Clinical Research Coordinator/manager

Rashmi Mishra

MBBS, CCRP, CCDM

Email: *********@*****.***

Phone: 734-***-****

Professional Summary

A Medic/Site Director with over 15 years of experience in successfully leading, executing, managing and monitoring all aspects of clinical operations including study planning, regulatory submissions, financial oversight, project deadlines, data management, quality assurance and ensuring compliance with SOP’s, Good Clinical Practices (GCP/ICH) as well as federal and local laws

Editorial Panelist for CISCRP; the Center for Information and Study on Clinical Research Participation

Performs overall scientific oversight and operational conduct of phase 1 to phase 4 clinical trials to ensure milestone and deliverables are achieved within timelines and budget

Knowledge, Skills and Abilities:

Proven track record of successfully leading and executing commercially/agency funded research studies by delivering complex/ high priority clinical trials within agreed time, quality and cost

Study feasibility survey submission and preparation for site selection, site initiation and study closure visits

Budget development, negotiation and implementation

Protocol development and execution, ICF, CRF and PRO design, establishing study timelines, study monitoring, data collection, review and analysis, database cleaning, database lock and assistance with publications

Proactive risk identification and management to ensure project deliverables are met according to regulatory, client and organization’s requirements

In-depth knowledge of ICH GCP and relevant regulations for the conduct of clinical trials and current industry standards (CDISC, SDTM, CDASH)

Thorough knowledge of applicable SOP’s, guidelines and study procedures

Project management and execution skills, risk management, trouble shooting, quick learner, detail oriented and high level of computer literacy

Strong leadership skills in managing personnel and projects, excellent verbal and written communication skills, decision-making, ability to work independently with multi-tasking skills and time management skills with a clear focus on delivery and client satisfaction

Provide training and mentorship to the study team

Aptitude for eCOA, electronic source data, data handling and data privacy

Advanced knowledge, certification and vast experience in Medidata/RAVE, Oracle RDC Onsite, RedCap, Bioclinica, Oncore, iMednet, Clinical Conductor, IVRS/IWRS and EPIC

Areas of Expertise: Site Management, Clinical Operations; Regulatory Affairs; Protocol and ICF Writing; Development of Data Management Plan; eCRF and PRO Design and development; Quality Assurance/Quality Control for data completion and accuracy; ICH/GCP Compliance; Quality Incident Reporting/ CAPA;

Agencies worked with: BARDA part of the HHS; PCORI partnered with AHRQ, NIH, NIA, USUHS)/HJF/DOD

Therapy Areas Handled: Oncology, Vaccines, Obstetrics and Gynecology, Cardiology, Genomics, Gastroenterology, Ophthalmology, Endocrinology, Hematology and Infectious diseases

Work Experience:

Synexus/Optimal Research Rockville, MD

June 2018 – Jan 2019

Center Manager

Managed Phase I & II trials and 17 direct reports

Managed daily operational site activities associated with trials including study start-up, interim conduct and closeout activities

Initiated, planned, executed, monitored and closed all aspects of assigned clinical trials

Provided leadership for clinical research studies, ensuring timelines and deliverables are met

Managed financials for each study including: budget negotiations, forecasting, assumptions, invoices and reconciliation

Oversaw the collection, review, maintenance and reconciliation of eTrial master file (TMF)/regulatory binder

Developed informed consent, CRFs and data collection tools with completion guidelines, training materials and monitoring plan for reference

Monitored and evaluated all field study activities such as study enrollment, data acquisition, data entry, data management, AE/SAE reconciliation according to GCP/ICH/FDA guidelines to ensure that consistent and accurate data is delivered to the client

Developed project timelines, procedures, forms and tracking systems

Maintained project documentation, tracked progress on projects, and worked with principal investigators to overcome barriers

Kept the site in an audit ready state, developed responses to audits/inspections and ensured appropriate CAPA implementation

Compiled and communicated various study metric and summary reports to senior management

Facilitated effective communication between internal and external stakeholders

Served as point of contact for the sponsor, study team and the IRB

Authored and revised SOPs, and managed Change Control system

Developed risk mitigation strategies, associated action plan and issue resolution

Managed cross functional teams such as data management, quality assurance, clinical monitoring, pharmacy and clinical laboratory

Led project meetings on a weekly basis with study staff and the sponsors

Inova, Falls Church, VA

Jan 2016 – May 2018

Clinical Research Manager, OBGYN

Managed Phase II, III & IV drug /device trials and 7 direct reports

Established and grew the OBGYN Research department from running 3 studies to 15 studies in 2 years

Built site infrastructure with the goal of FDA compliance, including writing SOPs

Prepared for study start up, interim monitoring, and closeout visits

Served as the primary contact for all assigned projects while providing managerial oversight and ensuring regulatory compliance for all trials conducted

Created all study documents including protocol, ICD template, CRFs and data collection tools, case study report and site training materials

Prepared and submitted protocols and study documents for initial approval, continuing reviews, amendments, AE’s, SAE’s deviations, violations and study termination to IRB

Tracked and maintained research team’s compliance with training requirements for federal grants applications and reviewed progress reports

Prepared Clinical Trial Agreements (CTAs), Confidential Disclosure Agreements (CDAs), Data User Agreements (DUAs) and Material Transfer Agreements (MTAs) with external stakeholders involved in the conduct of clinical research

Developed study level recruitment materials and reviewed all field specific materials to align with trial and organization

Reviewed clinical data, source documentation, case report forms and field regulatory files.

Oversaw the collection, maintenance, submission and reconciliation of study data, including study subject medical records

Worked closely with data management and QA team to resolve discrepancies.

Ensured conduct of the clinical trial was 100% accurate and in compliance with ICH/GCP guidelines

Created yearly project budgets and ensured completion of studies within budget

Selected, hired, and trained staff to perform assigned functions at competent levels

Inova, Falls Church, VA

May 2014– Dec 2015

Clinical Research Associate

Inova Translational Medicine Institute

Managed Phase II & III trials

Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets

Worked with principal investigator and sponsors to facilitate daily trial activities and ensure compliance with research protocols.

Screened patient records, obtained consent, enrolled, collected data and specimens and followed research protocols, operations manuals and case report form requirements.

Maintained compliance with protocols covering patient care and clinical trial operations.

Observed studies to safeguard continued effectiveness of the investigator, clinical site team and facility

Conducted internal audits for all the studies, generated data clarification forms for query resolution

Managed Corrective Action processes from inception, root cause analysis and closure in general and particularly for audits conducted

Clinical Research Management Consultant

Jan 2012 – Dec 2013

Medical Narrative Writing and Quality Control

Developed protocols, Informed consents, study procedure manuals, protocol synopsis, case report forms, patient safety narratives and performed quality analysis for multiple oncology trials in compliance with US FDA and ICH/GCP guidelines

James Brown Cancer Center, Louisville, KY

Feb 2011 – Oct 2011

Clinical Research Coordinator

Managed Phase II & III trials

Screened participants, obtained consents, randomized and completed CRF’s with minimal errors and resolved queries

Coordinated and managed laboratory samples and followed up on lab reports

Assisted with chemotherapy orders and coordinated with infusion/treatment room staff

Monitored drug toxicities, prepared and submitted Adverse Drug Reaction reports to appropriate agencies/sponsors as needed

Prepared for monitoring visits by ensuring that data is complete, accurate and consistent

Maintained patient logs, protocol deviation logs, site and archival of study documents at site

University of Michigan, Ann Arbor, MI

Nov 2005 – Dec 2009

Clinical Research Coordinator

Managed Phase II & III trials

Screened electronic health records to short-list eligible subjects, obtained informed consent and enrolled participants

Coordinated and managed collection of laboratory samples and follow-ups of lab reports

Designed CRF’s and completed with minimal errors and scheduled patient visits for follow-ups and query resolution

Made IRB submissions for approval in accordance with the University of Michigan IRB guidance

Maintained Investigator Site file, patient logs, protocol deviation logs, site contact and study material logs at site

Designed and administered patient information material including advertisements, information booklets/brochure used during the study

Administered patient reimbursements

Coordinated with Pharmacists for logistics support including storage of supplies in the pharmacy and onward distribution to participants in accordance with the protocol

Quarterly status updates to the University of Michigan IRB regarding status of study including protocol violation, protocol deviation, budgets, ORIO (Other Reportable Information or Occurrences) and assisting with grant submissions

Veterans Affairs Medical Center, Detroit, MI

May 2003 – Dec 2004

Clinical Research Assistant

Managed Phase II & III trials

Key liaison at site for the sponsor pharmaceutical company

Responsible for compiling and submitting research studies for initial approval, protocol amendments, violation, AE’S, SAE’s, deviation, budgets, ORIO (Other Reportable Information or Occurrences) if any, in accordance with the Veteran Review Board & IRB guidance including follow-up and query resolution

Screened participants, obtained informed consent process, performed CRF data entry and resolved queries

Coordinated and managed laboratory samples and followed up on lab reports

Maintained recruitment logs and ensured patient follow-up with minimal withdrawals

Degree and Certifications

Bachelor of Medicine and Bachelor of Surgery (MBBS) Equivalent to MD- MGM’s Medical College, Aurangabad

Certified Clinical Research Professional, CCRP- Society of Clinical Research Associates

CITI GCP Certification - CITI Program

BLS Certification- American Heart Association

Introduction to Rave Certification - Medidata Academy

PMP (Project Management Professional) Certification (Project Management Institute)– Ongoing

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