Kech James, RN

Phone: 404-***-**** • Email: addrzs@r.postjobfree.com

Highly driven research professional with over three years of experience managing Phase I - III clinical trials in the areas of oncology, neurology, diabetes, and rheumatology. Possess in depth knowledge of clinical trial conduct and regulatory guidelines. Excels at building and managing relationships with Principal Investigators (PIs) and scientific thought leaders. Background includes protocol development, data collection and analysis, and patient recruitment. Skilled at presenting scientific and clinical information to varied audiences in effective, translatable terminology.

SUMMARY OF EXPERIENCE

Extensive Clinical research experience in numerous therapeutic areas and trails phases

Competent in Good Clinical Practice (GCP) and ICH Guidelines as well as SOP of specific sponsors

Knowledgeable in various aspects of clinical studies such as study start up and close out, data management, study monitoring, site management, all forms of site visits, and investigative sites assessments for phases I, II and III of clinical trials

Identify, establish and maintain collaborative relationships with Key Opinion Leaders and Principal Investigators in each therapeutic area of study.

Strong organizational and problem solving skills as well as effective communication, detail oriented and time management

Identify key issues with the study and educate trial site staffs as well as healthcare professionals using insights from industry leaders, pertinent literatures to give presentations, facilitate meetings during site visits, and advisory boards.

Assist site in identify appropriate community need and subject for the study through working with relevant stakeholders within the region.

Ability to write reports in a timely manner

Excellent interpersonal skills, effective communicator, strong team player, with great problem solving skill and extremely detail oriented.

Certified Regulatory Affairs Associate

Certified Scrum Master: Able to lead various clinical projects implementation from planning through execution.

Able to travel up to 75%

THERAPEUTIC AREAS

Oncology – Breast Cancer, Multiple Myeloma

Neurology – Major Depressive Disorder, Parkinson’s Disease, Epilepsy

Nephrology – Diabetic kidney disorder, Amyloidosis

Cardiovascular – Stable Angina, Pulmonary Hypertension/Stroke

Infectious Diseases: Hepatitis C, Bacterial Pneumonia

Medical Device

oStent - 6 Sites

oPacemaker – 11 Sites

oBalloon Therapy – 8 Sites

SYSTEMS:

Electronic Data Capture: Medidata RAVE, DataLab, INFORM

CTMS: Oracle – Siebel, Medidata

IVRS/ IWRS: Balance, Bracket, IMPALA

Microsoft Office: Word, Excel, Access, Power Point, Outlook,

Professional Experience

Lead / Sr. Clinical Research Associate (Home Based)

Abbvie Pharmaceutical Jan 2017 – June 2019

Conduct clinical site monitoring visits across protocols and multiple therapeutic areas

Conduct site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes

Conduct all clinical site monitoring activities according to the monitoring plan and in accordance with the study timelines and company objectives

Ensure safety and protection of study subjects through compliance with the study monitoring plan, AbbVie SOPs, ICH Guidelines, and applicable regulations.

Report monitoring activities and study site conduct accurately and completely.

Prepare and submit written monitoring reports in a timely, concise and objective manner.

Participate in field training and mentoring of new/junior CRAs as well as insource CRAs.

Proactively identify issues that may impact enrollment and recruitment timelines and provide objective comments regarding these issues.

Maintain and complete own expense reports as per applicable guidelines.

Identify, evaluate and recommend new/potential investigators/sites on an on- going basis.

Participate in and present at departmental and other functional meetings as needed, including Site Management & Monitoring meetings.

Identifies and/or anticipates operational risks and mitigation plans within assigned clinical trials and escalates issues to Director of Clinical Operations as necessary

Reports study issues and recommended contingency plans to Director of Clinical Operations

Identify and partner with other AbbVie personnel to develop innovative processes to increase the quality, productivity, and efficiency of site monitoring.

Maintain knowledge and expertise across multi-therapeutic areas through clinical and scientific literature review, ongoing awareness and trends of industry practices and participation in professional activities.

Maintain appropriate communication with CTM, Medical Monitors and Site

Complete training as required by Global Clinical Operations and other

relevant company procedures, to ensure adherence to federal regulations, Good

Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes

CRA I (Home Based)

Abbott Pharmaceutical Jul 2014 – Oct 2016

Worked effectively with site staff to accomplish study goals

Provided co-monitoring assistance as needed in support of team initiatives

Acquired strong knowledge of GCPs, ICH guidelines and FDA regulations

Initiated clinical trial sites according to the relevant procedures to ensure compliance with the protocol, regulatory and ICH GCP obligations

Generated and resolve queries as required

Ensured the timely collection of data and query resolution.

Conducted evaluation, initiation, and routine monitoring visits at each assigned study site.

Instructed investigator and site staff in their responsibilities and ensures compliance with GCP and ICH guidelines

Researched and responded to various site inquiries which included study materials, protocol, electronic database use, study documents, CRF conventions, queries, payments, etc.

Determined completeness of study files and identifies deficiencies

Performed drug accountability and ensured prompt reporting of AEs/SAEs; and verified completeness of critical documents

Clinical Research Coordinator/ Trial Associate

Abbott Pharmaceutical July 2012- May 2014

Completed Case Report Forms and Regulatory documents for phase I through III studies

Established success in meeting tight timelines while ensuring accurateness

Facilitated study start-ups, study document design, and regulatory compliance

Track major milestones of the trial and highlight any concerns immediately

Create and maintain training protocol documents

Data listing review documentation within the electronic master file (uploading / completing documents) & other systems, ensured completeness, accuracy, and consistency of data

Setting up vendors during study start up period

Maintained financial records for research contract budgets

Enter necessary data / tracking in systems

Collect and distribute documents from / to sites during study life cycle

Supported Health Authority inspection and pre-inspection activities

Submitted study documents to IRB; Obtained and maintained necessary IRB approvals and documentation

Private (Army Reserve) 2000 – 2004

United States Army

I was a transportation coordinator for my railway unit – 747

I worked alongside other soldiers in my unit to accomplish various tasks assigned to us.

EDUCATION

Duke University School of Medicine Durham, NC

oRegulatory Affairs Certification

University of Belize Belmopan, Belize

oBachelors of Nursing

University of Wisconsin Milwaukee Milwaukee, WI

oBachelors of Science in Biology

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