Planet Pharma

Compensation

Full Description

• 20 hours a week (Part-time) • Oncology experience required JOB DESCRIPTION / SUMMARY This role will ensure studies are monitored in accordance with the clinical protocol, standard operating procedures, good clinical practices, and other applicable regulatory requirements. May be responsible for multiple projects and must have the ability to work both independently and in a team environment. RESPONSIBILITIES • The main responsibilities of this role include, but are not limited to, the following:Independently conduct monitoring visits at investigational sites, including site evaluation, initiation, interim, motivational (as applicable) and close-out visits. • Prepare and submit monitoring visit reports in accordance with InClin SOPs.Conduct co-monitoring visits at investigational sites, as needed. • May function as a Lead CRA (LCRA) and may assist the Project Manager as follows: • o Development of Clinical Monitoring Plan o Tracking compliance with Clinical Monitoring Plan o Oversight and management of other CRAs assigned to the project o Review trip reports and ensure CRA compliance with CMP o May lead CRA team calls, keep minutes of those calls, and submit those minutes for filing in the eTMF. o Systems testing (i.e. eCRF and edit check UATs)Obtain, collate, and file essential clinical documents in accordance with InClin SOPs. • Communicate project-specific information to and from trial sites and document communications with study site and team. • Escalate and triage issues to team in a timely manner. • Manage key study parameters including, but not limited to, clinical study start-up activities, clinical supplies preparation, enrollment, data collection, and close-out. • Train investigational site personnel to the clinical protocol and protocol-related plans, manuals, and guidance documents as well as industry standards including ICH-GCP. • Train investigational site personnel on any study-specific portals or vendors, if applicable. • Verify study data on source documentation and case report forms per ALCOA-C standards to ensure compliance with the study protocol and study-related plans, manuals, and guidance documents. • Identify and resolve data discrepancies. • Assist in the preparation and review of study documents including, but not limited to, clinical protocols and amendments, case report forms, informed consent forms, site training materials and clinical study reports. • Organize and present at project meetings. • Provide feedback, if applicable, on monitoring strategy, study enrollment strategies, and clinical monitoring plan. • Participate in reviews of study systems testing as requested by LCRA/PM. • Review data listings as requested by LCRA/PM. • Reconciliation of pharmacy/drug accountability (unless functioning as a blinded CRA). • Serve as a mentor to junior CRAs and participates in co-monitoring activities. • Assist in site identification, patient recruitment and planning. • Collaborate with Study Management Team to drive patient recruitment. EDUCATION AND EXPERIENCE REQUIREMENTS • Bachelor's degree or equivalent experience in relevant field (science, nursing, medical or pharmacy degree required) • At least 5 – 7 years previous CRA experience in a CRO or biotech/pharmaceutical industry. KNOWLEDGE & SKILL REQUIREMENTS • Knowledge of applicable standards, regulations and ICH-GCP for clinical study conduct • Excellent oral and written communication skills • Confident and influential approach • Understanding of the needs of others • Experience of coordinating people and time management • Excellent planning, organizing, interpersonal and leadership skills with a high degree of accuracy and attention to detail • Demonstrated experience in computer skills including Microsoft Word, Excel, and basic templates • Making independent choices and to take responsibility for own actions • Recognizing potential obstacles and working to resolve them within set timelines • Being conscientious and precise in the delivery of work even when under pressure ? Being collaborative and team-oriented • Willingness to travel up to 75% of the time • Willingness to be compliant with study-specific billing and budgetary constraints