Senior Clinical Trial Associate

Job Title: Sr. Clinical Trial Associate

Location: Parsippany, NJ (HYBRID- typically Fridays are work from home)

Duration: 9 months (Temp to Perm)

Job Description:

• The Senior Clinical Trial Associate (Sr. CTA) is responsible for providing support and oversight for the planning, execution, and financial aspects of Phase I – IV clinical studies, working closely with and under the supervision of Clinical Trial Managers (CTM) and Clinical Operations leadership.
• Works with the CTM to provide oversight for any Sr. CTA activities performed or managed by partner Clinical Research Organizations (CRO).
• Assists the CTM with achieving key study parameters including, but not limited to, clinical study start-up activities, clinical supplies preparation, study execution, data collection, regulatory document management, vendor/CRO communication and management, study close-out.
• Assists in the preparation and review of study documents including, but not limited to, clinical protocols and amendments, case report forms and source document templates, informed consent forms, site training materials, site regulatory binder, site pharmacy binder, and clinical study reports.
• Assists in the oversight of day-to-day operational activities and other specific projects as assigned within Clinical Operations, including communications with cross-functional teams and provision/review of project team meeting agendas and minutes.
• Accountable for the set-up and maintenance of electronic Trial Master Files (eTMF) in accordance with SOPs.
• Schedules, performs, and oversees ongoing reviews of eTMF to assure completeness and quality of the documentation/files and compliance with SOPs, GCP and ICH Guidelines.
• Accountable to develop and review regulatory documentation to support study start up activities, including ensuring all site supplies are available on site for site initiation visits and sites are ready for activation and enrollment activities.
• Acts as primary liaison for study sites and monitors to convey project information and answer questions in accordance with the CTM escalation pathway.
• Assists the project team in preparation for audits/inspections and is responsible for the quality and completeness of clinical trial documentation.
• Assists with planning and attends Investigator Meetings and study-specific training for assigned trials; presents training as assigned.
• Collaborates with the monitors to obtain/share trial-specific issues across all study sites concentrating on areas related to quality, site performance and metrics.
• Responsible for communicating issues in accordance with the CTM escalation pathway to the monitors or other project team members as appropriate.
• Develops and maintains collaborative working relationships with clinical investigative sites.
• Ensures all regulatory documents and study supplies are maintained during the lifecycle of any assigned project in collaboration with the assigned monitor.
• Liaises with Procurement, Legal and Finance to secure confidentiality agreements, master service agreements, and clinical trial agreements as appropriate.
• Reviews vendor/consultant and clinical site invoices; responsible for tracking all HCP/site invoices for Sunshine Act reporting.
• Monitors recruitment remotely through IRT, EDC, or other systems and/or communication with sites and prepares metrics for the CTM/project team.
• Prepares and reviews various study-related tracking systems to determine and report status of clinical trial documents (i.e., distribution, status, retrieval of such documents as protocol, IB, etc.; metrics related to trial milestones, timelines, financials).
• Liaises with sites and/or CRO to collect outstanding regulatory or other documents.
• Provides quality overview and consistency check on all developed ICFs and completes the informed consent checklist.
• Responsible for the oversight, submission, and correction of regulatory packages for drug release to the CTM for approval.
• Responsible to assure adequate and appropriate dissemination of information according to the clinical study plan between sites, clinical project team staff, and CRO to ensure project success.
• Responsible for coordinating, reviewing, and securing IRB approval (local and central).
• Responsible for providing step by step guidance and partnership with sites to secure IRB approval.
• Understanding of assigned protocol(s) and trial specific manuals/plans to ensure quality and deliverables are met across assigned sites/trials.
• Assists in dissemination of trial documents, manuals, or plans to other project team members to ensure trial-related training is completed.
• Assists in review of department SOPs, as assigned.
• Assists in the training and mentoring of junior-level CTAs.
• As experience warrants and under the mentorship/oversight of CTM, may function as trial lead for assigned projects.
• The incumbent may work closely with internal Medical, Data Management, Statistics, Regulatory Affairs, Pharmacovigilance, and Executive staff, as well as external consultants, clinical research organizations (CROs), vendors, and clinical site personnel.

Education and Experience:

• Bachelor’s degree from an accredited college or university or equivalent experience required.
• 2-4 years of closely related health sciences experience including at least 1-2 years pharmaceutical industry and/or clinical research experience is required.

Qualifications:

• Demonstrated knowledge of the pharmaceutical business and/or clinical research; ability to anticipate environmental changes and trends and implement changes; accordingly, familiarity with medical terminology is necessary.
• Proven ability to develop and track a variety of diverse project metrics, budgets, and identify key performance indicators, in a fast-paced, changing environment.
• Demonstrates understanding of clinical research processes/systems with coaching/assistance.
• Understanding of ICH GCP guidelines, FDA regulations and participation in implementing guidelines; awareness of global regulations, e.g., EMA, MHRA, PMDA.
• Proficiency in using Microsoft Outlook, Word, Excel, and PowerPoint.
• Experience presenting information to teams and team training/mentoring is a plus.
• Experience in various electronic data capture systems involving site enrollment and tracking is a plus.