The Medical Assistant’s Role in Drug Studies
Medical Assistants are increasingly working in facilities that conduct drug studies and have become important members of drug research and development teams. Read on to learn more about drug studies and about how working as a Medical Assistant in at a drug study program may be the right career fit for you.
Medical Assistants are increasingly being employed for
Pre-clinical studies which are also called phase 0 studies are not required for new drug approval but are often conducted before the beginning of the four phases of clinical drug studies to determine how a new drug works in the body.
In a pre-clinical study, varying small dosages of the medication being studied are used with a small number of patients over a short period of time to determine the drug’s therapeutic levels, toxicity and pharmacokinetics.
In the first phase of a clinical trial (drug study,) the drug is tested in one dose usually with approximately 10 people to see if the medication is safe for use in humans.
Phase 1 of a Drug Study
In Phase 1 of a Drug Study, the drug is tested on a small group of people who are either healthy or who have the disease being studied to help determine the highest dose of the drug which can be given safely and the side effect and toxicity profiles.
Phase 2 of a Drug Study
In phase 2 of a drug study, up to several hundred people with the disease in question are studied over a longer period of time to determine a drug’s efficacy and toxicity.
Phase 3 of a Drug Study
In Phase 3 of a drug study, people with the disease being considered are evaluated over 1 to 4 years to determine the best dose of the new drug being tested as compared to the usual treatment of choice. Any potential major or minor adverse reactions or side effects are carefully documented in a Phase 3 drug study..
Phase 4 of a Drug Study
Phase 4 of a drug study is called Post-Marketing Surveillance and involves studying the safety and efficacy of a new drug. This phase occurs after the drug has received approval by the FDA for sale and is being used by the public.
In Phase 4 of a drug study, several thousand volunteers with the disease or condition being studied are evaluated for drug side effects while taking the drug for at least a 2-year period.
If serious side effects are discovered, the drug may be pulled from the market or restricted to only very specific uses.
Important Required Skills for Medical Assistants Working in Drug Studies
Candidates who wish to work as Medical Assistants in Clinical Drug Studies must be competent in Medical Terminology, Phlebotomy and Laboratory Sample Processing.
Important Work Abilities for a Medical Assistant Working in Drug Studies
Medical Assistants working in a drug study must be able to work in a fast paced clinic.
Medical Assistants must be skilled in Phlebotomy and have excellent rapport with patients and staff.
Medical Assistants must also be able to multitask and have the ability to plan weeks or months in advance.
Medical Assistants must be detail oriented and have the ability to plan daily tasks with minimal supervision.
The Drug Study Team
As a Medical Assistant working in a drug study, you will be working with a team that usually includes:
Representatives from a Pharmaceutical Company
Quality Assurance experts
General Duties of a Medical Assistant Working in a Drug Study Group
The general duties of a Medical Assistant working in a drug study include:
Answering phones in the clinic
Attending staff meetings
Providing support to pharmacists, physicians and clinical and support staff
Principal Duties of a Medical Assistant Working in a Drug Study Group
The principle duties of a Medical Assistant working in a drug study group under the direct supervision of a Clinical Trials Study Coordinator will include:
- Vital Signs Collection
- Performing EKGs
- Performing PFTs
- Performing Medical History Reviews
- Preparing kits for Study Visits
- Preparing tracking receipts with required follow-up folder documentation
- Processing Laboratory Samples
- Overseeing shipping of Laboratory Samples
- Setting up pick-ups with appropriate vendors
- Tracking kit status
- Alerting CRC of low stock or kits expiring
- PK/Retention/Back Up/Batch – Frozen Shipment Tracking as needed
Additional Essential Functions of a Medical Assistant Working in a Drug Study include:
- Data Entry
- Query Resolution
- Point of Contact for CRA/Monitor
- QC check
- Temperature monitoring of Investigational Products
- Retrieving Study Medication for Clinical Research Coordinator (CRC) as needed
- Maintaining responsibility for receipt of study items
- Unpacking shipments
- Alerting Lead CRC on receipt of study materials
- Sorting and Shelving as needed
- Downloading temp tales
- Registering shipments into IVRS as needed
- Updating logs, under the direction of the CRC, as needed
- Breaking down shipping materials/boxes and sending them to waste as needed
- Preparing screen packs for enrolling studies
- Ensuring prompt Investigator for Study Visits while Subjects on Site for CRC
- Providing titration information/details
- Providing INC/EXC
- Obtaining signatures
- Transmitting electronic diaries while Subjects are on site for CRC
- Transmitting EKGs
- Calibrating Spirometers
- Calibrating Scales
- Calibrating Siemens a1c Vantage Analyzers
- Filing specific subject items as needed
- Preparing subject binders
- Re-shelving and organizing
- Scanning items to shared drives as needed
- Sending lost to follow-up letters as needed
- Compiling printing
- Pulling previous items as reference then forward to investigator for review and signature
- Confirming review and signatures have been completed
- Sorting and filing/FWD to CRC as needed
- Faxing Medical History Requests (Phone Call Follow Up as needed)
- Faxing alerts/copy to PCP
- Faxing notice of trial participants to PCP
- Entering demographics and contact information
- Registering visits as complete
- Updating screening/Rand #
- Assisting with building elements in to CTMS for studies
- Wiping down exam tables and chairs
- Wiping down arm cuffs (BP Machine)
- Sweeping exam rooms as needed
- Dusting administrative areas as needed
- Vacuuming of administrative areas as needed
The drug study market is projected to continue to expand providing well-paying, challenging and stable jobs for Medical Assistants. Working as a Medical Assistant in a drug study program provides the opportunity for a lucrative and rewarding career assisting in the research and development of new and potentially lifesaving medications. Understanding what a drug study entails and what your role is as a staff member in a drug study can help you decide if this specialty area of Medical Assisting complements your clinical skills and your professional interests.