Clinical Trial Management
A Clinical Research is a systematic study for new drugs in human subjects to generate data for discovering or verifying the Clinical, Pharmacological (including pharmacodynamics and pharmacokinetic) or adverse Effects with the objective of determining safety and efficacy of the new drug.
Clinical Research Industry has grown around the world at an unparalleled rate in the past few years. It has opened up new vistas of employment for a large number of people. The Clinical Trials market worldwide is worth over US$ 45 billion and the industry has employed an estimated 2,10,000 people in the US and over 70,000 people in the UK and they form one third of the total Research and Development staff. These large numbers can be attributed to the fact that this industry offers lucrative employment opportunities. The average nominal annual salary growth across all the positions is 4% as against less than 1% for other segments.
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Different early level positions/Designations in Clinical Trials
- Clinical Research Coordinator (CRC):
- Coordinates daily clinical trial activities.
- Ensures compliance with study protocols.
- Manages patient recruitment and follow-ups.
- Clinical Trial Assistant (CTA):
- Provides administrative support to clinical trial teams.
- Maintains trial documentation and databases.
- Assists with regulatory submissions and monitoring visits.
- Clinical Research Associate (CRA):
- Monitors clinical trial sites to ensure compliance with protocols.
- Reviews and verifies data from clinical trials.
- Conducts site visits and audits.
- Senior Clinical Research Associate (Senior CRA):
- Leads monitoring activities for complex or multi-site trials.
- Provides mentorship and training to junior CRAs.
- Manages escalations and critical site issues.
- Clinical Trial Manager (CTM):
- Oversees the planning, execution, and completion of clinical trials.
- Coordinates with cross-functional teams and external vendors.
- Manages timelines, budgets, and resources.
- Project Manager (Clinical Trials):
- Leads clinical trial projects from initiation to closure.
- Ensures project goals are met on time and within budget.
- Communicates with stakeholders and manages project risks.
- Clinical Program Manager:
- Oversees multiple clinical trials within a program.
- Develops program strategies and goals.
- Coordinates resources and resolves program-level issues.
- Clinical Operations Manager:
- Manages clinical operations teams and activities.
- Ensures adherence to SOPs and regulatory guidelines.
- Develops and implements operational strategies.
- Regulatory Affairs Specialist:
- Prepares and submits regulatory documents.
- Ensures compliance with regulatory requirements.
- Liaises with regulatory authorities.
- Quality Assurance Manager (Clinical Trials):
- Oversees quality assurance processes for clinical trials.
- Conducts audits and inspections.
- Implements corrective and preventive actions.
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).
All trials are conducted ethically, as defined by the Declaration of Helsinki, rigorously, as defined by the International Conference on Harmonization Guidelines (ICH).
Benefits outweigh risks for each patient.
Clinical Research Associate
CRA Is key participant in the design, implementation and monitoring of clinical trials, preparation of integrated medical reports, INDs, Investigational Device Exemptions (IDE), periodic reports, New Drug Applications (NDAs) etc. Participates in design and writing of protocols, case report forms and informed consent forms for clinical trials. Productive in recruitment/selection of new investigators, contract research organizations and outside vendors. Responsible for planning and implementing all activities required to conduct and monitor complex clinical trials and ensures that Good Clinical Practices (GCP) are followed. Conducts site visits pre-study, at study initiation, at regular intervals during the study and at study closeout. Monitors investigator performance and adherence to protocol, and proactively addresses conduct issues and enrollment problems, as necessary.
Ensures that Case Report Forms (CRF) are reviewed in a timely fashion and submitted to the data management group. Involved in the compilation/writing of integrated medical reports and clinical sections of INDs, IDEs, New Drug Applications (NDAs) etc. Assists in preparation of presentations and manuscripts of scientific meetings and technical journals. Attends scientific/professional meetings and training courses as appropriate.
