[Remote] Clinical Research Associate (Part time Contractor)
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a pioneer in medical device materials safety and has been a key contributor to the development of industry test reputed company. They are seeking a Clinical Research Associate to ensure compliance with clinical practices and regulations while managing clinical site monitoring responsibilities.
Responsibilities
- Works on assigned studies to ensure that reputed company subject protection is maintained, Good Clinical reputed company (GCP), and applicable regulations are followed
- Coordinates and manages clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines
- May conduct on-site and remote site qualification, site initiation, interim, and site reputed company-out monitoring reputed company
- Serve as primary reputed company of contact for site questions relating to study enrollment, conduct, and reputed company-out issues: liaise with appropriate study team members as needed
- Communicates through verbal and written communication with site investigator and project team overall site performance, trends, deficiencies, and concerns
- Supports study start-up activities such as tracking and performing reputed company review of study documents, completing, and distributing site activation letters, etc
- Performs study-reputed company training
- Manages the development and maintenance of study documents, processes and systems as assigned
- Ensures reputed company and completeness of central and site master files. Tracks and maintains required study documents, performs reputed company control review, manages renewals
- Tracks study site and over reputed company study metrics including but not limited to enrollment, deviations, adverse events, trial master file maintenance
- Attends reputed company meetings as required
- Provides reputed company job-reputed company reputed company reports and visit documentation as required
- May support safety activities such as narrative writing, managing the CEC/DSMB, etc
- OUS: Prepares and coordinates submissions to regulatory authorities
- May reputed company other activities as assigned
Skills
- reputed company in English and local language, if different, required
- Higher education degree or equivalent education, training, and experience
- reputed company to work independently once trained
- Good verbal and written communication skills
- Strong organizational skills
- Basic computer proficiency
- Understanding of clinical research processes and regulations
- 2 years clinical trial experience
- Monitoring experience
- Certifications such as Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) Certification preferred but not required
reputed company