Description Position at Premier Research The Senior Clinical Research Associate (SCRA) is accountable for conducting monitoring activities of assigned clinical trials in compliance with the protocol, ICH-GCP/ISO14155 and all applicable local laws and regulations, company policies and quality standards.
He or she performs the management of study site activities to ensure the collection of accurate clinical data within given timelines.
The CRA proactively identifies, resolves/mitigates and escalates risks and/or issues, may be responsible for multiple studies and must work independently with team support.
Position can be regional or office based.What you’ll be doing:Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelinesMaintains submission of expenses according to travel and expense requirements within company guidelinesResponsible for the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP/ISO14155, protocol and client requirementsMonitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulationsPlans day to day activities for monitoring of a clinical study and sets priorities per sitePrepares for and conducts on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites as required by clinical monitoring plan.Takes the initiative to move the project/program forward by reducing backlog and keeping it at a minimumMonitors with knowledge of quality/scope/timeline and budget parametersWorks with the Clinical Manager (CM), Clinical Lead or equivalent to enhance and proactively manage site visits and trial issues during the monitoring phaseMonitors the quality of clinical deliverables and addresses quality issues with the appropriate team member.
Escalates appropriately and in a timely manner to the appropriate team member.Manages query resolution process with sites and Premier Research Data ManagementMaintains Trial Master File (TMF)/electronic Trial Master File (eTMF) as defined by the organization’s processes per filing guidelines.
Has an understanding of the required essential documents according to ICH/GCP Section 8.
Reviews site documents and verifies they are accurate, complete, current, and include required updates.Assists project team with assessing project feasibility and recruitment, as applicableMaintains project tracking system of subjects and site information, as applicableParticipates in Investigators’ Meeting as designated by the Project ManagerMaintain communication with study sites as directed per CMP, and in agreement with the study site and complete documentation of contacts.Attends meetings as requiredEnsures site visit metrics and utilization are maintained as required and escalates available time as necessary to line managerCompletes timely entry of hours worked and project codes per time entry guidelinesMaintains high level of attention to detail to ensure subject safety for our projects and delivery of quality data for our clientsAcquire basic knowledge of disease or condition under study.
Participates in available training offered to increase therapeutic knowledgeReview of IP accountability and applicable logs (subject and site level) as directed per the Clinical Monitoring PlanMaintains proper, timely communication with study teams and management, as needed.Completes all required internal training (general and study-specific) on-time.Identifies confidential information and complies with global and local laws and guidelinesIn specific countries or situations, the CRA may be requested to also assume additional country specific responsibilities, being appointed as Subject Matter Expert in one or more areas including but not limited to the following: Start-up, Regulatory, Site Contracts, Office Manager, etc.
This will be documented with the appropriate guidance or functional descriptionIn specific projects, the CRA may be requested to also assume additional project specific responsibilities, e.g.
Clinical Management for smaller or less complex studies, under the appropriate supervision of the line manager or functional leadOther activities as designatedActs as a resource/mentor for other CRAs and shares knowledge base and best practices.You’ll need this to be considered:Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience requiredPrevious clinical research experience required, completion of CRA training programRead, write and speak fluent English; fluent in host country languageSuccessful previous experienceExperience in coaching/mentoring other CRAsGlobal experience preferredAt least 4 years’ experience in clinical trialsExperience in monitoring complex trials or global trials or equivalent experienceKnowledge of ICH / GCP regulationsWorking knowledge of FDA Guidance Documents / EU Directives / local regulations / ISO14155 regulations, drug / device development, and clinical monitoring proceduresKnowledge of web based communication tools for conferences and any other IT systems required for the jobKnowledge of clinical/health systems as well as knowledge of cultural/professional practices appropriate to the country/region where the site monitoring activities will be carried outFull-time availability to internal and external project team membersFluent verbal and written EnglishExcellent team player, collaborative and able to enable an effective teamAbility to multitask and work effectively in a fast-paced environment with changing prioritiesStrong verbal and written communication skillsExcellent organizational and time-management skills, able to meet deadlinesSelf-starter with a lot of common sense and able to act on own initiativeAccountable, dependable and strong commitmentApplies clear and consistent performance standards and handles problems decisively and objectivelyCustomer service focused in approach to work, both internally and externallyMaintains a positive, results orientated work environmentTravel: 70-85%Lifting up to 25lbsValid driver’s license, passport as required#LI-BL1