Senior Clinical Research Associate

7 days ago

Los Angeles, United States Embakire Full time
Job DescriptionJob DescriptionDescriptionSenior Clinical Research AssociateManage and monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH/GCP, and all applicable regulatory requirements.
Responsibilities:Manage and monitor clinical trials independently, across multiple studies, to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH/GCP guidelinesProvide input on clinical study documents such as Protocols, ICFs, Source Documents, and Monitoring PlansInitiate clinical trials at investigative sites, instruct site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sitesIdentify study-related issues, confirm resolution, and ensure proper documentation through event systemRecord site visit activities, including but not limited to, observations of clinical conduct, instructions/training given to sites, and action items to be completed as required by OPs or other contractual obligationsReview and verify accuracy of clinical trial data collected, either onsite or remotely, including query resolutionAssist with generating contents list of Enrollment Kits and other Study Supplies, as requestedFacilitate supply management and ensure clinical sites have necessary supplies to conduct studies according to applicable protocolsAssess IP accountability, dispensation, and compliance at the investigative sitesEnsure all required training is completed and documentedPerform essential document site file reconciliationEnsure maintenance of essential documents in TMF to facilitate timely transfer to clientServe as main contact for project-specific communications with investigative sitesWork closely with other clinical team members to facilitate timely resolution of trial and/or clinical issuesProvide regular site status information to team members, trial management, and updates trial management toolsParticipate in team meetings with clients, as needed, and keep project team members informed of study progress, issues and potential timeline delays by preparing weekly updates, as requestedResearch and learn project indicationServe as resource for and interact with other functional areas to resolve site issues and facilitate trial timelinesAnalyze process workflow; implement operational changes in coordination with Sr Management ?May be assigned additional Clinical Operations tasksHelp create a fun, rewarding and collaborative environment
Education/Skills:5 years of Clinical Research experience; IVD experience preferredBachelors degree in the Life Sciences or related field required, or equivalentPursuing a certification as a CCRP or CCRA through recognized professional organizationThorough knowledge of GCP, GLP, ICH guidelines and other U.S. and international clinical regulatory requirementsStrong work ethic and demonstrated ability to deliver assignments on timeAbility to travel (up to 80%)Ability to handle difficult situations professionally and maintain a professional and caring demeanorProven ability to collaborate in a team environment and work independentlyMust be a team-player, punctual and reliable, dependable and flexible in adapting to change in a multi-disciplinary, fast-paced work environmentMust be responsible, creative and highly motivatedWorks Closely With: CTAs, Clin Ops Specialists, CRAs, Reg CRA Supervisors, PMs, Dir of Clin Monitoring Data Management, Sr Mgr of Clin Ops, Dir of Clinical Programs

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