Clinical Research Associate/Senior Clinical Research Associate- FSP Job at Parexel

Job Description

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part to get treatments to patients sooner. Our CRAs' priority is the safety and well-being of the patients. As you travel to investigator sites and perform your monitoring duties, we encourage you to be inquisitive, take accountability, build relationships, and act with integrity. Join a team with a wide variety of experiences and knowledge, and work on global projects within a broad scope of therapeutic areas.

Job Responsibility

Contributes to the selection of potential investigators
As required, accountable for study start-up and regulatory maintenance
Trains, supports, and advises Investigators and site staff in study related matters
Confirms that site staff have completed and documented the required training appropriately
Actively participates in Local Study Team (LST) meetings
Contributes to National Investigators meetings
Initiates, monitors, and closes study sites in compliance with Client Procedural Documents
Drives performance at the sites
Updates CTMS and other systems with data from study sites
Manages study supplies, drug supplies and drug accountability at study site
Performs monitoring visits (remote and onsite), as well as remote data checks
Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV)
Performs regular Site Quality Risk Assessments
Ensures data query resolution in a timely manner
Ensures accurate and timely reporting of Serious Adverse Events and their follow ups
Prepares and finalizes monitoring visit reports
Follows up on outstanding actions with study sites
Follows quality issue processes
Assists site in maintaining inspection ready ISF
Prepares for and collaborates with the activities associated with audits and regulatory inspections
Ensures timely collection/uploading of essential documents into the eTMF
Ensures that all study documents under their responsibility are available and ready for final archiving
Provides feedback on any research related information
Collaborates with local Medical Science Liaisons (MSLs) as directed
Ensures compliance with the Client’s Code of Ethics and company policies
Ensures compliance with local, national, and regional legislation
Completes timesheets accurately as required
Submits expense reports as required
Updates CV as required
Maintains working knowledge of and complies with Parexel/Client processes, ICH-GCPs and other applicable requirements

Requirements

Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP
Good knowledge of relevant local regulations
Good medical knowledge and ability to learn relevant Client Therapeutic Areas
Basic understanding of the drug development process
Good understanding of Clinical Study Management including monitoring, study drug handling and data management
Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification
Excellent attention to detail
Good written and verbal communication skills
Good collaboration and interpersonal skills
Good negotiation skills
Proficient in written and spoken English language required
Fluency in local language(s) required
Ability to travel nationally/internationally as Required
Valid driving license per country requirements, as applicable
Oncology Experience required
Cell therapy experience is strongly preferred

Nice to have

Ability to work in an environment of remote collaborators
Manages change with a positive approach for self, team, and the business
Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials
Good analytical and problem-solving skills
Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines
Ability to understand the impact of technology on projects and to use and develop computer skills
Team oriented and flexible
Familiar with risk-based monitoring approach including remote monitoring
Good cultural awareness

What we offer

Flexible work arrangements
Career growth and development
Supportive and inclusive environment
Diverse therapeutic areas and project exposure
Advanced Technology

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Clinical Research Associate/Senior Clinical Research Associate- FSP

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