Beginner’s Guide to Clinical Research Coordinator

“A clinical research coordinator (CRC) assists Principle investigator (PI) in many clinical trial site-related activities. The clinical research coordinator is also called Clinical trial Manager (CTM)”

Under the supervision of the Principal Investigator (PI), the Clinical Research Coordinator is responsible for performing the trials according to the GCP guidelines.

It should be noted that the PI has overall responsibility for performing the study, But CRC conducts many activities on behalf of PI

“Protect and ensure the well-being of the participants in the study” is the core responsibility of all Clinical research professionals”

Responsibilities of Clinical Research Coordinator

Budget :

Participate in the planning and management of budgets for the study and financial payments. It may include IRB fees over the life of the clinical trial, pharmacy costs, PI and CRC travel costs for attending investigator meetings, facilities, dedicated fax and computer lines and all other associated costs.

Feasibility

CRA completes the questionnaire form regarding the feasibility for the site. It is sent by a sponsor before starting a trial on any site. CRC has to provide information about the following component.

• The patient population at the site
• support staff availability
• medical facilities availability
• Updates about Equipment and other facility needed to successfully carry out the study protocol

Informed consent:

Clinical Research Coordinator Manage the recruitment of subjects by ensuring that informed consent is actually obtained and recorded.

Institutional Review Board (IRB) review the IRB the informed consent template and CRC acts as a liaison between IRB and Sponsor regarding informed consent related communication.

Contract with Sponsor

Each site has to sign a clinical trial agreement for the common understanding on confidentiality, publishing the data, intellectual property, insurance, data protection, injury to the subject, legislative protections, termination clauses etc.

CRC coordinate between site, Sponsor and PI.

Educate the subject:

CRC educates subject regarding all study aspects relevant to them such as nature of drug candidate, dose, formulation type, possible side effect, visit schedules etc

Entering of data into database

CRCs enter the subject’s data in the database (eDC) such as Lab data, any assessment data, dose administration data, adverse event data, visit schedule, medical history, concomitant medication data etc.

The electronic forms where data is entered (in an electronic database or eDC) is called the case report form.

CRF follows the Case report form completion guidelines to enter the data. Case report form (CRF) completion guidelines are drafted by the sponsor and provide the instruction to enter the data into the database (eDC)

Adverse event

The CRC reports all adverse events to the sponsor and all serious adverse events (SAE)  to the IRB (institutional review board) and sponsor.

Audit

A site audit is one of the key activities in clinical research that is done by study sponsors, regulatory authorities, or exclusively designated review groups. CRC should be ready with all the relevant documents and answer the queries on behalf of PI.

Queries

Clinical research coordinator responds to queries raised on Database (eDC system). Generally, these queries are raised by CRA (clinical research associate), Data management and safety team.

Interaction with CRA and record-keeping

CRA visits the site and CRC gives the updates about the recent changes, document status and share any ongoing issues with CRAs.

CRC manages all the documents such as drug dispensation records, collection, labelling, storage and shipment of samples, lab reports, visit record etc (Source documents).

CRA checks all the source documents maintained by CRC for its completeness and correctness as per protocol (Source data review)

CRA also checks the data entered in the database and check it against data present in source documents. This is called source data verification.

CRC answers all the queries raised by CRA after Source data verification.

CRC must comply with the Food and Drug Administration’s (FDA), ICH’s, and clinical trial agreement record-keeping policies.

Sometime CRC has to •Collect and manage biological samples, such as saliva and urine.(depend on the study)

Other

Prepare advertising and other educational materials and conduct campaigns to enrol subjects.

The CRC is responsible for subject recruitment once the trial begins, or must conduct campaigns to enrol subjects.

Arrange space for the equipment going to be used in the study and other material related to trials.

CRC maintains the record of all subject visits and contacts the subject and reminds them to come for a site visit

Dispense the investigational drug to a subject

Average Clinical Research Coordinator (CRC) Salary:

These are the common factors which decide your salary in any organizations:

• Experience,
• Qualifications,
• Countries and
• Type of Organisations.

These above salaries based on various sources such as https://www.salary.com/research/salary/benchmark/clinical-research-coordinator-salary/ontario-ca
https://ca.indeed.com/salaries/clinical-research-coordinator-Salaries

How to become a clinical research coordinator:

You should have below combination of skills and education to become CRC.

1. You should have a degree in Life science such as Pharmaceutical sciences, clinical research, biotechnology, nursing etc.
   
2. Knowledge of GCP, ICH guidelines
   
3. Basic knowledge of clinical research. Below are the important topics, you must read if preparing for CRC interview:
   
   • What is a clinical trial
   • Type of Phases
   • Type of clinical studies
   • Clinical trial Protocol, Investigator Brochure (IB)
   • Blinding of data
   • Various randomization methods
   • Primary End Point
   • Secondary End Point
   • Surrogate End Point
   • Efficacy, Effectiveness
   • Basic about clinical Data Management
   • Basic about case report form
   • Basic about CRA role
   • Local lab and Central lab
     
4. Microsoft Excel, Word and PPT
   
5. Communication skills
   
6. The following bodies also conduct courses on various topics related to clinical research:
   
   https://lifepronow.com/blog/2020/05/01/free-but-best-clinical-research-courses-hurry-up/
   Association of Clinical Research Professionals
   National Institutes of Health
   Harvard Catalyst Clinical Research
   Oregon Health & Science University

Career path:

CRC role provides a great opportunity to learn about clinical research and the chance to interact with patients

• Centralised monitoring and clinical data management are the departments which are always open to CRC
• CRC can aim to become CRAs as well. Many CRCs tries to become CRA after 1-2 years of experience.
• You can continue as CRC and can move into the ladder as per organization hierarchy.

Experienced CRC can establish his/her career as a freelancer as well

Example of CRC Job description:

The screenshot has taken from Naukari and other online portals.

Keywords to be added in CRC-resume

Generally, recruiter sees the keywords in the resume while screening the resume of any job roles. You can add below keywords and learn about them.
Refer: Complete Guide for writing effective Pharma- Resume: Your First Impression

Clinical research,
GCP, ICH,
Excel, word and PPT
any relevant certificate

Complete Guide for writing effective Pharma- Resume: Your First Impression
Best Use of Naukari Portal for Pharma Jobs