12+ years of experience in Clinical Research (in a CRO) as CRA, SCRA, CRA Manager, Project Manager of local projects, Associate Director Clinical Operations. After taking some time off in Clinical Research to focus on entrepreneur- & mothership, I decided to start working as a freelance Clinical Research Professional to offer my experience and value to clients looking for high quality workers. My experience includes amongst other things: -CRA work (from feasibility, over contract negotiation, EC and CA submissions, to closing trials). -CRA Manager: training, mentoring, motivation, quality improvement, ... -Staffing and Resourcing, revenue taking, process improvement ...
Freelancer - Clinical Research Professional
Since January 2014
•Senior CRA: Performing the whole process of a Clinical Study, from feasibility to closing a trial. •Lead CRA: Mentoring and training CRA’s, guidance of a CRA Team, resourcing trials with CRA staff, supporting project management, performing CRA work, … •CRA Manager: Interviewing and hiring new CRA’s, Training and coaching CRA’s, Appraisals CRA’s, salary and benefits discussions, reviewing quality of CRA work, implementing improvement where needed, ..
Since August 2009
January 2012 --- December 2013
Teambuilder: •recruiting and coaching people in developing their own business •networker •presenter & organizer, planner
Associate Director, Clinical Monitoring
September 2010 --- December 2011
•Administratively manage a defined group of centrally based and remote Clinical Monitoring staff members for the geographical region, which could include, CRA, ACMM or CMM individuals (may vary across regions) •Assess staffing and resourcing needs, and determine appropriate assignments for the CRAs •Review actual and projected project needs to ensure maximum CRA utilization •Interview, evaluate and recruit new Clinical Monitoring Staff as required while providing recruitment and retention initiatives for existing staff •Identify Clinical Monitoring Staff training and development needs and ensure requirements are met in coordination with the HR department and TCR Training staff •Review CRA training and development to include accompanied visits and performance appraisals •Implement CRA team meetings •Complete, review and provide follow-up of the departmental metrics •Maintain communication with the Project Management department to identify and address performance, staffing, training or developmental needs for Clinical Monitoring staff members •Provide Clinical Monitoring support to Business Units, including proposals, budgets, project planning and execution •Represent Clinical Monitoring Department in internal (Company) meetings and external (client) meetings •Acts as Project Lead for projects where no Project Management is involved, as needed/requested •Support functional partnerships if applicable.
Clinical Monitoring Manager BE, NL, Nordics/Staffing & Resource Manager Europe
August 2006 --- August 2010
•Administratively manages a defined group of centrally and regionally based CRAs. •Assesses staffing and resourcing needs, and determines appropriate assignments for the CRAs •Reviews actual and projected project needs to ensure maximum CRA utilization •Interviews, evaluates and recruits new CRAs/Consultant CRAs as required while providing recruitment and retention initiatives for existing staff •Identifies CRA training requirements and development needs to ensure that these are met in coordination with the HR department and Company Training staff •Reviews CRA training and development to include accompanied visits and performance appraisals •Implements Standard Operating Procedures and process improvements through regular training sessions and CRA team meetings •Completes all other assignments given by management or as business needs require.
Senior Clinical Research Associate
January 2004 --- July 2006
•Identification of potential investigational sites •Coordinates and performs comprehensive site management •Conduct of pre-study, initiation, interim and close out monitoring visits •Produces comprehensive visit reports and status reports •Resolves data issues and audit issues •Adherence to the study timelines and budget •Within Europe, the collection of high quality critical documents and completion of ethics committee and regulatory submissions •Mentors less experienced CRAs.
ApproachabilityService orientedSelf-disciplineProblem solvingProactivityOrganizationOptimismIndependenceFlexibilityEfficiencyDiligenceCritical thinkingCreative thinkingCoordinationCollaborationAttention to detailAnalytical thinkingAssertivenessSociability
Skills and Expertise
Interact with nurses Interact with physicians Monitor a clinical study Report dataAdjust processes and methodsAdverse event reportingApprove consent documentsApprove monitoring reportsApprove patient informationAssess site feasibilityAssess subject safetyAssign activitiesAttend investigator meetingAttend seminarsClinical data collectionCollect patient forms and questionnairesCollect financial data from hospitalsCommunicate with investigatorCommunicate with sponsorConduct close-out visitsConduct monitor visitsComplete study proceduresConduct site initiationConduct the trialConfirm protocol complianceContract approvalDiscuss treatments with investigatorEnsure data consistencyEnsure good clinical practice (GCP)Facilitate sponsor monitoring visitsGastrointestinal diseasesIdentify investigatorsInteract with physiciansIndentify sitesInformed consent processInitiation visitInteract with CROsInteract with pharmacistsManage contractors managing a small teamMonitor a clinical studyMonitor clinical trials Monitor dataMonitoring enrolmentMonitoring subject complianceNegotiationOral presentationOrganise meetingsProvide trainingRespond to audit findingsRetrieve study documentsReview monitoring reportsSchedule sponsor monitoring visitsSchedule trial visitsScheduling trial visitsSelect contractors Select investigatorsSet up a clinical studySolve problemsSupervise clinical monitorsSupervise trial suppliesTrain off site staffTrain on site staffWritten presentation
Master in Science in Physical Education from Katholieke Universiteit Leuven in 1996