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Job Description Summary
Sr CRA in GermanyJob Description
ROLEThe Sr CRA is an important member of the Alira Health Clinical team. The Sr CRA is highly motivated and functions independently to conduct site monitoring responsibilities for clinical trials; as well as providing oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality. The Sr CRA works closely with US: Director of Clinical Monitoring, Lead CRAs, in-house CRAs, EU: Associate Director of Clinical Monitoring, CRAs, and Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues.
KEY RESPONSABILITIESProvides guidance, oversight, and feedback to the CRA team to ensure adherence to project scope, SOPs, timelines, and budget requirements.
Reviews monitoring visit reports, conducts co-monitoring and evaluation visits as needed.
Ensures appropriate and timely investigator site visits.
Coordinates with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues.
Assists in development of study-specific Monitoring Plans and training presentations as required.
Assists in set up/collection of site specific ethics documents and site contract negotiation as required.
Provides monthly billing information to finance team as required.
For monitoring stand-alone projects, manages study budget and acts as referent for the sponsor.
Performs qualification, initiation, interim, and close-out visits both remotely and onsite, ensuring proper documentation of monitoring visits.
Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status.
Ensures integrity of CRF data through meticulous and thorough source document review and verification.
Performs quality control and verification of documents collected at sites for eTMF/TMF.
Conducts investigational product accountability.
Reviews site regulatory binder for required documents.
Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests.
Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company/Sponsor SOPs.
Participates in internal, client/sponsor, scientific, and other meetings as required.
Facilitates adverse event reporting and ensures the reconciliation of SAE reports with source documentation and CRFs.
Works closely with in-house CRAs/CTC and data management to resolve queries on discrepant data.
Proactively identifies site issues and develops problem-solving strategies for sites.
Conducts audit preparation at study sites as needed.
Works with other CRAs to maintain consistency and promote a collaborative team atmosphere.
Participates in internal, client/sponsor, scientific, and other meetings as required.
Assists in CRA new hire training and onboarding.
Performs CRA mentoring.
Collaborates with development and maintenance of Clinical Trial Management System (CTMS).
Manages and resolves conflicting priorities to deliver on commitments.
Performs additional duties as assigned.
US: BS/BA from an undergraduate program (life sciences or related discipline preferred)
US: 3 years of experience in the pharmaceutical / biotechnology / CRO industry, 2 year of clinical monitoring experience with 1 year of management experience
EU: Minimum 2 years of clinical monitoring experience in the pharmaceutical / biotechnology / CRO industry and ability to autonomously manage monitoring activities
Quality focused; Proven ability to be careful, thorough, and detail-oriented
Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment
Able to manage priorities, organize time and solve problems
Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills
Ability to travel
Ability to manage stress
Professional, trustworthy and disciplined
Ability to problem-solve unstructured or ambiguous challenges
US: Strong command of English, both written and verbal
EU: Strong command of Local language, both written and verbal, in the country where monitoring activities are performed
Excellent communication and interpersonal skills with customer service orientation
Good computer skills, with ability to use clinical trial management systems, clinical trial databases and electronic data capture
Self-starter who thrives in a collaborative, yet less structured team environment
Knowledge of clinical research, ICH GCP and local regulations
Knowledge of Regulatory and Ethical requirements
Ability to establish and maintain positive relationships with Sponsor, Site and Project Team members
US: Permanent authorization to work in the U.S.
EU (Italy): Certified Monitor in compliance with Italian CRO decree dated 15Nov2011.
EU: Graduation in a scientific health field.
EU: Adequate English
Languages
EnglishEducation
Bachelor of Science (BS): Biology, Bachelor of Science (BS): Biotechnology, Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): PharmacyContract Type
RegularSkills Required
- US: BS/BA in life sciences or related discipline
- EU: Graduation in a scientific health field
- US: Minimum 3 years pharma/biotech/CRO experience; 2 years clinical monitoring and 1 year management experience
- EU: Minimum 2 years clinical monitoring experience with autonomous monitoring capability
- EU (Italy): Certified Monitor in compliance with Italian CRO decree dated 15Nov2011
- US: Permanent authorization to work in the U.S.
- Strong command of English (written and verbal)
- Strong command of local language where monitoring activities are performed (EU)
- Knowledge of ICH GCP, regulatory and ethical requirements, and local regulations
- Experience with CTMS, electronic data capture (EDC), clinical trial databases, and eTMF/TMF
- Proven ability to perform site monitoring visits (qualification, initiation, interim, close-out) onsite and remotely
- Experience preparing accurate monitoring visit reports, source document verification, SAE reconciliation, and investigational product accountability
- Strong organizational, leadership, mentoring, communication, and cross-functional collaboration skills
- Ability to travel for site visits
