Senior Clinical Research Associate - FSP

Parexel; United Kingdom; Remote; GBP 42,000 - 64,000; Full time

Job summary

Parexel is seeking a Senior CRA to support global studies from a remote UK-based position. You will engage in investigator selection, regulatory submissions, site initiation and ongoing monitoring, and manage eTMF/documents to ensure inspection readiness.

Strong English, ICH-GCP knowledge, and trial management experience are required. The role involves remote and onsite monitoring, collaboration with Local Study Teams, data management coordination, and timely reporting of safety events.

Qualifications

• Bachelor's degree in life sciences or related field.
• Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP and 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.

Responsibilities

• Contributes to the selection of potential investigators.
• Submits applications to EC/IRB and regulatory authorities for start-up and maintenance.
• Trains, supports, and advises Investigators and site staff on study matters.
• Ensures site training is complete and inspection-ready.
• Participates in Local Study Team meetings and National Investigators meetings.
• Initiates, monitors, and closes study sites in compliance with Client procedures.
• Drives performance at the sites and escalates issues.
• Updates CTMS and other systems with site data on schedule.
• Manages study supplies and drug accountability at the site.
• Performs monitoring visits (remote and onsite) per Monitoring Plan.
• Performs SDR, CRF review and SDV as per plan.
• Conducts Site Quality Risk Assessments and adjusts monitoring intensity.
• Ensures timely data query resolution and data quality with DM.
• Reports Serious Adverse Events timely and with follow-ups.
• Prepares monitoring visit reports in CTMS and sends follow-ups per timelines.
• Follows up on outstanding actions with sites.
• Escalates quality issues per SOPs to Local Management/CQM.
• Assists with audits and regulatory inspections.
• Ensures essential documents are uploaded into the eTMF.
• Supports archiving of site documents and communications.

Skills

Attention to detail

Written and verbal communication

Collaboration and interpersonal skills

Negotiation skills

English proficiency

ICH-GCP knowledge

Clinical study management

Monitoring and site management

Data management

Education

Bachelor’s degree in life sciences or related field

Tools

CTMS

eTMF

Regulatory systems

Job description

Key Accountabilities

• Contributes to the selection of potential investigators.

• In some countries, as required, SrCRAs 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 always inspection ready.

• 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 ICHGCP, 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 Scientific Liaisons (MSLs) as directed by LSAD or line manager

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.

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.

Education

• Bachelor’s degree in related discipline, preferably in life science, (or equivalent 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

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