Associate Construction Specialist

Hitachi Vantara Corporation; Lima Metropolitana; On-site; PEN 60,000 - 100,000; Full time

Job summary

Parexel FSP is actively hiring multiple Clinical Research Associates (CRA) and Senior Clinical Research Associates (SCRA) to join our growing team. The CRA is responsible for site delivery, initiation, monitoring, and closure across studies, ensuring adherence to ICH-GCP and local regulations.

Senior CRAs will lead site activities, support risk-based quality management, and collaborate with LSAD and local study teams to meet study commitments efficiently.

Qualifications

• Proficient in written and spoken English.
• Fluency in local language(s) required.
• On-site CRA experience is preferred for Senior CRA role.

Responsibilities

• Monitor and manage study sites in accordance with ICH-GCP and local regulations.
• Prepare, initiate, monitor and close study sites; ensure data quality and regulatory compliance.
• Coordinate with local study teams and LSAD to achieve study commitments on time.

Skills

English proficiency

Local language fluency

Education

Bachelor's degree in life sciences or related field

Job description

Senior Clinical Research Associate/Clinical Research Associate - FSP

Parexel FSP is actively hiring multiple Clinical Research Associates and Senior Clinical Research Associates to join our growing team.

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)

• Proficient in written and spoken English language required.
• Fluency in local language(s) required.

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.
• 3+ years of experience as an on-site Clinical Research Associate (CRA) for the Senior CRA position and 1+ years of experience for the Clinical Research Associate role.

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

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.

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