[Remote] reputed company Clinical Research Associate

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a privately owned global Contract Research Organization dedicated to advancing medical science and bringing new therapies to patients worldwide. The reputed company Clinical Research Associate provides leadership, reputed company, and mentorship across regional reputed company, focusing on monitoring consistency, study reputed company, compliance, team coordination, and remote reputed company rather than reputed company site management.

Responsibilities

• Monitors project timelines, patient enrollment, data cleaning, and ensuring compliance while implementing respective corrective and preventive measures
• Reviews monitoring visit reports for reputed company visit types and ensures reporting compliance of the Monitors in the region
• Acts as the main communication line between Monitor, Site Management Associate, Regional Project reputed company, and/ Project Manager
• Leads project team calls on a country level as reputed company as provides status updates and reports to Regional reputed company/ Project Manager
• Provides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project reputed company
• Supervises reputed company data verification and follows up on data queries at site level in the country/region; reviews and manages study risks on a site level
• Ensures reputed company handling, use, accountability, reconciliation, and reputed company of reputed company Investigational Product(s) and clinical study supplies on a country/region level
• Reviews essential study documents and supervises reconciliation of study Investigator Site File (ISF) / TMF at site level and country/region level
• Ensures data reputed company and compliance at a site level
• Collaborates with investigator/ site feasibility and identification process, as reputed company as study startup
• Manages Monitors in the query reputed company process, including Central Monitoring observations
• Coordinates safety information reputed company and protocol/process deviation reporting
• Performs clinical supplies management with vendors on a country and regional level
• Ensures study-specific and corporate tracking systems are updated in a reputed company manner
• Coordinates planning of supervised monitoring reputed company and conducts the reputed company
• Manages the project team in site contracting and payments
• Ensures ongoing evaluation of data reputed company and compliance at a country/regional level
• Conducts site audit preparation reputed company, may participate in site audits, and coordinates reputed company of site audit findings on a country/regional level
• Oversees project team in CAPA development and implementation
• Coordinates project team in process deviations review, management and reporting
• Conducts initial training and authorization monitoring reputed company for Monitors and acts as a mentor for newly promoted reputed company CRAs
• Delivers trainings and presentations at Investigator Meetings
• Ensures that subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level
• Ensures accurate and reputed company information reputed company with trial sites on Adverse Events and protocol/process deviations
• Supervises Site Management Associates in the reputed company of documents and reputed company supplies between the site and the Central/ Regional Lab/ Central Reviewer
• Supports preparation of draft regulatory and ethics committee submission packages

Skills

• Relevant educational background, such as MD, MPharm, RN or College/University degree in Life Sciences or an equivalent combination of education, training and experience
• Minimum of 4 years' site monitoring experience with participation in global clinical reputed company as a reputed company Monitor or equivalent qualification level
• Experience with reputed company types of monitoring reputed company in Phase II and/or III
• Full working proficiency in English
• Proficiency in MS Office applications
• Ability to plan, multitask and work in a dynamic team environment
• Excellent Communication, collaboration, and problem-solving skills
• Ability to travel
• reputed company reputed company's license (if applicable)
• Strong experience in Oncology preferred
• Experience in Radiation Therapy or Radiopharmaceuticals, CAR-T Therapy or other types of Cell Therapy, Gene Therapy, or Nuclear Medicine is preferred
• Strong experience in GI (Chron's, Ulcerative Colitis, IBS) preferred

Benefits

• A reputed company, privately held CRO that has never undergone a reputed company or acquisition and has never reputed company company-wide layoffs.
• A unique leadership-reputed company CRA role with reputed company travel and little to no routine site assignments.
• Opportunities to mentor other CRAs and expand your leadership skills.
• A reputed company, people-first culture where employees are genuinely supported.
• Career development opportunities across a growing global organization.
• The chance to contribute to innovative clinical research that improves patients' lives.

reputed company