You won’t be surprised to learn that jobs in Clinical Research are focused on the design, execution, analysis, and reporting of Clinical Trials. Clinical trials are the studies that are used to evaluate safety, efficacy, and pharmacokinetics in human subjects.
On this page and the following pages, we will outline key job families in Clinical Research. Unfortunately different companies use different titles for similar positions so we will describe these jobs by their functions. You can start with summaries on this page and then get more details about roles by choosing topics on the pull down menu.
Remember:
The Sponsor is the person or organization who designs and runs a clinical study, For discussions on this website, when we talk about a “Sponsor” it will usually be a BioPharmaceutical company that is conducting studies to get approval for a new drug or medical device. Investigators, the physicians who treat the subjects in a clinical trial, usually work at an Investigative Sites (often just called "Sites"), an office or hospital, separate from the Sponsor's company.
The Sponsor is responsible for designing the study; choosing the Investigators; supplying the investigative materials; for overseeing study conduct, analysis and reporting; and for paying the bills. The Sponsor is responsible for hiring staff with adequate training and experience to conduct the study properly and for providing study-specific training as needed. The Sponsor is also responsible for adherence to all FDA regulations in the conduct and reporting of the study. The Sponsor may hire their own staff or contract with Contract Research Organizations (CROs) to hire staff to do the work required for the study. A CRO can take on any of the roles of the Sponsor but these responsibilities must be specified in a written contract.
Clinical trials used to get FDA approval for a new drug or device require the following;
As noted above,the Sponsor is responsible for hiring staff with appropriate training and expertise to design, monitor, supply, and report the study. The Sponsor may use their own employees, hire independent contractors, or contract with Contract Research Organizations (CROs) to supply these personnel. Here are some of the roles that must be staffed to complete a clinical study. Remember, different companies use different titles for many of these roles.
Usually there will be a Clinical Research Project Manager or Project Director who oversees the protocol writing, selects investigative sites, supervises monitoring activities, and oversees the overall conduct of the study.
The Project Director or Program Director works with the Medical Director and Biostatistician to prepare the protocol. The Director works with the Data Manager to prepare the case report forms to collect data as outlined in the protocol.
The Clinical Trial Manager oversees the work of the clinical monitoring team in training Investigators and site staff and in conducting monitoring visits.
The Project Director estimates the amount of investigational product that will be required for the study and provide this information to the Manufacturing and Packaging team.
The Project Director makes sure that the contracts for the sites are completed before any investigative drug is shipped.
The Project Director does not work alone. In some companies, the Medical Director or Medical Monitor will play a major role in protocol writing and training Investigators. Sometimes there will be a Senior or Lead Clinical Trial Manager who will direct certain parts of the plan. And there is usually a Clinical Trial Assistant to help manage the paperwork and files and provide general administrative support for the Director and the team.
As noted above, a Medical Director or Medical Monitor will usually assist with protocol development and Case Report Form design. The Medical Monitor will monitor safety events including reviewing all laboratory or other diagnostic tests for each subject. The Medical Monitor will evaluate Serious Adverse Events (SAEs) and prepare SAE reports for regulatory submission.
Clinical monitors, usually called Clinical Research Associates (CRAs) train the Investigators and other site staff in protocol requirements. CRAs visit the Investigative Sites to make sure the the Investigators are adhering to the protocol and following the rules and regulations of Good Clinical Practices (GCPs). The CRAs also insure that the sites are completing CRFs accurately and storing and dispensing investigational drug properly. The CRAs may be employees of the BioPharma company that is sponsoring the study or employees of a Contract Research Organization hired specifically for site monitoring, or experienced independent contractors.
The Sponsor needs Biostatisticians who determine the sample size for the study (number of subjects to be enrolled) and write and execute the study analysis plan.
Clinical Programmers work with the Biostatistician to write the software programs that will be used for monitoring reports and to produce the Tables, Figures, and Listings for the Clinical Study Report.
Clinical Data Managers design the Case Report Forms (CRFs) and the computer fields that will be used to collect the CRF data.
Clinical Data Reviewers review the CRFs and interact with the Investigative sites, and the CRAs, to resolve questions related to missing data or data inconsistencies.
The Sponsor hires IT staff and database specialists to build and maintain the study database that will be used to collect the case report data.
The Sponsor may also hire Medical Writers or Medical Editors to assist in drafting the protocol and writing the Clinical Study Report when the study is completed.
The Sponsor will also have Regulatory Affairs Managers who make sure that the clinical study team understands and follows all pertinent FDA regulations. The Regulatory Affairs staff directs all interactions with the FDA or other regulatory agencies for protocol design, study initiation, study analysis and reporting. The Regulatory staff also assists in filing Serious Adverse Event reports according to FDA or international requirements.
The Sponsor must also have Manufacturing staff who produce the investigational product and any controls (e,g, active drug or placebo) for the study and who monitor the product stability throughout the study and resupply product if necessary. The Sponsor must also hire or contract with Clinical Packaging staff who provide the Investigative drug or device in the appropriate form for use in the study; ship the investigative product to the sites; and keep track of return or destruction of the investigational product.
And, the Sponsor must hire Investigators, the physicians who will enroll, treat, monitor and assess the subjects for the study. These Investigators work at the Investigative Sites such as hospitals, medical schools, doctor’s offices, etc. Investigators usually have their own staff including Clinical Study Coordinators and Study Nurses who work at the site. There may also be Co-Investigators, additional physicians who enroll and treat subjects at the site. Sponsors must select Investigators carefully and then monitor the sites to see that the Investigators conduct the study according to the protocol and in keeping with Good Clinical Practices (GCPs).
In addition to Investigators, Investigative Review Boards (IRBs), also known as Ethics Committees are needed to protect subjects in the study. An IRB is an independent group of clinical and ethics experts who review the protocol, supervise the information included in the Informed Consent forms, and review safety reports as the study progresses to protect subjects. There may be an IRB at each investigative site or a single IRB may be used for several or all of the sites.
Hiring and paying Investigators requires the work of Finance and Contract staff who prepare the budgets and supervise payments to the Investigative sites. They also negotiate and finalize the legal contracts with the Investigators and Sites. The Finance and Contract staff may also supervise payment to other providers who supply study services such as CROs, clinical laboratories, etc.
On the pull-down tabs associated with this topic, we will give more details about these roles including the education and experience usually that hiring organizations usually require. Remember, different companies may use different titles for similar positions.
On this page and the following pages, we will outline key job families in Clinical Research. Unfortunately different companies use different titles for similar positions so we will describe these jobs by their functions. You can start with summaries on this page and then get more details about roles by choosing topics on the pull down menu.
Remember:
The Sponsor is the person or organization who designs and runs a clinical study, For discussions on this website, when we talk about a “Sponsor” it will usually be a BioPharmaceutical company that is conducting studies to get approval for a new drug or medical device. Investigators, the physicians who treat the subjects in a clinical trial, usually work at an Investigative Sites (often just called "Sites"), an office or hospital, separate from the Sponsor's company.
The Sponsor is responsible for designing the study; choosing the Investigators; supplying the investigative materials; for overseeing study conduct, analysis and reporting; and for paying the bills. The Sponsor is responsible for hiring staff with adequate training and experience to conduct the study properly and for providing study-specific training as needed. The Sponsor is also responsible for adherence to all FDA regulations in the conduct and reporting of the study. The Sponsor may hire their own staff or contract with Contract Research Organizations (CROs) to hire staff to do the work required for the study. A CRO can take on any of the roles of the Sponsor but these responsibilities must be specified in a written contract.
Clinical trials used to get FDA approval for a new drug or device require the following;
- A detailed study design -- the Protocol
- A statistical analysis plan (SAP) that describes how many subjects will be enrolled, what data will be collected, and how the results will be analyzed and reported.
- Investigators to enroll, treat, and evaluate the subjects who participate in the study.
- Investigational Review Boards (IRBs) to protect study subjects and oversee the Informed Consent forms used in the study.
- Medical Directors or Medical Monitors to oversee the conduct of the study and evaluate and report Serious Adverse Events (SAEs).
- Site monitors to instruct the Investigators and Clinical Sites about the protocol and to visit the investigative sites to assure that the Investigators are following the protocol, reporting data appropriately, and dispensing investigational drug properly. These monitors are often called Clinical Research Associates (CRAs) or Clinical Trial Monitors or Clinical Trial Managers.
- Case Report Forms to record events in the trials and a computerized study database collect to safety and efficacy information from the clinical sites.
- Drug or Device supply--supplies of the investigative product (IP), also called investigational medical product (IMP), and any comparator products (controls). These investigational products must be packaged appropriately for use at the clinical site and delivered to the site.
- A Clinical Study Report (CSR) that fully summarizes the results of the study.
- FDA Interactions --These interactions include notification of the FDA and Clinical Trials.gov about the initiation and progress of the study and filing the Clinical Study Report at the completion of the study. Annual Safety reports and expedited reporting of serious, unexpected Serious Adverse Events (SAEs) are also required.
- Clinical Trial Management All of the work described above requires planning, management, and record keeping. As discussed below, the "managers" may have different titles at different companies. Some of the titles include: Clinical Project Directors/Managers or Clinical Scientists who develop protocols, identify investigators, and manage the clinical teams.
As noted above,the Sponsor is responsible for hiring staff with appropriate training and expertise to design, monitor, supply, and report the study. The Sponsor may use their own employees, hire independent contractors, or contract with Contract Research Organizations (CROs) to supply these personnel. Here are some of the roles that must be staffed to complete a clinical study. Remember, different companies use different titles for many of these roles.
Usually there will be a Clinical Research Project Manager or Project Director who oversees the protocol writing, selects investigative sites, supervises monitoring activities, and oversees the overall conduct of the study.
The Project Director or Program Director works with the Medical Director and Biostatistician to prepare the protocol. The Director works with the Data Manager to prepare the case report forms to collect data as outlined in the protocol.
The Clinical Trial Manager oversees the work of the clinical monitoring team in training Investigators and site staff and in conducting monitoring visits.
The Project Director estimates the amount of investigational product that will be required for the study and provide this information to the Manufacturing and Packaging team.
The Project Director makes sure that the contracts for the sites are completed before any investigative drug is shipped.
The Project Director does not work alone. In some companies, the Medical Director or Medical Monitor will play a major role in protocol writing and training Investigators. Sometimes there will be a Senior or Lead Clinical Trial Manager who will direct certain parts of the plan. And there is usually a Clinical Trial Assistant to help manage the paperwork and files and provide general administrative support for the Director and the team.
As noted above, a Medical Director or Medical Monitor will usually assist with protocol development and Case Report Form design. The Medical Monitor will monitor safety events including reviewing all laboratory or other diagnostic tests for each subject. The Medical Monitor will evaluate Serious Adverse Events (SAEs) and prepare SAE reports for regulatory submission.
Clinical monitors, usually called Clinical Research Associates (CRAs) train the Investigators and other site staff in protocol requirements. CRAs visit the Investigative Sites to make sure the the Investigators are adhering to the protocol and following the rules and regulations of Good Clinical Practices (GCPs). The CRAs also insure that the sites are completing CRFs accurately and storing and dispensing investigational drug properly. The CRAs may be employees of the BioPharma company that is sponsoring the study or employees of a Contract Research Organization hired specifically for site monitoring, or experienced independent contractors.
The Sponsor needs Biostatisticians who determine the sample size for the study (number of subjects to be enrolled) and write and execute the study analysis plan.
Clinical Programmers work with the Biostatistician to write the software programs that will be used for monitoring reports and to produce the Tables, Figures, and Listings for the Clinical Study Report.
Clinical Data Managers design the Case Report Forms (CRFs) and the computer fields that will be used to collect the CRF data.
Clinical Data Reviewers review the CRFs and interact with the Investigative sites, and the CRAs, to resolve questions related to missing data or data inconsistencies.
The Sponsor hires IT staff and database specialists to build and maintain the study database that will be used to collect the case report data.
The Sponsor may also hire Medical Writers or Medical Editors to assist in drafting the protocol and writing the Clinical Study Report when the study is completed.
The Sponsor will also have Regulatory Affairs Managers who make sure that the clinical study team understands and follows all pertinent FDA regulations. The Regulatory Affairs staff directs all interactions with the FDA or other regulatory agencies for protocol design, study initiation, study analysis and reporting. The Regulatory staff also assists in filing Serious Adverse Event reports according to FDA or international requirements.
The Sponsor must also have Manufacturing staff who produce the investigational product and any controls (e,g, active drug or placebo) for the study and who monitor the product stability throughout the study and resupply product if necessary. The Sponsor must also hire or contract with Clinical Packaging staff who provide the Investigative drug or device in the appropriate form for use in the study; ship the investigative product to the sites; and keep track of return or destruction of the investigational product.
And, the Sponsor must hire Investigators, the physicians who will enroll, treat, monitor and assess the subjects for the study. These Investigators work at the Investigative Sites such as hospitals, medical schools, doctor’s offices, etc. Investigators usually have their own staff including Clinical Study Coordinators and Study Nurses who work at the site. There may also be Co-Investigators, additional physicians who enroll and treat subjects at the site. Sponsors must select Investigators carefully and then monitor the sites to see that the Investigators conduct the study according to the protocol and in keeping with Good Clinical Practices (GCPs).
In addition to Investigators, Investigative Review Boards (IRBs), also known as Ethics Committees are needed to protect subjects in the study. An IRB is an independent group of clinical and ethics experts who review the protocol, supervise the information included in the Informed Consent forms, and review safety reports as the study progresses to protect subjects. There may be an IRB at each investigative site or a single IRB may be used for several or all of the sites.
Hiring and paying Investigators requires the work of Finance and Contract staff who prepare the budgets and supervise payments to the Investigative sites. They also negotiate and finalize the legal contracts with the Investigators and Sites. The Finance and Contract staff may also supervise payment to other providers who supply study services such as CROs, clinical laboratories, etc.
On the pull-down tabs associated with this topic, we will give more details about these roles including the education and experience usually that hiring organizations usually require. Remember, different companies may use different titles for similar positions.