Summary
Overview
Work History
Education
Skills
Affiliations
Timeline
BusinessAnalyst

MANUELA MBACFOU, CCRP

Montreal

Summary

Versatile clinical research professional knowledgeable about overseeing study implementation for diverse studies from site evaluations to closeouts. Highly organized and thorough with ability to work independently. Certified in Clinical Research (CCRP) with an in-depth knowledge of the drug development process. Offering advanced planning, problem-solving and communication skills developed over 5 years of clinical research success.

Overview

10
10
years of professional experience

Work History

Clinical Research Coordinator

The CHUM Research Centre - CRISM
02.2021 - Current

Establishing key partnerships with community-based organizations to facilitate successful study implementation. Managed 5 sites, performed sites qualification and initiation visits.

  • Verified data on CRFs, filed and collated study documentation and reports via interim (onsite/remote) monitoring.
  • Developed study-related MOP, SOPs and Case report forms, ICFs and other documents.
  • Data management in EDC systems.
  • Directed multiphase clinical research trials from startup to closeout by overseeing all operational aspects, including supervising [Number] employees, training and certifying staff, recruiting patients for trials, administering budgets and managing sites relationships

Senior Research Officer

The CHUM Research Centre - CRISM
09.2020 - 01.2021
  • Maintained and protected electronic databases.
  • Provided assistance with preparation of project-related reports, manuscripts, and presentations.
  • Assisted with study specific document writing and review (i.e. protocols, consent forms and other documents).

Research Officer

The CHUM Research Centre - CRISM
06.2020 - 01.2021

Maintained and organized study documents (i.e. CVs, REB documents such as approvals, renewals and other study agreements, etc.) in Trial Master File

  • Managed [Number] clinical studies over [Number] years.
  • Streamlined research processes to meet tight deadlines for multiple projects.
  • Provided 10+ clinical research professionals education on ethics review.
  • Interacted with participants in [Type] studies in diverse ways, including preparing for examinations, obtaining consent and collecting specimens.
  • Performed data entry for a phase IV trial.

Research Assistant Intern

The CHUM Research Centre - CRISM
09.2019 - 05.2020

Point of contact for ethics committee (REB) submissions and renewals for 20+ research studies.

  • Supported design and implementation of data collection instruments
  • Recruited [Number] participants.
  • Evaluated potential participants to assess eligibility for planned studies and obtained informed consent.

Research Clerk

The CHUM Research Centre - CRISM
05.2019 - 09.2019

Coordinated and facilitated research activities and submitted protocols for ethics approval. Exhibited excellent organizational abilities when managing multiple concurrent assignments without sacrificing attention to detail.

  • Scheduled appointments with participants over phone and through email.
  • Collected data in REDCap (through quantitative surveys) as per research protocols.
  • Worked both independently and collaboratively in fast-paced laboratory environment.
  • Conducted two studies on withdrawal management and psychosocial treatment and role of each in treatment of substance use disorders.

Communication Agent

Abbott Laboratories
11.2017 - 04.2019

Conferred with patients and healthcare professionals by telephone to provide information about glucose meters. Trained and coached 20+ new Communication Agents on best practices, leading to a more cohesive and efficient team environment.

  • Handled [number] calls and emails per day to address customer inquiries and concerns, delivering exceptional level of service.
  • Recorded adverse events reported by customers (pharmacovigilance).
  • Recommended improvements in shipping, or service to prevent future problems.
  • Used company troubleshooting resolution tree to evaluate technical problems and find appropriate solutions.

Customer Care Team Lead

Dynacare Health Solutions
09.2016 - 09.2017

Liaised with management, doctors or medical staff within different departments. Supervised a team of 6 customer care representatives.

  • Served as a primary customer service professional to assist all clients or patient needs daily.
  • Trained new employees on best practices and customer care procedures to eliminate inefficiencies.
  • Responded to customer needs through competent customer service and prompt problem-solving.
  • Provided lab tests results to customers and health care professionals.
  • Wrote, implemented, and maintained SOPs.
  • Collaborated with staff members to enhance customer service experience and exceed team goals through effective client satisfaction rates.

Customer Care Representative

Dynacare Health Solutions
08.2014 - 08.2017
  • Built long-term, loyal customer relations by providing top-notch service and detailed order, account and service information.
  • Logged call information and solutions provided into internal database.

Education

Master of Science - Pharmaceutical Sciences, Clinical Research

University of Montreal
Montreal, QC
01.2021

Certificate in Health Management - Health Care Administration

University of Montreal
Montreal, QC
02.2019

Skills

  • Study protocols
  • Good Clinical Practices (GCP)
  • Informed consent
  • Research MOP/SOPs understanding
  • Data Collection
  • Project Management
  • Organization and Time management
  • Self-motivated Professional
  • Problem Solving
  • Clinical Research Ethics
  • Participant Screening
  • Planning and Coordination
  • Clinical Trial Management
  • Electronic Data Capture (REDCap)
  • Trial Master File
  • Staff training

Affiliations

  • Society of Clinical Research Associates (SOCRA)

Timeline

Clinical Research Coordinator

The CHUM Research Centre - CRISM
02.2021 - Current

Senior Research Officer

The CHUM Research Centre - CRISM
09.2020 - 01.2021

Research Officer

The CHUM Research Centre - CRISM
06.2020 - 01.2021

Research Assistant Intern

The CHUM Research Centre - CRISM
09.2019 - 05.2020

Research Clerk

The CHUM Research Centre - CRISM
05.2019 - 09.2019

Communication Agent

Abbott Laboratories
11.2017 - 04.2019

Customer Care Team Lead

Dynacare Health Solutions
09.2016 - 09.2017

Customer Care Representative

Dynacare Health Solutions
08.2014 - 08.2017

Master of Science - Pharmaceutical Sciences, Clinical Research

University of Montreal

Certificate in Health Management - Health Care Administration

University of Montreal
MANUELA MBACFOU, CCRP