BioSRL is a leading clinical research organization that plays a pivotal role in conducting high-quality clinical studies. They are committed to providing a broad range of services aimed at delivering innovative and effective medical solutions. The company’s mission is to ensure optimal healthcare by conducting thorough clinical research while upholding the highest standards in safety and compliance. Bi SRL values professional growth and offers a dynamic work environment for individuals who are passionate about contributing to healthcare advancements.
Job Responsibilities: As a Clinical Research Associate (CRA) at BioSRL, you will be involved in a wide range of clinical activities, ensuring the smooth execution of studies and compliance with regulatory requirements. Your main responsibilities will include:
- Preparation of Protocol and Regulatory Documents: You will be responsible for creating and reviewing clinical study protocols, informed consent forms, and other essential regulatory documentation. This is a key step in ensuring all studies are carried out according to ethical and regulatory standards.
- Clinical Study Report Compilation: After completing clinical studies, you will be tasked with preparing detailed study reports that reflect the data collected, including analysis and conclusions drawn from the findings.
- Standard Operating Procedures (SOPs): You will be involved in preparing, reviewing, and ensuring the accurate implementation of clinical SOPs. These SOPs are critical for the consistency and standardization of clinical research processes.
- Change Control Documentation: In collaboration with the team, you will raise and document changes for clinical SOPs, instruments, and equipment used in clinical studies.
- Screening Activities: You will assist in the screening process, including biometric verification, demographic examinations, alcohol consumption tests, and drug abuse tests to ensure the subjects meet the study’s criteria.
- Assist in Protocol Meetings: As part of the team, you will help organize and assist the principal investigator during protocol meetings.
- Informed Consent Distribution: You will play a crucial role in distributing informed consent forms to volunteers and conducting group counseling for the study subjects.
- Support in Consent Presentations: Assist physicians and clinical investigators in presenting the informed consent forms to subjects and ensuring they are fully understood.
- Labeling for Sample Collection: You will be responsible for preparing labels for samples to ensure correct identification and proper storage during the study.
- Dispensing and Dosing Activities: Monitoring and conducting dispensing and dosing activities will be a part of your role to ensure proper medication administration to study participants.
- Sample Processing and Transfer: You will help in processing, segregating, and transferring study samples for analysis.
- Monitoring Clinical Activities: Monitoring clinical activities, including blood collection, sample processing, meals, and restrictions, is critical to ensure compliance with the study protocol.
- Documentation and Record-Keeping: You will compile and review study documents such as the Trial Master File (TMF), Case Report Forms (CRF), Informed Consent Forms (ICF), and others to maintain a comprehensive record of the study.
- Subject Tracking: Keeping track of subject check-in and check-out details is essential to ensure the proper management of study participants throughout the clinical trial.
Qualifications: To be eligible for this Clinical Research Associate role, the following qualifications are required:
- Education: A Bachelor’s or Master’s degree in Pharmacy (B. Pharma / M. Pharma) is mandatory.
- Experience: Ideal candidates will have 0 to 2 years of experience in clinical research or related fields.
- Knowledge: A sound understanding of Good Clinical Practices (GCP), regulatory requirements, and clinical trial processes is highly beneficial.
Skills: As a Clinical Research Associate, the following skills are essential to excel in your role:
- Attention to Detail: Precision and accuracy are crucial in clinical research to ensure correct documentation and protocol adherence.
- Communication Skills: Excellent written and verbal communication skills to effectively work with teams and present information to participants.
- Problem-Solving: Ability to address issues and challenges as they arise during clinical trials.
- Organizational Skills: Strong organizational skills to manage multiple tasks, including documentation and regulatory compliance.
- Teamwork: A collaborative mindset, working closely with various stakeholders such as physicians, investigators, and other clinical research staff.
Interested candidates Please send your CV titled “CRA” to hr2@biosrl.com