environment. SKILLS:Clinical Research, GCP, clinical data managementADDITIONAL SKILLS & QUALIFICATIONS:
* Study Coordinators are ideal b/c they know how to work hard, and work independently. The In-House CRA candidate who wants to get into management eventually will be taught vendor and budget management as well as teach them how to monitor.
* 2-3 years at the site level, good communication skills are critical, all previous performance issues have been around communication (follow-through, closing loop, lacking understanding).
* Looking for someone who is not easily frustrated must be self starters and be okay w/finding and hunting things on their own, someone who isnt afraid to take risks, explore and ask questions is the right fit.
ABOUT ACTALENT: Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. Were supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
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