New studies are initiated worldwide at a growing pace in the constantly evolving clinical trial industry that has shown a phenomenal increase in developing novel innovative products for treatment and prevention. Every drug product undergoes clinical trials before their launch in the market.
Clinical Trial Professionals
Research studies called clinical trials are conducted to evaluate safety and efficacy of preventive strategies, treatments, medical approaches or devices for certain diseases or illnesses in humans and help in healthcare decision-making. The professionals in clinical trials follow strict and highly scientific standards that protect patients and produce reliable results. Clinical trial professionals conduct research studies that begin with developing new test ideas followed by animal testing and finally human studies before reaching the market.
Clinical Research is a booming field that hires trained and skilled candidates in various health or medical organizations. There are endless clinical research job opportunities available due to increasing global demand for these trained professionals. Career paths in clinical research vary from administrative to technical positions. Positions available are managers, investigators, research nurses, auditors, quality assurance specialists, business development manager and more.
Job Opportunities in Clinical Trial Management
Clinical Research Associate (CRA) also called Field Monitor, Clinical or Trial Monitor supervises administrative needs of clinical trial. Their duties and responsibilities include ensuring data filing; reviewing case reports; accounting for investigational product; monitoring investigators and assisting with the research on biologics, pharmaceuticals and devices with application of Good Clinical Practices and protocols. Clinical Research Coordinator (CRC) also called Research Nurses or Site Managers come under the immediate direction of the investigator. CRCs prepare the site location, monitor trials, screen patients and comply with good clinical practices (GCP). Clinical Research Manager (CRM) supervises writing case report forms or informed consents and designing protocols in clinical trials.
Clinical Research Scientist or Investigator is experienced in monitoring and conducting clinical research trials and scientific tests. They are familiar with submission process and regulatory framework. Research Assistant work with the trial sponsor and perform administrative duties of maintaining and updating data entries, databases and distributing trial related data; recruiting patients; recording adverse results and documenting all the information. Clinical Data Managers are incredibly important architects of the clinical systems that produce and maintain data; collect strategic, thorough and analytical clinical data; review trial protocol and instruct team members on protocol implementation.
Clinical Safety Analysts are experienced in clinical field to organize, monitor, code and track medical care and adverse events, if any. The Clinical Quality Assurance Auditor (CQA) needs to ensure quality assurance, comply with standard operating procedures (SOP) and remain updated on changing rules, standards and guidelines of clinical trials. A Quality Assurance Specialist complies with clinical and manufacturing practices; reviews and approves documentation; assist in training and auditing. A Clinical Trial Management System manager and associate ensure trials are conducted and recorded with complete documentation. Administrator of Clinical System Information oversees functioning of computer programs and computer systems to maintain operative status of the trial facility.
Honest and ethical biostatistician set parameters for data collection and analyse compiled trial data while medical writers formulates reports of clinical trial results. A pharmacovigilance associate (PVA) evaluates and reports benefits and risks of pharmaceuticals investigated in a trial. Patient Recruitment Manager and specialists are involved in the recruitment and retention of participants or volunteers along with maintaining strict patient confidentiality in a study.
A Regulatory Coordinator and Specialist monitor procedures and reports while ensuring strict adherence to regulations and ethical code. Regulatory Affair Manager bridges gap between government agencies and pharmaceutical companies with responsibilities to track legislation process, ensure legal compliances and register documents for filing. The Senior Regulatory Associate manager regulatory department to ensure the documentation complies with regulatory authorities.
A business development assistant and manager assists in client relationships; proposal presentation; preparation and distribution ofinformation to team members and clients. The Senior Business Development Associate work largely with clinical research clients and prospective clients, prepare study proposals, manages timelines and budgets. The Manager of Clinical Development manages the team; reports results; creates strategies for trial, procedure for medicine development and oversees performance of clinical trials.The Director oversees guidelines and budgets, manages the staff and monitors development of clinical procedures and processes. The Vice President and President communicate with investors, monitor study plans and goals along with managing staff and budget.
Online Course in Clinical Research
James Lind Institute (JLI) provides an online program Post Graduate Diploma in Clinical Research which helps secure jobs in the field of clinical trial. JLI also conducts online programs in Pharmacovigilance, Medical and Scientific Writing, Clinical Data Management, Regulatory Affairs and Quality Assurance.
For more information please visit: www.jliedu.com