- Assist in study startup, monitoring and close out activities.
- Assess the suitability of potential clinical trial and study sites, identifying investigators to be responsible for studies.
- Develop clinical trial and study procedures and protocols and design clinical investigation materials.
- Collect case report forms (CRFs) or electronic case report forms (eCRF) and run sourcing document verification (SDV) and adjudications.
- Set up clinical study sites.
- Conduct site initiation visits and training for clinicians and site staff on procedures, protocols and study requirements.
- Monitor clinical trials throughout their duration in collaboration with team members, ensuring that it has been carried out in line with relevant laws and regulations, and writing visit report documentation.
- Track clinical trial/study trends or adverse events.
- Close out trial/study sites upon completion, ensuring any unused supplies are accounted for and prepare final reports.
- Verify and review clinical trial/study data and source documents for accuracy, completeness, and compliance with Good Clinical Practice (GCP) standards.
- Address and resolve data discrepancies promptly, ensuring data quality and integrity throughout the trial/study.
- Collaborate with investigative sites and study personnel to address protocol deviations and implement corrective actions.
- Maintain study documentation and records in accordance with regulatory requirements and company standard operating procedures (SOPs)
- Participate in study team meetings, investigator meetings, and training sessions as required.
- Assist with the preparation and review of study-related documents, including protocols, informed consent forms, and monitoring plans.
- Support regulatory submissions and inspections by providing timely and accurate documentation as needed.
- Contribute to the development and implementation of risk-based monitoring strategies to enhance trial/study efficiency and data quality.
- Bachelor's degree in a relevant field of study.
- Minimum of 2 years of experience in clinical research, preferably as a Clinical Research Associate.
- Clinical experience preferred; nursing, non-practicing MD, in-facility healthcare experience.
- Strong understanding of clinical trial/study processes, GCP guidelines and regulatory requirements.
- Excellent communication, organization and problem-solving skills.
- Ability to work independently and collaboratively in a dynamic, fast-paced environment.
- Proficiency in Microsoft Office applications and electronic data capture (EDC) systems.
- Experience with risk-based monitoring approaches and centralized monitoring techniques.
- Knowledge of FDA and ICH regulations.
- Experience with Global Retrospective Studies, and familiarity with GDPR.
- Experience with electronic trial/study master file (eTMF) systems and document management tools.
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Clinical Research Associate - Boston, United States - Elucid
Description
Are you working in a job that is making a difference for millions of people? If not, keep reading to learn more about Elucid. We are a rapidly growing, Boston-based medical technology company using AI to help clinicians make more informed decisions on cardiovascular care - leading to better patient outcomes, improved quality of care, and reduced healthcare costs. Come work at Elucid and be part of delivering on our mission to prevent heart attacks and strokes.*** While the position is listed in Boston, MA we are accepting resumes from candidates in the continental US, eastern time zone preferred ***
Join Elucid as we expand our team with the newly created role of a Clinical Research Associate. This is a unique opportunity to play a pivotal role in groundbreaking clinical trials aimed at conquering cardiovascular disease. The Clinical Research Associate is responsible for the execution of clinical investigations, ensuring compliance with protocols, regulatory requirements and quality standards. You will also be responsible for monitoring clinical trial sites, assessing data integrity, and fostering effective communication between sponsors, investigators and study staff. The position does involve a significant amount of travel.
Responsibilities:
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Even if you don't check every box, but see yourself contributing, please apply.
