MEA CRA - Clinical Research Associate I

Company: Labcorp Drug Development - USA
Location: Durham
Posted on: January 26, 2023

Job Description:

Clinical Research Associate I - Monitoring Excellence Academy - Biopharma - Home Based USAre you ready to redefine what's possible, and discover your extraordinary potential at Labcorp? A career here provides the unique chance to create a lasting impact and difference in our patient's lives. Joining our team will offer you a rewarding career, an opportunity to work in a high-energy & collaborative workplace, along with access to comprehensive benefits. Your work will be meaningful, the patient outcomes are real, and the results are lasting. With the support of exceptional people from across the globe and an energized purpose, you'll be empowered to own your career journey with mentoring, training and personalized development planning.Our mission is to help our clients bring the miracles of medicine to market sooner - join us for your next career moveConducts site monitoring of clinical research studies according to Labcorp Standard Operating Procedures, ICH Guidelines and GCP.Provide clinical support for project according to Labcorp Standard Operating Procedures, ICH Guidelines and GCP.Site management responsibility for clinical studies according to Labcorp Standard Operating Procedures, ICH Guidelines and GCP.Essential Job Duties:Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, with or without guidance (as per the training status of the CRAI-MEA); liaise with vendors; and other duties, as assignedResponsible for aspects of registry management as prescribed in the project plansGeneral On-Site Monitoring Responsibilities:Assist Senior CRAs and CRA-2 with on-site tasks as required and according to training goals (e.g. review of Case Report Forms and Study File Notebook, drug accountability)Initiate, monitor and close out clinical investigative sites, with or without direct supervision from Senior Clinical Research Associates, Clinical Team Leads, Project Managers or Project Directors, as assigned based on training status and adequate skillset acquisition. On-site Routine Monitoring Visits should be accompanied by an experienced co-monitor (as per training status and agreement from Line Management).Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the studyEnsure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirementsEnsure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document reviewMonitor data for missing or implausible dataEnsure the resources of the Sponsor and Labcorp are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Labcorp travel policyTravel, including air travel, may be required as per essential job functions.Prepare accurate and timely trip reportsPerform CRF review, query generation and resolution against established data review guidelines, with or without direct supervision, on Labcorp or client data management systems, as assigned by managementAssist with the administration of clinical research projects, recruiting investigators, collecting investigator documentation and site managementProvide coverage for clinical contact telephone lines, as requiredUpdate, track and maintain study-specific trial management tools/systemsGenerate and track drug shipments and supplies, as neededTrack and follow-up on serious adverse events as assignedImplement study-specific communication plan as assignedAttend investigators' meetings, project team meetings and teleconferences, as neededPerform other duties as assigned by managementLabcorp is proud to be an Equal Opportunity Employer:As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.For more information about how we collect and store your personal data, please see our Privacy Statement .

Keywords: Labcorp Drug Development - USA, Durham , MEA CRA - Clinical Research Associate I, Healthcare , Durham, North Carolina