What Are the Different Jobs You Could Do in Clinical Research?
Hey clinical research wizards!
This article was inspired by many people who want to start their career in clinical trials or switch from a different field, but don't have the slightest idea what we actually do. I understand that clinical trials can be an overwhelming concept, especially when you're searching and applying for jobs without really understanding what the job titles and descriptions mean.
So I'm here to help you out and give you some hints.
First, it matters whether you're going to work for a pharmaceutical/biotech company (we call them sponsors), a CRO (Clinical Research Organization), or a clinical trial site. While there are many more niche jobs, for the purpose of this article, I'll keep it simple and review the different job options in these three main categories.
Jobs in a Pharmaceutical or Biotech Company (Sponsor)
Sponsor companies develop new drugs and medical devices and oversee the entire clinical trial process, from early research to market approval. These include companies like Pfizer, UroGen, AstraZeneca, and Bristol-Myers Squibb, Actavis (previously a major pharmaceutical company in Bulgaria is now integrated into Teva, a global generics giant) etc.
Research & Development (R&D) – “The Inventors”
What they do: These scientists discover new medicines and test them in laboratories before human trials. They study how drugs work and evaluate their safety prior to the first human tests.
Key Jobs in R&D:
Preclinical Research Scientist – Tests new drugs on cells or animals in laboratory settings before human trials.
Translational Medicine Scientist – Bridges the gap between lab research and human trials, ensuring drugs are suitable for human testing.
Example: When a company discovers a new cancer drug, R&D scientists test it in the lab to verify it can safely eliminate cancer cells.
Clinical Development & Operations – “The Trial Conductors”
What they do: This team plans and runs clinical trials (human studies) to test the effectiveness of new drugs. They ensure studies are conducted correctly, on time, and within budget.
Key Jobs in Clinical Development:
Clinical Scientist – Helps design the study plan (protocol) and analyzes trial results to evaluate drug effectiveness.
Clinical Trial Manager (CTM) – Oversees the entire trial process, coordinating all aspects to ensure smooth operation.
Clinical Research Associate (CRA, that is me) – Visits hospitals and clinics to monitor the study and ensure protocol compliance. This role exists in both sponsor companies and CROs. While I've worked exclusively in CROs, the core responsibilities remain similar across both settings, with some minor differences.
Medical Science Liaison (MSL) – Works closely with doctors and scientists to explain how a new drug works.
Example: If a company wants to test a new asthma inhaler, the CTM organizes the trial, the CRA visits hospitals to check if the study is done correctly, and the Clinical Scientist analyzes the results.
Regulatory Affairs – “The Rule Keepers”
What they do: These experts make sure all trials and medicines follow the laws and safety rules set by health authorities like the FDA (USA) or EMA (Europe). Without them, companies cannot get drug approval. And may we all say Amen for the RA specialists! Having gotten my hands dirty with a decent amount of regulatory work, I can tell you it's complicated, messy, and extremely precise. It's time- and energy-consuming, requiring you to stay constantly on top of your game with all regulation updates. With complete honesty, this is my least favorite work in the clinical trial scope—I personally find it very challenging.
Key Jobs in Regulatory Affairs:
Regulatory Affairs Associate – Prepares and submits documentation to FDA, EMA, or other agencies for clinical trial approvals.
Regulatory Strategy Lead – Develops strategic plans for efficient drug approval while ensuring full regulatory compliance.
Example: When a company develops a new painkiller, regulatory affairs teams must secure approval both for initial human testing and eventual market release.
Data Management & Biostatistics – "The Number Crunchers"
What they do: They collect, organize, and analyze trial data to ensure accurate and unbiased results. They're also the ones who keep raising queries in your otherwise perfectly clean EDC data (just kidding, DM team — you know I love you).
Key Jobs in Data Management:
Data Manager – Ensures all study information is collected and stored accurately.
Biostatistician – Applies statistical analysis to determine drug effectiveness compared to placebo.
Example: When a study collects 10,000 blood pressure readings, the data manager ensures proper data organization, while the biostatistician analyzes whether the new drug is more effective than existing treatments.
Safety & Pharmacovigilance – "The Drug Safety Guards"
What they do: This team tracks and reports side effects of medicines during trials and after market approval.
Key Jobs in Safety & Pharmacovigilance:
Drug Safety Associate – Collects and reports side effects to health authorities.
Risk Management Specialist – Develops safety plans to reduce risks when a drug enters the market.
Example: When a new diabetes drug causes nausea, the Drug Safety Associate reports it, and the Risk Management Specialist creates strategies to minimize nausea for patients.
Medical Affairs & Medical Writing – "The Science Communicators"
What they do: They explain trial results and drug information to doctors, regulators, and the public.
Key Jobs in Medical Affairs & Writing:
Medical Science Liaison (MSL) – Educates doctors and researchers about new medicines.
Medical Writer – Creates scientific reports, drug labels, and journal articles.
Example: When a new migraine drug is approved, the Medical Writer prepares a comprehensive report for doctors, and the MSL guides them on safe usage.
Quality & Compliance – "The Trial Police"
What they do: They ensure trials follow Good Clinical Practice (GCP) rules to protect patients and guarantee accurate results.
Key Jobs in Quality & Compliance:
Quality Assurance Specialist – Verifies that trials follow legal and ethical guidelines.
Audit & Compliance Manager – Performs inspections to ensure proper clinical trial documentation.
Example: During a hospital inspection, the Quality Assurance team verifies that all patient records and data are properly maintained.
Jobs in a Contract Research Organization (CRO)
CROs conduct clinical trials on behalf of sponsors, handling study setup, monitoring, and regulatory compliance. They don’t invent the drugs, but they organize, monitor, and ensure that trials follow the rules. These include companies like Cromos Pharma, IQVIA, ICON, PSI, PPD etc.
Many roles in a CRO overlap with those in a sponsor company, but they focus more on the actual trial execution. CROs build close relationships with sponsor companies and provide regular updates on study progress. To secure a clinical trial, CROs participate in a bidding process, submit proposals to sponsors, and if successful, are awarded the study.
Clinical Operations & Monitoring – "The Trial Supervisors"
This team ensures clinical trials are conducted correctly. They verify that hospitals and clinics follow the study plan, treat patients safely, and record all information properly.
Key Jobs in Clinical Operations:
Clinical Research Associate (CRA, yey me again) – Visits hospitals and research sites to monitor the trial. They verify protocol compliance and data accuracy. And yes, we're the ones who keep track of every PI's numerous passwords, including email!
Example: If a trial is testing a new diabetes drug, the CRA visits hospitals to check if patients are getting the correct dose and if doctors are reporting any side effects properly.
How this role is different in a CRO vs. a Sponsor?
• In a CRO, CRAs usually monitor multiple studies for different sponsor companies.
• In a sponsor company, CRAs often focus on one or a few trials that the company is directly funding.
Project Manager (PM) – Manages the entire study, ensuring timelines, budgets, and tasks stay on track. This is the equivalent of a clinical trial manager in a sponsor company.
Example: If a trial is supposed to last one year but patient enrollment is too slow, the PM works with different teams to find solutions and speed up recruitment.
Clinical Trial Assistant (CTA) – Supports CRAs and project managers by organizing documents and reports.
Example: If a hospital in the study needs to update its consent forms, the CTA ensures the newest version is sent and stored properly.
Regulatory & Start-Up – "The Rule Followers"
Similar to the sponsors' RA team, this team ensures the trial follows government laws. They secure approvals from ethics committees and regulatory agencies before the study starts.
Key Jobs in Regulatory & Start-Up:
Regulatory Affairs Specialist – Prepares and submits documents to government health agencies to obtain trial approval.
How this role differs in a CRO vs. a Sponsor?
• In a CRO, the Regulatory Affairs Specialist handles submissions for multiple sponsors and multiple trials.
• In a sponsor company, this role concentrates solely on trials related to the company's own drugs.
Example: If a company wants to test a new vaccine, the specialist sends all necessary forms to the FDA or EMA to get study approval.
Feasibility and/or Start-Up Specialist – Works on the first steps of a study, like identifying potential sites and PIs for a specific study indication, setting up contracts with hospitals, assessing site suitability, and managing documentation. In some companies, the feasibility department operates independently, focusing on trial bidding, proposal preparation, site identification, and maintaining the company's database of investigator and hospital contacts.
Example: Before a hospital joins a cancer drug trial, the Start-Up Specialist makes sure the hospital has the right equipment, documentation and trained staff.
Data Management & Biostatistics – "The Number Checkers"
This team collects and analyzes all the information from the trial to evaluate treatment efficacy and safety.
Key Jobs in Data Management & Biostatistics:
Clinical Data Manager – Ensures that all patient information is collected, stored, and cleaned properly before final analysis.
Example: If 1,000 patients are in a study, the data manager verifies that all their test results are correctly entered into the system without errors.
How this role is different in a CRO vs. a Sponsor:
• In a CRO, Data Managers work with multiple trials from different companies.
• In a sponsor company, they focus on the sponsor's own products and trials.
SAS Programmer – Uses specialized software to analyze the trial results and find patterns.
Example: If doctors want to know if a new painkiller works faster than an old one, the SAS Programmer compares all patient pain scores to determine differences.
Safety & Pharmacovigilance – "The Drug Watchdogs"
This team checks for side effects and safety issues during the trial and after market release.
Key Jobs in Safety & Pharmacovigilance:
Safety Associate – Collects side effect reports from doctors and patients, then sends them to health authorities.
Example: If patients in a new asthma drug trial experience dizziness, the Safety Associate records all cases and alerts the medical team.
Pharmacovigilance Scientist – Analyzes safety data to find trends in side effects and determines if additional safety measures are needed.
Example: If many patients taking a new antidepressant report headaches, the scientist investigates if the drug is the cause and recommends a warning label.
How this role is different in a CRO vs. a Sponsor:
• In a CRO, Safety Associates handle side effect reports for multiple studies.
• In a sponsor company, they focus only on the company's drugs.
Quality Assurance & Compliance – "The Rule Enforcers"
Or as I like to call them, the long arm of the law (ICH-GCP).
This team ensures trials follow Good Clinical Practice (GCP) guidelines and are inspection-ready.
Key Jobs in Quality Assurance & Compliance:
GCP Auditor – Visits hospitals and clinics to audit trial records and ensure all rules are being followed.
Example: If a doctor is missing important patient signatures in their study files, the auditor flags this as a serious issue.
Inspection Readiness Manager – Prepares CROs and sponsors for government inspections before drug approval.
Example: If the FDA is coming to check trial records, this manager reviews all documents to make sure they are correct and complete.
Other Important Roles in Clinical Research (in both Sponsor & CRO companies)
Business Development & Market Access – Identifies new opportunities and ensures medicines reach patients effectively.
Legal & Ethics Teams – Handle contracts, safeguard patient rights, and obtain trial approvals.
Medical Writers – Create clear, accurate reports, study summaries, and regulatory documents.
Vendor Managers – Coordinate with external partners like labs, software providers, and service companies.
Site Relationship Managers – Support hospitals and clinics to maintain study engagement and resolve challenges.
Before we dive into clinical trial site roles, I want to note that there are many different companies, structures, and organizations—from big players to small "underdogs"—which significantly determine the scope of each role above. Now, dear CRAs, let me tell you: there's no such thing as "this doesn't fit my job description." Yes, there are boundaries, depending on your company, but remember - you're in this amazing position where you connect with everyone: sites, CROs, and sponsors. You see their challenges, understand their goals, and help bridge the gaps. You're basically a trial diplomat! Need to help a PI figure out their payment status? You're on it. Site coordinator struggling with their EDC login? You've got their back. Company needs feasibility data for a new study bid? You'll make it happen. The RA team needs help with submissions - you pitch in. New CRAs need mentoring? You step up. Site negotiations need to be done — you'd better bring your A-game! Marketing team needs blog content? ... well, you write articles 😉! Just kidding. But you get my point - being a CRA means being adaptable, solution-focused, and ready to help wherever needed. It's what makes this role both challenging and incredibly rewarding.
As I mentioned earlier, there are some nuances to this - some companies prefer to keep you more specialized in just one or few things, while other companies don't mind being more broad and giving you the space to do your thing in every aspect possible.
Jobs at a Clinical Trial Site
Clinical trial sites are hospitals, research centers, or private clinics where patients receive investigational treatments as part of a clinical study. Unlike CROs or sponsor companies, these professionals work directly with patients to ensure the study runs smoothly and that participants are safe.
If a clinical trial were a movie production, the sponsor company would be the studio financing the film, the CRO would be the film crew organizing everything, and the clinical trial site would be the actors, directors, and production team making it happen on screen.
Investigator & Research Team
Investigator (PI or SI) – This is essentially the doctor conducting the clinical trial, either as the Principal Investigator (PI) or Sub-Investigator (SI). If you have a medical background and enjoy working with patients while helping advance science, this role is perfect for you. I have friends who are doctors who (very sadly) believe they need to become a CRA or take another role is either CRO or sponsor company in order to make money. Unfortunately, young doctors aren't well paid (at leats in Bulgaria) for their hard work and long hours. I always advise them to join an investigator team instead, as this will open their career path in clinical trials. Once they gain enough experience they could become PIs, and then they'll make considerably more than a CRA! 😉
How this role is different from working as a regular doctor?
Instead of only treating patients with approved medicines, investigators test new treatments that could become future standard therapies.
Being a PI or SI allows doctors to be involved in cutting-edge medicine while still treating patients.
Once a doctor gains enough experience as an investigator, they can become highly sought-after in the research field and earn significantly more than some industry roles.
Example: A hospital is running a study for a new diabetes treatment. The PI meets with patients, checks their health before they start the treatment, and monitors their progress throughout the study.
Clinical Trial Coordinator/ Study Coordinator (CTC/SC)
Manages the day-to-day activities of the study at the site.
Schedules patient visits, organizes paperwork, records the data captured during patient visits in the EDC, and ensures the trial follows correct procedures.
• Acts as the bridge between doctors, nurses, patients, and the sponsor/CRO.
How this role is different from a hospital administrator:
• A CTC focuses only on clinical research and supports the specific needs of a clinical trial, such as keeping track of study timelines, patient visits, and reporting requirements.
Example: If a clinical trial requires a patient to have blood tests every two weeks, the CTC ensures the appointments are scheduled and that results are entered into the trial database.
Other Key Roles at a Clinical Trial Site
Some positions don't fit into one category but are still critical to the success of the trial.
• Lab Technicians – Process patient blood samples and test results for the study.
• Pharmacists – Ensure investigational drugs are stored, prepared, and dispensed correctly.
• Data Entry Coordinators (unless the SC handles this task) – Input and verify patient data into clinical trial systems.
And now, Which Career Path is Right for You?
• Love science & labs? 👉 R&D or Biostatistics
• Enjoy organizing & planning, putting out fires? 👉 Clinical Operations
• Interested in laws & regulations? 👉 Regulatory Affairs
• Want to communicate science? 👉 Medical Writing or Medical Affairs
• Care about safety & ethics? 👉 Pharmacovigilance or Quality Assurance
Clinical research offers many career paths, and you can fairly easily move between departments based on your interests!
There are opportunities for career growth and movement between these sectors, depending on your interests and skills. Whatever you choose, the most important thing is simply to start somewhere.
Good luck! ✌️