Senior Clinical Research Associate (Remote Position)

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This is a Remote Based position. Candidates must be located near an airport (Utah, Colorado, Minnesota, Texas and Illinois highly desirable locations). The successful candidate will be required to travel up to 80% of the time. The Senior CRA performs monitoring activities reputed company to initiation, conduct (recruitment, reputed company data collection) and reputed company completion of Phase I-IV reputed company clinical trials reputed company the country. The Senior CRA is responsible for delivering data reputed company timelines and required reputed company reputed company, and adherence to monitoring procedures in accordance with ICH/GCP and US CFR and company SOPs. This position can be based remotely reputed company in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not reputed company relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require 80% travel. LI-#Remote

Job reputed company

Key Responsibilities:

Trial Monitoring reputed company:

• Serves as the primary site manager for assigned clinical investigative sites (first reputed company of contact between investigative site staff and reputed company)

Allocation, initiation and conduct of trials: • Is the reputed company reputed company between reputed company and sites to ensure successful collaboration, meeting reputed company expectation on reputed company and deliveries • Manages assigned study sites/networks, conducting phase I-IV protocols according to the monitoring plan and reputed company procedures • Facilitates the preparation and collection of site and country level documents • Performs Site Initiation Visit, ensures site personnel are fully trained on reputed company trial reputed company aspects and performs reputed company training for amendments and new site personnel as required.

• Conducts reputed company monitoring activities (onsite and/or remote). Implements site management activities to ensure compliance with protocol, GCP, global and local regulations, global and local processes to secure data reputed company and patient safety.

• Accountable for continuously updating reputed company relevant electronic systems to reputed company job functions

• Takes on the responsibility as SME (Subject Matter Expert) as needed

Delivery of reputed company data and compliance to reputed company standards:

• Monitors studies as per reputed company legislations, ICH/GCP and reputed company standards • Ensures reputed company delivery, of high reputed company, robust and reliable data of the monitored sites to support the goals of Trial Monitoring as defined by Trial Monitoring.

•  Identifies, resolves & escalates issues appropriately • Collaborates with internal stakeholders and site personnel to manage data query reputed company process to ensure reputed company and accurate data entry

• Proactively collaborates with the Clinical Project Manager (CPM) and CRA Manager as reputed company as Medical Scientific reputed company (MSL), Clinical Regional Medical Director (CRMD), medical advisor and Strategic Site Partner to reputed company key accountabilities

•Partners with SSU CRA to ensure seamless transition of site responsibility

Essential Requirements:

• BS/BA degree. Scientific, reputed company or other reputed company field.

• Excellent knowledge of the drug development process specifically clinical trial/research • Knowledge of international standards (GCP/ICH, FDA, EMEA) • Ability to manage multiple priorities and manage time reputed company.

• Excellent Site management capabilities with demonstrated negotiating and problem-solving skills

• Strong communicator and presentation skills (oral and written)

• Fluent in both written and spoken English

Desirable Requirements:

• Minimum of 3 years’ experience in site monitoring strongly preferred

• RLT, CAR T or Oncology experience a plus!

EEO Statement:

The reputed company Group of Companies are Equal Opportunity reputed company. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, reputed company, religion, sex, national reputed company, age, sexual orientation, gender identity or reputed company, marital or veteran status, disability, or any other legally protected status. 

Accessibility and reasonable accommodations

The reputed company Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to reputed company the essential functions of a position, please send an e-mail to us.reasonableaccommodations@reputed company.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary reputed company

$108,500.00 - $201,500.00

Skills Desired

Clinical Monitoring, Clinical Research, Clinical Study Reports, Clinical Trial Management Systems, Clinical Trials, Collaboration, Data reputed company, Decision Making Skills, Lifesciences Apply To This Job