How to Choose a Good Research Study Coordinator

If you read the regulations related to clinical trials, you probably will not find the term Research Study Coordinator nor will you find Clinical Research Coordinator. This leads many to ask how can you know what job description would apply to a Research Study Coordinator if the regulations do not specify or define the position? Read on and find out how to select the right Research Study Coordinator to help you with your clinical trials.

Things You'll Need

• Basic Clinical Research Knowledge

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Instructions

• 1

  Basic medical knowledge should be one of the main criteria for a Study Coordinator. I believe it is important for a Study Coordinator to have sufficient clinical knowledge to know when a subject (i.e. patient) is experiencing a serious medical event. For example, in a case I investigated, a subject started having a heart attack while sitting in the waiting room. The coordinator was aware of this and immediately called for a doctor who responded and provided immediate assistance. An untrained Study Coordinator may not have recognized the symptoms which could be disastrous. Medically trained persons, in my opinion, make the best Study Coordinators because they are typically asked to do a lot of interacting with the subjects. They sometime perform physical exams, draw blood, record health history, dispense medication, etc. Therefore, sufficient knowledge to help identify qualified subjects for the clinical trial is a big help to the Clinical Investigator.

• 2

  Good Clinical Practices (GCP) knowledge should be a major requirement for your Study Coordinator. Even if the Coordinator is a trained medical person, learning the content of the ICH Good Clinical Practice Guidelines and applicable FDA 21 CFR regulations along with the appropriate state laws is imperative to determine clinical trial compliance. Having a knowledgeable Study Coordinator serves as a second check to the clinical investigator to ensure protocol requirements are met. The sponsor's clinical data management team would be happy with the reduced number of data correction forms resulting from working with trained site personnel. See the resource section for a link to WQATS where you will find clinical research training resources.

• 3

  Training is also essential as the regulatory authorities expect clinicians to be informed about current industry trends, practices and regulatory expectations. Much of this training can be done from the comfort of your home on the internet. Take advantage of your local organizational chapter meetings. For example, a local SoCRA Chapter exists in almost every state. They are inexpensive in that once you're a national member; local meetings are a part of that membership. You may have to pay for your meal if the location is a restaurant, but other than that, the meetings are free and the information is invaluable. Additionally, you get to network with other professionals. Check out the national organization's website for listings in your area: http://www.socra.org/html/chapters.htm.

• 4

  Experience is invaluable.

  You can learn the regulations forward and backwards but practical experience will take you to places you cannot imagine. How? The book tells you what is required but seldom depicts real life situations. Just suppose you end up with a mix up in your scheduling and have more subjects than you can handle show up at once. What do you do? Everybody is screaming at you at once that they are in a hurry and can't wait much longer. Some can't come back because they live too far away and to have them return is an unscheduled visit. Does the protocol tell you how to handle unscheduled visits? Does the protocol even allow unscheduled visits? Situations like this are not covered in the books and experience is the only way a Clinical Research Coordinator would know how to handle it.

• 5

  A people's person.

  A good Study Coordinator need to be a pleasant, patient and tolerant person. They're dealing with people, a sea of varying personalities. It's important that they know and understand each subject and be willing to smile and say the right things

• 6

  Good documentation practices.

  In the industry, we say "if it isn't written, it didn't happen". It doesn't matter if the person voluntarily consented to participate in the clinical trial if you didn't write it down. Especially if the person is a long time patient of the physician. One goal of the human protection groups (called IRBs and Ethics Committees), is to ensure the patient didn't become a subject for fear of making the doctor mad. It doesn't matter if the subject was sitting for five minutes before you took the blood pressure as required by protocol if you didn't document it. Without documentation, nothing done can be verified. The Clinical Research coordinator need to be meticulous, consistent and clear when writing case histories, visit notes, and other information about the clinical trial.

• 7

  Good verbal skills.

  The Clinical Research Coordinator might find themselves negotiating contracts with sponsors, hiring additional help, and doing a lot of task outside their realm of comfort. However, if these tasks are delegated to the Clinical Research Coordinator, ensure the person is capable of expressing himself or herself clearly and firmly in a friendly manner, as appropriate.