Clinical Research Associate

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Rosa Shamlou

Senior Clinical Research Associate

CLINICAL RESEARCH PROFESSIONAL with 24 years solid clinical research experience. Proven ability to manage multiple studies simultaneously from inception to completion. Very strong critical thinking, problem solving, research and liaison skills. Recognized for outstanding communication skills, flexibility, and leadership abilities. Experienced in phase I-IV of human clinical trials. Therapeutic Areas of Research Include: Aesthetics

Cardiology

Dermatology

Endocrinology

GI

Infectious Disease

Medical Device

Neurology

Oncology

Pediatric Vaccine

Psychology

Pulmonology

Urology

PROFESSIONAL VALUES OFFERED:

Clinical Trial Management

Site Management

Oncology CRA

Study Start-up Program Management

HIPPA Regulation

Health Data Analytics

GCP/ICH Guidelines

Data Management

Health Information Systems

FDA Regulatory Requirements

COMPUTER

SKILLS:

Windows XP, Microsoft Word, PowerPoint, Excel, Access, CTMS, EDC(Medidata Rave, Inform, Phase Forward), Salesforce, TMF. EDUCATION:

University of Wisconsin-Milwaukee

B. S. – Biology

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PROFESSIONAL EXPERIENCE

Advanced Clinical: Lead Senior Clinical Research Associate October2019-Present

• Contributed to successful FDA audit preparedness by providing valuable assistance to both sites and sponsors, resulting in two consecutive FDA approvals.

• Ensured studies were conducted according to the study protocol, SOPs, ICH/GCP regulations, and study specific manuals and procedures.

• Approved monitoring visit reports and tracked metrics to ensure compliance with study protocol plans.

• Responsible for evaluation and performance of the assigned CRAs.

• Actively participated in the study startup process, leading site identification, qualification, selection, and initiation activities. Collaborated with Global Study Start-Up to meet study timelines effectively.

• Skilled in performing critical functions for Site Selections, Site Initiation, Interim Monitoring, and Closeout Visits.

• Developed study-specific templates to streamline processes at investigative sites. This included designing Case Report Forms and Source Documents.

• Developed and maintained positive relationships with internal and external stakeholders, including clients, team members, and site personnel (PIs, Study coordinators, etc.).

• Conducted Data Review to ensure data integrity and quality.

• Prepared for and attended kick-off meetings, investigator meetings, and other study-specific meetings as required.

• Oversaw the management and auditing of Trial Master Files and Investigator Document Files to guarantee regulatory compliance.

• Communicated with study sites regarding issues such as protocol, patient participation, case report form completion, and other study-related issues. Ferring Pharmaceuticals: Senior Clinical Research Associate October2018-October 2019

• Primary point of contact with assigned investigative sites.

• Conducted monitoring visits and complete monitoring reports.

• Conducted data review, query generation and resolution.

• Assisted sites with audit preparedness.

• Assisted with IRB submissions and tracking.

• Managed the development and implementation of site corrective actions as needed to address any compliance issues.

• Participated in the study site identification and qualification process.

• Led study site initiation visits and trainings.

• Reviewed and approve study site activation documentation.

• Ensured ongoing site training needs are met.

• Collaborated with contracted vendors, including but not limited to: Clinical research organization (CRO), central laboratory, Medical Monitor, etc.

• Assisted with the development and management of study-related documents and monitoring tools, including but not limited to: Clinical protocols, case reports forms, monitoring plan, 3

study manuals, and study-related tools for monitoring.

• Contributed to SOP development and review.

DOCS: Senior Clinical Research Associate July 2016– Sep 2018

• Provided domestic monitoring services for Pharmaceutical, and biotech companies.

• Performed site selection/qualification, initiation, monitoring and termination visits.

• Drove successful activation of trial sites according to time, quality/scope and budget parameters.

• Ensured that the CRAs are properly coached/mentored and trained using training plan

(including company's SOPs, study specific documents & ICH-GCP guidelines addendums/FDA regulations) and conducting one-on-one meetings to evaluate each CRA 's Career Goals and feedbacks on the company's systems.

• Took the initiative to move the project/program forward and leads in country and global projects where applicable.

• Led and manage the clinical monitoring teams with focus on quality and timely deliverables Work with the Project Manager to ensure transparent and proactive sponsor and internal communication regarding study progress and trial issues

• Planed and conduct initial and ongoing training for the study team on project-specific matters and enlists therapeutic assistance

• Applied clinical and monitoring expertise in the design of case report forms.

• Created and maintain a study specific clinical monitoring plan (CMP), annotated monitoring report (PSV, SIV, IMV and COV) and tracking CRA training matrix.

• Monitored the preparation and timely completion of all monitoring visit reports, reviewed them for appropriate content, and ensured effective follow up and resolution of site issues.

• Reviewed CRA Site Visits calendar and tracker to ensure monitoring visits (both remotely and on site) are being scheduled and conducted following monitoring plan frequency.

• Prepared and executed a site and patient recruitment and retention plan.

• Served as initial point of contact for all clinical management and monitoring issues, vendors and other functional areas, escalating as required.

• Ensured effective communication plans are in place for the clinical team and are actioned.

• Monitored the quality of clinical deliverables and address quality issues with the appropriate team member.

• Worked with the Data Management team to identify data related issues and risks to clinical activities; assist in the development of mitigation plans to minimize risk. PharmaNet/i3 (an inventive Health Company): Senior Clinical Research Associate June 2014 – June 2016

• Acted as the primary point of contact for investigator sites, and responsible for ensuring that the clinical trial is conducted according to CFR, ICH guidelines and GCP.

• Responsible for the efficient execution of monitoring and other clinical trial management activities, tracked the progress of assigned studies/projects and proactively identify potential challenges and developed appropriated actions to resolve issues and achieved target objectives.

• Investigator site pre-study site qualification visits including collection of site regulatory documents.

• Site start-up activities including site contracts and budget development/negotiation, preparation 4

of IRB submissions (including follow through to ensure successful outcome).

• Responsible for the preparation of the study reference manual, including consulting with contract research organization team (including central lab, specialty labs and vendors) to ensure efficient preparation and delivery of study materials to investigator sites.

• Ensured investigator sites have met all contractual and regulatory requirements for site initiation and first release of study drug.

• Participated/lead the Investigator/Initiation Meetings and ensured that the study staff conducting the study has received the proper materials, instructions and training to safely and accurately conduct the study in-line with protocol requirements.

• Assisted in the development of study/program plans (e.g., Monitoring Plan, eCRF Completion Guidelines, Data Management Plan, Safety Management Plan).

• Tracked the movement of laboratory samples and the resulting data. Managed patient recruitment strategies.

• Liaised with study site personnel to ensure timely and correct entry of data into eCRF, including the timely resolution of data queries.

• Identified and completed follow- up of SAEs at study sites.

• Assisted with data listing, data coding, and patient profile reviews, and database lock, and site close- out activities

• Ensured appropriate and timely submission of documents to the Trial Master File. PPD: Clinical Research Associate June 2013 – May 2014 Managed all clinical operational aspects of a government clinical trial program for oncology and infectious disease studies.

Spectrum Pharmaceuticals: Clinical Research Associate Apr. 2012 – May 2013

• Performed and coordinated assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products for Bladder cancer and prostate cancer studies.

• Conducted site visits to determine protocol and regulatory compliance and prepare required documentation.

• Developed collaborative relationships with investigative sites and client company personnel.

• 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.

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

• Acted as a mentor for clinical staff including conducting co-monitoring and training visits. Urology Clinics of North Texas: Senior Clinical Research Coordinator Mar. 2008 – Mar. 2012

• Served as Senior Study Coordinator for a number of prostate cancer and bladder cancer clinical trials for Dr. James Cochran at UCNT.

• Managed onsite research protocol activities and assist staff in organization to ensure study protocol procedures and good clinical practices.

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• Managed and participates in study recruitment to ensure enrollment goals are met or exceeded.

• Provided patient education regarding disease process and involve with patient and family in decision- making processes.

• Generated reports for supervisor on patient enrollment and tracking.

• Tabulated enrollment statistics.

• Maintained strict confidentiality of patients, employees and company information at all times and adhere to HIPAA Guidelines.

• Responsible for drug accountability, maintaining logs and inventory of study product and supplies.

• Coordinated and conduct pre-study, initiation, monitoring and close-out visits with the pharmaceutical representative, including completion of minutes and follow-up reports. Baylor Research Institute: Clinical Research Coordinator Jan. 2005 – Jan. 2008

• Coordinated Psoriasis and studies at Dermatology Research for Dr. Alan Menter, Director of the Dermatology Program at Baylor University Medical Center in Dallas.

• Provided progress reports and status updates, and communicated effectively with other personnel, as well as with CROs, IRBs and investigational sites.

• Coordinated study initiation among clinical staff, subjects, and Sponsor/CRO.

• Prepared and submitted IRB/IEC documents including informed consent/assent forms, advertising, protocol and summary, and Investigator’s brochure.

• Maintained documents per FDA/ICH guidelines.

• Prepared study summary for Sponsor/CRO.

• Prepared for and respond to Sponsor/CRO or FDA audits.

• Dispensed investigational products according to the protocols.

• Communicated with laboratory, Investigator, and Sponsor/CRO regarding laboratory findings.

• Assisted the Investigator in determining idiosyncrasies, causality, expected or unexpected results associated with investigational products.

• Reported serious adverse events to Sponsor/CRO and IRB/IEC.

• Maintained the continuity of the clinical trial while satisfying obligations to the Sponsor/CRO and/or monitor.

• Performed study initiation, monitoring, study completion, and authoring of clinical pharmacology study reports and publications / presentations.

• Developed necessary documentation for IRB submissions to clinical trial sponsors in collaborations with clinical research associates and other regulatory staff.

• Coordinated site visits for Federal and State regulators.

• Provided education and training about laws and regulations that affect operations. UT Southwestern Medical Center: Senior Research Associate Jan. 1998 – Dec. 2004

• Functioned as Lab manager at the Department of Molecular Genetics for Dr. Joseph Goldstein and Dr. Brown.

• Performed administrative duties such as maintaining sub ledgers for various accounts including reviewing expenditures and encumbrance, reconciling accounts, and ensuring appropriate use of NIH funds.

• Responsible for ordering and maintaining stocks of variety of supplies including chemicals, office supplies, lab equipment and office furniture.

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• Performed DNA purification and sequencing, electrophoresis, Western Blots, and cell culture.

• Functioned as a primary liaison with ARC department to observe research animals weekly.

• Prepared routine animal reports on health, death, and census.

• Trained other technicians and Graduate Students on lab policies, functions, procedures, and technical equipment utilization.

PUBLICATIONS:

White, Martha J., Scott, Laura M., Mann, Linda M., Shamlou, Rosa, Saracino, Giovanna, Agura, Edward D., Fay, Joseph W., Pineiro, Luis & Vance, Estil A. (2002). Changing Patterns of Fungal Infection in a Blood and Marrow Transplant Program. BMT abstract249. White, Martha J., Mamlouk, Khalid, Saracino, Giovana, Shamlou, Rosa, Agura, Edward D., Berryman, Robert & Vance A. Estil (2002). Utilizing a Customized Epidemiological Drug- Susceptibility Database to Monitor Resistance Patterns and Trends to Make Appropriate Empiric Antibiotic Selections for Blood and Marrow Transplant Recipients. BMT abstract256. Wilson, Mary C., King, Jeri, Pierce, Tamara N., Shamlou, Rosa, Saracino, Giovanna, White, Martha J., Agura, Edward D., Berryman, Robert, Fay, Joseph W., Pineiro, Luis & Vance, Estil A. (2002). Program Overview: Disease Treated, Types of Transplants, Regimen, and Outcomes in an Outpatient Blood and Marrow Transplant Program. BMT abstract 250. Rachui, Steven, King, Marie K., Shamlou, Rosa, CAAT-IVTG Symposium on Mechanism of Toxicity (1997). An in vitro method for the evaluation of skin whiteners. Rachui, Steven, King, Marie K., Shamlou, Rosa, CAAT-IVTG Symposium on Mechanism of Toxicity (1997). An in vitro method for the evaluation of Metabolic Stimulants.

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