Clinical Research Associate

** ***** ****

Cranbury, NJ ***** Home: 609-***-****

Mobile: 609-***-****

******.******@*****.***

PROFESSIONAL SUMMARY:

Certified and seasoned Clinical Research Professional with 12+ years of clinical research experience.

Demonstrated expertise in clinical site management including performing site visits, negotiating budgets, authorizing ICF’s and study manuals, maintaining trial master file, vendor management & IRB continuation report. Proficient in use of EDC, CTMS and IVRS systems. Experienced in managing investigator site activities from study start up through data base lock in Phase I, II and III in multiple therapy areas including Diabetes, Alzheimer, Genetic disorder, Cardiology, Prostate cancer, Breast cancer, Solid Tumor, Liquid Tumor, Arthritis, Gout, Leukemia, GI, ED, Dyspepsia, & Multiple sclerosis study, Genetic mutation. Covid-vaccine trial

ICON Government and Public Health Solutions and PLC

Full time-Sr. Clinical Research Associate: Novavax Covid trial for Adult and Peds Oct 2020 – Dec 2024

Provides GCP and project training to site staff.

Assists in development of associated study documents (Safety Monitoring Plans, Manual of Operations and Informed Consents).

Identifies site issues/problems, and associated root causes, and develops action plans to ensure resolution, including escalation of appropriate issues in a timely manner.

Acts as the main line of communication between the site and project manager.

Leads study start up team as needed. Provides support and acts as primary point of contact for collection and review of site essential documents.

Manages study sites to ensure site compliance with study protocols, GGP/ICH, and applicable regulations.

Conducts monitoring visits (Qualification, Site Initiation, Interim, Close-out, Audit Prep).

Generates clinical monitoring reports and follow up letters in a timely manner.

Verifies that all research staff and facilities have adequate qualifications and resources and are maintained throughout the course of the clinical study.

Verifies that the investigator and research staff follow the approved protocol and all GCP procedures.

Ensures adverse events, concomitant medications, and inter-current illnesses are reported in accordance with the protocol on the CRF.

Risk based monitoring performed-SDR-SDV-onsite and remotely

Communicates deviations from the protocol, SOPs, GCP, and applicable regulatory requirements to the investigator and ensures corrective action is implemented.

Reviews queries and assists in resolution.

Experienced with remote and on-site monitoring and proficiency in industry standard system including Medidata RAVE, Veeva Vault and eTMF.

Utilizes CTMS to generate, review and provide study reports and run reports from the electronic Trial Master File ( eTMF) Veeva to review overdue quality issue by document type, study and timeline for TMF completeness.

Assists with setup, quality and maintenance of the Trial Master Files (TMF) in accordance with ICON Government and Public Health Solutions SOPs, Good Clinical

Practice (GCP), ICH guidelines and federal regulations.

Participates in project team meetings.

Clinical Research Associate 1/2017- May 2020

Integra Life Science (Plainsboro, N.J) MEDICAL DEVICE (SHOULDER, WOUND MANAGEMNT-DFU)

Conduct site pre-study, initiation, routine monitoring, and study closeout visits

Ensure compliance with ICH-GCP guidelines and all pertinent government regulations for conducting clinical studies.

Assist in preparation of protocols, monitoring plans, ICF’s, MVR’s.

Assist in the IRB/EC application process, including review of informed consent/HIPPA forms for conformance to pertinent regulations.

Contribute to overall data management such as Case Report Forms design, edit check, review, data clarifications process and evaluation and analyzing clinical data.

Recruit qualify and train investigators and clinical site personnel for study participation.

Coordinated activities of investigators and clinical site personnel to ensure compliance with the protocol.

Assure data integrity through proper on-site monitoring, verification of source records, documentation of protocol deviations, and completion of written reports, in accordance with department of Standard Operating Procedures (SOPs).

Communicate with clinical sites to expedite the exchange of information and to ensure that clinical studies are kept on schedule and within budget.

Handling submission for IRB, ICF documentation and Veeva Vault certified

Ensure subject safety in all areas of clinical research, following procedures to report AE’s, SAEs and UADEs for clinical, regulatory and quality management.

Promote good communications with investigational sites, within the clinical department as well between other Integra department members.

Assist with the implementation of investigator meetings and general clinical meetings

Travel 50% nationwide

MedDRA certified

EDC (Clindex, CTMS)

Familiar with Veeva Vault- CTMS

Senior Clinical Research Associate 2/2015-12/2016

CurAccel, LLC (Newtown, PA) (Contract)

Oversee performance of CROs, third party vendors, and field CRAs including monitoring, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to Director or CRO as appropriate

Perform clinical data review of data listings and summary tables, including query generation

Identify, select, and monitor performance of investigational sites for clinical studies; prepare accurate and timely visit reports from all site interaction visits

Develop and maintain good working relationships with investigators and study staff

Track and report on progress of study including site activation, patient enrollment, monitoring visits

Review key study quality

Investigate queries, monitor discrepancies

Manage investigational product (IP) accountability and reconciliation process

Responsible for review or approval of IP release packages

Negotiate and manage the budget and payments for investigative sites

Contribute to preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms

Travel 50% nationwide

Managing vendors and overseeing payments to vendors like labs and CROs

Maintaining of TMF

Clinical Research Associate 1/2013- 2/2015

Taha Consulting LLC (Raritan Bay Cardiology Group)

Lead Coordinator in SMO

Working with Medi data and First Doc system

Conduct full clinical research coordinator/Associate duties

Manage all trials within this facility

Manage Patient Recruitment. Regional Study Enrollment Management (contingency plan)

Handles all query resolutions

Manage study start up to closeout. Regional Data-Lock activities of all TMF review

Drug Accountability

Handling Phase II and III of AstraZeneca Trial for Diabetes and Cardiology

Working with all other trials with Atrial fibrillation

Managing 2 sites in NJ with 30 patients & 1 site in Michigan with 15 patients.

Working on Declare and Carmalina studies by BMS and Boehringer Ingelheim

Managing TMF in eDrive and hard copy i.e. regulatory docs and monitoring reports

Handles Labs and Equipment Vendors for Declare study

Working together with outside data vendors for Declare and Carmalina study

Ongoing review of Protocol deviations

Monitoring 30% nationally

Clinical Study Coordinator III (Oncology) 6/2011- 1/2012

Clinical Research Group Drexel University Center City Phildalphia

Conduct full clinical research coordinator duties for assigned Trials

Review protocol for budget cost analysis, in conjunction with CRG budget group

Coordinate and participate in the pre-site and site initiation visits

Coordinate study initiation and assist with planning and design of source documents for protocol.

Assist with accurate source documentation and appropriate forms as per protocol on all participant record, drug accountability, test devices and clinical supplies

Compliance with all CRG, HR, office of Compliance and any other departmental training

Working with NIH trials including NSABP, RTOG’s, & ECOG

Work with cancer collaborative team

Working with internal departments such as: contracts, regulatory and finance and study site management.

Assessment, startup, & management of all study vendors and study sites

Conducting phase I studies in Myeloma, Skin Biopsy, Virus TB Vaccine from Celgene, & Shingles Vaccine from Merck

Regional CRA II (oncology, ENDO, GI) 2/2010- 6/2011

Taha Consulting LLC, DM clinical LLC

Conducted independent monitoring of sites.

Reviewed Protocols and Amendments

Reviewed and approved ICF. Revised ICF to confirm with site/local IRB requirements

Review site/study budgets

Review and reconcile Drug Accountability Log

Close out visit report review /Regulatory compliance review

Conduct Initiation visit/start up and closeout visits

Conduct phase II and Phase III studies

Regional liaison between specific project team investigational sites, and sponsors

Work with The Data Base lock team (Finalize data & reviewed Subject Listing including AE & SAE)

Clinical Research associate II (In- house) 1/2010- 2/2010

Johnson and Johnson PRD, Raritan NJ (Contract)

Documents Specialist

Clinical Audit for Global Dermatology studies

Documentation of findings for Global Country study files.

Study drug record Compliance for FDA submission.

Conduct Phase I study for skin biopsy

Conducting audits for international trials for FDA/MHRA audit

Senior Clinical Research Associate 10/2008-10/2009

Amicus Therapeutics, Cranbury NJ (Full Time)

Studies: Genetic disorder (Lysosome storage disorder) Pompe, (Protein misfolded) Fabry, Gauche

Reviewed regulatory documents for site initiation and closeout procedure

Reconciled and tracked Adverse and Serious Adverse events

Attended team meetings and teleconferences to capture deliverables

Monitored sites for Pompe and Gauche

Authored study manuals

Designed CRFs and Source Documents according to protocol details.

Reviewed and approved ICF. Revised ICF as necessary to conform with site/local IRB requirements

Created, updated and reviewed protocol related study documents and study start-up Documents (i.e. monitoring plan, training plan, and recruitment plan.)

Direct contact at investigation site for budget development and negotiation

Reviewed and negotiated site/study budgets

Provide GCP/ICH compliance mentorship, auditing, and training to site and industry personnel.

Reviewed study Listings for accuracy

Managed 9 study sites all over USA and including CRO for Ex-US

Handled vendor management like Central Lab, Fisher Lab and shipping vendors

Trained CTA for 4 months to promote for a CRA role monitoring and getting familiar with Study related Guidelines and for GCP required of a CRA.

Conducted Pre-study site visits, initiation visits, interim monitoring visits, and close-out visits

Participated and presented in investigator meetings and recruitment of sites.

Provide consultation on site selection and final recommendation.

Managed and attend meeting with Study vendors

Involved in conducting Phases I to Phase III studies and performed some Phase II studies

Proficient in EDC system including Phase forward’s INFORM

Worked with I-Review and eTMF

Handled Study Start up to database Lock. Patient AE & SAE listing.

Involved in Drug Development Process (process of ordering Drugs for site)

In-house CRA (Contract Position) 4/2007-8/2008

Savient Pharmaceutical, Inc., East Brunswick NJ

Study: PEG LOTICASE (GOUT) TOPHI

Review regulatory documents for site initiation and closeout

Reconcile and track Serious Adverse event

Attend team meetings and teleconferences

Work with Vice President of Clinical and Director of Clinical Research to review study documents and drugs listings

Conduct patient data listing review

Create and maintain data tracking tables

Review Protocols and Amendments

Review and approve ICF

Create, update, and review protocol related study documents (i.e. ICFs, Visits Reports, etc.)

Review site/study budgets

Review data /Bio-statistics documents

Manage appropriate study documentation

Review Monitoring visit report

Monitored 3 Infusion sites in Philadelphia (Domestic)

Update and maintain study specific tables that document protocol deviation/violation

Assists in the recruitment of potential sites that meet protocol requirements

Review SAE and Infusion reaction listings and physical examination listings for the BLA (Biological License application)

Manage the ordering and distribution of study related supplies

Manage Lab and device Vendors

Review vendors contract invoices/payments

Review and reconcile Drug Accountability Log

Conduct Phase I and Transition to Phase II studies in Gout and Arthritis

Close out visit report review /Regulatory compliance review

Responsible for any protocol related question /site supply

Clinical Research Associate and Data Analyst 4/2006-3/2007

Theradex Inc., Princeton, NJ (Oncology) (Full time)

Study: LUITPOLD Pharmaceuticals

Conducted multiple Clinical Studies for the Commercial and Government Sectors (NIH) in Oncology (Leukemia, Solid Tumors, and Liquid Tumors)

Involved in conducting multiple Phases I to Phase III studies and performed some Phase I study and some Phase IV study

Conducted independent monitoring visits - domestic and globally

Conduct Initiation visit, start up and closeout visits

Work study start up till data base lock

Responsible for data auditing and GCP compliance at study sites

Responsible for auditing the Clinical Research Auditors

Reviewed SAE reporting at sites

Accountable for Pharmacy and Drugs for the studies

Worked with NCI/CTMS for Government Sites for Only Oncology. RECIST and NCI (CTC).

Handled ten to fourteen protocols at once and travel about 80% of the time

Familiar with Regulatory Affairs and report writing

Handled and transcribe queries

Conducted Clinical Trials (Clinical Trial Management Service) for the NIH

Worked in CCOP Trials

Handled COOP monitoring

Managed and train Junior Level Clinical Research Associates

Worked with Health Canada as an FDA auditor

Worked as head of the team in FDA Auditors group

Clinical Research Manager/Clinical Research Coordinator 2/2003-6/2006

R-Research, Hamilton, NJ (ED, ONCOLOGY, ENDO, GI)

Collected histories from patients including vital sign checks and chart preparation

Performed EKG and Ultrasound testing

Handled front desk reception and office administration

Reviewed and administered insurance claims in accordance with medical regulations

Conducted Diabetes and Oncology Clinical Trial

Worked In Prostate CA, Breast CA, Intestinal Carcinoma and Lung CA

Conducted phase I and phase II trials

Created Regulatory Binders/1572 forms

Was in charge of GCP for the company

Handled Regulatory Affairs for the company

Instructor, Biology, Mathematics and General Science 1/1992-5/1993

Saint Mary High School, Hyderabad, Pakistan

EDUCATION:

Sind University, Hyderabad, Pakistan

Bachelor of Science, Biology

CERTIFICATIONS:

Certified CCRP (SoCRA) 2017

EDC Certified 2009

Certified EKG Technician 1997

Barnett Educational Services 2009

National Healthcare Association 1997

Complete GCP training 2009

Ultrasound Technician Training 1998

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