This listing was posted on Bevov.
Clinical Research Associate (East Coast)
Location:
Princeton, NJ
Description:
Job Description Our client is a full-service Clinical Research Organization (CRO), a leading provider of Clinical research services and mission is Science with Integrity. It has fifteen years of impeccable regulatory history and has accumulated expertise in Early Phase (BA/BE), First in Man, Late Phase (various therapeutic areas), Respiratory, Tobacco Research, Dermatology, Consumer Research, Analytical lab, Diagnostic Central lab, IVRT, IVPT, Biometrics, Environmental Exposure Chambers, Pharmacovigilance and Medical Services.This role is Full Time, permanent, Regionally Home Based position with around 70to 75% travel from Apr 2022 Onwards (Based upon COVID-19 travel restrictions) Responsibilities Prepare or submit or supportother colleagues for Regulatory and EC submissions and in the generation ofFinancial Agreements according to standard and local country practices.Conduct monitoring visits asper the monitoring plan in order to check compliance with studymanagement, protocol and otherrequirements at all assigned sites.Responsible for training ofsite study team regarding the monitoring plan, recording and maintenance of essential documents, and for startup activities and site initiation as per the guidance of Project Manager. Assist in the preparation andpresentation at investigator meetings, as required to ensure that the clinical and investigational sitestaff team are well informed about the study and related procedures.Maintaining a working copy of the Central Investigator File and ensuring consistency with the Site Investigator File in order tomaintain a working record of all essential documents and reports.Perform source documentverification as per monitoring plan and ensure that source documents and other trial records are accurate, complete, kept up-to-date and maintainedaccording to applicable SOPs to avoid incomplete records.Ensure timely collection ofdocuments like CRF, DCF, etc. from the site along with SAE reports in order to provide Biometrics/licensingauthority and others with the necessary documents. Responsible for study updates and Coordination with Labs and other trial-related services as per the study requirements.Responsible for IPaccountability and availability, tracking and management of all Clinical Trial related supplies shipped to thesites/ warehouse and accordingly clinical trials supplies vendor management for the study.Ensure proper escalation ofsite/project-related issues to the Project Manager/ Designee in a timely manner. Responsible for site-closeout and follow-up activities in order to maintain documents at the site.Attend staff meetings andtraining sessions as required to complete the training curriculum in a timely manner.Assist with the audit of aninvestigational site or central files and liaise with Quality Assurance personnel as required to ensure thatthe study is being conducted in accordance with ICH GCP and applicable regulatory guidelines.To liaise with otherdepartments within the organization for timely achievement of the project milestones.Ensure to follow and adhereto organizations general rules, policies, and applicable SOPs.CRA will review the studyfeasibilities and assist the PM in preparing the feasibility report/ tracking Qualifications Bachelors degree in lifescience or related field of study or equivalent combination of studies, and/orwork experience2+ years relevantexperience, including substantial monitoring experience KNOWLEDGEIn-depth knowledge of ICH-GCPguidelines, and applicable regulations, rules, and guidance, as applicableKeeps abreast of regulatoryrequirements and scientific knowledge and maintains technical expertise byreading relevant publications, attending courses, and through membership inrelevant industry/professional associations SKILLSProven IT proficiency andskills including Microsoft OfficeEffective problem solving, timemanagement, and organization skillsEffective verbal and writingskills; English and local language, if relevantThis position requires theability to perform varied tasks, maintain an appropriate work pace, exercise logic and reasoning, and comprehend and follow instructionsThis position requires the abilityto travel 70 - 75% Performing the duties of thisjob regularly involves speaking and listening, repetitive hand movement (atleast 15 minutes), and sitting for long periods of time; involves somestanding, walking, grasping, reaching and lifting of up to 10 pounds
Company:
Bevov
Posted:
April 9 on Bevov
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More About this Listing: Clinical Research Associate (East Coast)
Clinical Research Associate (East Coast) is a Research Research Associate Job at Bevov located in Princeton NJ. Find other listings like Clinical Research Associate (East Coast) by searching Oodle for Research Research Associate Jobs.
Clinical Research Associate (East Coast) is a Research Research Associate Job at Bevov located in Princeton NJ. Find other listings like Clinical Research Associate (East Coast) by searching Oodle for Research Research Associate Jobs.