Lindsay Cotton, MPH

Senior CRA

858-***-****

ad38z5@r.postjobfree.com

San Diego, CA

Summary

I have held varying roles in the clinical research field since 2006. Roles include Senior CRA, Clinical Monitor Manager, Clinical Trials Assistant (CTA), and Behavior Assess/Facilitator. As a CRA since 2008, my therapeutic experience includes: Neurology/CNS, Chronic Pain, Cardiology, Device, Dermatology, Psychiatry and Genetic Disorders. I have extensive experience in conducting site selection, initiation, pilot, phases I-IV, and close-out visits.

Formal Educational History

Last Date Attended

Institution Name, Country

Education Level/Degree

Area of Study

Completion Status

09/2006

UCSD Extension, United States

Certificate

Clinical Trials Design and Management

Completed

05/2004

San Diego State University, United States

Master of Public Health

Epidemiology

Completed

05/1999

Slippery Rock University, United States

Bachelor of Science

Exercise Science

Completed

Employment History

IQVIA and its Affiliated Companies Employment History

Date of Employment:

01/2023 - 5/2023

Job Title:

Sr. CRA

Key Responsibilities:

Major Depressive Disorder Study

• Performed site selection (if applicable), initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.

• If applicable, was accountable for supporting development of project subject recruitment plan on a per site basis.

• Worked with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability.

• Provideed monitoring visits and site management for a variety of protocols, sites and therapeutic areas.

• Administered protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.

• Evaluated the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.

• Escalated quality issues as appropriate.

• Managed the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.

• Supported project/site start-up phase.

• Created and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.

• Acted as a mentor for new clinical staff including conducting co-monitoring and training visits.

• Provided assistance with design of study tools, documents and processes, if needed.

• Conveyed features and opportunities of study to site.

• Collaborated and liaised with study team members for project execution support as appropriate.

Date of Employment:

01/2020 - 07/2022

Name of Employer:

ICON

Job Title:

Sr. CRA

Key Responsibilities:

Assigned to Boston Scientific

Device study to demonstrate value of Spectra WaveWriter Spinal Cord Stimulator System in the treatment of Chronic Pain

Key Responsibilities:

• Study start-up, monitoring, and study closeout.

• Ensured expert knowledge of ICON Clinical Research SOPs/WPs, ICH, GCP and appropriate regulations is maintained.

• Maintained timelines.

• Ensured accuracy and completeness of data entered into ICON systems.

• Ensured independent and proactive coordination of all the necessary activities required to set up and monitor a study, including identifing investigators.

• Helped, when requested, in preparation of regulatory submissions.

• Designed patient information sheets and consent forms.

• Coordinateed documents translation, verification and back translations where required.

• Ensured timely submission of protocol/consent documents/safety reports for ethics/IRB approval according to local requirements.

• Conducted Pre Study/placement and initiation visits.

• Conducted regular monitoring visits in accordance with the ICON site monitoring SOP/Sponsor site monitoring SOP, as appropriate.

• Maintained all files and documentation pertaining to studies.

• Motivated investigators in order to achieve recruitment targets.

• Completed accurate study status reports.

• Ensured the correct storage of drugs and the diligent account of all drugs in accordance with SOPs.

• Kept the project manager or designees regularly informed.

• Processed case record forms to the required quality standards and timelines.

• Delt with sponsor generated queries in a timely manner.

• Ensured the satisfactory close-out of investigator sites.

• Participated, if requested, in the preparation of and review of study documentation, e.g. draft protocols, draft CRFs, monitoring guidelines and elements of final report.

• Ensured correct archiving of files on completion of a study.

• Maintained patient and sponsor confidentiality.

• Assumed additional responsibilities as directed by Project Manager (PM) Responsible for the conduct/management of any aspect(s) of a project, when requested and authorized by a Project Manager.

• Acted in a Lead role on a study, assuming additional responsibilities as detailed/documented by the Project Manager, if appropriate.

• Coordinated and/or participated in feasibility studies for new proposals, as required.

• Ensured Investigational Products (IPs) is stored and managed by the site.

• Ensured storage conditions and acceptable supplies are provided

• Ensured IPs are supplied only to eligible patients.

• Ensured IP receipt, use and return are controlled and documented.

• Ensured disposition of unused IP comply with regulatory requirement and are in accordance with the sponsor.

• Participated in training and mentoring new staff up to Clinical Research Associate level as appropriate.

• Participated in data listing reviews, as applicable.

Date of Employment:

07/2017 - 11/2019

Name of Employer:

Aperio

Job Title:

Sr. CRA

Key Responsibilities:

Studies for lower back pain, Parkinson’s disease, Lewy Body

disease, Tardive Dyskinesia, visual hallucinations.

• Conducted clinical monitoring to include qualification, initiation, interim and close out visits.

• Completed and submitted confirmation letters, follow-up letters and monitoring reports in accordance with SOPs and Clinical Monitoring Plan.

• Assured compliance with local regulations, Code of Federal Regulations (CFR) / International Conference of Harmonization (ICH) and Good Clinical Practice (GCP) guidelines, and Aperio SOPs (and Sponsor SOPs if applicable).

• Subject Rights - Verified the process of obtaining informed consent has been adequately performed and documented for each subject. Demonstrated diligence in protecting the confidentiality of each subject. Assessed factors that might affect subject’s safety and clinical data integrity at an investigator site such as protocol deviation/violations and pharmacovigilance issues.

• Assured all study staff who will conduct the study have received proper training and are qualified to complete tasks as delegated to them by the Principal Investigator.

• Proactively worked with sites to meet patient recruitment goals and project milestones.

• Performed all tasks required for onsite/remote data monitoring including source document verification (SDV).

•Applied query resolution techniques remotely and on site and provided guidance to site staff as necessary, driving query resolution within agreed timelines.

• Performed IP accountability and completed reconciliation, reviewed storage and security, and verified the IP has been dispensed and administered to subjects according to the protocol.

• Routinely reviewed the site Regulatory Binder for accuracy, timeliness and completeness. Reconciled contents of the site’s Regulatory Binder with the site-level trial master file (TMF).

• Critically evaluated the ongoing adequacy of investigator sites including site staff qualifications, facilities, equipment and performance.

• Maintained effective, accurate, and timely communication with site staff and project team, and ensured appropriate issue escalation.

• Attended clinical monitoring/project team meetings and attended clinical training sessions according to the project-specific requirements.

• Prepared for and attended Investigator Meetings and/or sponsor face to face meetings as needed.

• Co-monitored as needed to support study goals.

• Served as a resource for other Clinical Research Associates, mentoring as appropriate and sharing knowledge and best practices.

• Acted as therapeutic or protocol expert lead to team and sites.

• Performed other duties as requested.

Date of Employment:

06/2015 - 07/2017

Name of Employer:

University of California

Job Title:

Clinical Monitor Manager

Key Responsibilities:

• Provided leadership and direction to on-site and off-site ADCS clinical monitors including external agency staff for multiple Phase I through Phase III Alzheimer’s Disease Research trials.

• Responsible for making important original contributions to the clinical monitoring group including: setting priorities, goals, and objectives for the group. Along with developing strategies to meet these goals, set expectations for individual monitors and manage performance accordingly.

• Responsible for evaluating business needs, analyzing resources, prioritizing workload, allocating resources to ensure appropriate assignment and fair distribution of workload for all clinical monitors.

• Conducted on-site monitoring activities for multi-site clinical trials to ensure compliance with study protocols, internal SOPs, and GCP/ICH.

• Responsible for managing and overseeing all aspects of the day to day activities of the ADCS clinical monitoring group, as the interim monitor manager.

• Acted as the main line of communication and decision-maker between monitoring group and all other ADCS cores and groups; contributed ideas pertaining to the planning, development, modification and execution of new and ongoing studies.

• Served as the monitor representative in meetings and conferences.

Date of Employment:

07/2010 - 07/2015

Name of Employer:

University of California

Job Title:

CRA

Key Responsibilities:

• Lead and directed protocol implementation of approximately 10-15 centers throughout the United States and Australia in multiple Alzheimer’s disease (AD) clinical trials.

• Independently conducted study site visits which include training and leading site personnel in protocol procedures and compliance, implementation and administration of neuropsychological tests.

• Responsible for protocol management at assigned ADCS centers to review data collection for accuracy and completeness, identify problems in protocol implementation and conduct, and review/resolution of regulatory issues.

• Worked closely with ADCS functional groups to carry out studies in various stages of development, maintenance, and closeout; also facilitated in various project meetings and conference calls, contributing with original ideas.

Date of Employment:

11/2008 - 07/2010

Name of Employer:

Therapeutics Inc.

Job Title:

CRA

Key Responsibilities:

• Provided multi-task administrative support to various clinical personnel for the implementation of clinical studies.

• Monitored clinical studies to ensure the studies are conducted in compliance with current applicable federal, state, local and corporate regulations and procedures [including Good Clinical Practices (GCP) and International Conference on Harmonization (ICH)].

• Managed clinical study sites to ensure subject safety and compliance with the study protocol, timeline and budget, in support of on time and within budget regulatory submission.

Date of Employment:

04/2007 - 11/2008

Name of Employer:

Cardium Therapeutics, Inc.

Job Title:

CRA/CTA

Key Responsibilities:

• Performed and coordinated all aspects of the clinical monitoring process in accordance with GCPs, ICH, Title 21, FDA Clinical Research Guidelines and global SOPs.

• Assigned to monitor five clinical sites for a multi-centered gene therapy cardiac study and five sites for a multi-centered gene therapy diabetic foot ulcer study

• Trained principal investigators and site personnel on study protocols and the use of TrialMaster, an electronic data capture system, to resolve queries of patients’ source documents and electronic case report forms.

• Represented Cardium Therapeutics in medical research community and developed collaborative relationships with investigative sites and client company personnel.

• Collected and verified accuracy of FDA/NIH regulatory documents for 45 sites participating in a cardiac clinical trial.

• Collaborated on study manuals, amendments to protocol and Investigator’s Brochures.

• Designed and edited company newsletter.

Date of Employment:

02/2006 - 04/2007

Name of Employer:

UCSD Cancer Center

Job Title:

Behavior Assessor/Facilitator

Key Responsibilities:

• Interactively conducted 300+ telephone interviews with adolescent and parent participants in the nationwide Parenting Project Study.

• Established rapport and gained trust of parent participants by using motivational interviewing techniques to facilitate resolutions to a variety of their teenager’s behavior problems.

• Motivated and assisted participants in teaching their goals including: behavior change, preventing problem behaviors, and improving communication with their teenager.

• Scheduled assessment interviews for participants and ensure scheduled interviews are covered.

• Reviewed and coded qualitative behavioral data using complex data coding system.

Therapeutic Experience

Therapeutic Area

Years Exp

Experience (Roles)

Neurology

7.5

Alzheimer's Disease

7.0

Sr. CRA and Clinical Monitor Manager

Chronic Pain - lower back pain

1.0

Sr. CRA

Lewy Body Disease

1.0

Sr. CRA

Tardive Dyskinesia

1.0

Sr. CRA

Visual Hallucinations

1.0

Sr. CRA

Parkinson's Disease

1.0

Sr. CRA

Major Depressive Disorder

0.5

Sr. CRA

Medical Devices

2.5

Chronic Pain - Medical Device - Indirect Decompression System

2.5

Sr. CRA

Chronic Pain- Medical Device - Spinal Cord Stimulator

2.5

Sr. CRA

Genetic Disorder

1.0

Down Syndrome

1.0

CRA

Cardiovascular

1.5

Cardiovascular Disease

1.5

Sr. CRA

Cardiac surgery

1.0

CRA/CTA - Angiogenic gene therapy

Dermatology

1.5

Lice study

1.0

CRA

Lidocaine

1.0

CRA

Wrinkled skin

1.0

CRA - Wrinkle repair

Psychiatry

1.5

Not applicable

1.5

Behavior Assessor/Facilitator

Language(s)

Language

Speaking

Reading

Writing

English

Fluent

Fluent

Fluent

Publications, Doctoral Thesis (selected items)

Complete list of publications is available upon request

Master's Thesis - Comparison of Computer vs Paper surveys of Fruits and Vegetables for adolescence – Year - 2004

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