Senior Clinical Research Associate
The Senior Clinical Research Associate (Sr. CRA) will perform monitoring and site management activities for all Phases I-IV of clinical research projects to assess the progress of studies at assigned investigative/physician sites (on site and remotely) and to ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, Sponsor standard operating procedures (SOPs), ICH-GCP and all applicable local and federal regulatory requirements. The Sr. CRA performs all tasks independently, seeking guidance as needed.
Under the direction of the Clinical Project Manager, and other members of the Clinical Development Management Team:
- Participates in drafting key study documents such as protocols and amendments, Informed Consent Forms (ICF), study procedure documents, and vendor or site manuals.
- Reviews informed consent forms (ICFs) and documents review using ICF checklist. Reviews other patient facing material to ensure accuracy against protocol.
- Collects, reviews and tracks essential trial documents.
- Participates in the review of site budgets and contracts.
- Participates in the review of EDC, eCRF, ePRO, edit checks specifications and eCRF guidelines. Performs UAT of all systems used in clinical trial conduct.
- Oversees CRO and vendor performance by conducting oversight monitoring to ensure vendors are providing services in accordance with corporate expectations for quality, budget and timelines.
- Reviews CRO monitoring reports, CTMS data and reports including protocol deviation reports, and patient profiles to identify and correct data issues and site performance trends.
- Participates in development of study tools, trackers, worksheets, and reports to ensure documentation of data quality, study progress and to provide updates to Clinical Development Management Team.
- Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the Clinical Development Management Team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
- Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes, conducts Source Document Review of appropriate site source documents and medical records, verifies required clinical data entered in the EDC 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 tools to support the effective conduct of the clinical study data capture and review.
- Performs investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients 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 maintained, dispensed and returned.
- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures investigators are aware of the requirements for archiving essential documents in accordance with local guidelines and regulations.
- Documents monitoring activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Makes appropriate revisions to documents based on review and feedback from the Clinical Project Manager, or other members of the Clinical Development Management Team.
- Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution.
- Manages site-level activities/communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals/targets.
- Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
- Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required.
- Tracks clinical trial progress and provides the clinical team and the program team with information regarding vendor and site performance and recommends remediation when needed.
- Performs clinical data review to ensure data are clean and validated using data tracking tools and forms. Maintains the tracking tools and forms to document review.
- Other duties as assigned.
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Must demonstrate good computer skills and be able to embrace new technologies
- Excellent communication, presentation and interpersonal skills
- Ability to manage required travel of up to 70% on a regular basis
- Knowledge of the clinical trials process, the application of SOPs, and medical terminology
- Attention to detail with the ability to handle multiple tasks with competing priorities
Preferred Experience and Education
- Minimum B.S. / B.A. (science or health care field) or RN or equivalent combination of education, training and experience.
- Minimum of four years of monitoring experience working in clinical research for a Sponsor company or CRO.
- Proficiency with EDC, eTMF and CTMS systems.
- Additionally, experience working in a laboratory, and/or study coordinator experience is desirable.
Please fill out the form below to submit your application.