Clinical research co-ordinators conduct clinical trials for medical world. They are responsible for ensuring that the trials are conducted in an ethical manner, referring to a good clinical practice. They majorly work under Clinical Research Managers (CRM) and are allocated with the administering clinical trials. The primary roles and responsibilities of CRC comprise of managing clinical trials, collecting data, informing participants about study objectives, and administering questionnaires.
Also clinical research co-ordinators are ‘the organizers’ in the research lab. They enable quality clinical trials which are completed with only selected subjects, organized information, and accurate reports. Co-ordinators make it possible for the great strides made in the medical world by offering accurate proof of medical advances found in clinical trials in all areas from basic preventive care to curing diseases, and everything in between. Additionally, CCRC is granted to a CRC meeting the qualification necessities, confirming the capability of specific information and job‐related aptitudes, and passing the institutionalized ACRP CRA Certification test.”
In clinical research trials, main work is done by clinical research coordinator (CRC) who is the organizer of the research lab. CRC works closely with the study’s principal investigator and oversees the team of clinical research associates. This role is significant owing to which success of a research study is achieved. CRCs have duties such as informed consent and ensuring that the study is run in compliance with the protocol as well as good clinical practices (GCPs). Every project of the clinical research includes one or more coordinators depending on the project size. Clinical trials get divided into three stages which include:
- Pre-work: Before starting the clinical trial.
- At-work: During the conduct of clinical trial.
- After-work: Completion of the clinical trial.
What’s a Typical Work for a CRC?
- Ensuring each study patient is fully informed of the study at the time of the consent.
- Create source documents for study visits.
- Train to particular staff who will be working on the study.
- Communicate closely with monitors, sponsors, and Investigators.
- Conduct procedures such as vital signs, blood draws, EKGs, and bladder scans, and assure they are seen by the physician at the required visits.
- Act as schedulers. For example, assure study subjects are scheduled with the doctor and any other procedures that might be required to complete that visit such as pap smears, endometrial biopsies, mammograms, transvaginal ultrasounds, bone scans, etc.
- Gathering lab results or procedure reports, and assure the investigator reviews them in a timely manner.
- Collecting information for investigators to review and assess whether or not a patient is eligible to enrol in a study or safe to continue if they are already enrolled in the study.
- Coordinates the approval of new study contracts and agreements.
- Upholds the protocol deviation logs and subject screening logs.
- Collecting supplies from sponsors and ensure everything is accounted for such as lab kits, ancillary supplies, and investigational medication.
- Participating in web conferences and teleconferences for each study protocol in order to stay updated.
- Organises the secure storage of study documents which will be maintained by permitting the institutional policy or the contracted length of time.
- Collaborate with investigators to arrange reports or presentations of clinical study trials, results, and conclusions.
Education, Training, and Skills Required:
A bachelor’s degree is preferred but not required. Medical knowledge is preferred as well. However, many people start working in research without any experience but requires training and certification. Coordinators must be good at multitasking. They must be organized, self-motivated and should have good decision-making skills.
Employers for a Clinical Research Coordinator
Research facilities are a typical employer for CRCs. Another setting is working in a private doctor’s office for a clinician who conducts research alongside a private practice.
A CRC can move up to become a team lead, site director, or start a research business. They can even pursue working with sponsors so that they can become a clinical research associate.