Clinical Research Associate

Alira Health•Boston, MA

12d

About The Position

The CRA is an important member of the Alira Health Clinical team. The 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 CRA works closely with Lead CRAs, Sr CRAs, Clinical Trial Coordinators, Director of Clinical Monitoring and Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues.

Requirements

Dedicated and results oriented professional with a bachelor’s degree in a relevant field (sciences, nursing, medical preferred).
Preferred 5+ years’ experience in the clinical research or health care fields.
Clinical monitoring experience in the pharmaceutical, biotech, medtech or CRO industries.
Expertise in data management, site management and monitoring, including proficiency in clinical trial software and tools.
Committed to quality with a proven track record of being thorough and detail-oriented in ensuring protocol adherence and data integrity.
Excels in organizational and time management skills, enabling effective multitasking in fast-paced environments while managing priorities, organizing time efficiently, and solving complex problems.
Possess strong analytical, negotiation, meeting management, cross-functional team collaboration, and leadership skills to drive successful trial outcomes.
Willing and able to travel up to 85% to support site visits and project needs, approximately 5-12 days of monitoring per month as appropriate for region of assignment.
Professional, trustworthy, and disciplined self-starter who thrives in collaborative team settings, fostering a positive and productive atmosphere.
In-depth knowledge of ICH GCP and ISO 14155 guidelines, along with local regulatory requirements.
Skilled at establishing and maintaining positive relationships with sponsors, investigative sites, and cross-functional project teams to facilitate seamless communication and achieve study milestones.
Strong command of English, and the local language as necessary, both written and verbal.

Responsibilities

Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work, Alira Health SOPs and regulatory requirements, i.e. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines.
May perform Central Monitoring activities, or act as the primary liaison between site and Central Monitor.
Work with sites to adapt, drive and track subject recruitment in line with project needs and expectations.
Provide protocol and study related training to assigned sites and establish regular lines of communication to manage ongoing project expectations and issues.
Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol.
Collaborate with cross-functional teams and CRAs to maintain high standards of clinical trial conduct.
Ensures that the informed consent process is properly conducted and documented for every participant, in line with applicable requirement and standards.
Exhibits meticulous care in upholding the privacy of all subjects/participants.
Escalates quality issues or trends appropriately per the escalation pathway.
Conducts investigational product (IP) inventory and accountability, while evaluating storage conditions and access protocols.
Confirms IP has been dispensed and administered to participants in compliance with the study protocol.
Leverages expertise in GCP, local regulations and Alira Health procedures to ensure IP is properly labeled, relabeled, transported, released, returned or destroyed.
Routinely reviews the Investigator Site File (ISF) for audit readiness including accuracy and completeness.
Reconciles the ISF with the Trial Master File (TMF), ensuring filing of essential documents in accordance with local guidelines and regulations.
Performs quality checks on regulatory documents per ALCOA+ principles, collecting copies for TMF filing.
Supports audit readiness by submitting documents to the TMF, utilizing the filing index and medidata as necessary.
Supports research sites with local Institutional Review Board (IRB)/Ethics Committee (EC) submissions and confirms approvals.
Verification and review of safety events (AE/SAE/UADE/AESI, etc) including reconciliation of concomitant medications and medical history to confirm accurate reporting in accordance with the protocol, local regulations and regulations.
Assists in set up/collection of site-specific ethics documents and site contract negotiation.
Provides monthly billing information to finance team, as required
For monitoring stand-alone projects, manages study budget and acts as referent for the sponsor
Consistently prepares accurate monitoring visit reports and communication logs in alignment with Alira Health SOPs and the Clinical Monitoring Plan timelines.
Reports detail site-specific concerns, follow-up tasks, corrective actions, protocol deviations and violations, enrollment progress and safety events collected.
Ensures integrity of source records and case report forms through review and verification for accuracy and completeness.
Participates in internal, client/sponsor, scientific, and other meetings as required.
Completes consistent review of CRF queries, working closely with site staff and data management to resolve CRF queries on discrepant data.
Conducts audit preparation at study sites as needed.
Works with other CRAs to maintain consistency and promote a collaborative team atmosphere.
Can assist in development of study-specific Clinical Monitoring Plans and training presentations as required.
Can assist in monitoring visit report review.
Review will ensure evidence of adequate CRA oversight and site management per the Clinical Monitoring Plan (CMP), Alira Health SOPs and ICH GCP. Specifically, adequate oversight of IP and accountability, routine review of ISF and audit readiness, clear and adequate reporting of protocol deviations, ensuring resolve of follow-up items in a timely manner and study compliance by the site staff and PI.
Trends are shared with the Lead CRA, Project Manager and escalated to the Sponsor as necessary.
Can assist with oversight and accountability of monitoring visit reports, ensuring CRAs submit the draft, and the report is finalized within the Alira Health SOP and CMP timelines.
Responsible for tracking study specific metrics, sharing with the Project Manager and escalating to the Director of Clinical Monitoring as needed.
Assists in CRA new hire training and onboarding.
Performs CRA training and mentoring to more level CRAs.
May co-monitor and perform Evaluation Visits for CRAs.
Collaborates with development, maintenance and training of the Clinical Trial Management System (CTMS) and Trial Master File (TMF).
Prepares for and attends Investigator Meetings.
May participate in audits, including preparation at study sites as needed.
May participate in or lead clinical monitoring or project specific meetings.
May be mentored and assigned Lead Clinical Research Associate or other operational tasks under supervision of an experienced team member.
Collaborates with study team members for project execution and performs additional duties and tasks as assigned.