Are you passionate about making a difference in the healthcare industry? Samahitha Research is thrilled to announce a fantastic job opportunity for freshers as a Clinical Research Coordinator. This role is based in Bengaluru, Karnataka, and offers an excellent starting point for individuals looking to build a career in clinical research.
Company Introduction
Samahitha Research is a leading clinical research organization committed to advancing medical research and improving patient outcomes. Known for its innovative approach and excellence in clinical operations, the company is focused on bringing fresh talent into the fold to support its mission. As a Clinical Research Coordinator, you’ll play a crucial role in ensuring the smooth execution of clinical trials, making it an exciting and rewarding career choice.
Responsibilities in Job
As a Clinical Research Coordinator, your responsibilities will include:
- Confidentiality Management: Safeguarding proprietary information related to Samahitha, sponsors, investigator sites, and third parties.
- Subcontractor Oversight: Acting as the main point of contact for subcontractors like clinical laboratories, translation agencies, and CRF/document printing agencies.
- Study Documentation: Developing or customizing essential study documents such as Study Management Plans, Monitoring Plans, Informed Consent forms, IMP Labels, and Study Guidelines in consultation with the Project Manager (PM) and sponsors.
- Regulatory Activities: Managing regulatory aspects of clinical trials, including compiling and verifying submission packages, and informing the project team of updates and new approvals.
- Meeting Coordination: Organizing and representing Samahitha at investigator meetings.
- Adverse Event Reporting: Overseeing the reporting process for adverse events during the trial.
- Clinical Trial Supplies Management: Ensuring the proper arrangement of clinical drug supplies, assisting in storage logistics, and maintaining accountability for drugs received and distributed to/from sites.
- Trial Master File Maintenance: Administering all study-related documents, including drug accounting, correspondence, and monitoring reports.
- Site Visits: Planning and conducting site initiation visits, routine monitoring visits, and site closure visits, ensuring quality control and greenlight approvals.
- Team Coordination: Supporting CRAs (Clinical Research Associates) and CTAs (Clinical Trial Assistants) involved in the trial and administering study data to databases.
- Study Progress Reporting: Providing progress updates to sponsors or Samahitha’s management team and archiving relevant documentation.
- Data Management: Handling data clarification flow and preparing co-monitoring visit plans when required.
- Team Communication: Maintaining updated communication with investigators and team members through newsletters, phone conferences, and other channels.
Qualification
This position is open to freshers, making it ideal for recent graduates or individuals looking to enter the clinical research field. While specific qualifications may vary, the ideal candidate should have:
- A degree in life sciences, pharmacy, nursing, or a related field
- A keen interest in clinical research and medical studies
Skills
To thrive in this role, you should possess the following skills:
- Attention to Detail: Precision is key in handling clinical data and ensuring compliance with protocols.
- Organizational Skills: You’ll be managing various tasks and timelines, making organization a top priority.
- Communication: Effective written and verbal communication skills are essential for interacting with the clinical team and study participants.
- Basic Computer Skills: Proficiency in MS Office and basic data entry is required.
- Problem-solving Ability: You should be able to think critically and address issues as they arise.
Ready to kick-start your career in clinical research? Samahitha Research is eager to hear from you! Interested and eligible candidates are encouraged to submit their resumes to career@samahitha.com.
