The clinical trial industry is growing and expanding due to demand for new products, procedures and intervention for emerging health conditions, increasing prevalence of chronic diseases and increasing health care expenditures. The personnel and demand for people with experience required to conduct clinical trials are also growing. Below is a summary of some of the key human resources required to conduct a quality study. Principal Investigator (PI)

The principal investigator in a clinical trial is the most important personnel, as the responsibility of starting and conducting the study lies with the PI. Most clinical trials are conducted by pharmaceutical companies to try a new medicine or a medical device and usually make the ultimate decisions and are also ultimately responsible in the eyes of the government. The PI is primarily responsible for designing, conducting, managing, and reporting the study. He is the overall leader in the clinical trial and ensures that all activities and personnel are in compliance with industry standards.

Clinical Research Associates (CRA)

The Clinical Research Associate, also, referred to as the Monitor, is involved in all stages of the clinical trial, including identifying sites, setting up the sites, starting, monitoring, and closing the site upon completion or termination of the trial.

At the site level, the CRA is responsible for identifying a site, investigator, and study staff at that site. S/he ensures appropriate approval from the Institutional Review Board (IRB) or Institution Ethics Committee (IEC); manages personnel at the study site to ascertain if they have the desired knowledge adequate for the study; and ensures that they receive the necessary training to comply with the trial protocol in line with Good Clinical Practice (GCP) and the study’s Standard Operating Procedure (SOP).

The CRA performs supervisory visits to conduct spot checks in order to verify the source data and review adverse events, case reports, and consent form reviews. The CRA performs technical and administrative roles throughout the lifespan of the study.

Site Investigator

Sometimes, clinical trials are conducted in multiple centers, and in such settings, a site investigator leads the study at each of the centers and becomes the liaison between the PI, CRA and the Site. The site investigator is responsible for activating the particular site, execution, S/he maximizes enrollment of subjects for the trial and ensures their retention throughout the study in line with the protocol. S/he ensures that the site regulatory requirements are satisfied and maintained. S/he hosts site meetings with trial site staff, performs knowledge check and conducts training when necessary. For the subjects, S/he ensures that their rights, safety and welfare are maintained.

Clinical Trial Manager (CTM)

The Clinical Trial Manager (CTM), sometimes could also be referred to as the Clinical Research Operations Manager (CRO), The CTM performs the role of project management by collaborating with the project manager in implementing study-specific monitoring tools and documentation. The CTM manages trial plans, tracks timelines and budget, provides project-specific training to CRAs, and regular meetings to assure compliance with SOPs and GCP guidelines on other ethics/regulatory requirements.The CTM manages the Contract Research Organization (CRO) and other vendors in the clinical trial. Interacts with cross-functional personnel in the trial and assists with processes to maximize efficiency and quality.

Clinical Data Manager (CDM)

The Clinical Data Manager (CDM) designs the Case Report Forms (CRFs) as per the standard and as applicable to the protocol, and also, develops the database design and edit checks specification. Guarantees User Acceptance Testing (UAT), data deployment and transfer protocols, develops codes, manages and tracks data entry, and locks the database after the trial is completed. These tasks are usually performed by the Lead Data Manager (LDM) from the CRO in trials that have more than one data manager, especially when there is one representing the sponsor organization.The CDM also develops the SOPs, guidelines, data standards, and data management compliance. He/she validates the database and generates report summaries. S/he applies principles of clinical data management and GCP in all of its tasks to ensure compliance.

Also read SIMPLE AND EASY-TO-UNDERSTAND BASICS OF CLINICAL TRIALS. 

Regulatory Affairs Manager

The regulatory affairs manager performs a role that outlives the clinical trial period. Saddled with the responsibility of securing all necessary regulatory approvals. S/he is responsible for product registrations, regulatory consultations, product dossiers, developing regulatory reports, and communicating with regulatory agencies/authorities, and also provides training related to regulatory affairs. Coordinates depositions with the legal team and manages the regulatory audits and inspection participates in the development of study protocols and represents the organization in local, national, and international regulatory agencies.

Pharmacovigilance and Drug Safety Specialist

Pharmacovigilance, or drug safety, is a critical aspect of any clinical trial. This is to provide a security level to assure the safety of the subject to the trial product. Pharmacovigilance continues throughout the use of a product beyond the clinical trial. The Pharmacovigilance and drug safety specialist gathers and analyzes serious adverse events (SAEs), and adverse drug reactions (ADRs). This is because drug safety reports are very important to determine if a trial product will make it to the next phase of the trial.

Quality Specialist/Manager

The quality specialist/manager in a clinical trial conducts quality management of all aspects of the clinical trial. The roles and responsibilities include; creating, implementing, and ensuring compliance with the study SOP among all study personnel; conducting assessments at various stages of the trial for quality improvements, ensuring risk management, and conducting quality assurance visits.

Medical Writer

The medical writer is key personnel before, during, and after the trial to draft communication and study findings to relevant stakeholders. The roles include protocol writing, study reports, manuscripts, informed consent forms, medicine package inserts, safety and efficacy reports, regulatory applications, etc. Other personnel in clinical trials include the study starter manager, clinical scientist, finance manager, contracts manager, etc.