Summary
Overview
Work History
Education
Skills
Websites
Accomplishments
Volunteer Civic Activities
Therapeutic Experience
Training
Affiliations
Certification
Hobbies
Additional Information
Timeline
Generic

Staci Potts

Douglass,KS

Summary

Knowledgeable Clinical Trial Manager with seasoned experience as a Senior CRA and Senior Site Manager for several global sponsors and CRO organizations. Successful trial outcomes have been accomplished with 100+ start-up, 150+ initiation, 200+ maintenance and 100+ close-out visits conducted, along with feasibility and pre-study visits. Years of experience originated from a foundation of a CCRC to understanding project management practices and tools within small, mid-size, large CROs and sponsors. Involvement in multi-therapeutic areas of phase II-IV clinical trials has provided oncology, rare disease, immune disorders, ophthalmology, vaccines and observational study experiences in pediatric and adult environments. These environments led to knowledge, experience and leadership over the years and provided support. Responsibility held in quality management of clinical programs and budgets within risk-based monitoring approach using e-source, EDC, regulatory and IRT platforms. Adherence to strict compliance of FDA regulations and ICH/GCP guidelines, combined with sponsor SOPs led to project management skills and trial leadership, while working in a CRA atmosphere for many years. Remote office environment using relevant tools and effective communication with various computer software and clinical research platforms led to understanding “daily activities” of project management practices. Successful clinical research protocols require knowledge of clinical trial design, planning and organizational skill. Various communication software has developed computer literacy.

Overview

13
13
years of professional experience
1
1
Certification

Work History

Senior Clinical Research Associate

PAREXEL
06.2020 - 08.2023
  • Conducted monitoring of clinical trials in compliance with FDA regulations and ICH/GCP guidelines combined with sponsor SOPs and deliverables in a risk-based monitoring approach
  • Adhered to strict regulatory compliance and quality assurance
  • Managed project risk by identifying, quantifying and monitoring potential threats.
  • Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
  • Communicated project status to Project management verbally and through technical documentation and presentations.
  • Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
  • Conducted independent research to validate efficacy of solutions, assimilate results and prepare written technical reports.
  • Maintained knowledge of company strategic direction, goals and objectives and aligned projects appropriately.
  • Monitored unit budget to meet financial objectives for spend rate and funding.
  • Good clinical operations helped to identify site problems and provide direct resolution with problem solving
  • Traveled to perform onsite visits with remote home-office to include qualification, initiation, interim and close out, while adhering to monitoring visit report completion timeframes and experienced with FTRs
  • Managed and performed on-going site risk assessments, with site management activities, completion of preventive and corrective measures
  • Collaborated with Quality Assurance (QA) to identify need of corrective and preventative action plans
  • Ordered drug and study supplies via vendor and sponsor websites
  • Reviewed filing of Essential Documents in eTMF to ensure sponsor and investigator obligations were met and in compliance with applicable local regulatory requirements and ICH guidelines
  • Managed collection of information from investigational sites including being the direct contact during feasibility, start-up, pre-qualification, and maintenance and close-out activities with first-time quality
  • CTMS systems were updated and managed in timely manner
  • Proficient in Microsoft Word and Excel
  • Experienced building relationships and communicating by collaborating with PIs and site personnel, while being team player, with strong interpersonal and analytical skills
  • Led and participated in Power Point and Team meetings
  • Provided Project Oversight and Leadership for deliverables to sites, including first point of contact
  • Possessed leadership skills while mentored CRAs in clinical research industry and taught 1:1 in a hands-on environment, in observational setting, and provided verbal and written direction
  • Conducted Assessment visits for job-related tasks and report completion
  • Limited oversight was needed, as self-driven capacity work environment was maintained.

Senior Clinical Site Manager

PAREXEL
09.2018 - 06.2020
  • Ensured compliance with study protocols, regulatory compliance and strict adherence to GCP monitoring clinical trials for qualification through close-out visits
  • Completed onsite and remote monitoring visits in compliance with sponsor's Monitoring Plan
  • Managed and performed on-going site risk assessments, with site management activities, completion of preventive and corrective measures
  • Collaborated with Quality Assurance (QA) to identify the need of corrective and preventative action plans
  • Reviewed filing of Essential Documents in the eTMF to ensure sponsor and investigator obligations were met and in compliance with applicable local regulatory requirements and ICH guidelines
  • Oversaw and verified inspection readiness from FDA, IRB and sponsor audits
  • Verified subjects' safety and rights were protected through proper consenting techniques
  • Delivered organizational and project skills with enthusiasm
  • Administrative duties were delegated and managed with good judgments and decision making, while being detailed oriented and owning personal accountability
  • Strong administrative abilities and ability to prioritize projects with success are strong characteristics
  • Possessed leadership skills while mentored and taught CRA I's in a 1:1 in a hands-on environment, or observational setting, with verbal and written direction
  • Taught CRAs job management skills to be successful with their employment, juggle job-related tasks and how to be detailed-oriented for reports
  • Experienced creating an alliance with PIs and site personnel at the start of a project collaborating, while being a team player, with strong interpersonal and analytical skills
  • Organized and led Power Point and Microsoft Team meetings
  • Provided Project Oversight and Leadership for deliverables to sites, including the first point of contact and protocol knowledge.

Senior Clinical Research Associate

PRA International
10.2013 - 08.2018
  • Performed clinical monitoring via onsite and remote in compliance with FDA and ICH/GCP regulations following the sponsor's Monitoring Plan for qualification through close-out visits
  • Conducted site management activities and coordinated the collection of essential documents
  • Mentored newly assigned CRAs' to the industry with verbal teaching, 1:1 hands-on
  • Held a leadership role for observational and assessment visits.

Senior Clinical Research Associate

Premier Research
04.2012 - 10.2013
    • Perform clinical monitoring via onsite and remote in compliance with FDA and ICH/GCP regulations following sponsor's Monitoring Plan for qualification through close-out visits
    • Conducted site management activities and coordinated collection of essential documents
    • Mentored newly assigned CRAs' to the industry with verbal teaching, 1:1 hands-on leadership role for observational and assessment visits.

Clinical Research Associate III

I3/Pharmanet
07.2010 - 03.2012
  • Perform clinical monitoring via onsite and remote in compliance with FDA and ICH/GCP regulations following sponsor's Monitoring Plan for qualification through close-out visits
  • Conducted site management activities and coordinated collection of essential documents
  • Mentored newly assigned CRAs' to industry with verbal teaching, 1:1 hands-on leadership role for observational and assessment visits.

Education

No Degree - Coursework in PTA Degree

Wichita State University
Wichita, KS

No Degree - Coursework in Physical Therapy

Pittsburg State University
Pittsburg, KS

Bachelor of Science - Health Management

Friends University
Wichita, KS
05.1994

Associate of Science - Physical Therapy (Pre-Physical Therapy)

Butler Community College
El Dorado KS
05.1992

Skills

  • Data Management Proficiency
  • Informed Consent Process
  • Adverse event reporting
  • Audit preparation
  • QA
  • Work independently in a remote environment
  • Phlebotomy
  • Specimen handling and processing
  • eSDV
  • esource documents
  • eRegulatory Files
  • Vendor Management
  • Medical terminology fluency
  • First-Time Quality
  • Coordinating supplies
  • Scheduling proficiency
  • Knowledge of Schedule II drugs, such as opioids

Websites

Accomplishments

  • Collaborated with team members via Team meetings for successful completion of several projects over the work years.
  • Documented and resolved site study procedure issues which led to meeting deadlines, developing specific organizational tasks and source documents.


Volunteer Civic Activities

  • Sign Language Interpreter
  • Speaker for Career Day at Douglass High School
  • Ministerial Alliance - Douglass, KS

Therapeutic Experience

  • CV BP-Adult & Pediatric, Phase II & III, 2, USA, Sr. CRA, Sr. Site MGR
  • CNS- (Schizophrenia-adult and pediatric, also Anxiety, Bi-Polar Disorder, Depression, Binge Eating Disorder, Phase II & III, 13, USA, Sr. CRA, Sr. Site MGR
  • Hematology- (Liver Transplant), Phase III, 1, USA, Sr. CRA
  • Sickle Cell Disease, Phase III, 1, USA, Sr. CRA
  • Sleep Disorders-Traumatic Brian Injury, Phase III, 0.5, USA, Sr. CRA
  • Seasonal Allergic Rhinitis, Phase III, 1, USA, Sr. CRA
  • Adult Influenza, Phase III, 1, USA, Sr. CRA
  • Chronic Cough, Phase III, 1, USA, Sr. CRA
  • Osteoporosis, Phase III, 1, USA, Sr. CRA, Sr. Site MGR
  • Axial Spondyloarthritis (AxSpA), Phase III, 1, USA, Sr. CRA, Sr. Site MGR
  • Ankylosing Spondylitis (AS), Phase III, 1, USA, Sr. CRA, Sr. Site MGR
  • Ped Psoriatic arthritis (PsA), Phase III, 1, USA, Sr. CRA, Sr. Site MGR
  • Overactive Bladder, Phase III, 1, USA, Sr. CRA, Sr. Site MGR
  • Heart Failure with LVEF & CKD, Phase III, 1, USA, Sr. CRA
  • Observational study-Long-term effects of Neurovascular age-related Macular Degeneration (nAMD), Phase IV, 1, USA, Sr. CRA, Sr. Site MGR
  • Observational study- Diabetic retinopathy without center involved-diabetic Macular Edema, Phase IV, 1, USA, Sr. CRA, Sr. Site MGR
  • Pediatric Subjects with Community Acquired Pneumonia (in-patient trial), Phase III, 2, USA, Sr. CRA
  • Post-operative illus (POI), Phase III, 1, USA, Sr. CRA
  • Optic Neuropathy-ischemic, Phase III, 1, USA, Sr. CRA
  • Seizures-focal onset, Phase III, 0.5, USA, Sr. CRA
  • Augmented Renal Clearance (in-patient trial, infusion), Phase III, 2, USA, Sr. CRA
  • Skin disorders-(Pediatric-Generalized Epidermolysis Bullosa and Atopic Dermatitis-Adult Atopic Dermatitis), Phase II & III, 2.5, USA, Sr. CRA, Sr. Site MGR
  • Oncology- (Non-Hodgkin's Lymphoma, ALS, large oncology trials, Phase III, 2, USA, CRA III
  • Pain Management- (HA, Back, Rheumatoid and Osteoarthritis, Opioids), Phase II & III, 11, USA, Sr. CRA, Sr. Site MGR

Training

CTMS, Veeva and sponsor vaults, Calyx, SharePoint, FDA Regulations, ICH/GCP regulations and guidelines, Learning Management Systems, EDC, EMRs, e-source docs, e-regulatory systems, eTMF systems, various vendor support software platforms including x-ray, ECG and questionnaires, IWRS/IRT, various scales measuring QOL, mental illness and pain scales, various QA platforms, home health support services, ordering study supplies Schedule II drugs-shipping and handling, sponsor guidelines on drug inventory and, drug accountability, multiple therapeutic areas 

Affiliations

  • Past member of ACRP
  • ACSM
  • Personal Training

Certification

CCRC 1999-2005

Personal Training 1990-1993

First Aid 1987-1994

CPR 1987-2004

Advanced Lifesaving 1986-1990

Hobbies

  • Spending time with my husband, gardening, cooking and scrapbooking

Additional Information

  • Sign Language interpreter
  • Knowledge of Lifesaving, CPR and First Aid techniques
  • Wichita Kansas - Full Marathon Athlete, half marathon and many 5k and 2.5k races
  • Lifeguard Pittsburgh State University, Boeing Airplane Company, Douglass Municipal Pool

Timeline

Senior Clinical Research Associate

PAREXEL
06.2020 - 08.2023

Senior Clinical Site Manager

PAREXEL
09.2018 - 06.2020

Senior Clinical Research Associate

PRA International
10.2013 - 08.2018

Senior Clinical Research Associate

Premier Research
04.2012 - 10.2013

Clinical Research Associate III

I3/Pharmanet
07.2010 - 03.2012

No Degree - Coursework in PTA Degree

Wichita State University

No Degree - Coursework in Physical Therapy

Pittsburg State University

Bachelor of Science - Health Management

Friends University

Associate of Science - Physical Therapy (Pre-Physical Therapy)

Butler Community College

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Staci Potts