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Senior Research Program Coordinator

Location:
Baltimore, MD
Salary:
85000
Posted:
December 28, 2020

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Resume:

Michael Grant Webb, Sr.

Home No.: 443-***-**** E-mail: adi0hz@r.postjobfree.com

Executive Summary

Over 30 years of experience working in clinical research

** ***** ******* ** * CRA in several therapeutic areas

Knowledgeable in FDA regulations, ICH/GCP guidelines, IRB guidelines, SOPs and SAE

Experienced in site start-up to close out, monitoring, training and guidance to Principal Investigator (PIs) and staff

Proficient in data management, EDC systems, Microsoft Word and Excel

THERAPEUTIC EXPERIENCE

Therapeutic Area

Indication(s)

Phase(s)

Renal / Urology

Overactive Bladder

III

Pharmacology

Pharmacokinetics/Pharmacodynamics

I & II

Respiratory

Community Acquired Pneumonia

III

Asthma; Rhino Virus

II

Cardiovascular

Hyperlipidemia

III

Hypertension

III

Deep Vein Thrombosis & Pulmonary Embolism

Safety & Efficacy

Musculoskeletal

Chronic Low Back pain

Osteoarthritis - Knee & Hip

II & III

Osteoporosis

III

Rheumatoid Arthritis

IIIB & IV

Oncology

Myelodysplastic syndromes

II

Acute Leukemia AML/APL

Compassionate Use

Newly Diagnosed Multiple Myeloma

III

Acute lymphoblastic leukemia

II & III

Gastrointestinal

Diverticulitis

III

Neurological

Pediatric Refractory Complex Partial Seizures

III

Post-Operative Pain (Bunionectomies)

I

Orthopedic

Gram negative skin and soft tissue infections

IV

Vaccine

Anthrax

Immunogenicity/ Safety

Cytomegalovirus

II

Enterotoxigenic Escherichia coli

Immunogenicity/ Safety

Human papillomavirus (HPV)

Immunogenicity

Hepatitis C

I & II

Influenza

Immunogenicity/ Safety

Leishmaniasis (caused by protozoan Parasites)

I

Shigellosis (caused by Bacterial S. sonnei)

Immunogenicity/ Safety

PROFESSIONAL EXPERIENCE

Johns Hopkins University School of Medicine

Division of Pediatric Oncology

Baltimore, Maryland

Senior Research Program Coordinator September 2018 – Present

• Maintain good working knowledge of all assigned protocols and reporting requirements.

• Assist the Clinical Trials Project Team in defining information and plans required to accomplish goals of studies, while assuring the adherence to patient confidentiality and safety guidelines.

• Develop and maintain a protocol database or spreadsheet for tracking patient activity, financial management and data analysis as needed.

• Assist the regulatory staff with the maintenance of each assigned protocol’s study regulatory binder(s), and will transmit and distribute protocol information as required.

• Verify study specific patient’s eligibility for studies participation via reviews of patient history and clinical laboratory results. Confirms patient registrations and relevant data points in databases for the SKCCC (Sidney Kimmel Comprehensive Cancer Center) Clinical Research Office and Oncology Information Systems.

• Verifies scheduling of patient appointments, tests, and follow up visits at the appropriate time in the treatment cycle to ensure completion of protocol requirements. Assist in the design and compiling of materials which aid Clinical staff in complying with protocol participation requirements.

• Collect and compile clinical data (e.g. patient demographics) from a variety of sources, ensuring the accuracy and timeliness entry of subject data so, that study related data may be used by the Clinical staff in treatment planning, presentations, and publication.

• Enter study and subject data into institutional database and Registry as required. Responds in a timely manner to special projects or queries related to the data.

• Meet regularly with Principal Investigator, Research Nurse, and Research Program Manager to review data accuracy and overall study progress. Participates in all mandatory meetings to develop increasing knowledge of assigned clinical trials.

• Prepare and submit adverse event reports in accordance with the center/local IRBs and Sponsor requirements.

• Prepare for and participate in study monitoring and audits, correcting errors in the study/patient database when necessary. In addition to preparing with input from the Principal Investigator responses to monitoring site visits and site audits.

• Meet with clinical trial financial management staff as needed to identify procedures, laboratory tests and protocol events that require invoicing to the Sponsor as defined in the financial contract.

ICON Clinical Research

Baltimore, Maryland

Senior Clinical Research Associate February 2013 – July 2017

• Performed training and provided guidance to multiple investigative study sites (Principal Investigator and research staff) during Site Initiation, Interim Monitoring and Close-out visits for NIH- Division of Microbiology and Infectious Diseases studies.

• Conducted investigative site visits to review the validity and integrity of the clinical data collection processes and data storage procedures in accordance with all applicable protocol, local regulations, International Council for Harmonization (ICH), Guidelines of Good Clinical Practice (GCP), and Institution Review Board (IRB) guidelines.

• Confirmed each investigative study site's adherence to patient confidentiality and safety guidelines.

• Received and prepared narratives from reported Serious Adverse Events (SAE) for submission to the Drug Safety Group.

• Provided guidance and leadership to new hires as requested by the assigned study’s Project Team Manager.

Clinical Trials and Surveys, Corporation

Baltimore, Maryland

Clinical Research Coordinator/Associate July 2011 – January 2013

• Managed the day–to-day operations (e.g. serial collection of questionnaire data, CT scans, Bio-repository management) of multiple-international sites involved in NIH-National Heart, Lung, and Blood Institute funded studies to ensure protocol adherence and HHS (Health and Human Services) Policy compliance.

• Managed multiple investigative sites study specific information via the DCC’s Clinical Trial Management System (CTMS).

• Used the DCC‘s Electronic Data Capture (EDC) system software to design Case Report Forms (CRF’s) and subjective questionnaires with functional consistency checks and skip logic.

• Conducted investigative site visits to review the validity and integrity of the clinical data collection processes and data storage procedures.

• Performed data quality assurance checks; issued and resolved queries with investigative sites as needed.

• Received patient Serious Adverse Events (SAE) data and prepared narratives for submission to the Data and Safety Monitoring Board (DSMB) for review.

• Tracked and maintained regulatory files (e.g. approval letters, renewals, Informed Consent and Protocols) for the DCC’s Internal Review Board (IRB) submission and the trial master files.

• Collated with IT staff developer (Java & Oracle) and statisticians in developing data processing system and performing statistical analyses.

• Coordinated study meetings (e.g. telephone and off-site conferences for DCC personnel, clinical sites and affiliated governing boards (e.g. Steering Committee, DSMB, etc.).

• Trained and certified site staff on the use of the DCC’s CTMS data entry requirements and methods.

• Organized and participated in study meetings and training sessions with clinical centers.

• Prepared, finalized and posted various reports for the NIH-National Heart, Lung, and Blood Institute project officials, Steering Committee, Data and Safety Monitoring Board, via the ClinicalTrials.gov National Institutes of Health (NIH) website.

• Negotiated and monitored individual site’s budgets and provided quarterly reports to the DCC’s CEO.

i3 Research

Baltimore, Maryland

Senior Clinical Research Associate July 2010 – July 2011

• Provided training and guidance to multiple investigative study sites (Principal Investigator and research staff) during Site Initiation, Interim Monitoring & Close-out visits.

• Conducted investigative site visits to review the validity and integrity of the clinical data collection processes and data storage procedures in accordance with all applicable protocol, local regulations, International Council for Harmonization (ICH), Guidelines of Good Clinical Practice (GCP), and Institution Review Board (IRB) guidelines.

• Provided clinical/technical support to fellow Clinical Research Associates as requested by the assigned study’s Project Team Manager.

2 Smart Productions

Baltimore, Maryland

Key Grip/ Editor (owner part-time) August 2009 – Present

• Assisted in the development of documentaries, commercials and producing, multimedia presentations, music and training videos. First major productions were for the NFL Retirement Organization, Johns Hopkins School of Medicine and Maryland Science Center

U.S. Department of Commerce - Census Bureau

Baltimore, Maryland

Enumerator / Assistant Crew Leader March 2010 – June 2010

• Hired to collect decennial statistics of population and housing, as well as social and economic data via conducting personal interview for use by the Federal Government, businesses and industries and various other public and private organizations

Kendle International, Inc.

Baltimore, Maryland

Regional Clinical Research Associate II March 2008 – June 2009

• Performed training and provided guidance to multiple investigative study sites (Principal Investigator and research staff) during site Initiation, Interim Monitoring and study Close-out visits.

• Conducted investigative site visits to review the validity and integrity of the clinical data collection processes and data storage procedures in accordance with all applicable protocol, local regulations, International Council for Harmonization (ICH), Guidelines of Good Clinical Practice (GCP), and Institution Review Board (IRB) guidelines.

• Provided guidance and leadership to fellow new hires Clinical Research Associates and as requested by the assigned study’s Project Team Manager.

Falcon Consulting Group, LLC

Baltimore, Maryland

Senior Consultant, Good Clinical Practice Services June 2006 – February 2008

• Conducted investigative site, contract research organization and central laboratory audits to assessments and reported the adequacy of the facility’s performing clinical human subject research.

• Assessed and reported the adequacy and readiness of select investigative site, contract research organization and central laboratory personnel to performed assigned task via training record reviews and interviews of key personnel.

• Assessed, confirmed and reported select medical research facilities, laboratories and pharmacies compliance with the International Council for Harmonization (ICH), Guidelines of Good Clinical Practice (GCP), and Institution Review Board (IRB) guidelines.

• Conducted quality assurance reviews of Investigative sites and contract research organization Trial Master File management processes.

• Conducted investigative site and contract research organization audits reviewing the validity and integrity of the clinical data collection processes and confidential data storage procedures.

• Conducted central laboratory audits reviewing the current warehouse inventory and supplies, kit production, specimen chain of custody processes, staff training, data storage and recovery processes.

• Reviewed select central laboratory equipment/reagents usage and maintenance and management including quality control guidelines and practices

• Conducted central laboratory and contract research organization quality assurance audits of proprietary IT Systems, developmental lifecycle and integrity. Quality assurance audits included extensive SOP reviews and critiques in the areas of SOP development procedures

• Conducted quality assurance reviews of Investigative study's Clinical Study Reports.

• Executed auditing assignments in both domestic and international environments.

MDS Pharma Services

Baltimore, Maryland

Regional Clinical Research Associate July 2005 - June 2006

• Performed training and provided guidance to multiple investigative study sites (Principal Investigator and research staff) during site Initiation, Interim Monitoring and study Close-out visits.

• Assessed select investigative site's adherence to patient confidentiality and safety guidelines.

• Conducted investigative site visits to review the validity and integrity of the clinical data collection processes and data storage procedures in accordance with all applicable protocol, regulatory and ICH / GCP guidelines.

• Performed literature searches, prepared and presented at a bid defense, presenting the contract research organization’s ability to conduct a phase III clinical trial investigating the use of a schedule II oral medication for pain management.

• Provided tutorial and on-site training scenarios for newly hired Clinical Research Associates.

SCIREX Corporation

Baltimore, Maryland

Regional Clinical Research Associate May 2002 – July 2005

• Performed Pre-study, Initiation, Interim monitoring and close-out visits.

• Confirmed the investigative site's adherence to patient confidentiality and safety guidelines.

• Conducted investigative site visits to review the validity and integrity of the clinical data collection processes and data storage procedures in accordance with all applicable protocol, regulatory and ICH and GCP guidelines.

Covance Clinical and Periapproval Services Inc.

Princeton, New Jersey

Regional Clinical Research Associate I September 2000 - May 2002

Clinical Research Associate March 2000 - September 2000

Clinical Research Assistant April 1998 - March 2000

• Acted in the role as a Lead Clinical Research Associate managing the processes of investigative site recruitment, prepared and managed the collection of clinical study agreements, and the review, tracking and preliminary approval of the investigative sites regulatory documentation.

• Performed training and provided guidance to multiple investigative study sites (Principal Investigator and research staff) during site Initiation, Interim Monitoring and study Close-out visits.

• Conducted investigative site visits to review the validity and integrity of the clinical data collection processes and data storage procedures in accordance with all applicable protocol, regulatory and ICH and GCP guidelines.

• Managed the in-house "clinical contact" lines to assist the investigative sites with protocol issues.

• As a project team liaison to a study Sponsor, maintained study specific databases and prepared monthly status reports.

Johns Hopkins University (Bayview Campus)

Behavioral Pharmacology Research Unit

Baltimore, Maryland

Research Program Coordinator II August 1996 – April 1998

Research Coordinator August 1993 - August 1996

Supervisor of Residential Studies January 1990 - August 1993

Directed and implemented translational Investigation of behavioral and pharmacological interventions protocols for opiate and/or cocaine dependence.

Assisted in the development and coordinated the execution of individual phase I and II psychiatric and behavioral research protocols.

Directly assembled relevant research data, regulatory documents and progress reports for ongoing research for submissions to IRBs and National Institute on Drug Abuse (NIDA).

Developed administrative standard in regards to data collection and management operating procedures for the research assistant staff.

Monitored subject recruitment, enrollment, subjective data collection, retention, and data management. Ensure the proper completion and review of submitted case report forms.

Organized, cleaned and checked computer generated subject physiological, pharmacokinetics and pharmacodynamics data prior to performing preliminary data analyses.

Accountable for all developed internships, summer students and casual employee training and documentation.

Develop the metrics to identify and measure the success of the research assistant staff.

Monitored the in-patient portion of the unit’s operating budget. Responsible for daily expenditures of study, reporting, and reconciliation of research accounts.

Developed the administrative and operations infrastructure of the unit. Managed unit functions that included staffing, supervision, performance development and counseling. Assisted on the management of the unit’s information systems, facilities, and space needs.

University of Maryland, School of Pharmacy

Baltimore, Maryland

Laboratory Scientist February 1985 - December 1989

• Assisted in the designed, preparation, and implementation of pre-clinical research protocols via small animals implanted with cerebrocortical EEG recording electrodes.

• Instructed graduate students and post-doctoral researchers in small animal surgical techniques and protocol methodologies in the areas of basic physiology and toxicology.

• Prepared test progress and procedural reports.

• Responsible for daily expenditures of Lab, reporting, and reconciliation of research accounts

Morgan State University

Pre-Professional Health & Science Resources

Baltimore, Maryland

Counselor January 1984 - January 1985

• Provided academic assistance to health and science students.

• Formulated a student academic status evaluation system.

• Scheduled science related seminars and workshops for science undergraduate students.

• Arranged employment opportunities within local medical and health care agencies and facilities for health and science students (for college credit).

Baltimore City Hospital

Behavioral Pharmacology Research Unit

Baltimore, Maryland

Medical Research Assistant October 1982 - January 1984

• Developed and maintained computerized databases of human behavioral protocols.

• Performed enzyme urine immunoassay for outpatient treatment program.

• Instrumental in the development of a chemical indicator used to assess cigarette smoke consumption in human subjects.

ELECTRONIC DATA /MEDICAL RECORDS, IVRS and MONITORING SYSTEMS EXPERIENCE

- Oracle Clinical: Remote Data Capture - Rave Medidata

- eClipse Electronic Data Capture - Inform 5.5 & 6.1

- Dynarand / United BioSource Corp - ClinPhone

- Epic - Rees Scientific

OTHER SKILLS: Familiar with various Macintosh and PC software packages: Microsoft Outlook and Power Point. Audio/Visual Services Hardware/Software: Digital Beta, HD, 16/35mm film, CD/DVD duplications, Adobe Premiere Pro and Wave Lab

EDUCATION

Master of Business Administration

Concentration: Management

Johns Hopkins University, Baltimore, MD

Master of Administrative Science

Concentration: Management and Information Technology

Johns Hopkins University, Baltimore, MD

Bachelor of Arts

Concentration: Biology Minor: Biochemistry

University of North Carolina @ Asheville, Asheville, NC

CITIZENSHIP: United States of America

REFERENCES: Furnished upon request



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