Clinical Research Associate
What do Clinical Research Associates do?
A Clinical Research Associate (CRA) can also be called a Monitor, a Clinical Monitor, a Trial Monitor or a Medical Monitor. The title will vary from company to company. The job description will be the same. A CRA is an individual employed by a pharmaceutical or medical device manufacturer, by a contract research organization (CRO) usually acting on a sponsor's behalf or by an academic institute conducting clinical trials.
Federal Regulations require that sponsors of clinical studies select individuals who are qualified by training and/or experience to monitor their studies per Good
clinical practice and local regulations. It also states that Monitors be appropriately trained and their qualifications documented. In
the United States, the rules are codified in Title 21 of the Code of Federal
Regulations. In the European Union these guidelines are part of EudraLex. In India
he / she requires knowledge about schedule Y amendments in drug and cosmetic
The major responsibilities of a CRA are:
- To analyze and evaluate clinical data, to ensure investigator and site compliance with the study drug protocol, overall clinical objectives, FDA regulations, ICH Guidelines, Good Clinical Practice (GCP) and HIPAA.
- Assure the protection of the rights, safety and well being of human study subjects.
- Identify, help in the study site selection process, initiate, and eventually close out clinical study sites.
- To monitor the progress of clinical study sites participating in a clinical study, and to assure the protocol is followed and data is reported accurately.
- To make certain that the scientific integrity of the data collected is protected and verified.
- Assure that adverse events are correctly documented and reported.
- Review all case report forms and compare them to source documents.
The relevant minimum requirements to begin a career as a Clinical Research Associate (CRA) include the following:
CRA frequently has a Bachelor's, Masters, or a Ph.D degree.
- Sound knowledge of Good Clinical Practices (ICH-GCPs) and FDA regulations
- Medical/scientific knowledge and medical terminologies
- Use of electronic data capture systems (EDC)
- Clinical Trial Management Systems (CTMS) and IVRS systems
- Electronic Trial Master File (eTMF)
- Conversant with the design and review of Case Report Form (CRF)
- Site Monitoring knowledge (including PSVs, SIVs, IMVs and COVs) to meet study expectations
- Source data/document verification (SDV)
- Adverse events (AE/SAE) reporting according to regulations and company policy
- Reviewing protocol compliance, focusing on inclusion/exclusion requirements
- Drug safety/ Pharmacovigilance
- A graduate with no previous relevant experience is more likely to enter the profession at an entry- level responsibility.
What do Clinical Research Coordinators (CRCs) do?
The Clinical Research Coordinator (CRC) is responsible for conducting clinical trials using good clinical practice (GCP) under the auspices of the Principal Investigator (PI).
- Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.
- Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms.
- Code, evaluate, or interpret collected study data.
- Track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.
- Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.
- Prepare study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
- Oversee subject enrollment to ensure that informed consent is properly obtained and documented.
- Maintain contact with sponsors (CRAs) to schedule and coordinate site visits or to answer questions about issues such as incomplete data.
- Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses.
- Schedule subjects for appointments, procedures, or inpatient stays as required by study protocols.
What is a Clinical Data Manager (CDM)?
The Clinical Data Manager plays a
key role in the setup and conduct of a clinical trial. The data collected
during a clinical trial forms the basis of subsequent safety and efficacy analysis
which in turn drive decision making on product development in the
The CDM is
involved in early discussions about data collection options and then oversees
development of data collection tools based on the clinical trial protocol. Once
subject enrollment begins, the clinical data manager ensures that data is
collected, validated, complete and consistent.
The CDM liaise with other data providers (e.g. a central laboratory processing blood samples collected) and ensures that such data is transmitted securely and is consistent with other data collected in the clinical trial. At the completion of the clinical trial, the clinical data manager ensures that all data expected to be captured has been accounted for and that all data management activities are complete. At this stage, the data is declared final (terminology varies but common descriptions are Database Lock and Database Freeze) and the clinical data manager transfers data for statistical analysis.
- Serves as the primary Clinical Data Management contact with sponsors and represents CDM on project teams.
- Responsible for timelines, reporting and data collection.
- Coordinates the receipt and processing of information for projects (e.g., coding dictionaries) as well as electronic data capture.
- Ensure databases are validated and ready for transfer and/or analyses.
The relevant minimum requirements to begin a career in clinical data management include the following:
- A database specialist degree, a Bachelor's degree in computer science or other information technology (IT) field.
- Previous data entry experience and intermediate level skills using a range of software applications (such as Oracle, Oracle Clinical, SAS, SQL, PowerPoint, MS Excel, MS Word, and MS Access) is required.
- Excellent interpersonal, communication and problem solving skills are required.
- Data management systems knowledge and experience is also required.
- ICH GCP (Good Clinical Practice - international guidelines) knowledge is essential.
- A graduate with no previous relevant experience is more likely to enter the profession at an entry- level responsibility, such as a clinical data coordinator.
What does a Principal Investigator (PI) do?
A Principal Investigator (PI) is the lead scientist for a particular clinical trial.
Although the PI is responsible for the conduct of the trial, “it has been said that the CRC is the heart and soul of the research study and that, ultimately, it is the CRC who carries forward the research goals, thereby playing a significant role in the success of the research study. Most importantly, CRCs are often involved in essential duties that have been traditionally performed by the PI, such as conducting the informed consent process and ensuring compliance with the protocol”. The CRC’s primary responsibility, as with all clinical research professionals, is the protection of human subjects, but the CRC has many other responsibilities. Although not inclusive, some of the CRC responsibilities include preparing the Institutional Review Board submission, writing the informed consent document, working with the institutional official in contract negotiations, developing a detailed cost analysis, negotiating the budget with the Sponsor (i.e. pharmaceutical company or granting agency), subject recruitment, patient care, adverse event reporting, preparing the case report form (CRF), submitting CRFs and other data to the Sponsor as necessary and study close-out.
What is Good Clinical Practice (GCP)?
Clinical trials are conducted according to Good Clinical Practices (GCP) Principles ensuring that:
- All trials are conducted ethically, as defined by the Declaration of Helsinki, rigorously, as defined by the International Conference on Harmonization Guidelines (ICH).
- Benefits outweigh risks for each patient.
- Rights, safety and well-being of patients prevail over science.
- All available non-clinical and clinical information on any investigational agent can support the trial as designed.
- All trials are scientifically sound and clearly described.
- All clinical trials have current Institutional Review Board approval.
- Medical decisions and care are the responsibility of qualified health care professionals, specifically physicians and, if applicable, dentists.
- Everyone involved in the clinical trial is qualified by training, education and experience.
- Informed consent is given freely by every participant.
- All study documentation is recorded, handled and stored to allow accurate reporting, interpretation and verification.
- Confidentiality of subjects is respected and protected.
- Investigational products maintain Good Manufacturing Practice in storage, manufacturing and handling.
- Systems to ensure quality are implemented in all aspects of the trial.
How long will it take to complete your online training program?
On average, it will take most people 2 - 3 months (assumes 8 - 10 hours study per week) to fully understand and learn the material presented and complete the various required Exams/Assignments. You are however free to study at your own pace and can complete the program sooner or later depending on your personal schedule and time allocated to study.
All salary information will depend on experience and the needs of the hiring companies. Typical starting salaries for new CRAs are around $75,000 and higher. Salaries quickly rise with experience. With a few years experience, you can expect to earn between $85,000 and $95,000. Some companies pay up to $120,000 and supply their CRAs with a company car....
What are CRC Salaries?
All salary information will depend on experience and the needs of the hiring companies. Typical starting salaries for new CRCs are around $45,000 and higher.
What are CDM Salaries?
All salary information will depend on experience and the needs of the hiring companies. Typical starting salaries for new CDMs are around $80,000 and higher. Salaries quickly rise with experience. With a couple years experience, you can expect to earn between $90,000 and $95,000.
Do you guarantee that I will obtain a CRA or CDM position after taking your Certificate program?
No, we cannot guarantee anyone a position as a CRA or CDA upon completion of our program. Since it is out of their control, providers of training programs do not guarantee anyone a job upon successful completion of their program. If you were referred to us by a potential recruiter or employer, chances are that they will be looking to hire you upon successful completion of the program. We do however research, collate and maintain a very comprehensive and up-to-date Jobs Database with CRA and CDM positions from pharmaceutical manufacturers, recruiters and CROs who are looking to attract and hire our graduates.
What is a CRO?
An organization (commercial, academic, or other) contracted by the pharmaceutical manufacturer/sponsor to perform one or more of a sponsor's clinical trial-related activities. There are hundreds of large and small CROs, all of them employing CRAs, CRCs and CDMs.
What is the typical background of a CRA?
Usually, the CRA will have a health care or life-science background although persons from other academic disciplines have comfortably transitioned into the field after completing the required training.
Will I have to relocate if offered a job as a CRA or CDM?
It will depend on the individual company, university/academic institution or Contract Research Organization where you are hired. A CRA or CDM can either work from the company headquarters, a branch location specifically for CRAs and DMs, or from their own home.
What other positions in the pharmaceutical industry can an experienced CRA hope to move into?
Clinical Research jobs/positions include: Clinical Research Coordinator (CRC), CRA Manager, Project Manager, Research & Development Project Managers, GCP QA/QC Auditors, Data Managers/Biostatisticians, Regulatory Affairs & Compliance Professionals, Safety Managers, Corporate Managers, Clinical Research Trainers, Clinical Site Managers and Business Development Professionals.
Who does the CRA interact with while on the job?
The CRA will work and Interact with internal/sponsor company personnel working in clinical trials, e.g. Clinical Study Managers, other CRA's, Drug Safety, Regulatory Affairs, Quality Assurance, Medical Writers, Statisticians, Data Management, etc. External interactions can include people from the FDA, a Contract Research Organization, the Hospital Pharmacy Department, Study site staff particularly the Investigator and Study Coordinator.
How current is the information in this certificate program?