An important objective of clinical research is to ensure that marketed drugs are as safe and effective as possible. When a promising drug is discovered, a pharmaceutical company will plan a clinical development programme involving several phases of clinical research. Each phase will involve at least one clinical trial or trial, sponsored by the pharmaceutical company responsible for the drug to be tested.
CRAs are involved in all phases of clinical research and at all stages of a particular trial. Therefore, possible CRA duties include most of the activities required to set up, monitor and complete a clinical trial. A new CRA is most likely to be involved in the initiation, monitoring and close-out of a selected group of investigational sites.
Recruitment of CRAs may be directly into a pharmaceutical company or into a Contract Research Organisation (CRO) which can plan, organize and/or conduct clinical trials on behalf of pharmaceutical companies.

This Web page aims to provide ideas, information and guidance to those who might be interested in becoming a CRA, either within the Pharmaceutical Industry or within the Pharmaceutical Service Industry. Existing CRAs and colleagues may wish to refer friends and family members who express an interest in the CRA role to this web page. Careers Advisors, recruitment and Human Resources may wish to use this web page to provide information, in a concise and relevant form, to those actively seeking a CRA position.

“Clinical Research Associates are research professionals carrying out activities that may include investigational site selection, set up, initiation, monitoring and close-out, and can be involved in all operational aspects of the clinical phases of drug development”.

Clinical Research Associates are also known as CRAs, Clinical Research Monitors, Clinical Trial Monitors, Clinical Research Scientists etc. and the titles used vary from company to company. CRAs can be full-time or part-time and based in the field (home based) or in the office, either at the Sponsor/CRO office or at the investigational site.

It is quite common to work on 6 -12 month contracts with a company rather than as a permanent employee. Some CRAs therefore choose to work freelance for a variety of clients once they have gained enough experience.
They may be involved in all phases of clinical research and at all stages of a particular trial, within a variety of therapeutic areas. Although the role and functions of CRAs will vary slightly from company to company, it is likely that a CRA will be involved in all activities required to set up, conduct and complete a clinical trial, including:
• Investigator identification and selection.
• Co-ordination of ethics committee and regulatory authority applications and approvals.
• Pre trial procedures including collation of necessary documentation. This usually involves a visit to the investigational site to assess their suitability to conduct the trial.
• Organization, attendance and/or presentations at investigator meetings.
• Initiation, monitoring and close-out of investigational sites (see Table 1).
• Training of site staff to trial specific and industry standards.
• Supervision and/or distribution of trial supplies, including the trial drug (investigational medicinal product).
• Protocol and Case Report Form (CRF) development.
• Archiving of trial documentation and correspondence.
• Clinical Trial Report and manuscript for publication (occasional).

 
Site selection activities – contact potential investigators to discuss the proposed study and arrange Pre-Study visits as appropriate; following the visits, document activities and recommendations in a Pre-Study Visit Report;
• For sites selected for study participation, assist site staff with IEC submission activities – help with completion of IEC application forms and provide any necessary information or documentation (protocol; Investigator Brochure; Patient Information Sheet and Informed Consent forms; indemnity; advertisements); assist investigator in answering IEC queries to ensure IEC approval.
• Negotiate financial agreements with investigators.
• Answer any study-specific queries raised by site staff.
• Liaise with Regulatory Affairs/obtain regulatory approval for study/sites.
• Prepare/write study-specific documentation – forms and procedures, including tracking spreadsheets for documents, patient recruitment, CRFs, data queries.
• Liaise with Head Office/Data Management with regards to design, review, (translation if necessary), production and delivery of CRFs/Patient Diary Cards/Questionnaires.
• Liaise with the Central (or Local) Laboratory to organize production of lab kits, lab manual, shipping/handling of samples and reporting of results;
• Liaise with Head Office/local Drug Depot to order clinical supplies, arrange labeling, shipping, tracking and accountability; ensure randomization procedures are in place.

Site Initiation Visits:
• Visit sites selected for trial participation and ensure they are set-up and trained prior to recruitment of the first patient.
• Ensure all GCP/regulatory documentation is complete (filed in the Investigator File) and the protocol, Case Report Form (CRF) and all trial procedures have been reviewed and the staff fully trained.
• Ensure all study and drug supplies have been delivered to the site (if appropriate) and conduct an inventory.

In a nut shell. This is the visit to the investigational site at the very beginning of the trial that is carried out once all the appropriate approvals and paperwork are in place. This involves meeting with all the appropriate departments/site staff within the investigational site (e.g. pharmacy, laboratories, radiology etc) This is to ensure that they are aware of the trial protocol, procedures, ICH GCP and the logistical aspects of running the trial, to name a few. This can involve speaking one to one, or speaking in front of a group about the trial.

Visit sites selected for trial participation and ensure they are set-up and trained prior to recruitment of the first patient.
• Ensure all GCP/regulatory documentation is complete (filed in the Investigator File) and the protocol, Case Report Form (CRF) and all trial procedures have been reviewed and the staff fully trained.
• Ensure all study and drug supplies have been delivered to the site (if appropriate) and conduct an inventory.

Compile Investigator Files with all appropriate GCP/regulatory documentation and trial procedures (ie. IEC correspondence and approval; CVs; signed protocol; Investigator Brochure; regulatory approval; indemnity; signed financial agreement; drug shipping records; drug storage and dispensing procedures; lab manual, and reference ranges).
• Ensure all required documentation is complete prior to site initiation and dispatch of drug to site.
• Participate in preparation and presentation of Investigator Meeting.

Interim Monitoring Visits:
 
Visit sites every 4-6 weeks to ensure the trial is being conducted according to the protocol, ICH GCP and company SOPs. Perform the following tasks
Review the Investigator File to ensure all regulatory and GCP documentation is complete ie. Subject Screening and Enrolment Logs; Drug Shipment, Dispensing and Accountability Logs; Serious Adverse Event Reports (if applicable); and correspondence with Sponsor/IEC.
• Ensure that the protocol and all trial procedures are being adhered to by the investigator/site staff.
• Ensure that all patients have signed an Informed Consent form prior to their participation in the study.
• Review CRFs and source data (patient medical records, and lab reports) for completeness and perform source document verification ie. Compare CRFs with patient medical records to ensure that the data is accurate and consistent.
• Retrieve or arrange shipping of completed CRFs to Data Management.
• Ensure that Adverse Events have been reported appropriately.

• Arrange shipment of all study and drug supplies to the site.
• Arrange Initiation visits and following the visits, document activities in an Initiation Visit Report.
• Visit pharmacy (if appropriate) and perform drug accountability and ensure drug has been stored and dispensed correctly (review documentation).
• Check lab samples (blood/urine) have been taken and handled/shipped/ stored according to instructions provided in the lab manual.
• Resolve data queries with site staff.
• Address any study issues with site staff at each visit ie. Protocol violations/deviations; recruitment issues; CRF entry errors/omissions; inadequate source documentation, and work to resolve these

Answer study specific queries from site staff ie. Study-coordinators, investigators, pharmacists.
• Manage patient recruitment strategies to ensure target patient numbers are met ie. Prepare study Newsletters, advertising campaigns, and investigator meetings.
• Ensure that Serious Adverse Events are reported according to SOPs.
• For any protocol amendments, ensure that IEC approval is obtained and all necessary documentation is filed.
• Arrange Monitoring visits at appropriate time intervals (depending on rate of recruitment, number of patients enrolled and complexity of the study).
• Write up Monitoring Reports to summarize the monitoring activities including significant findings, deviations, deficiencies and any recommended actions to be taken. Based on the findings, prepare follow-up letters to Investigators.
• Follow-up and resolve any issues arising from monitoring visits.
• Participate in global/local conference calls and meetings to review progress of ongoing trial.
• Track completed CRFs sent to Data Management; track issued and resolved data queries.
• Maintain in-house project files to ensure complete documentation, including all correspondence

Close-out Visits:
• Final visit to the site (usually after database closure) to ensure that all study documentation and records are complete (including drug accountability and destruction records; subject identification list; data queries) and arrange for retention/archiving of these on or off-site, (including Investigator File and copies of CRFs), for the required timeframe.
• Ensure patient medical records are labeled to ensure retention by Medical Records.
• Ensure that all CRFs, data queries and unused drug/study supplies have been retrieved

Ensure any outstanding documentation is filed (including drug accountability and destruction records) and archive project files according to company SOPs, ensuring retention for the required time (at least 15 years).
• Arrange Close-Out visits with sites and organize on-site or off-site archiving; document activities in a Close-Out (Final) Monitoring Report.

Essential Skills of a CRA include:
• Organisational skills (including multi-tasking).
• Methodical and meticulous nature with attention to detail.
• Administrative and writing skills.
• Time management.
• Communication skills.
• Interpersonal skills.
• Diplomacy.
• Ability to motivate and organise others.
• Flexibility and versatility.
• IT skills.