We are looking to add a CRC to our growing team- if you enjoy a collaborative environment and are looking for a company with a ton of room for growth- join our team! We are looking for someone interested in moving into a leadership role in the next 12 months.
Qualified candidates will have at least 3-4 years of experience working in therapeutic or medical device clinical trials.
Responsibilities include :
- Maintaining thorough knowledge of study-specific inclusion / exclusion criteria
- Performing safety and efficacy assessments per protocol
- Vital signs, EKGs, and other assessments as assigned
- Accurate and timely completion of source documents recording participant's participation in the study
- Communicate closely with all departments to ensure study visits are coordinated in compliance with protocol and GCP guidelines
- Assist investigators in the collection of information from participants regarding AEs, concomitant medications, and other changes throughout participation
- Responsible for timely data entry and query resolution
- Timely reporting of study events (SAEs, protocol deviations,
- Following subjects through study completion and creating a follow-up care plan with a physician, study subject, and primary care provider;
- Ensuring preparation for and facilitating of all study monitoring visits and following up promptly with monitor follow-up letters
- Prompt and professional communication with sponsors, representatives, and other study-related parties
- Maintaining professional and appropriate interactions with study subjects, caregivers, sponsors, and all other study-related personnel, and staff members
- Interacting with nursing / unit staff on a daily basis as applicable to ensure communication and accurate completion of source through daily chart review
- Keeping CTM informed of study status and any study-related issues
- Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials
medixLS
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