Career Opportunities

in Clinical Research, RA

and Pharmacovigilance (PV)

CRA School, Access Pharma Group

• Presented at the Pharmacolloque 2017

by Svelt Kristof, MSc, CCRA, CEO of CRA School, Access Pharma Group

Access-Pharma is a group 3 Non-For-Profit organisations having

the common mission to facilitate the career reorientation of highly

educated professionals interested to work in the clinical trials industry

Job opportunities in clinical research,

regulatory affairs & pharmacovigilance

• Observational study on new drugs safety & efficacy

• Already tested on animals in the pre-clinical phase

• Collects statistical data to justify marketing request

• The same approach applies for medical devices

What is a Clinical Trial

Phase I Clinical Trial

Phases of clinical trials

Phase I – First in humans, 80-100 healthy volunteers

Phase II – Safety study on 200-300 patients, Phase IIa/IIb

Phase III – Safety & Efficacy study on 2000-3000 patients

Phase IV – Post-marketing studies, Pharmacovigilance

Drug discovery process

Canada – Food & Drug Act, Div. 5 (F&DA)

USA - 21 CFR Food, Drugs & Cosmetics Act (FD&CA)

ICH GCP – International Council of Harmonisation (ICH)

of the Good Clinical Practices (GCP), part E6

Laws & regulations on

clinical trials conduct

INVESTIGATORS & CRC

MONITORS

SPONSORS

Associations

Pharma Labs

Hospitals

Biotechs

PharmaLabs

Hospitals

C R O

C. R. C.

ClinicsHospitals

Physicians

PATIENTSPATIENTSPATIENTS PATIENTS

PROTOCOLResearch Initiation

Stat Analysis

Data Management

Clinical study

Close Out

Report

NDA

CRF

SDV

Data Base LockActors in a Clinical Study

RA / Sponsor

IRB / IEC

PATIENTS

DSMB / FDA

Reg. Agency TPD/ FDA

Reg. Agency TPD/ FDA

Clinical Trial Organigram

Clinical Research Associate

The CRA is called also Monitor

• verifies that investigator sites

conduct the study according to the protocol, laws and

regulations. As verificator must know all aspects of a trial.

• responsible for ensuring the clinical data integrity at the

assigned sites. If not in-house, travels 60-70% of the time.

Clinical Research Associate (CRA)

•CRAs are employed both by Sponsor companies and by Contract Research Organizations (CROs), 70% - women

• at a CRO - constant changes - they get to work with a variety of people & new drugs, often every 3 months

• at a drug company they can follow a new therapy all the way through.

• Experienced CRA can work also from their homes as home-based

CRA average salaries (1500 + companies in US)

(US salaries: 10k$ higher than in QC)

SrCRA: among the 10 best US jobs

(independent contractors can work less)

Measures to reduce travel:

• Central monitoring• Remote monitoring • Risk based monitoring

Risk-based monitoring

Clinical Data Manager (DM)

The Data Manager is the person responsible for

processing the clinical study data. This includes :

Tracking

Entering

Reviewing

Cleaning

Coding

Clinical Data Manager

• reviews draft protocols for the study to ensure that the trial isdesigned with correct data points and precise instructions

• writes a data-management plan and confirms that all thereporting forms and data-transfer procedures make sense.

• reviews incoming data and maintains its database, ensuring thateveryone follows the rules and data is complete,

• cleans the data from errors and omissions and after data lockhands it off to the biostatisticians for review and analysis.

The product of clinical trials is data, so this job is a very important one.

Clinical Biostatistician

• Helps setting the parameters for data collection and review

• Responsible for all stastics-related activities associated with designing

of protocol, and analyzing & interpreting the data from clinical studies.

The regulatory body will approve a product only if the data meets certain

statistical criteria, so this position is very important for the trial’s success.

Clinical Biostatistician

Because statistics are known to be massaged from time to time to suit the needs of the pharmaceutical company, this area of work is highly regulated.

Regulatory Affairs Specialist (RAS)

Manages all the activities related to the regulatory approval of the new drugs or devices in the different countries

• compiles regulatory documents,

• communicates with local regulatory authorities,

•maintains regulatory materials on marketed products.

Regulatory Affairs Specialist (RAS)

RA professionals are essential to all aspects

of the drug development including preparing, submitting, and

monitoring submissions to regulatory agencies, addressing

issues raised in the regulatory review process, managing

reports, and tracking PV and other post-marketing activities.

Regulatory Affairs Specialist (RAS)

• RA professionals come from a variety of disciplines such

as law, academic and industrial research, and medicine.

• RA is also a promising field for scientists looking for

alternative careers because it offers a multitude of

starting jobs and opportunities for advancement.

Drug Safety Advisor (DSA)

A DSA is responsible for the collection, tracking

evaluation, organizing and coding of all the

suspected Adverse Events (AE) that happen

to subjects during clinical trials. Nurses or other medical specialists

with 2-4 years clinical experience are preferred.

No licence to practice in the country is required, DSA work with data

and not with patients, and don’t perform any medical acts.

Drug Safety Advisor (DSA)

• The Drug Safety Advisor formulates an educated guess can

the Adverse Event observed in the trial be related to the

tested product and suggests preventive measures.

•Usually requires PhD, PharmD or MD degree

Pharmacovigilance Associate (PVA)

The Pharmacovigilance Associate (PVA) has

the same role to assess the extremely rare AE but after

Adverse Events (AE) after the marketing autorisation

when long-term AE start showing, and to suggest CAPA

(Corrective Actions/Preventive Actions) measures

Pharmacovigilance Associate (PVA)

Drug Safety Risk Management

• Writes Risk Management Plan for Marketing Autorisation

• Signal detection, analysis and evaluation

• SAE processing, Aggregate reporting

• Medical review, Medical monitoring, Medical management

• PV Inspections / Audit preparation (FDA, EMA, HC, others)

• Global Safety Surveillance

• PV Systems Validation,

Medical Writer

•Writes study protocols, final reports, investigator’s brochures, productmonographs, marketing brochures

•Produces educational materials and slide kits used for training of doctors and nurses on the protocol

•Produces sales training materials, press releases for the industry, and fact sheets or Web site materials.

•Writes in medical journals about research discoveries, Web sites, magazines, newspapers, newsletters

Medical Information Specialist

Provides in-depth answers to inquiries regarding the

pharmaceuticals. Develops local non-promotional tools,

including standard medical information response letters,

literature updates, product bibliographies and posters or

slide presentations and manuscripts.

Medical Science Liaison (MSL)

The MSL role is to establish and maintain

peer-to-peer relationships with leading

physicians, referred to as Key Opinion Leaders (KOL) at major

academic institutions and clinics and inform them about new drugs.

Usually doctorate degree (Ph.D., PharmD., M.D.) and some sales

experience is required. Presentation skills are essential.

Clinical Research Coordinator (CRC)

Works with and under the direction of

the study site Principal Investigator (PI).

Supports, facilitates and coordinates all

daily activities of the trial site and plays

a critical role in the conduct of the study.

Usually nursing license is not required. Entry level job.

IRB Associate

An IRB manages the ethics review process

Assures all the administrative support to the IRB Panel.

These administrative duties require a high degree of accuracy

and following tight timeliness, in-depth knowledge of the IRB

policies and procedures, and familiarity with the regulations for

Human Protection in Research.

How to get in? The Catch 22 is in the law:

ICH GCP 2.8. Each individual involved in conducting a trial should be qualified by education, training, andexperience to perform his or her respective task(s).

Entry level jobs

A number of entry level jobs usually do not require clinical trial experience:

Clinical Data Entry, Patient interviewer, Clinical Documentation Assistant,

Study Start-up Assistant, Data Management Assistant, Clinical Trial Assistant,

Clinical Research Assistant, Clinical Research Coordinator, Project Manager

Assistant, Pharmacovigilance Assistant, Medical Information Assistant, etc.

With the 25-30% shortage of experienced staff, the first promotion can come

still in 6-7 months, or latest in 1 year. If not, listen to your answering machine,

recruiters will start calling you as you will have already ‘hands-on’ experience.

NEW: Flexible individual E-learning programaddresses all the needs of the job seekers

New unique concept provides all the tools:

Regulatory training + internship +

Job Insertion assistance till hired +

7/7 LIVE support till late evening +

+ preparation for every interview !

E-Internship

Designed to provide

hands-on experience

in different study tasks

in e-CRO environment

Your Net Worth is your Network.

Unique Job Insertion Program not offered by other providers

- Regular meetings with 4+ companies- Adaptation of the CV for every job- Support on the use of Linkedin

Goal: get info about the "hidden" jobs

Unlimited mentorship (till hire)

You will never be left alone in this unknown field

Objective: not to learn from your own mistakes

• Service: Adapt CV for every job• Support: 7/7 till late evening• Goal: Access jobs faster• Result: 2/3 of studentsdon’t finish the course,they get a job earlier.Mission accomplished !

Other training opportunities in Quebec

McGill University

Montreal University

Laval University

QUESTIONS?

Free consultations: every Wednesday from 6:00 PM to 8:00 PM

at 6767 chemin-de-la-Cote-des-neiges, room 601-1

Reserve 2 hours time, there a lot of jobs to discuss

(Free parking behind the Plaza Cote-des-neiges)