Company Description
Hart Clinical Consultants (HCC) is a full-service Contract/Clinical Research Organization providing staff augmentation and comprehensive study management services through all phases of clinical trial operations. We assist business partners to provide unparalleled world-class support and service to ensure clinical and regulatory activities are conducted expertly in the conduct of global or US focused clinical trials. Our team is expert operating under either 312 or 812 regulations managing studies from phase 1 (first in man) to phase IV (post-market).
Role Description
This is a remote contractor role with potential for a full-time position for a Senior Clinical Research Associate (CRA) at Hart Clinical Consultants (HCC). As a Senior CRA, you will be responsible for conducting and managing clinical trials, ensuring compliance with regulatory standards and protocols, and supporting the overall success of clinical research projects. You will collaborate with cross-functional teams and stakeholders, collect and analyze clinical data, and communicate effectively with investigators and study sites.
Qualifications
- Bachelor’s degree in a relevant field (e.g., Life Sciences, Pharmacy, Nursing)
- Minimum of 2+ years of experience as Clinical Research Associate in a CRO with Cardiovascular, Neurovascular medical device and Diabetes or a pharmaceutical company
- Thorough knowledge of ICH-GCP guidelines and regulatory requirements
- Experience in coordinating and managing clinical trial activities
- Strong organizational and problem-solving skills
- Excellent communication and interpersonal skills
- Attention to detail and ability to work independently
- Proficiency in using electronic data capture systems and clinical trial management systems
- Flexibility to travel