The Clinical Research Associate I (CRAI) will complete project activities associated with monitoring functions of Phase I-IV clinical research studies while starting to develop an understanding of the drug development process. Performs monitoring functions to assess the progress of clinical studies at assigned investigative sites (either on site or remotely) to ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements. Requires guidance and oversight prior to independently conducting tasks onsite.
Assures compliance with local regulations, Code of Federal Regulations (CFR) / International Conference of Harmonization (ICH) and Good Clinical Practice (GCP) guidelines, and Company and Sponsor SOPs.
Under supervision, evaluates adequacy of investigator sites (qualifications, facilities, equipment and performance). Performs all tasks required for onsite/remote monitoring, including but not limited to source document review (SDR) and source document verification (SDV). Plans and conducts study initiation visits for investigator sites. Applies planning techniques for monitoring visits to ensure efficient and effective monitoring. Plans and conducts study close-out visits for investigator sites. Manages and prioritizes workload effectively.
Completes and submits monitoring visit reports in accordance with SOP/Work Instructions or Sponsor requirements as agreed in the scope of work. Maintains awareness of key study performance indicators for own sites. Supports subject recruitment and retention strategies. Updates study and subject status information. Documents and tracks the resolution of all outstanding site-specific protocol-related, quality or ICH-GCP compliance issues from contact to contact.
Ensures all assigned sites are trained and compliant with requirements of the study protocol, informed consent process, data collection requirements/data collection tools. Serious Adverse Event (SAE) reporting requirements, Investigational Product (IP) management, bio sample management and subject reported outcomes instruments as applicable. Follows standard process for documentation of site contacts (visits, phone, email etc.)
Extensive travel may be required, 50% to 75% on a regular basis.
Subject Rights & Well-being—Verifies the process of obtaining informed consent has been adequately performed and documented for each subject. Demonstrates diligence in protecting the confidentiality of each subject. Assesses factors that might affect subject’s safety and clinical data integrity at an investigator site such as protocol deviation/violations and pharmacovigilance issues.
Reporting & Tracking
Maintains site performance metrics and, with guidance, implements action plans for sites not meeting expectations.
Maintains current regulatory documentation for assigned sites according to Essential Regulatory Document Guidelines and/or regulatory project plan.
Maintains up to date information within the deployed Clinical Trial Management System (CTMS).
Audit – Maintains all areas of cover as assigned with guidance (site & study level) to audit readiness standards and supports preparation for audit and required follow up actions.
Demonstrates sufficient time management to achieve required deliverables: consistent on time expense reports, timecard submissions, trip report submissions/finalization, monitoring visit frequency as per Statement of Work (SoW), Clinical Monitoring Plan (CMP).
Data Management— Uses analytical thinking to review data recorded in source documents for accuracy and completeness and in accordance with the clinical monitoring and associated plans. Verifies clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture.
Investigational Product—Performs investigational (medicinal) product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned.
Documentation and Record Keeping—Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the trial master file (TMF). Ensures the investigator site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. Verifies site compliance with electronic data capture requirements.
Communication—Maintains effective, accurate and timely communication with site staff and project team, and ensures appropriate issue escalation. Demonstrates the ability to successfully establish and maintain a diplomatic and collaborative working relationship with others (sites or team colleagues) for effective issue resolution and execution of tasks. Seeks guidance to resolve non-routine tasks. Participates in global conference calls and meetings to review progress of ongoing clinical trials.
Prepares for and attends Investigator Meetings and/or sponsor face to face meetings.
Attends clinical monitoring/project staff meetings and attends clinical training sessions according to the project specific requirements.
Maintains required and functional job specific training.
Performs other work-related duties as assigned.
As a representative of the Company, demonstrates professional attire, attitude and behavior in meetings & teleconferences, site visits and interactions, and interpersonal activities in general.
BA/BS degree in science/health care field or nursing degree or equivalent combined education and experience. Basic understanding of SOPs, WIs, FDA and local regulations, as well as ICH-GCP guidelines. Demonstrates ability to prioritize and manage time for the preparation, completion and follow up of monitoring tasks. On site experience: signed off to independently conduct at least two types of visits; PSSV, SIV, IMV, COV. Experience of Observation/Training visit on all types of visits. Ability to describe clear and technically accurate information and instructions to site and Company/ Project staff, both orally and in written form, regarding monitoring related activities, identification of discrepancies/issues and necessary corrective and preventative actions. Demonstrates ability to successfully establish and maintain a diplomatic and collaborative working relationship with others. Cultivates relationships and establishes credibility to influence others in situations without direct authority. Ability to adapt & manage attitude to optimize performance under pressure. Demonstrate proficiency in navigation within: CTMS systems, Data Platforms for projects, Microsoft Suite: Excel, Word, Power Point, Outlook, Site EMR systems. Demonstrate sufficient time management to achieve required deliverables: Consistent on-time expense report/timecard submissions, trip report submission/finalization. Ability to handle multiple tasks to meet deadlines in a dynamic environment.
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.pate
Primary Location North America - US Home-Based
Other Locations North America - USA-Raleigh-3201-Beechleaf-Ct
Job Clinical Monitoring
Travel Yes, 75 % of the Time
Employee Status Regular