Freelance/Consultant/Freiberufler Clinical Research Associate/CRA

freiberufler Freelance/Consultant/Freiberufler Clinical Research Associate/CRA auf freelance.de
Referenzen
offline
Weltweit
en  |  fr  |  de
75‐110€/Stunde
64397 Modautal
21.03.2019

Kurzvorstellung

My name is Yvonne and I am a Freelance CRA. I have had study monitoring experience across all levels in the Pharma industry. I will be happy if you contact me using the link below. I am available for short-notice jobs worldwide.

Auszug Referenzen (2)

"I have had the opportunity of mentoring Yvonne 2 timesduring her professional life. All I can say is that, I was very impressed with her work ethics."
Clinical Research Associate
Nicole Merline
Tätigkeitszeitraum

4/2017 – 8/2018

Tätigkeitsbeschreibung

-Site Visit Initiation
-Site Monitoring Visits
-Site Close Out Visit
-Patient eCRF management
-Maintain adequate patient-site-sponsor relationship
-Drug Inventory
-Site Documentation Management
-Invistigator's Meeting
-SVR and FUL reporting

Eingesetzte Qualifikationen

Pharmaforschung


"Yvonne was a very good team lead during her employment with UNFPA.
I will recommend Yvonne without any reservations."
Project Director (Festanstellung)
Nicole Merline
Tätigkeitszeitraum

10/2006 – 3/2011

Tätigkeitsbeschreibung

Provides medical oversight for clinical and ancillary research products .
-Provides medical insight during implementation of key trial responsibilities.
-provides clinical leadership and strategic input for protocol consistent plans.
-Manages other associates.
-Works in closed collaboration with KOL and other board members.
-Ensures compliance with clinical research and ethical standards

Eingesetzte Qualifikationen

Pharmaforschung

Ich biete

Forschung, Wissenschaft, Bildung
  • Pharmaforschung
  • Klinische Studie
Finanzen, Versicherung, Recht
  • Regulatory Affairs Management

Projekt‐ & Berufserfahrung

Regional Clinical Research Associate
Odonate Therapeutics, Weltweit
8/2018 – offen (2 Jahre, 2 Monate)
Gesundheitswesen
Tätigkeitszeitraum

8/2018 – offen

Tätigkeitsbeschreibung

Monitors the conduct of clinical trials at Investigative sites to ensure the studies are conducted in
accordance with the protocol, standard operating procedures (SOPs), ICH-GCPs, and all applicable
regulatory requirements. The employee is responsible for local oversight of patient rights and safety,
and the credibility of clinical trial data. This is the primary liaison between the Investigator site and
sponsor and takes responsibility for overall site conduct. The employee is expected to be
knowledgeable about the therapeutic area, protocol design and all applicable regulations and
guidelines.
Identifies, assesses, escalates, and resolves site performance or quality issues in a timely manner
• Accountable for overall delivery of all patient data for all assigned sites
• Facilitates and supports Investigator site audits and/or inspection activities as needed
• Works as part of the Clinical operations team and contributes to overall team knowledge by sharing
best practices, co-monitoring, attending regional meetings
• Works cross-functionally with all other Odonate departments and team members to ensure open
communication flow, standardization and sharing of working practices, and issue notification and
escalation.

Eingesetzte Qualifikationen

Pharmaforschung


Clinical Research Associate
MSD, Deutschland und Österreich
4/2017 – 8/2018 (1 Jahr, 5 Monate)
Gesundheitswesen
Tätigkeitszeitraum

4/2017 – 8/2018

Tätigkeitsbeschreibung

-Site Visit Initiation
-Site Monitoring Visits
-Site Close Out Visit
-Patient eCRF management
-Maintain adequate patient-site-sponsor relationship
-Drug Inventory
-Site Documentation Management
-Invistigator's Meeting
-SVR and FUL reporting

Eingesetzte Qualifikationen

Pharmaforschung


Clinical Research Associate
Quintiles/Lilly, Deutschland
8/2016 – 2/2017 (7 Monate)
Gesundheitswesen
Tätigkeitszeitraum

8/2016 – 2/2017

Tätigkeitsbeschreibung

Site Visit Initiation
-Site Monitoring Visits
-Site Close Out Visit
-Patient eCRF management
-Maintain adequate patient-site-sponsor relationship
-Drug Inventory
-Site Documentation Management

Eingesetzte Qualifikationen

Pharmaforschung


Medical Monitor
EVK, Deutschland und Österreich
4/2013 – 6/2016 (3 Jahre, 3 Monate)
Gesundheitswesen
Tätigkeitszeitraum

4/2013 – 6/2016

Tätigkeitsbeschreibung

Helps to further the clinical development program by assisting in the design and conduct of clinical
trials.
• Be the Medical Expert for assigned clinical trials and is readily available to advise on trial related
medical questions or problems during the conduct of the trial.
• Contribute to investigator training.
• Contributes in the Integrated Summary of Safety and Efficacy
• Assist in medical review, assessment and interpretation of clinical and safety data to ensure that the
data are correct and presented with the appropriate medical interpretation.
• Works closely with others in the medical monitoring team. Also works closely with the
Pharmacovigilance and Safety representatives providing medical input into safety reports including,
SAE narratives and analysis of similar events, Development Safety Update Reports (DSURs) and
Suspected Unexpected Serious Adverse Reactions (SUSARs) reports, Company Core Safety
Information (CCSI), Investigator Brochure (IB), Risk Management Plans, Integrated Summaries of
Safety and Efficacy, Clinical Study Reports and preparation of labels.
• Responsible for medical monitor expertise input into the development and implementation of
standard operating procedures for all aspects of Adverse Event report handling, aggregate reporting
and assuring compliance with global and local regulatory requirements.
• Attendance at teleconferences and face-to-face meetings with global regulators and KOLs in the
region. Responsible for implementing alignment across policies/procedures and ensure that data
generated meet monitoring and compliance with FDA, ICH guidelines and GCP.

Eingesetzte Qualifikationen

Pharmaforschung


Project Director (Festanstellung)
UNFPA, West Afrika
10/2006 – 3/2011 (4 Jahre, 6 Monate)
Gesundheitswesen
Tätigkeitszeitraum

10/2006 – 3/2011

Tätigkeitsbeschreibung

Provides medical oversight for clinical and ancillary research products .
-Provides medical insight during implementation of key trial responsibilities.
-provides clinical leadership and strategic input for protocol consistent plans.
-Manages other associates.
-Works in closed collaboration with KOL and other board members.
-Ensures compliance with clinical research and ethical standards

Eingesetzte Qualifikationen

Pharmaforschung


Ausbildung

Public Health
(PhD)
Jahr: 2019
Ort: USA

Molekular Biologie
(MSc.)
Jahr: 2012
Ort: Schweden

Mikrobiologie
(BSc.)
Jahr: 2007
Ort: Kamerun

Qualifikationen

As a scientist, I have had much experience during my studies in different areas of functioning, namely;
Medical Laboratory Technology, Medical physics, Medical technology, Molecular biology, Microbiology,
and Pharmaceutical sciences. Another important area of interest during my studies was Oncology,
Radiation therapy and Epidemiology in which I studied Infectious Disease Control and Protocol
Reportage of different research topics and techniques.I have Higher Education Degrees in Life
Sciences with an approximate 4+ years general Oncology experience in Germany. I have monitoring
experiences in other areas apart from oncology; Cardiology, Infectious Diseases, Neurology and
Children Studies.
Because of my strong interest in the area of Pharmaceutical Innovation and research,I will like to
support your team in various ways especially with my knowledge.
I also have a fault-free driver's license and I am very flexible.

Über mich

Fluent in English, German and French and an excellent communication skills obtained through my
many interactions with various groups of people professionally and personally. I am a team-oriented
player who has excellent problem-solving skills with attention to details and organization. I am also
able to demonstrate a strong personality, fair judgement and self-control with little direction under
pressure and in a changing working environment when need be.

Persönliche Daten

Sprache
  • Englisch (Muttersprache)
  • Französisch (Gut)
  • Deutsch (Fließend)
Reisebereitschaft
Weltweit
Arbeitserlaubnis
  • Europäische Union
  • Schweiz
  • Vereinigte Staaten von Amerika
Home-Office
unbedingt
Profilaufrufe
1122
Alter
35
Berufserfahrung
13 Jahre und 11 Monate (seit 10/2006)
Projektleitung
5 Jahre

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