Clinical Research Roles
Clinical Research Associate (CRA)
A Clinical Research Associate (CRA) can also be called a Monitor, a Clinical Monitor, a Trial Monitor or a Medical Monitor. The title will vary from company to company. The job description will be the same. A CRA is an individual employed by a pharmaceutical or medical device manufacturer, by a contract research organization (CRO) usually acting on a sponsor's behalf or by an academic institute conducting clinical trials. Federal Regulations require that sponsors of clinical studies select individuals who are qualified by training and/or experience to monitor their studies per Good clinical practice and local regulations. It also states that Monitors be appropriately trained and their qualifications documented. In the United States, the rules are codified in Title 21 of the Code of Federal Regulations. In the European Union these guidelines are part of EudraLex. In India he / she requires knowledge about schedule Y amendments in drug and cosmetic act 1945. The major responsibilities of a CRA are: To analyze and evaluate clinical data, to ensure investigator and site compliance with the study drug protocol, overall clinical objectives, FDA regulations, ICH Guidelines, Good Clinical Practice (GCP) and HIPAA. Assure the protection of the rights, safety and well being of human study subjects. Identify, help in the study site selection process, initiate, and eventually close out clinical study sites. To monitor the progress of clinical study sites participating in a clinical study, and to assure the protocol is followed and data is reported accurately. To make certain that the scientific integrity of the data collected is protected and verified. Assure that adverse events are correctly documented and reported. Review all case report forms and compare them to source documents. Skills/Requirements: The relevant minimum requirements to begin a career as a Clinical Research Associate (CRA) include the following: The CRA frequently has a Bachelor's, Masters, or a Ph.D degree. Sound knowledge of Good Clinical Practices (ICH-GCPs) and FDA regulations Medical/scientific knowledge and medical terminologies Use of electronic data capture systems (EDC) Clinical Trial Management Systems (CTMS) and IVRS systems Electronic Trial Master File (eTMF) Conversant with the design and review of Case Report Form (CRF) Site Monitoring knowledge (including PSVs, SIVs, IMVs and COVs) to meet study expectations Source data/document verification (SDV) Adverse events (AE/SAE) reporting according to regulations and company policy Reviewing protocol compliance, focusing on inclusion/exclusion requirements Drug safety/ Pharmacovigilance A graduate with no previous relevant experience is more likely to enter the profession at an entry- level responsibility.
Clinical Data Manager (CDM)
The Clinical Data Manager (CDM) plays a key role in the setup and conduct of a clinical trial. The data collected during a clinical trial forms the basis of subsequent safety and efficacy analysis which in turn drive decision making on product development in the pharmaceutical industry. The CDM is involved in early discussions about data collection options and then oversees development of data collection tools based on the clinical trial protocol. Once subject enrollment begins, the clinical data manager ensures that data is collected, validated, complete and consistent. The CDM liaise with other data providers (e.g. a central laboratory processing blood samples collected) and ensures that such data is transmitted securely and is consistent with other data collected in the clinical trial. At the completion of the clinical trial, the clinical data manager ensures that all data expected to be captured has been accounted for and that all data management activities are complete. At this stage, the data is declared final (terminology varies but common descriptions are Database Lock and Database Freeze) and the clinical data manager transfers data for statistical analysis. The Clinical Data Manager: Serves as the primary Clinical Data Management contact with sponsors and represents CDM on project teams. Responsible for timelines, reporting and data collection. Coordinates the receipt and processing of information for projects (e.g., coding dictionaries) as well as electronic data capture. Ensure databases are validated and ready for transfer and/or analyses. Skills/Requirements: The relevant minimum requirements to begin a career in clinical data management include the following: A database specialist degree, a Bachelor's degree in computer science or other information technology (IT) field. Previous data entry experience and intermediate level skills using a range of software applications (such as Oracle, Oracle Clinical, SAS, SQL, PowerPoint, MS Excel, MS Word, and MS Access) is required. Excellent interpersonal, communication and problem solving skills are required. Data management systems knowledge and experience is also required. ICH GCP (Good Clinical Practice - international guidelines) knowledge is essential. A graduate with no previous relevant experience is more likely to enter the profession at an entry- level responsibility, such as a clinical data coordinator.
Clinical Research Coordinator (CRC)
The Clinical Research Coordinator (CRC) is responsible for conducting clinical trials using good clinical practice (GCP) under the auspices of the Principal Investigator (PI). The major responsibilities of a CRC are: Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices. Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms. Code, evaluate, or interpret collected study data. Track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts. Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies. Prepare study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports. Oversee subject enrollment to ensure that informed consent is properly obtained and documented. Maintain contact with sponsors (CRAs) to schedule and coordinate site visits or to answer questions about issues such as incomplete data. Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses. Schedule subjects for appointments, procedures, or inpatient stays as required by study protocols.
Principal Investigator (PI)
A Principal Investigator (PI) is the lead scientist for a particular clinical trial. Although the PI is responsible for the conduct of the trial, “it has been said that the CRC is the heart and soul of the research study and that, ultimately, it is the PI who carries forward the research goals, thereby playing a significant role in the success of the research study. Importantly, CRCs are often involved in essential duties that have been traditionally performed by the PI, such as conducting the informed consent process and ensuring compliance with the protocol”. The PI’s primary responsibility, as with all clinical research professionals, is the protection of human subjects, but the PI has many other responsibilities. Although not inclusive, some of the PIs responsibilities include: Preparing the Institutional Review Board submission, writing the informed consent document. Working with the institutional official in contract negotiations. Developing a detailed cost analysis, negotiating the budget with the Sponsor (i.e. pharmaceutical company or granting agency). Subject recruitment, patient care, adverse event reporting. Preparing the case report form (CRF), submitting CRFs and other data to the Sponsor as necessary. Study close-out.