Jr. Clinical Research Associate Job in Watertown, Massachusetts US
Yoh has a contract opportunity for a Junior Clinical Research Associate to join our client in Watertown, MA. Job Summary: A Jr. CRA always works under supervision of a CRA, Sr. CRA or COM. May perform monitoring visits according to monitoring plan (including trial initiation, training and closeout activities).
Perform all required activities to ensure appropriate support of monitoring of investigator sites and trial execution May directly monitor 200-300 subjects of trials of limited complexity under supervision, typically after 1 year of experience in role Job Responsibilities: After 12 months of experience, may act as point of contact for sites and facilitator of communication between sites and key company line functionsEnsure preparation, collection and distribution of trial master file documents and maintenance of investigator site file Timely write-up of study monitoring visit reports Set up and ensure maintenance of investigator site file May manage site vaccine supply and sample management during course of study typically after 12 months of experience Support more experienced colleagues and investigator in implementing appropriate contingency plans as needed Support more experienced colleagues in ensuring continual compliance with GCP, ICH and the companys SOPs in informed consent process, source data verification, AE and SAE reporting, protocol execution, vaccine accountability, and other tasks as specifiedResolve deviations to standard through remedial action and training Escalate any issues regarding study conduct to his/her manager as neededWhen assigned to CRO Trials: Support more experienced CRA and CTM as required in relationship management management) and evaluating CRO and site performance May review CRO monitoring visit reports and ensure appropriate follow up and escalation of issues identified; occasionally, co-monitoring with CRAs from CROs Typically after 12 months in role Excellent knowledge of written and spoken English (and local language as applicable) 0-12 months field monitoring experience 2-3 years experience in pharma/health care desirable Understands and can apply knowledge of clinical trial designs to trial executionKnowledge of international standards (GCP/ICH), international and national (FDA, EMEA) and local regulations ideal Expertise in communication, managing multiple priorities and computer literacyJob Requirements: A higher education degree in a scientific, health care, or other related discipline requiredDiscover all thats possible with Yoh. Apply now.
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