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Sr. Clinical Trial Associate
5 Sylvan Way Parsippany, NJ 07054 US
Job Description
Summary:
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).
Job Responsibilities:
- 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 to coordinate, review, and secure IRB approval (local and central).
- Responsible to provide 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.
- 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 using Microsoft Outlook, Word, Excel, and PowerPoint.
- Excellent oral and written English communication skills.
- 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.
- 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:
- 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
Pay Rate Range: $40-57/hr depending on experience
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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