KELLY COMER

Raleigh, NC

PROFESSIONAL SUMMARY

Experienced monitor, study coordinator, study start-up specialist, safety associate and medical researcher seeking position where knowledge of medical terminology, clinical trials experience, regulatory knowledge, organizational strengths, and strong people abilities can add to a company's overall quality and growth.

Since 1998 I have been in Clinical Research. I have a strong background in clinical monitoring, phases II-IV in study coordinating along with quality control in aspects of project phases from site selection to close-out.

Clinical Research Consultant – Throughout my years working in clinical research

During the last 2+ years I have been working with pharmaceutical companies, Biotech and CROs providing my experience as CRC, CTA, and CRA. My availability has led me to take contracts that offered me some flexibility to support my family. Currently, I am working towards getting connected with a long-term contract or a permanent role that will utilize my experience, skills, and strengths in clinical research.

Please find below a few of the companies I have worked with as a contractor and in permanent roles.

You will see that I have 20 years of cross training experience in research.

PROFESSIONAL SKILLS

Team Player, Self-Starter, Leadership, Goal Oriented, Communications

Thorough knowledge and understanding of ICH, CFR, and all GCPs related to Clinical Trials

Strong vocabulary and communication

Clear and precise writing skills

Not a Programer but very solid at Analytics / Analytical skills.

EDUCATION

BS, Psychology, Mount Olive College, Mount Olive, NC

SYSTEMS

Deltek Time Tracking (CCSA Inc)

DRS/eTMF/TMF (Trial Master File)

Veeva Vault

Clinical eTMF

Study Hub

Preciousa

WAND Timekeeping

Endpoint IWRS

Medidata/Rave EDC (CCSA Inc, Quintiles, ICON, Parexel)

Argus (Safety Report Tracking/CCSA Inc, GlaxoSmithKline, Syneos Health)

Infolink (Med Source, ICON, I3 InVentiv)

Microsoft Word, Access, Excel, Word-Perfect, FoxPro, Lotus Notes, WinWord, CAPI and Internet Explorer

ICOTrack/Citrix (GlaxoSmithKline)

Phase Forward eDC Certificate (Quintiles)

MedNet eDC Certificate

Inform eDC Certificate (Quintiles, Parexel)

etrack Certificate (GlaxoSmithKline Regulatory document tracker)

FIDs Tracker/Database (GlaxoSmithKline financial disclosure software program)

US MedImage/Database (GlaxoSmithKline software program to view documents submitted to FDA)

CTMS Systems (Quintiles International and CCSA Inc)

One World Financial Reporting System (Viewing and reporting payments to sites)

Pfizer Systems/eTMF

RedCap/EDC and eTMF

THERAPEUTIC EXPERIENCE

Oncology (2 years); Pfizer (end client)

Pulmonology (8 months); Astra Zeneca

Neuroscience/Psychiatry (3.5 years); Eli Lilly, Shire and John Hopkins Medical Center

Cardiovascular (1.5 years); Pfizer (end client)

Orthopaedics (3 months); Stryker

Immunology (1 Year); Merck

Gastrointestinal (1 year); Astra Zeneca

Autoimmune Disorders (3 months): Sanofi Aventis

Infectious Diseases (3mths): GlaxoSmithKline

Rare Diseases (3 months): Grifols

PROFESSIONAL EXPERIENCE

Safety and Medical Affairs Experience (5 months)

Clinical Research Associate Independent and Co-monitoring

In house Clinical Research Monitor (5 years 7 months)

Regulatory Affairs and Start up Associate (3 years)

Site Study Coordinating and Call Center in Clinical Research & Government Studies (1 year and 3months)

In- house Study Site Management (3 years and 6 months)

Quality Control Experience (1 year and 9 months)

Clinical Study Coordinating (2 years and 8 months)

Patient Recruitment Support (2 years 6 months)

Sr. In house CRA (3 months)

John Hopkins Medical Center Nov ’22 - Jan ‘23

Clinical Research Site Manager

Main Role and Responsibilities:

It is important to establish early communication lines with the clinical teams as they are identified, selected, and prepared for activation.

Assist with site feasibility evaluations, detailing the availability of critical local resources necessary to be successful at activating trials and enrollment and protocol performance once a trial begins.

Assist sites in central IRB (Institutional Review Board) on-boarding, ensure timely and accurate submission to IRBs (Institutional Review Board), sponsors and expert agreements, local IRB/ethics committee review/approvals, and assist with the collection of all necessary regulatory documents needed before site activation for study subject enrollment.

Oversee site compliance with investigational products, reporting or safety events and contracting.

During trial implementation, the Site Manger will oversee site performance, assist with subject eligibility and randomization, identify local recruitment problems, personalize remediation programs with site teams, and help to assure that site investigators quickly implement local solutions to keep the recruitment goal on track for trial completion.

Assembles research equipment & handles and distributes the clinical trial supplies and maintain tracking information.

Conduct weekly (or more frequent) teleconferences and manage monthly training broadcasts with the clinical teams and individually mentor new coordinators and investigators.

Provide support to quality assurance monitors in all facets of work related to communications with and management of the enrolling center clinical teams.

Responsible for managing site investigator relationships and executing site start up and performance plans, assigning tasks and deadlines to site clinical teams, directing, and monitoring clinical site work efforts daily, identifying resource needs, performing quality reviews, and escalate functional, quality and timeline issues appropriately.

Execute lean management processes and methodologies to ensure sites deliver on-time and within the budget, adhere to high quality standards, and benefit the investigative effort by ensuring smooth implementation of trial policies and goals from site launch through study activation and completion of the trial at the local levels.

Performed self-audits and audit performance of clinical sites; and the Site Manger will recommend changes to protocol operations based on audit results and revised goals.

Responsible for tracking proposals and other documentation through signature/approval processes then through collaboration with contracts personnel and IRB Navigators.

Building and maintaining strong, trusting relationships

Allucent, Durham, NC Feb’22 – Aug’22

Site Activation Specialist

Main Role and Responsibilities:

Main line of communication with potential sites, investigators and study (start-up) teams

Perform feasibilities post-award and if business requires supports pre-award feasibilities

Create lists of potential investigators and sites

Develop feasibility questionnaires

Oversaw and supported team in drug development

Initiate contact and relationship with investigators and sites

Perform pre-study visits (PSV)

Assess sites’ and investigators’ suitability

Discuss and negotiate different types of contracts (incl. budget, vendors) with sites, investigators and third parties.

Collect essential (site) documents

Support management of regulatory (site specific) requirements

Organize hand-over of sites prior to Site Initiation Visit (SIV)

Care Access Research; specializing in decentralizing research sites (Part time) Mar’21 – Jan’22

Clinical Study Manager

Liaison between the CRO and the Sponsor on a study of Donanemab Versus Placebo in Participants at Risk for Cognitive and Functional Decline of Alzheimer's Disease

Ensuring that staff at the facilities have sufficient equipment and skill base to successfully execute trial related procedures (laptops, printer/scanners, Vital Sign monitor with Pulse Oximeter, IR thermometers, centrifuge, Quidel, etc.

Ensure timely distribution of and track clinical trial supplies, such. CRFs, study medication, lab kits, study equipment if provided, etc and ensuring that sites have sufficient supplies to continue recruitment.

Works with the facility team to ensure study supplies are adequate (lab kits, nasal swabs, etc.)

Attend all on-going training activities organized for this role

Prepare for remote monitoring visits by ensuring that all source documents are completed, scanned and uploaded to Study Team prior to the scheduled visit.

Participate in remote sponsor visits (SEV, SIM, IMV, etc.) and worked on trial analysis .

Maintain close contact with sponsor/CRAs and respond to them in a timely manner.

Help facilitate the resolution of queries and ensure sponsor timelines are met for ongoing data review and analysis in collaboration with CARE Data Management Team.

Ensure visit data are entered into Veeva EDC within 48 hours of the visit. Assist the jump team with data entry for visit 0 and visit 1, if needed, to meet study timelines. Consult with CARE Data Management Team for possible delays.

Supported team in drug development process.

Responsible for providing the Jump Team the Delegation of Authority (DOA) Log immediately upon arrival to the facility and ensures each team member is included in the DOA and tasks are delegated accordingly. Ensures DOA is enforced by verifying signatures/initials of individual study personnel along with PI signature/initials and date prior to study-related activities.

Make necessary revisions on the DOA, if necessary, for staffing changes.

Responsible for sending staff CVs/licenses/certificates to the PI for review.

Complete routine departmental tasks in a timely manner (e.g., DOA, SAE reports, lab reports, etc.)

Complete study specific trackers (GDrive Trackers, Regulatory Trackers.)

Attend all internal activities and corporate meetings relative to SM work.

Assist with study start up trainings, certifications prior to site being activated for Investigational Product.

Decentralized and confirmed with all vendors that they have completed all study start up required tasks.

Effectively forecasting and planning, Inventory Management along with the clinical supply chain group, and determining ideal packaging and labeling distribution

Grifols Pharmaceuticals Aug’21-Nov’21

Sr In House CRA

Main role and Responsibilities:

Reviewing monitoring trip reports for rare and infectious diseases phases 2-3.

Participating in the deviation review committee on a weekly basis with the US and EU countries.

In-house Monitoring / Remote Monitoring

TMF review and audited for monitoring visits.

Sponsor / Vendor Liaison, Budget management.

Home Health Oversite & Coordination

Reports: - Reviewing and approving SIV, IMV, and COV Trip reports, Deviation Reviews, SDVS and ability to read reports to see trends.

Metrics & KPIS

Assist Spanish team with Blinded and Unblinded Monitoring reviews.

Confirming the CROs have no issues with vendors before remotely activating the site to receive drug and study supplies.

IQVIA CRO/Spectra force Technologies Jan’21-Mar’21

Clinical Research Associate/ Research Site Support Assistant

Verify and/or correct research study information on source documents.

Research queries and variances, and provide feedback to the site data collect or Input research study data into trial Electronic Data Capture (EDC) system, maintaining quality control for content, accuracy, and completeness, prepare and maintain research study files

Compile, collate and submit study information within established deadlines

Assist in maintenance of regulatory documentation

Schedule subject visits and generate appropriate reports and documents for research subjects prior to visits Input visit data into Clinical Trial Management System (CTMS) to track patient visits and procedures completed against the study budget.

Processing of required lab specimens, labelling of vials, and accurately filling out requisitions for storage and/or shipment per the study protocol and packaging and shipment regulations

Perform various administrative support functions such as reception, office organization, and office supply management.

Closing out studies and running reports for outstanding missing supplies such as iPads, EKGS, and investigational products.

Ensured clinical supply chain records and related documentation were complete and archived in both electronic format on SharePoint and in paper format in file room, including creation and maintenance of applicable folders to maintain record organization and tracking of any outstanding items for resolution.

Contego Medical/Integrated Embolic Protection Device Aug’20-Nov’21

Clinical Research Specialist Consultant (Consultant for study start up)

Supporting project managers during the study startup phase on a study to get a new integrated embolic protection device in the US approved.

Site Start-up

Sets up eTMF

Assist sites for study Regulatory readiness for SIV.

Assists with the CTA for investigational sites based on parameters set by company guidelines; elevates contract issues outside guidelines to Team

Maintains inventory of devices. Tracks shipment and arrival of medical devices; communicates with sites to confirm arrival

Confirms adequacy of device supply for SIV

Maintains regulatory files for study

Develops expiry spreadsheet for all study and regulatory documents

Tracks monitoring visits to ensure milestones and visits remain in budget

Participates in EDC UAT testing

Investigator Meeting: Locates venue, obtains contracts for accommodations and meeting room, audio visual equipment and food

Tracks attendees to meeting: PI and RC

Ensures forms are available for signature during meeting

Enrolment Period

Keeps Monitoring Visit Calendar current

Prepares Monitoring Visit Reports for CRAs

Supports Clinical Team with evaluation of sufficient site monitoring coverage

Track throughput of monitored data

Develops tool to identify device implanters for all sites

Oversee subject enrolment to ensure that informed consent is properly obtained and documented as noted in the Monitoring Visit Report

Prepare CEC/DSM meeting invoices and forward to Accounts Payable

Reviews monitor receipts and invoices. Processes monitor expenses and forward to Accounts Payable

Submit patient reimbursement requests; processes study expenses to Accounts Payable

Reviews and submits monthly invoices from vendors: Core Labs/EDC

GlaxoSmithKline/Contractor; Alphanumeric Inc (Consultant) Nov’19 – Jan’20

Clinical Safety Associate

Managed Source Documents, PDFs incoming email source documents and saves to the shared area, noting case type, product, and receipt date for triage.

Syneos Health /Beacon Health Consulting Company (Consultant) Oct’19-Nov’19

Clinical Research Associate II/ Contract

Identified potential clinical events, as well as collected, reviewed, and prepared required documentation for review by clinical event or adjudication committees.

Assisted the Endpoint Adjudication Manager in management of the activities of the Endpoint Adjudication team

Assisted with the development of rigorous and study-specific endpoint or event reporting and adjudication processes.

Received and reviewed Investigator Record of Potential Endpoint or Event forms from investigator sites

Followed-up with Investigator sites to obtain additional supporting, documentation for potential endpoints or events.

Reviewed medical information to ensure completeness of endpoint or event package, blinding of study subject, and to identify any unreported potential endpoints or events.

Reviewed Serious Adverse Event (SAE) listings and provided appropriate follow-up with the Investigator site to ensure that all potential endpoints or events have been reported.

Assembled endpoint or event adjudication packets for Clinical Events Committee Members.

Generated tracking reports for internal or client purposes.

CCS Associates Incorporated Oct’16-Sep’18

Clinical Research Associate II (Permanent)-Solid Tumor Oncology

Provided site management and monitoring support for sponsored clinical studies.

Prepared sites for internal and external audits.

Ensured response to Non-Conformances, NC Evaluations, Root Cause Analysis and Action plans as well as writing up Corrective and Preventive Action Plans (CAPA).

Tracked and closed out Corrective and Preventive Action Plans while utilizing the information to prepare sites for sponsor and FDA audits.

Verified non-compliance issues at sites during remote and on site visits, while validating the issues per GCP/ICH guidelines.

Performed on-site pre-study/qualification, initiation, routine, and close-out visits.

Provided the visit reports in CTMS within 5 days of completion; finalized report within 15 business days of completion; provided follow-up letter to the site within 15 business days of visit completion.

Educated and trained site and study staff in management of sponsored studies, including assurance to regulatory and ICH/ GCP compliance.

Collected and processed all regulatory (1572s, MLs, CVs, FDFs, IRB approvals, etc.) and site-required documentation (SIS, DOA, certificates, etc.).

Assisted in protocol, Informed Consent, and CRF design and review.

Maintained working knowledge of SOPs, FDA and ICH/GCP guidelines. Maintained knowledge of changes in SOPs, plans, and GCP-required documentation.

Reviewing lab reports for out-of-range labs and monitoring if the cancer has become metastatic in the subject’s body.

ICON Clinical Research Company Nov’15-Aug’16

Clinical Research Associate I (Permanent)

Maintained a working knowledge and assured compliance with ICH-GCP guidelines, federal regulations, and SOPs.

Conducted Interim Monitoring Visits in the East Coast Region for a Hyperlipidemia Outcomes study. Travel was up to 65-70% as a co-monitor.

Submitted a report upon conclusion of the visits that were conducted in this area.

Reported and submitting expense reports in a timely manner.

Initiated weekly site telephone contacts

Reported and tracked telephone contacts to lead Clinical Report Associate.

Ran TMF reports prior to onsite visits to complete an onsite full Investigator Site File reconciliation.

Ran reports in Oracle, EDC and IcoTrial prior to the onsite visits, while closing out any prior action items or queries while on site during the Interim or remote monitoring visits.

Ensured response to Non-Conformances, NC Evaluations, Root Cause Analysis and Action plans.

Wrote up Corrective and Preventive Action Plans (CAPA).

Tracked and closed out Corrective and Preventive Action Plans while utilizing the information to prepare sites for sponsor and FDA audits.

Verified non-compliance issues at sites during remote and onsite visits, while validating the issues per GCP/ICH guidelines.

Med Source, Raleigh, NC Mar’15-Jun’15 Regulatory Affairs Study Start Up (Consultant)

Assisted with collecting, logging, filing, and/or tracking of study documents/trial master file in the project tracking system including site correspondence, vendor correspondence, IRB submissions and approvals, IND safety reports, case report forms (CRFs), regulatory and other study documents according to client/company Standard Operating Procedures (SOPs), ICH, and federal regulations.

Reviewed Informed Consents for accuracy and required elements per FDA guidelines.

Received and disseminated study-related regulatory documents and correspondence from assigned sites; screened documents for completeness and compliance with protocol and appropriate regulations; investigated incomplete, inaccurate, or missing documents to ensure accuracy and completeness of data.

Assisted in the production and distribution of various study-related, investigator, regulatory tools, and documentation (correspondence, operations, guidelines, training manuals, study forms, site regulatory binders, and worksheets).

Communicated with sites to provide information, request updates, track documentation, and help to ensure the overall progress of clinical trials and adherence to established guidelines.

Ensured that study materials and drug kits are shipped and re-supplied as requested; respond to routine questions related to study protocol and refer more complex questions to management as appropriate.

Communicated and coordinated with other study personnel including data entry and randomization personnel, pharmacy, laboratories, study sponsors, and others as needed for study implementation and routine problem resolution.

When specified, scanned study-related documents and ensured that the quality of the electronic document was adequate, corrected naming conventions were utilized, and verified the paper file matched the electronic file.

Prepared, proofread, and edited correspondence and other written materials (presentation, reports, etc.) as needed.

Emerging Med Jan’15-Mar’15

Clinical Trials Coordinator and Navigator Oncology (Consultant)

Worked with Emerging Med’s clients to facilitate matching and referral to clinical trials for which the patient may be eligible. This includes:

Assessing: identified and understood what the caller is looking for clinical trials and what they need.

Educating: informed patient/caller as it relates to Emerging Med’s services, clinical trial basics, the matching process, and other potential external resources available to support their medical care.

Troubleshooting: identified and proactively assisted in problem solving when basic information or logistical support can eliminate a barrier (e.g making contact with trial sites).

Setting Expectations clearly laid out the process and role of the medical team for clinical trial enrolment.

Creating Clinical Profiles: extracted and synthesized basic clinical data ((e.g diagnosis, symptoms, treatment history) to support decision making regarding clinical trial eligibility.

Achieving Outcomes: to track a patient’s success in pursuing clinical trial options and/or build long-term relationships to assist patients in identifying appropriate clinical trials in the future.

Proactively followed-up with clients after initial encounter to track their progress in contact and enrolment in clinical trials; troubleshoot logistical and/or psychosocial barriers to trial participation.

Processed complex medical information and terminology to enable a refined clinical trial matching for clients.

Promoted enrolment in a particular trial and procurement of therapeutic agents/medications.

Identified process improvement opportunities for the Call Center and provided constructive suggestions.

Assisted with ad-hoc assignments and projects in conjunction with the Operations, Medical Information and Technology teams as needed.

Quintiles International/Permanent Oct’11-Jun’14

In House Clinical Research Associate (Permanent)

Ensured compliance with protocol guidelines and requirements of regulatory agencies, including the provisions of the Anti- Kickback Statute (USA) and the False Claims Act (USA).

Ensured response to Non-Conformances, NC Evaluations, Root Cause Analysis and Action plans and writing up Corrective and Preventive Action Plans (CAPA).

Tracked and closed out Corrective and Preventive Action Plans while utilizing the information to prepare sites for sponsor and FDA audits.

Communicated any deviations noted during remote monitoring visits to the on- site field monitor prior to the on -site field monitor’s visit.

Closed out all CAPAs per ICH/GCP guidelines at the end of a study. Entering all information pertaining to the CAPA into CAPA tracker for completion and closure.

Collected, tracked, and reviewed study site critical documents used to monitor interest for enrollment of investigative sites.

Thoroughly documented and tracked all communication (email, voice, fax, call reports) with all study site personnel and any sponsor client interaction in accordance with study plans.

Assisted in the development of site-specific recruitment, retention and follow up plans / processes in line with the project strategy provided by Project Coordination Centre (PCC) Lead. Ensure the site is recording data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources in accordance with study plans.

Followed established guidelines in the collection and tracking of clinical data and resolution of data queries in accordance with study plans and client preferences.

Evaluated and assured quality of data collected; ensure that all data and study documents are handled consistently with the demands of regulatory agencies with respect to data protection.

Identified problems and/or inconsistencies; monitored site and subject progress, including documentation, and reporting of adverse events; recommended corrective action as appropriate; escalate to PCC Lead or line manager as appropriate.

Provided guidance to PCC Clinical Assistant staff as needed upon closing out studies and preparing for internal and sponsor audits.

Liaison with field CRA’s to provide site update and solutions to support and follow up on any open action items, or deviations that were not reported to the IRB or updated on deviation log.

I3 Research/United Healthcare/Pfizer (end client) Contractor Oct’10-Feb’11

Clinical Project Coordinator/eTMF Quality Control Specialist (Consultant)

Maintained internal metrics based on the established guidelines.

Performed eTMF Review and QC activities using the Sponsor systems and tools.

Reviewed trip reports for any noted CAPAs, while following up to verify that the correct documentation for the CAPAs were closed and filed accordingly.

Confirmed Presence of Essential Documents per study utilizing the TMF Essential Documents List. Reviewed relevant Sponsor systems (can include EDMS, etc) to locate required documents.

Performed relational QC amongst documents where applicable.

Performed QC on all studies including protocol and Center level documents (using a randomized sampling of at least 5% of total documents) Studies with an error rate 5% will go through 100% re-review and re-route through the QC process, while studies below this threshold will need to have all recognized errors corrected.

Maintained a QC log and corrected all errors prior to returning study inventory.

CERTIFICATES & TRAININGS

EDMS-Electronic Data Management System (Pfizer)

ASPT-Phlebotomy, Duke University (Certificate)

IVRS Certificate/Covance

GCP, GXP Training Certificates

Clinical Foundation Program, PPD, Inc, RTP, NC

IRB Training, Duke University, Durham, NC

American Society of Phlebotomy Technician Training and Certification, Durham, NC

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