Insourced Clinical Research Associate

Description

Summary: The Senior Clinical Research Associate monitors investigational sites to ensure subject safety and high-quality data in compliance with regulations and guidelines. Highlights: 1. Ensures subject safety and high-quality data in clinical research 2. Serves as primary contact for assigned research sites 3. Monitors investigational sites and supports project teams **li{ margin:** \-8px;} **Job Description:** **Job Overview:** The Senior Clinical Research Associate monitors investigational sites to ensure subject safety and provide high quality data review and reporting in compliance with the Company and/or client Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) guidelines, ISO14155, and other applicable regulations. Builds, manages and supports strong site relationships while serving as liaison between the Sponsor and assigned sites. **Job Duties and Responsibilities:** * Provides support to Project Team and Clinical Operations Team. * Maintains strong working knowledge of protocols and Monitoring Plans for assigned projects. * Demonstrates strong written and verbal communication skills. * Serves as primary contact for assigned research sites. * Verifies that the investigator, staff, and site facilities remain adequate throughout the trial period. * Responsible for the scheduling and conduct of pre\-study visits, site initiation visits, interim monitoring visits and close\-out visits according to the Monitoring Plan. * Ensures research sites conduct studies according to protocol requirements or investigational plan and applicable regulations and guidelines. * Verifies that the rights and well\-being of trial subjects are protected. * Reconciles site regulatory binder assuring collection and completeness of regulatory documents. * Collects and ensures completeness of all essential regulatory documentation from sites from study start\-up through close\-out. * May support translations of essential documents. * May support submission of trials to IRB/IEC and regulatory authorities. * Verifies that written informed consent was obtained before each subject’s participation in the trial. * Verifies that the investigator is enrolling only eligible subjects. * Performs source data verification against Case Report Form/Electronic Data Capture entries in compliance with the Monitoring Plan. Ensures accurate and complete data and that corrections are appropriately documented by authorized site staff. * Verifies the quality of all recorded data. Issues and ensures timely resolution of all data queries remotely or at investigator site. * Performs Investigational Product accountability, including product storage, inventory, return/destruction, and dispensing/receipt records. * Verifies and supports the recording and reporting of adverse events/serious adverse events. Ensures all types of adverse events are reported and tracked per regulatory requirements and the Monitoring Plan. * Ensures that sites have sufficient project specific supplies. * Manages investigative sites in respect to the trial conduct and motivates sites to meet study goals. * Communicates deviations from the protocol, SOPs, and/or GCP, to the investigator, and project management team and takes appropriate action to prevent recurrence. * Delivers high quality written trip reports, confirmation and follow\-up letters within timelines of SOPs and monitoring plans. * Participates in site audits, as requested. * May conduct site and study feasibility assessments. * Provides input into study documentation and monitoring worksheets. * Uphold the confidentiality agreements with all clients and colleagues outside the Company Clinical Research. * Pays attention to signals of fraud, misconduct and escalates per Company SOP. * Work according to the Company Quality Management System and actively participate in giving feedback and suggesting improvements to current processes. * Work according to the project\-specific timelines and budget agreement, which has been agreed upon with the sponsor. Accurately document the time spent per project in the Company time allocation system. * May conduct project co\-monitoring visits. * May conduct Team calls (as needed). * May provide project\-specific performance feedback. * May serve as site contact for protocol clarifications and subject enrollment. * May manage Protocol Deviation documentation, tracking, and escalation. * May relate project status and issues to Project Manager and/or CRAs. * May serve as Sponsor contact for monitoring/site issues. * Attends and participates in team teleconferences/meetings providing mentoring and training. * Participates in relevant trial meetings, e.g. Kick\-off, Investigator, and Monitor meetings, and provides support, as requested. * Demonstrates flexibility and adaptability. * Proactively identifies, manages, escalates (as needed) and resolves site issues effectively and independently. * May assist project team in development of monitoring guidelines and tools. * May provide mentorship, training and direction to Clinical Research Associates when needed. * May perform Site Visit Report review, management, resolution and escalation. * May provide support to Project Team and assume additional roles on the team as necessary. * May assist the Project Manager with coordination and management of the project budget, grant administration and project invoicing. * Other duties as assigned by Clinical Monitoring Manager/Project Manager and per project\- specific requirements. **Supervisory Responsibilities:** No supervisory responsibilities. **Job Requirements:** * Education o 4\-year college graduate or above, preferably with a healthcare or life science degree. o In lieu of a degree, candidates with 3 or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered. * Experience o Minimum of 3 years of experience in on\-site monitoring of clinical studies o Monitoring experiences in several different indications and study types o Experience in all areas of monitoring (on\-site, remote, etc.) * Skills/Competencies o Strong written and verbal communication skills o Strong interpersonal skills o Expert monitoring skills to independently conduct all types of site monitoring visits o Good documentation skills; good command of English and the local language in the area of activity (reading, writing, understanding) o Strong computer skills, including Microsoft Office o Comprehensive knowledge of GCP/ICH guidelines o Proficiency in medical terminology o Able to exercise judgment within defined procedures and practices and to determine appropriate action independently. o Attention to detail o Strong problem\-solving skills o Strong presentation skills. o Ability to work in a matrix environment o Strong time management and organizational skills * Capabilities o Ability to drive an automobile and have a valid driver’s license, if applicable. o Valid passport required in the case of international business travel, if applicable. o Ability to travel up to 80%.