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Oncology Training


Clinical Research Associate Program

Introduction to Clinical Research, Roles and responsbilities of a CRA, Drug Development, Clinical trial phases, regulatory requirments, regulations, good clinical practice, roles and responsbilities in clinical research, IRB, The research process, Informed Consent Process, Study Start Up, Study Maintaince, PSSV Prep-Initiation-followup, Audits, Case Report Forms, Clinical Investigators, SIV Prep-Initiation-followup, Recruitment Retention and Compliance, IMV prep-initiation-followup, COV prep-initation-followup, Investigational Product Accountability, Serious Adverse Events and Adverse Events, Pharmacoviligance, Source Document Verifcation, Risked Based Monitoring, Protocol Deviations.

Clinical Trial Management Program

Introduction to Clinical Research, Introduction to Trial and Project Management, Roles and Responsibilities, CRO Oversight, Sponsor Oversight, Vendor Management/oversight, Study Start Up, Informed Consent Process, ICF review/development, Building Budgets, Budget planning, Process mapping, Schedule management, communication building, project tracking, Contract review and negotiation, team building for project managers, data base locks, audits and insoections

Oncology Training Program

Introduction to Cancer Research, Historical Perspective of Oncology Clinical Trials PSV/SIV Preparation for Oncology, IMV Preparation for Oncology, Source Data Review for Oncology, End Points, Toxicity Monitoring, Dose Escalation, Establishment of Maximum Tolerated Dose, TNM Staging, RECIST Criteria, CTCAE, ECOG, Interim Analysis, Biomarkers and Surrogate End Point in Clinical Trials, Use of Genomics in Clinical Trials Imaging, Pharmacokinetics and Pharmacodynamics Monitoring in Clinical Trials, Drug Evaluation Process in Oncology

Post Training Program

Introduction to monitoring, communication, site management, study team correspondence, organization, email organization and filing, expense report writing, timesheet development, VeevaVault training, EDC training, site transition processes, study start up, feasibility, PSSV prep- -conduct-followup, IRB approval/renewals, SIV prep-conduct-followup, IMV prep-conduct-initation, COV prep-conduct-initiation, Query writing, SDV review, Pulling Data reports in EDC, Schedule of Assessments Review, Audit Readiness, Protocol Deviation (minor and major), issues/actions reconciliation, metrics, phamacoviligance review, AE/SAE review, risked based monitoring, Key Performance Indicators, Investigator Site File, Invstigational Product Accountability, data review and reconciliation, data base lock, intrerim anaysis, in-between visit expectations, trip report writing, follow up letters, confirmation letters, eTMF review/reconciliation, Note to Files, Corrective and Preventitive Action Plans (CAPA), Tracker deveopment, Protocol Deviations (major vs minor), SDV vs SDR, eTMF reconciliation, essential documents review, onsite clinical exam, informed consent review, trip report writing


If you would like get the opprotunity to directly impact quality of care and medical research to be engaged in the company training program to gain knowledge and skills required to independently conduct clinical monitoring visits in accordance with study protocol, standard operating procedures, good clinical practice and applicable regulatory requirements. We seek dynamic and motivated people who truly want to make a difference in the life sciences industry. At Clinopharm, we look for the very best people and give them meaningful work to do. The internship program will assist in managing clinical trials from start-up through close-out. We have internship positions available in monitoring, data management and study coordination where we support Phase I and II clinical trials across multiple disease areas at our clinical research site. To be eligible one must have seccessfuly completed one of Clinopharm CRA, CDM or CTM curriculum.

Post Training Program
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