Clinical Research Associate/Senior Clinical Research Associate- FSP
PAREXEL
Parexel FSP is looking for a CRA/Sr CRA in the US. Oncology Experience required. Cell therapy experience is strongly preferred.
Job Purpose:
The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study.
The CRA is responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.
Key Accountabilities :
Site Management 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.
Compliance with Sponsor Standards
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.
Compliance with Parexel Standards
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.
Skills (Essential):
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.
Skills (Desirable):
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.
Knowledge and Experience (Essential) :
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.
Knowledge and Experience (Desired):
Familiar with risk-based monitoring approach including remote monitoring.
Good cultural awareness.
Education:
- 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.
Other:
Ability to travel nationally/internationally as Required
Valid driving license per country requirements, as applicable.
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
#LI-KW1
#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
- ...Oncology experience required - All locations The Clinical Research Associate is responsible for the following: Act as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites...SuggestedLocal areaRemote work2 days per week3 days per week
$124.5k - $168.08k
...people truly BELIEVE in what they're doing! Job Description Summary: The Infrastructure Modernization business unit is seeking a Senior Principal Software Engineer to serve as a visionary and hands-on technical leader for our Workload Automation solutions. The...SeniorRemote workWorldwide$96.8k - $251.6k
...excited to learn. **Responsibilities** With your superb technical, research and analytical capabilities and demonstrated ability to get... .... You will perform professional software development tasks associated with the developing, designing and debugging of software applications...SeniorTemporary workWork experience placementLocal areaRemote workFlexible hours$126.2k - $264.1k
Job Description The ideal candidate is a proactive problem solver who can anticipate risks, remove obstacles before they impact delivery, and leverage emerging AI technologies to drive efficiency, productivity, and business outcomes at scale. The successful candidate...SeniorTemporary workFlexible hours$135.2k - $306.4k
Job Description In this role, you will help design, build, and operate software that powers the full data center lifecycle, including planning, design, build, and operations , within the DC Software and Automation organization. We are rapidly scaling our data center...SeniorTemporary workFlexible hours$126.2k - $264.1k
...quality of life globally by making health and research data easier to access, understand, and... .... About the Role As an Senior Principal Product Manager, you will own... ...alignment across product, design, engineering, clinical, compliance, support, operations, and go...SeniorTemporary workFlexible hours$126.2k - $264.1k
...maintain strong relationships with key clinical teams. Deliver executive briefings on... ...regulatory and policy impacts. Advise senior leaders on compliance risks and strategy... ...and customer needs. Conducting market research, gathering customer feedback....SeniorTemporary workFlexible hours- Husch Blackwell is searching for a Corporate Paralegal to join their Mergers & Acquisitions team in Jefferson City, Missouri. This full-time position offers the opportunity to support attorneys throughout the lifecycle of M&A transactions, involving document management ...SeniorFull time
$135.2k - $306.4k
...liveness using model checkers such as TLC and Apalache. ~ Ideally, skilled at applying mechanical proof tools such as TLAPS, with associated experience of finding inductive invariants for concurrent algorithms. ~ Excellent at collaborating with software engineers to...SeniorFull timeTemporary workFlexible hours$150k - $185k
A leading global technology firm is seeking a Pricing Senior Manager responsible for directing pricing strategies and proposal developments. The position is remote with a preference for candidates close to HQ facilities. Qualified candidates will have a Bachelor’s degree...SeniorRemote job- A global consulting firm is seeking a Senior Technology Analyst specializing in SAP Manufacturing. This role involves engaging with clients to ensure project success, analyzing technology solutions, and collaborating with technical teams for effective system architecture...Senior
- ## Qualifications**Qualifications****Education & Certifications*** Bachelor's degree in Accounting or related field required* CPA or CPA candidate preferred**Experience*** 3-6+ years of progressive accounting experience* Public accounting and/or large company experience...Senior
$25.93 - $41.43 per hour
City National Bank is hiring a Mortgage Loan Processor III in Jefferson City, Missouri. This role entails processing home equity loans, ensuring timely closures, and evaluating client applications. Candidates need a high school diploma and at least 3 years of mortgage ...SeniorHourly payWork at office- CVS Health is seeking a full-time position focused on investigating healthcare fraud, waste, and abuse. The successful candidate will analyze pharmacy behaviors, collaborate with various stakeholders, and ensure compliance with laws. Applicants should have 3-5 years of ...SeniorFull time
- ...The Opportunity Step into a leadership role where your expertise drives operational excellence. As a Senior Purchasing Manager at Hitachi Energy, you'll lead factory-level purchasing activities that keep production running seamlessly. This is your chance to influence...SeniorLocal area
- A leading engineering firm is seeking a Senior Mechanical Engineer to work with major technology clients remotely. Responsibilities include project coordination, design calculations, and report writing. Candidates should have a bachelor’s in mechanical engineering with...SeniorRemote jobFlexible hours
- ...Jefferson City, MO Why you'll love this position: The senior structural designer is responsible for structural design... ...questions concerning constructability, structural theory, American Association of State Highway and Transportation Officials codes and design...SeniorWork at officeFlexible hours
$60k
Maximus is a trusted federal partner supporting mission‑critical programs across national security, defense, and public service delivery. Our work focuses on sustaining, operating, and improving essential government systems and services, with proven operational excellence...SeniorContract workRemote work- ...Biostatistician III/Senior Biostatistician (Remote - United States... ...make a meaningful impact in clinical development? Join a... ...expertise beyond biostatistics by researching the medical literature and regulatory... ...articulated hypotheses associated with them and that the trial...SeniorRemote workFlexible hours
$190k - $240k
...the United States, dedicated to our clients and the industries they serve. We have an immediate opening for an Intellectual Property Senior Counsel with a minimum of eight years of experience preferred. We will consider candidates for any of our offices including our...SeniorWork at officeImmediate startFlexible hours- ...Strong stakeholder management and influencing skills, with the ability to challenge, align, and drive decisions across HR, IT, and senior leaders. Experience in roadmap and pipeline management , ensuring delivery of high-value initiatives aligned to business...SeniorWork at officeLocal areaRemote work2 days per week3 days per week
- ...Parexel is seeking a Senior Real-World Evidence (RWE) Analyst Programmer Join a high-impact team as a remote Sr. Real-World Evidence... ...and performing raw data analysis (not derived solely from clinical trials) Includes running analyses and/or developing code for...SeniorRemote workFlexible hours
- ...Job Title Senior Application Developer Client Company/Dept. Name State of Missouri, Office of Administration (OA), Information Technology... ...for the DWC Automated Integrated Claims System (AICS) and associated interfaces. Investigate application incidents, defects, and...SeniorWork at officeRelocation
- ...work in providing administrative, business and information technology services to the Missouri courts. We are recruiting to fill a Senior Database Administrator position responsible for installation of the database software, new releases and upgrades, and supporting...SeniorWork at office
- ...Cytel successful. Cytel is a place where talent, experience, and integrity come together to advance the state of clinical development. We are seeking a Senior Director, Business Development with extensive experience with Biometric Service Provider sales to drive Cytel'...Senior
$70k
...active Public Trust and/or DHS suitability is preferred. Must be a U.S. Citizen without dual citizenship. This role is remote. The Senior System Administrator provides senior‑level IT operations and ServiceNow platform administration support. The role supports...SeniorContract workRemote work$62.25k - $82.99k
Lumen is the trusted network for AI. We're transforming how businesses connect, secure, and scale in an AI-driven world. By connecting people, data, and applications quickly, securely, and effortlessly, we help organizations move faster and unlock what's next. At...SeniorTemporary workWork at office- ...MO-SSM Health St. Mary's Hospital - Jefferson City Worker Type: Regular Job Highlights: · Department: Multi Specialty Clinic · Schedule: Full Time, Days · Medical Office experience required · Location: Jefferson City Our mission and values put the...SeniorHourly payDaily paidFull timeWork experience placementWork at officeFlexible hoursShift workDay shift
$62.4k - $93.6k
...achieve your goals – and to help others accomplish theirs, too. Join our team as we help shape the future. The Workers' Compensation Senior Claim Representative is accountable for planning, recommending, and executing the investigation of workers' compensation claims....SeniorTemporary workRemote workMonday to Friday3 days per week$89k - $120.15k
...Job Description Summary A Vertica Senior Technical Support Engineer at Rocket Software delivers advanced Tier 3 Vertica support. They independently troubleshoot escalated issues, perform root cause analysis, and serve as mentors for junior engineers. A Vertica Senior...Senior
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Clinical Research Associate/Senior Clinical Research Associate- FSP. Be the first to apply!
- on-site clinical research associate (traveling/remote) Jefferson City, MO
- senior implementation project manager Jefferson City, MO
- senior commercial counsel Jefferson City, MO
- senior director diversity & inclusion Jefferson City, MO
- senior software engineer remote Jefferson City, MO
- senior living Jefferson City, MO
- senior resident engineer Jefferson City, MO
- senior infrastructure engineer Jefferson City, MO
- senior brand designer Jefferson City, MO
- senior consulting engineer Jefferson City, MO

