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Parexel · 1 hour ago

Sr. Clinical Research Associate - FSP

United States

Full-time

Remote

Senior Level

Parexel is a leading global provider of biopharmaceutical services, and they are seeking a Senior Clinical Research Associate. The role involves managing clinical study sites, ensuring compliance with regulations, and collaborating with local study teams to deliver studies efficiently.

Pharmaceuticals

H1B Sponsor Likely

Responsibilities

Contributes to the selection of potential investigators

In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study

Trains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles

Confirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times

Actively participates in Local Study Team (LST) meetings

Contributes to National Investigators meetings, as applicable

Initiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST

Drives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriate

Updates CTMS and other systems with data from study sites as per required timelines

Manages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicable

Performs monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines, and discusses with LSAD the correct timing and type of visits

Performs Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring Plan

Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study

Ensures data query resolution in a timely manner

Works with data management to ensure robust quality of the collected study data

Ensures accurate and timely reporting of Serious Adverse Events and their follow ups

Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOP

Follows up on outstanding actions with study sites to ensure resolution in a timely manner

Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required

Assists site in maintaining inspection ready ISF

Prepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD)

Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegate

Ensures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMF

Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market

Collaborates with local Medical Science Liaisons (MSLs) as directed by LSAD or line manager

Ensures compliance with the Client’s Code of Ethics and company policies and procedures relating to people, finance, technology, security, and SHE (Safety, Health and Environment)

Ensures compliance with local, national, and regional legislation, as applicable

Completes timesheets accurately as required

Complies with required training curriculum

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

Qualification

ICH-GCP knowledgeClinical Study ManagementOncology experienceFluency in local languageAnalytical skillsAttention to detailCommunication skillsCollaboration skillsNegotiation skillsProblem-solving skillsTeam oriented

Required

Bachelor's degree in related discipline, preferably in life science, or equivalent qualification (adapted to local country market needs), that supports skills and capabilities of the position and ensures successful conduct of responsibilities and appropriate interactions with internal and or external customers

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

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

Ability to travel nationally/internationally as Required

Valid driving license per country requirements, as applicable

Preferred

ONCOLOGY Preferred

Ability to work in an environment of remote collaborators

Manages change with a positive approach for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business

Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time

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 while making appropriate use of systems/software in an e-enabled environment

Team oriented and flexible; ability to respond quickly to shifting demands and opportunities

Familiar with risk-based monitoring approach including remote monitoring

Good cultural awareness

Company

Parexel

Glassdoor3.9

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster.

Founded in 1983

Raleigh, North Carolina, US

10001+ employees

http://www.parexel.com

H1B Sponsorship

Parexel has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (23)

2024 (47)

2023 (42)

2022 (51)

2021 (54)

2020 (33)