[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 leading Contract Research Organization with over 25 years in the industry, focusing on delivering reputed company and reputed company services across various therapeutic indications. The reputed company Clinical Research Associate will reputed company and guide the clinical team while ensuring high-reputed company execution and compliance in clinical trials at a country or regional level.
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 return 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 laboratory 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
- Valid 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
reputed company