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How to choose your WIP and CRA position

You start a CRA career or you want to change the CRA position? You do not know what type of position of CRA or SSC to choose, what kind of structure will be adapted to your and what prospects to expect? In this article we will help you to make a choice by presenting you every type of position, missions, structures in which to apply with the carrer evolution. You could then choose knowingly 🙂

There are several CRA professions: in CRO, in laboratory, in cooperator group and hospital. All of these positions require the same level of education (a Bachelor’s degree, to Masters degree).

1. CRA monitor

The main mission of a CRA monitor is monitoring. He travels between 50 and 60% of the time (3 to 4 times / week). He may have to travel in his region, in France and even abroad.

His tasks while traveling:

• Screening visit
• Implementation visit
• Follow-up visit
• Closure Visit

His missions in the headquarters::

• Phone contacts with the centers
• Data entry on the CTMS (Clinical trial management system) or administrative database study
• Visit reports writing
• Writing to the investigator

In CRO :

You will have the opportunity to work on different diseases with different promoters. In some structures, you may work with colleagues and foreign customers. This will allow you to develop your English level and your adaptation and flexibility qualities. Depending on the complexity of the project, you will get between 2 and 5 protocols simultaneously. Depending on the structures, salaries can be quite incentive.

Generally, you will go through periods of intense stress during final or interim analysis and quiet periods between these periods.

In laboratory :

You will have the opportunity to communicate with the various company departments (marketing, sales, pharmacovigilance, regulatory affairs, statistics, and data-management) that will be affected by the developed molecule. You could follow the same molecule, and you will work on the same pathology and / or disease for several years. In some laboratories, entrepreneurial and membership spirit is very pronounced. You can enjoy the benefits of being in a large group (wages, profit and competitive premiums, internal transfer and change of positions).

Depending on the structure, you can also go through some disadvantages such as the difficulty of progress and the risk of inter-laboratory fusion (reclassification, unemployment …).

In cooperative group or hospital:

You will have the opportunity to work on projects with high scientific interest (promoted and supported by hospital doctors themselves). You will work with medical  highly motivated teams and involved in their project. You can perform a variety of tasks (regulatory submissions, contract management …).

At the hospital, the positions may be more precarious. Wages will be lower and tighter budgets than in CRO or in the laboratory.

The usual Evolutions: CRA Coordinator, CRA lead, project manager, CRA Manager, CRA  regulatory submissions and contracts in charge.

2. Clinical Study Technician (Study Coordinator):

Clinical research technician works directly with the investigator who delegates the coordination of studies in the hospital service. There are two types of Study coordinator positions. One is sedentary and the other involves travels. The one who moves is often hired by a CRO and the other one who is sedentary is hired by an association of the hospital or by the hospital.

The responsibilities of the Study coordinator:

– He manages the study data: he fulfills the case report forms, represents and follows serious adverse events (SAEs). It also prepares the monitoring visits (availability of patients’ medical records) and performs corrections of case report forms according to the demands of the clinical research associate.

– He provides logistical follow-up of test: he controls the reception and storage conditions of the material needed to study such as documents, protocols, questionnaires, patient consent forms and ensures archiving at the end of the study.

– He communicates effectively to ensure relationship between promoter / investigator: he takes part in the establishment and other training meetings; he cooperates with specialized services as well as with the departments of pharmacovigilance and data management.

– He monitors patients: organization of patients’ appointments according to the visits timetable, preparation and management of patient questionnaires, help investigator during the randomization (necessary elements preparation), biology kits preparation, tubes technique (centrifugation, transfer), laboratory information analysis, preparation and forwarding tubes and verification of sample storage.

In CRO: You will have the opportunity to travel and see different methods of work between your different centers. You may develop adaptability and flexibility skills. Depending on the structures, wages can be incentive and Permanent contract positions exist. You will not always be on the pot, hence a center coordination that can sometimes be difficult. You will rarely meet  patients.

At the hospital: You will coordinate studies throughout the service and you can work more closely with the team members. You will be required to meet with patients. This will allow you to develop your interpersonal skills. The number of protocol to manage may be important (up to 30 protocols), which requires the ability of all this information integration in order to allow optimal patient inclusion. The position is precarious in many hospitals. In general, wages are lower than in the CROs.

The usual developments: CRA monitor, centralized CRA, Site Study Coordinator manager.

Responsible for regulatory submissions and contracts (CRA start-up):

The CRA is responsible for regulatory submissions (French Competent Committee (ANSM), Ethics Committee, CNOM, CNIL, CCTIRS), and negotiating contracts (investigator, hospital).

You’ll have strong synthesis skills and a good knowledge of the different institutions needs  such as the French Competent Committee (ANSM), the Ethics Committee, CNOM (French National Medical Council), the CNIL (National Commission for Data Protection and Liberties), the CCTIRS (French Advisory Committee on Information Processing in Material Research in the Field of Health). You’ll also have great negotiating skills to convince your interlocutors.

The position is in some laboratories and CROs. The CRA is sedentary. His role is crucial because he allows setting up studies quickly. This requires organizational and rigor qualities. The head of submissions’ tasks are to recover all the required documents for regulatory submissions and establishment of contracts; either directly from the investigator or through the CRA monitors. This CRA is regularly under pressure as promoters want a quick implementation of the projects. The average time to implement is 5 to 9 months (from receipt of the first documents of the study and the opening of centers). The CRA may be required to manage around ten submissions at the same time.

The usual developments: CRA Coordinator, CRA lead, project manager, CRA Manager.

Centralized CRA:

The CRA is in charge of managing the studies solely from the office. He is sedentary. The position exists in some CROs.

The CRA performs remote monitoring:

The Remote monitoring is a review of some data remotely, this implies of course  the use of an electronic CRF (E-CRF). Once the center’s staff entered the data in the e-CRF, the CRA checks their consistency and valid as « data reviewed. » Check the consistency of data is simply to check, for example, that a patient defined as « masculine » does not have as medical history hysterectomy…

This review is done every week or as soon as the data is entered during patient selection in order to identify possible failures of selection and especially to avoid wrongly included.

All data entered in the e-CRF are reviewed in this sense, and some can be checked by comparison with other electronic systems used in the study:

• Review system of laboratory results (date of birth, date of visit, patient weight, sex of the patient …)
• System for dispensation of study treatment (date of dispensation, arms attributed to the patient if applicable, number of batches delivered to the patient, patient weight if applicable). When data does not seem to be consistent or is different from that found on another system, a query can then be issued and allow the Study Coordinator to check and correct (or not) the data.

The CRA is also in charge of the administrative part of the study; he retrieves the study documents from the investigators and revives them regularly. On some studies, he works with a CRA monitor.

The CRA does not physically meet the members of the investigation team unlike the CRA monitor. This requires high quality of oral communication because everything happens by telephone.

The usual developments: CRA monitor, CRA in charge of regulatory submissions and contracts.

CRA monitor (CRO, lab, hospital), SSC (CRO, hospital), submissions and contracts managers or centralized CRA; the CRA’s profession is diversified; there is something for every taste. There are positions suited to your personality and your skills. You just have to make the right choice!

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