Cliantha Research is seeking a dedicated Clinical Research Associate to join our team. The ideal candidate will play a crucial role in ensuring the successful execution of clinical trials and research studies. You must have 2 years experience in this roll. We would also lie this person to be on the east coast as most of our locations are on the east coast.
This is a fully remote position. However, you will be required to travel as much as 75% of the time and we do not want this to be an issue.
You will be provided with full benefits within 30 days of employment. You will receive 2 weeks of vacation and 2 weeks of PTO every Year! Cliantha Research also offers paid life insurance at two times your salary for NO COST!
We want the very best for our employees!
Responsibilities:
- Supervise and monitor clinical trials to ensure adherence to protocols and regulatory standards
- Perform vital sign assessments and blood sampling as required
- Oversee compliance management and documentation throughout the research process
- Collaborate with clinical laboratory staff to coordinate sample collection and analysis
- Maintain accurate records of all research activities in accordance with Good Clinical Practice (GCP) guidelines
- Assist in the development and implementation of clinical research protocols
- Identify and qualify potential investigators to ensure that the sites have adequate time and can fulfill their obligation to the study.
- Responsible for identification & collection of necessary documents to be forwarded to Project Manager/ designee, to check the feasibility of site/ investigator and approval from authorities.
- Prepare or submit or support other colleagues for Regulatory and EC submissions and in the generation of Financial Agreements according to standard and local country practices.
-Conduct of monitoring visits as per monitoring plan to check compliance with study
management, protocol & other requirements at all assigned sites.
-Responsible for training of site study team regarding the monitoring plan, recording &
maintenance of essential documents and for startup activities & site initiation as per the
guidance of Project Manager.
- Assist for the preparation and presentation at investigator meetings, as required to ensure that the clinical and investigational site staff team are well informed about the study and related procedures.
-Maintaining a working copy of Central Investigator File & ensuring consistency with the Site Investigator File to maintain a working record of all essential documents and reports.
-Perform source document verification as per monitoring plan and ensure that source documents & other trial records are accurate, complete, kept up to date & maintained according to applicable SOPs to avoid incomplete records.
-Ensure timely collection of documents like CRF, DCF etc. from the site along with SAE reports in order to provide Biometrics/licensing authority & others with the necessary documents.
-Responsible for study updates & Coordination with Labs & other trial related services as per the study requirements.
-Responsible for IP accountability and availability, tracking and management of all Clinical Trial related supplies shipped to the sites/ warehouse & accordingly clinical trials supplies vendor management for the study.
-Ensure proper escalation of site/project related issues to Project Manager/ Designee on timely manner.
-Responsible for site-closeout & follow up activities to maintain documents at the site.
-Attend staff meetings and training sessions as required to complete the training curriculum in a timely manner.
-Assist with the audit of an investigational site or central files and liase with Quality Assurance personnel as required to ensure that the study is being conducted in accordance with ICH GCP and applicable regulatory guidelines.
-To liaise with other departments within the organization for timely achievement of the project milestones.
Requirements:
- Bachelor's degree in a relevant field such as Life Sciences or Nursing(Prefered)
- Proven experience in clinical research, preferably in a supervisory role(2 years experience)
- Strong knowledge of medical terminology and clinical development processes
- Familiarity with GCP guidelines and regulatory standards in clinical research
- Proficiency in blood sampling techniques and vital sign assessments
- Excellent organizational skills with attention to detail
- Ability to work effectively in a fast-paced environment
This is an excellent opportunity for individuals passionate about advancing medical research and contributing to the development of innovative healthcare solutions.
Job Type: Full-time
Pay: $70,902.00 - $80,522.00 per year
Benefits:
- 401(k)
- Dental insurance
- Flexible schedule
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Experience level:
Schedule:
- Monday to Friday
- Weekends as needed
Work Location: Remote