White Papers         Sitemap

Clinical Research Career Options


Target Audience:


Students willing to choose clinical research career options or willing to undergo a clinical research training.


Not many people are aware of the fact that they need not necessarily belong to purely scientific educational background to become a part of clinical research industry. One can be a part of this flourishing industry even if he/she have a degree in life sciences, nursing, computer/IT, chemistry, engineering, commerce, marketing and business management.


This article helps you navigate through a variety of clinical research career options and their corresponding qualification, skills and talent. This is an attempt, to make the choice of an appropriate clinical research career, simple and effortless. This article also throw some light on what qualities recruiters in clinical industry are looking for.


Major pharmaceutical industries around the globe are in a race to bring new drugs and other pharmaceutical products onto the pharmacy shelves. This in turn, will require switching the focus of pharmaceutical industry from pre-clinical research and development to large-scale clinical trial work. This suggests that coming few years, hold a major boom for clinical research and bio-pharmaceutical industry. As a result, industry will witness a sky rocketing demand for CRPs (Clinical Research Professionals), belonging from various professional qualifications. The article provides a comprehensive information about various career options available in clinical research.



Clinical Reseach Career Options


Some of the most promising career opportunities in clinical research and their respective educational requirements are mentioned here.



1. Clinical Research Associate (CRA)


CRA is a professional engaged in monitoring and progress of clinical trials and clinical research studies on behalf of the sponsor. A CRA may also be referred as Clinical research monitor, coordinator or scientist.


Roles and Responsibilities:


  • To locate and consult a doctor/investigator to conduct clinical trial.

  • Checking trial materials in study center and ensuring that the investigator knows his job.

  • Paying regular visits to the study center and checking the patient’s information in Case Report Forms (CRFs).

  • Validating that CRFs collected from hospitals.

  • Closing the study center after the trial is over.

  • Discussing results with statistician.


Qualification and Skills Required:


A relevant degree in life sciences (especially pharmacology, pharmacy, biochemistry, immunology, physiology and toxicology) and medical sciences (Nursing degree) is required. A simple graduate with no relevant prior work experience is likely to enter into the industry at a lower level (data handling/coordinator). Experience in initiating and designing of trials can qualify you to be a CRA.



2. Clinical Data Manager


Clinical data manager is responsible for handling the data processing and analysis on behalf of the sponsor. This data is collected from the sites of clinical trials.


Roles and Responsibilities:


  • Maintaining accuracy, security, confidentiality and integrity of computerized records by applying relevant knowledge, policies, protocols and procedures.
  • Screening, grouping, summarizing and coding of the data to solve operational problems.
  • Preparing status standards and statistical reports.
  • Data related activities include CRF tracking, reviewing, validation, updating and applying safety codes.
  • Other duties include data entry, library searches etc.

Qualification and Skills Required:


A relevant Bachelor’s degree in computer science, mathematics, statistics, or database specialist, life sciences and medical sciences is required. Candidates with experience in data entry and skills in Computer Programs, Oracle, SAS, MS word, Power Point, Access are preferred. An IT degree and a nursing degree is one of the requirements for working as a clinical data manger. Graduate with no relevant work experience and necessary personal skills is likely to be absorbed in this industry at lower level. Required skills include knowledge of Good Clinical Practices (GCP). Pre-entry experience include statistical work or data management, a medical practice, a nursing background, clinical data work or pharmaceutical work. One with the above stated qualifications and skills will be employed either in a pharmaceutical company or a Contract Research Organization (CRO).



3. Quality Assurance (QA):


Quality assurance department supremely deals with validation of all aspects of the clinical trial process. In biotechnology industry, the role of quality assurance specialist is relatively complicated. This includes proper vigilance of safety, efficacy, purity, and stability of end products.


Roles and Responsibilities:


  • Ensure timely completion of QA procedures, packaging, Formulation Department in-process testing checks, sampling and other related duties.
  • Ensure implementation of Good Clinical Practices (GCPs), Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMPs) with specific emphasis on any one of them depending on employer’s requirement.
  • Timely inspection and reconciliation of the production rooms, equipments and raw material.
  • Report non-conformances identified during routine monitoring and in-process testing to QA Supervisor.
  • Ensure that all the aspects of manufacturing process, packaging process, and Formulation Department are in accordance to the SOPs (Standard Operating Procedures) and safety guidelines.
  • Assist in development and execution of inspection system for quality inspection in manufacturing and packaging facility.

Qualification and Skills Required:


A relevant degree in Engineering, Chemistry, Biochemistry, Computer Science Pharmaceutical, Biology, Medical Sciences and Business Administration is required. Thorough knowledge of GCP, GLP, and GMP with interpersonal and organizational skills are prerequisites for this job. People with an additional experience in pharmaceutical industry and computer literacy (general word processor/database software) are the most promising candidates for this position. Additional skills include good interpersonal skills, excellent verbal and written communication skills, ability to identify GMP and quality related issues, time management skills and knowledge of Food and Drug Administration (FDA) regulatory requirements.



4. Project Manager and Marketing Executives:


The project managers and marketing professionals make sure that a particular drug is not only safe and effective but is also cost-effective for efficient disease management.


Roles and Responsibilities:


  • Manage client requirements, project planning, and evaluation of risks.
  • Maintain a record of patient number, data quality, GCP standards, protocol and regulatory approval, and appointment of CRAs.
  • CRF printing, investigatory drug manufacturing, packaging and estimation of budget.
  • Proper vigilance and monitoring till the project is over.

Qualification and Skills Required:


Academic degree in Business Administration, Commerce and Economics is required. A complete knowledge of GMP, GCP and GLP with computer literacy is a must. Prior experience in pharmaceutical industry would be an added advantage for aspiring candidate. Additional skills include excellent verbal and written communication skills, along with organizational and interpersonal skills.



5. Clinical Investigator:


Clinical investigator is generally a physician possessing a license to practice anywhere in the country.


Roles and Responsibilities:


  • Physician conducting clinical research is responsible for providing patients with additional treatment options.
  • Helping people suffering from life-threatening diseases, who have not found appropriate medical solution.
  • Offering drugs which are potentially effective.
  • Providing patients with opportunity to improve health care.

Qualification and Skills Required:


Academic qualification required is equivalent to that of a physician with special interest in drug development and other aspects of clinical research/trials are required.



6. Other Jobs:


Some other jobs which require relevant educational background and experience in clinical research processes are listed below.


  • Account Diectors: This includes a number of other designations like business development analyst, clinical project director, clinical program manager. A degree in life sciences and interest in medical writing and pharmaceutical marketing is a must. Extensive knowledge and experience in project management will be preferred.


  • Clinical Auditors: This includes GCP specialist and QA auditors. A graduate level qualification in life sciences with a strong knowledge about GCP, GMP, GLP auditing processes.


  • Contract Managers: This includes contract associates, senior proposal and contract managers, senior project managers. One must possess a bachelor's degree in life sciences with work experience in proposal writing and thorough understanding of complete clinical development process.


  • Drug Safety Scientist: This includes Drug Safety Monitor, Drug Safety Officer, Drug Safety Associate. A masters degree in life sciences/pharmacology with good experience in medical writing, computers, regulatory requirements, drug information and other clinical processes.


  • Regulatory Affairs Manager: This includes Senior Regulatory Associates, Manager (Regulatory Affairs) etc. A graduate degree in life sciences and at least 4 years of clinical research experience and knowledge of FDA requirement is a must.

A degree in clinical research management will always give the candidate an upper edge over other candidates for all the positions.

Conclusion


A variety of job opportunities offered by the clinical research industry suggests that the future of this industry is more hopeful than gloomy. All you need is the right attitude, positive approach and hard work to accept the challenges posed by this industry. The combination of complete understanding of clinical trial processes and appropriate skills can make you a candidate of choice for several leading international pharmaceutical companies and government agencies. Apart from all the above qualities and qualification required, a clinical research career needs extreme dedication and commitment.

 

TO KNOW ABOUT CLINICAL RESEARCH CAREER OPENINGS WITH FERMISH PLEASE CLICK HERE


Clinical Research  |  Regulatory Affairs  |  IT Services  |  E-Learning
home  |  About us  |  Career  |  Collaboration  |  Why Us  | News Room  |  Blogs  |  Contact Us