In-House CRA
Description
Job Summary We are seeking an experienced In-House Clinical Research Associate (In-House CRA) to support the execution of clinical trials through remote monitoring, site management, and cross-functional collaboration. This role serves as a key point of contact for investigative sites and field CRAs, ensuring protocol compliance, regulatory adherence, timely safety reporting, and overall study quality. Experience in Neurology or Psychiatry clinical trials , including Schedule I controlled substances , is highly preferred. Responsibilities Perform remote monitoring activities and provide ongoing support to investigative sites and Clinical Research Associates (CRAs). Serve as a secondary point of contact for study sites, assisting with site management throughout the clinical trial lifecycle. Review, track, and follow up on serious adverse events (SAEs) and other reportable events, ensuring timely documentation and regulatory compliance. Monitor study metrics, identify protocol deviations or non-compliance issues, and support issue resolution and escalation. Assist with study start-up activities, data reviews, monitoring visit support, and audit/inspection readiness. Collaborate with cross-functional teams to support study execution, site performance, and regulatory compliance. Participate in study meetings, teleconferences, and protocol-specific training. Qualifications Bachelor's degree in Life Sciences, Clinical Research, Healthcare, or a related field, or an equivalent combination of education and experience. 3–5 years of clinical research experience , including in-house CRA, clinical trial coordination, or remote monitoring experience. Highly preferred: Experience in Neurology or Psychiatry clinical trials , including Schedule I controlled substances . Strong knowledge of ICH-GCP and applicable clinical research regulations. Preferred location: East Coast or Central U.S.