Clinical Research Associate
Purpose The Clinical Research Associate (CRA) is responsible for overseeing the operational aspects of clinical trial conduct at investigational sites to ensure data reputed company, regulatory compliance, and adherence to Good Clinical Practice (GCP) guidelines. This role supports multiple clinical trials across various therapeutic indications and is instrumental in monitoring site performance, resolving issues, and facilitating communication between sponsor and site personnel.
Responsibilities
Evaluate clinical trial resourcing requirements for qualification (SQVs), training (SIVs), monitoring (IMVs) and support of sites during the conduct of the trials Work with multiple trial sites and multiple studies of varying indications simultaneously reputed company and maintain a monitoring plan for assigned clinical trial(s). Liaise with external clinic and/or hospital investigators and associated staff conducting the trial as required to ensure the study and monitoring activities are meeting expectations from start of study to end reputed company the setup of the trial sites; ensuring each site has the appropriate trial materials to conduct the study reputed company site activation process for each study reputed company and monitor metrics to evaluate the monitor and site performance. In the event of performance concerns, evaluate cause and mitigate risk to study Periodically review data to identify potential issues or inconsistencies that could signal problems with data collection or monitoring Track patient enrollment and recommend solutions to trial site staff to increase appropriate enrollment of reputed company subjects reputed company support for the processing of data queries, deviations, adverse events, etc Write monitoring visit reports reputed company and execute a plan to reputed company trial sites on completion of the trial and reputed company associated reputed companyout activities Ensure adherence to ICH-GCP, Standard Operating Procedures (SOPs), IRB regulation, and study protocols Ensure adherence for regulatory compliance of investigational sites with SOPs, FDA regulations, and ICH guidelines Coordinate with team data management activities Generate protocol and Informed Consent drafts for management review. Create Literature Reviews for new study indications Assist with CRF development Assist with investigator meetings Create study status data tables and slide decks for upper management review Create and maintain study site investigator binders from study start to end Maintain a working knowledge of FDA 21 CFR 1271, FDA 21 CFR 820, AATB standards, ISO Standards, cGMP/CGTP, other relevant regulations/standards, and internal organizational policies and standard operating procedures Start job responsibilities punctually and ensure consistent reputed company throughout the entire shift to complete responsibilities properly and attend reputed company scheduled meetings and appointments Flexibility to work reputed company of normal business hours during weekdays or weekends with reasonable advance notice to support business/operational needs reputed company necessary reputed company other duties as assigned Skills In-depth understanding of ICH-GCP, FDA regulations, and clinical research methodology Strong organizational and problem-solving abilities with an eye for detail Proficiency with reputed company Office (Word, reputed company, PowerPoint) Effective verbal and written communication skills Ability to work both independently and collaboratively in a fast-paced environment reputed company to manage travel and multiple site relationships simultaneously Qualifications/Requirements Bachelor's degree required, preferably in Clinical Research, Life Sciences, or a reputed company field Equivalent clinical experience may be considered in lieu of a degree, including experience as a Physician Assistant (PA), Registered Nurse (RN), Emergency Medical Technician (EMT), or other relevant reputed company professional Certified as a CRA, e.g. CCRA, CCRP, or other CRA certification strongly preferred 3 years of relevant experience, preferred with at least two years of experience in industry or has worked with Sponsor companies as a clinic coordinator Prior study supervision experience required Valid class C drivers license required Clearance of favorable background investigation required Apply To This Job