Roles of Clinical Research Coordinator (CRC)

The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI).The main qualification needed is one should be GCP trained and should be of medical or life science background.

While the Principal Investigator is primarily responsible for the overall , conduct, and management of the clinical trial, the CRC supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. By performing these duties, the CRC works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study. 

CRC connected to other departments

1.      Training And Protocol Orientation

Attend sponsor’s study training meeting and develop a comprehensive understanding of the protocol, related schedule of events and procedure for overall compliance

2.   Site Organization & Management: (a) Maintain adequate inventory of supplies/IP drug   accountability record Help the investigator maintain essential documents at the site. (b)Make sure that all personnel involved in the study are well informed and follow    GCP guidelines (c) Make sure that the PI receives all the updated trial related documents (d) Manage the ERB submissions on clinical study up dates/communication by investigator on time

3. Recruitment and Randomisation: (i) Conduct initial in-office interviews of patients for acceptibility  (ii) Assess patient interest and protocol understanding (iii) Participate in obtaining the consent of pts. (iv) Randomisation of patients

4.   Patient visit scheduling: (i) Schedule the patient visits as per protocol schedule of events (ii)Coordinate patient visit with the physician schedule (iii)Network with the other departments (iv) Coordinate lab sample collection and pickup schedules (vi) Ensure protocol compliance for all events and procedures (vii)Evaluate patient status for safety and assure optimum health care

5.      Data Collection, Query Resolution and SAE Reporting: (i)Screen pt. chart to check eligibility (ii) Collect reports from various departments to complete the Source document (iii) CRFs completion (iii)Periodically update all the logs of study file (iv)Collaborate with the CRA (V) Query resolution (vi) SAE reporting on time

6.   Audits: Provide assistance for Routine auditing by sponsor and Other regulatory bodies to view

(i)       Study records

(ii)     Patient files

All source data of all patients in the study     

Clinical Research Associate (CRA) Job, Resposiblity, Qualification & Salary

Clinical Research Associate: CRA has an important task within the clinical trial process. He or she has the responsibility to verify that the rights and well-being of human subjects are protected and that the reported trial data are accurate, complete, and verifiable from source documents. Most importantly, the CRA makes sure that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirement. There are various levels at which a CRA can work. Examples of this are Junior, level 1 and 2 (also known as CRA Senior or Lead CRA). These differing levels determine the tasks and responsibilities to be carried out, and are often experience dependent.

Responsibilities of CRA 1:

• Perform routine site visits, including pre-study, initiation, interim, and closeout visits. Visits to include monitoring of proper informed consent procedures, compliance with protocol, GCP/ICH Guidelines and other applicable regulatory requirements and assurance of good site performance. This is accomplished by detailed review of subject records, essential documents, investigational product disposition and accountability, site personnel and procedures.
• Assist investigator meeting including preparation, liaison, presentations, problem resolutions, and follow up.
•  Ensure timely submission of protocol / consent documents for EC/IRB approval.
•  Maintain all files and documentation pertaining to studies.
• Motivate investigators in order to achieve recruitment targets.
• Manage assigned sites by regular contacts to ensure site compliance, adequate enrollment, and understanding of study requirements.
• Report to Research project team, client, and site personnel any findings noted at monitoring visits. This is accomplished by completion of monitoring reports and follow-up letters within the project-specific timelines. Significant issues noted must be reported to appropriate personnel immediately.
•  Maintain eClinical or alternative project tracking system of subject and site information.
•  Serve as back-up for Regional Manager, Clinical Operations when required.
•  Provide training for colleagues on clinical, regulatory, administrative, and company procedures and processes.
•  Participate in feasibility studies.
•  Assist with company’s quality control initiative.
•  Present study materials at Investigator/study launch meetings when required.
•  Support project management team with assessment of workload and site assignments within the project team.
•  Assist project management team with review of monitoring reports and study documents when required.
•  Participate in the interview process of potential candidates when required.
•  Participate in company-required training programs.
•  Perform necessary administrative functions (e.g., tracking of expense reports, time and attendance).
•  Maintain home office (e.g., procurement of office supplies, submission of documents).
•  Perform other duties as assigned.

Qualification:

• Bachelor’s level degree in life sciences, science related area, pharmacy, nursing, Medical, Dental, Allied Health Science, Master degree is preferred.  

• Clinical monitoring experience

• Strong knowledge of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements

• Proven ability to work independently in a fast-paced environment

• Strong communication, interpersonal, and organizational skills

• Must demonstrate good computer skills

• Ability to provide clear direction and guidance to others.

• Position requires approximately 60% travel (up to 80% during peak times).

Remuneration:

There is high demand for trained professionals in this field. Its a novel profession and pay package is very impressive which depends on candidate qualification and recruitment company. At entry level candidate can expect of around three to four lakhs or more per annum in INR. Salary is directly proportional to the experience.

Adverse Drug Reaction its classification, analysis and future trends

Adverse drug reaction (ADR) is defined by WHO as a response to a drug that is noxious and unintended, and occurs at doses normally used in patients for prophylaxis diagnosis or therapy of a disease.

ADR is classified as such-

Type A-Type A (Augmented) Reactions: are those related to exaggerated pharmacological effects of drug & tend to be fairly common (usually more than 1 in 100)

Type B (Bizarre) Reactions: are those that are unexpected & unpredictable, have genetic predisposition, allergy etc., are often serious.

Type C (Chronic) Reactions: which are due to long term use of drug.

Type D (Delayed) Reactions: e.g., teratogenesis, carcinogenesis.

Type E (End of Use) Reactions: which occur when discontinuation of drug is too abrupt.

Some adverse reactions subside with continuous use e.g., drowsiness with paroxetine.Patient has to tolerate sometime mild ADR to obtain appropriate therapeutic response. Some ADR are dose related & disappear if dose reduced.
Some are hazardous & unacceptable, require discontinuation of drug

ADR is analyzed by

COHORT STUDIES where patients taking a particular drug identified and events recorded. Only drawback is that can be done on small number of patients and lack of suitable control. Advantage is that incidence can be determined

CASE – CONTROL STUDIES which are retrorespectve studies where patient with diseases are compared with patients having no diseases. Its disadvantage is that difficult to get control and casualty cannot be ascertained. Advantage is that it requires less time.

USE OF POPULATION STATISTICS like based on the mortality data such as increase in death due to use of B2 agonist. Teratogencity data can also be utilized.

Causalty assessment is done based on the de-challenge and re-challenge of the drug.
Causalty categories like certain, probable and possible is based on the time factor as well as de-challenge and re-challenge.

Post marketing surveillance by pharmaceutical industry detects the ADR which is mandatory for new drugs released in the market. It is useful in generating signals and educating and informing patients. It also identifies the risk factors and the underlying mechanisms.

The science of pharmacovigilance could be enhanced with the availability of systems-based tools that facilitate analysis of aggregate data for purposes of signal detection, signal evaluation and knowledge management. One of the known pharmaceutical company has recently implemented Online Signal Management (OSM) as a data-driven framework for managing the pharmacovigilance of marketed products.

Ethical violations of informed consent

Ethics plays a very vital role in the conduct of a clinical trial. It is present in order to safe guard the physical health and mental integrity of a person. Taking about ethics what comes first to our mind is the importance of informed consent.

Informed consent is the consent given by an competent individual, who have been given all the necessary information about the trial and after having understanding and considering the information has come to a conclusion to take part in a trial without having been subjected to undue intimidation. It is a written signed and dated document done in presence of a impartial witness.

But this was not so always. There are different cases in the history of research that tells us about the unethical research conducted on the individuals.

During World War II in America and Britain president Franklin Roosevelt created an office of scientific research and development to combat diseases like dysentery influenza and malaria. One of the teams created a potential vaccine for dysentery.

This Vaccine was researched on orphans and mentally retarded individuals.Orphans developed high fever and died - Vaccines were proved a failure .Research Team felt that some sacrifices had to be made to benefit the society. An Anglican journal published that at least four residential schools were included in a clinical trial .5 year nutritional study was conducted in 1940’s with out the parents consent. The government presumed that research would benefit native communities.

One Dr. Southam who was an investigator at Memorial Sloan Kettering Cancer - centre was studying the immunology of cancer in cancer patients as well as healthy volunteers without their consent. Southam defended by stating that there was no risk that cancer would develop; and if he had mentioned the word ‘cancer’ it would have caused bizarre and defensive reactions in patients. He also defended saying that he had taken their oral consent. Dr.Henry Beecher, a physician in Harvard University published as many as 22 examples of unethical clinical trials in the New England journal in 1966.

Thus it is seen that a lot of ethical violations have happened in the history which had lead to establishment of ethical guidelines in clinical research.