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Clinical Research Associate I
1 month ago
We are seeking a highly skilled and experienced Clinical Research Associate I to join our team. As a Clinical Research Associate I, you will be responsible for performing site qualification, site initiation, interim monitoring, site management, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.
Key Responsibilities- Perform site qualification, site initiation, interim monitoring, site management, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.
- Verify the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate.
- Assess factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.
- Conduct Source Document Review of appropriate site source documents and medical records.
- Verify required clinical data entered in the case report form (CRF) is accurate and complete via review of site source documents and medical records.
- Apply query resolution techniques remotely and on site, and provide guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
- Utilize available hardware and software to support the effective conduct of the clinical study data review and capture.
- Verify site compliance with electronic data capture requirements.
- May perform investigational product (IP) inventory, reconciliation, and reviews storage and security.
- Verify the IP has been dispensed and administered to subjects/patients according to the protocol.
- Verify issues or risks associated with blinded or randomized information related to IP.
- Routinely review the Investigator Site File (ISF) for accuracy, timeliness, and completeness.
- Reconcile contents of the ISF with the Trial Master File (TMF).
- Ensure the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
- Document 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.
- Support subject/patient recruitment, retention, and awareness strategies.
- Enter data into tracking systems as required to track all observations, ongoing status, and assigned action items to resolution.
- Understand project scope, budgets, and timelines for own and others' activities in the clinical team; manage site-level activities/communication to ensure project objectives, deliverables, and timelines are met.
- May act as primary liaison with project site personnel, or in collaboration with Central Monitoring Associate.
- Ensure all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
- Prepare for and attend Investigator Meetings and/or sponsor face-to-face meetings.
- Participate, and may, with supervision, lead, global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attend clinical training sessions according to the project-specific requirements.
- Provide guidance at the site and project level towards audit readiness standards and support preparation for audit and required follow-up actions.
- May provide training or mentorship to more junior level CRAs.
- May perform training and sign-off visits for junior CRA staff, as assigned.
- May be mentored and assigned clinical operations lead tasks under supervision of an experienced Clinical Operations Lead (COL), or operational line manager.
- For Real World Late Phase (RWLP), the Sr. CRA I will use the business card title of Sr. Site Management Associate I.
- Bachelor's degree or RN in a related field or equivalent combination of education, training, and experience.
- 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. Basic level of critical thinking skills expected.
- Ability to manage required travel of up to 75% on a regular basis.
