Resume

Sign in

Clinical Research Coordinator

Location:
Oakland, California, United States
Posted:
May 29, 2019

Contact this candidate

Resume:

Artrice Bodden Goudeaux

ac9hh1@r.postjobfree.com

ac9hh1@r.postjobfree.com

510-***-****

SUMMARY

• Experienced Healthcare professional with over 15 years of Administrative&Clinical Supervisor experience

• Experience working with EDC systems

• Mentor and supervise clinical research staff; assign daily tasks and ensure timely completion and accuracy; document disciplinary incidents, guidance to staff to resolve data related issues;queries/data management and conduct annual performance reviews.

• Manage, mentor and monitor Clinical Research Coordinators

• Experienced working in Labor Management environment

• Develop, author and establish SOPs for clinical research conduct, activities and operations

• Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines

• Business development, secure clinical research projects, negotiate contract, budgets, payments and financial issues related to the project

EDUCATION AND CERTIFICATION:

Presently Enrolled-

San Francisco State -Clinical Trail Design and Management Biotechnology 2018 IATA- GCP Certificate 2018

Brookwood- Essential GCP 2018

AMCA-Certified Phlebotomist /CLS 2009

AMCA-Certified EKG Tech 2009

Associates Degree from San Joaquin Delta College, Stockton, CA 1997 AAMA- Certified Medical Assisting 1995

Everest Medical College San Jose, CA - Medical Assisting 1993 EXPERIENCE

Biometrix Inc. (Contracted) March 2019-Present

Clinical Research Manager/Supervisor

Clinical staff management; Study Coordination:

• Adhere to Research SOP’s, Good Clinical Practices and the study protocols

• Ensure scientific integrity of data, QA, QC, and protect the rights, safety, and well-being of patients enrolled in clinical trials

• Develop, author and establish SOPs for clinical research conduct, activities and operations

• Conduct the day to day operations of a clinical study being conducted in federally qualified health centers (FQHCs)

• Develop and manage clinical protocols and ICF.

• Manage Bio sample and Biospecimen, subject recruitment

• Manage and coordinate patient visits

• Discuss study protocols with patients and verify the informed consent documentation

• Ensure patient’s referring physician receives notification of patient’s participation in studies as requested by the patient

• Meet with patient for each visit and be available to discuss any questions/concerns regarding the study

• Dispense study medication in a professional and accountable manner following protocol requirements Collect, process, and ship blood/urine specimens at scheduled patient visits

• Schedule all patient research visits and procedures consistent with protocol requirements

• Complete and maintain case report forms per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy

• Ensure that non-serious and serious adverse events are properly documented and reported

• Screen all laboratory results when received and follow protocol procedure regarding abnormal results Ensure all laboratory results are given to appropriate doctors for review of clinical significance, then file results in the patient study binder

• Submit patient reimbursement requests at the conclusion of patient’s participation in protocol

• Ensure the filing and maintenance of all regulatory documents

• Act as IRB coordinator when necessary to be responsible for submitting applications, renewals and amendments

• Submit necessary compliance paperwork/Ensure billing compliance Schedule monitor visits and set up for monitoring visits prior to monitor’s arrival

• Resolve issues and questions with sponsors.

• Serve as the liaison between the Principal Investigator and study subjects and sponsors and sites

• Create and execute participant and staff workflows in clinical and research units for recruitment, eligibility and retention

• Mentor and supervise clinical research staff; assign daily tasks and ensure timely completion and accuracy; document disciplinary incidents and conduct annual performance reviews. Manage, mentor and monitor Clinical Research Coordinators

• Perform and train Clinical Staff of laboratory duties

• Coordinate all study activities with clinic staff, including administrators, providers and other staff members

• Travel to different site and Investigator Meetings

• Business development, secure clinical research projects, negotiate contract, budgets, payments and financial issues related to the project

LCGK Research/CDE Medical - San Carlos, CA May 2015 – Feb 2019 Sr. Manager Clinical Research Coordinator/Supervising Coordinator

Internship/training with LCGK Research formaly Bay Area Clinical Reseach 2013-2015 Activities include and are not limited to:

• Coordinating patient visits

• Managing patient visits in accordance to protocol

• Coordinating site monitor visits

• Submitting necessary compliance paperwork/ Ensuring billing compliance

• Create and execute participant and staff workflows in clinical and research units for recruitment, eligibility, and retention

• Mentor and supervise clinical research staff; assign daily tasks and ensure timely completion and accuracy; and conduct annual performance reviews

• Act as IRB coordinator responsible for submitting applications, renewals, and amendments

• Resolving issues/questions with sponsor

• Serving as the liaison between the Principal Investigator and study subjects

• Perform and train Clinical Staff of laboratory duties

• Coordinate all study activities with clinic staff, including administrators, providers, and other staff members.

• Manage, Mentor and Monitor fellow Clinical Research Coordinators

• Conduct the day-to-day operations of a clinical study being conducted in federally qualified health centers (FQHCs).

• Develop, author and establish SOPs for clinical research conduct, activities and operations

• Have demonstrated a strong knowledge and working experience in clinical protocols, ICF development and in Bio sample & Biospecimen management

• Extensive experience working on study start-up to close out, working on clinical trial from phase I-IV, on diabetes/endocrinology studies.

• Transitioning clinical biospecimens related responsibilities to Post-Study Biospecimen Steward after clinical database lock.

• Attention to detail; strong interpersonal skills; excellent, effective verbal and written communication skills to coordinate with subjects, team members, other departments and outside institutions; and the ability to multi-task in a fast-paced environment while working with a diverse subject population

• Travel to different site and Investigator Meetings in different states

• Ability to work well independently, complete projects in a timely manner, and prioritize multiple projects to ensure the completion of essential tasks by deadlines

• Responsible for the oversight of all clinical research study operations with the Principal Investigator, Sub-investigators, Study Coordinators, and Site Director. Oversaw study preparation

(study start-up), enrollment activities, regulatory submissions, study maintenance and final close out, as well as study archive.

• Proficient with Microsoft Office; Word, Excel, PowerPoint and Outlook Sacramento Job Corps/US Board of Labor - Sacramento, CA Sep 2013 - Aug 2016 Sr. Clinical Medical Assistant/Phlebotomy/EKG Instructor CMA/HHA Training Program Director

• Prepared and provided all lecture(s) and clinical instruction according to required curriculum

• Maintained a lesson plan of daily instructional events.

• Mentored all Medical Cluster Instructors Bureau

• Implemented the unit policies and procedures to the staff

• Responsible for hospital and clinic compliance with the Joint Commission, State and regulatory standards

• Assist with infection control surveillance and reporting

• Immediate supervisor of nursing and provide leadership Valley Heart Associates/Doctors Medical Center - Modesto, CA 2010 - 2012 EGK Tech/Phlebotomist

Obtains and processes a collection of blood specimens using a variety of techniques and performs EKG's on patients per department and RHS guidelines.

Kaiser Permanente - Stockton, CA 1992 - 2008

ADHA Coordinator/Sr. Medical Assistant

• Responsible for completing a comprehensive clinical assessment of clients who have been involuntarily detained under Title 25

• Gather pertinent clinical, psychosocial and risk history from the client, the clients chart documentation, and the client's significant others as appropriate

• Attend clinical rounds and staffing regarding the involuntary client.

• Maintain clinical documentation and data collection and submission to appropriate and authorized entities

EXPERIENCE SPONSORS, CRO'S, IRB'S, EDC'S AND LABS: Sponsors: Diasome, Theracos, Sentier, Sanofi and Lilly Contract Research Organizations: Syneos Health, Integrium, and PRA Health Sciences Central IRB: Schulman and Advarra

Electronic Data Capture Systems: Committee of Human Research (CHR), Medidata, Almac, eCaseLink, Marvin, MyHealth Point, ERT, Study Works, Entra Health, eClinical, Oracel Health Sciences, iMedris,Datatrak and EPIC

Labs: Covance, AMC, Q2 and Eurofins

Current Research Experience (2018-Present):

• A Phase 3, Randomized, Double-Blind, Active-Controlled Trial- Subjects w/ Type 2 Diabetes

• A Phase 2. Multicenter, Randomized, Double-Blind, Titration Trial- Subjects w/ Type 1 Diabetes Observational Trail- Subjects w/ Hypothyroidism

• Phase 3-A 26-week Randomized, Open-label, Active-controlled, 2-Treatment arm, parallel- group Multicenter Trail- Subjects w/ Type 2 Diabetes

• A Randomized, Open-label Trial- Subjects w/ Type 2 Diabetes at High Risk for Cardiovascular Events

• Phase 4-Efficacy and Safety of Tirzepatide Once Weekly versus Insulin Glargine in Patients with Type 2 Diabetes and Increased Cardiovascular Risk



Contact this candidate