Clinical Trial Specialist II
- Experience Level
- Experienced (non-manager)
Job Title: Clinical Trial Specialist II
Responsible for performing investigative site recruitment/feasibility, site project training, remote clinical data monitoring and resolution, site progress status tracking, in-house site management, documentation filing, and other duties in accordance with Sponsor and/or UBC requirements. Performs essential document collection and review for site start up and initiates in compliance with project specifications and applicable SOPs with adherence to FDA Regulations, ICH/GCP guidelines and good documentation practices. Demonstrates ability to successfully lead and mentor CTS staff, take on high level tasks as delegated by Project Manager/Functional Manager, and escalate and mitigate risk as appropriate.
- Bachelor's degree or relevant work experience required.
- 2+ years of relevant clinical research experience required.
- Excellent written and verbal communication skills required.
- Strong Microsoft Office skills (Outlook, Word, and Excel) required. Aptitude in learning new computer systems required.
- Ability to be flexible and multitask required.
- Basic medical terminology or knowledge desired.
Supervisory Responsibilities: N/A
Specific Job Duties:
Manage Regulatory and Institutional Review Board (IRB) Activities:
- Prepare, distribute, collect, evaluate, and approve regulatory documents required for regulatory compliance and IRB submission.
- Submit regulatory documents to Central IRBs and manage site submissions to Local IRBs; confirm IRB approval is received and documented.
- Conduct regulatory packet submissions to clients for site approval and drug release.
- Create and review project planning documents including but not limited to Essential Document Review Plan (EDRP), Site Management Plan, and Project Plan.
- Track milestones, generate study metrics, and provide written and verbal updates to internal and external customers.
- Confirm sites have notified IRB of closure and final subject status in compliance with regulations.
- Confirm sites have returned or destroyed study drug and other study supplies as required.
- Train sites on their continued contractual, regulatory, and legal obligations.
Conduct Site Management Activities:
- Evaluate sites to determine interest, adequate subject population, facilities, staff and qualifications to conduct a study.
- Execute confidentiality agreement, contract and budget negotiation with sites.
- Provide site training and access to required systems, including vendor systems.
- Provide site training and guidance in reference to protocol compliance.
- Provide site training and guidance in reference to regulatory requirements and ensure compliance.
- Manage site relationships to ensure positive interactions through routine site contact.
- Evaluate site performance and compliance with required FDA regulations, ICH/GCP, and local laws.
- Confirm sites are compliant with subject rights and privacy requirements.
- Ensure sites meet subject safety reporting regulations: subject safety information is disseminated appropriately by evaluating consistency, quality and timeliness of serious adverse events reported by the site and submission to the IRB.
- Manage site inventory of study drug, laboratory supplies, and any other study materials to ensure sites have sufficient inventory to conduct study activities without delay.
- Escalate potential misconduct , fraud or noncompliance by sites to Project and Functional Management and Quality Assurance.
- Instruct sites on study or protocol requirements and determine subject qualification based on subject eligibility parameters.
- Track study activities, milestones, document receipt, and payment status in CTMS.
- Participate in internal/external project team meetings.
- Assist with other duties as assigned.
Essential Document Management and Audit Readiness:
- Create Trial Master Files (TMF) and maintain essential documents in compliance with FDA regulations, ICH/GCP, and local laws.
- Manage ongoing collection and quality review of updated essential documents for submission to the TMF.
- Preserve document security and integrity.
- Ensure Regulatory Authority and Client audit readiness of TMF.
- Prepare, package, and archive TMF at study closure.
Perform Remote Monitoring Activities:
- Verify accurate and timely electronic data entry of study subject information.
- Review electronic data and ensure protocol deviations are reported to IRB as appropriate.
- Collaborate with sites to achieve query resolution of electronic data.
- Manage sites in meeting subject enrollment targets to meet contractual obligations.
- Conduct remote monitoring visits and complete requisite visit reports.
Facilitate Payment Distribution to Investigative Sites:
- Contribute to project plans outlining payment strategy.
- Evaluate data to identify milestones ensuring sites are paid according to the contract.
- Process and distribute investigative site payments.
Job Duties Specific to CTS II:
- Demonstrates ability to successfully lead, mentor, and train CTSs.
- Provides feedback on CTS performance regarding department goals and objectives.
- Proficient at CTS duties with minimal oversight.
- Exhibits good decision-making skills utilizing all available resources for determining positive outcomes.
- Develops solutions to a variety of moderate to complex issues, analyze current policies and procedures, and recommend changes as needed.
- Demonstrates thorough knowledge of clinical research, industry standards, practices, and regulations.
- Demonstrates understanding and application of UBC systems and work environment.
- Generates and review project specific metrics as needed.
- May serve in a leadership/mentoring role for a specific project.
United BioSource Corporation (UBC) is a leading provider of pharmaceutical support services, partnering with life science companies to make medicine and medical products safer and more accessible. Our services support the full lifecycle of medicine and medical products, including development, commercialization, and long-term value and safety.
While UBC offers employment within Patient Support, Nursing, Pharmacy and Corporate, two main focus areas for the company are Clinical Development & Research and Safety & Risk Management. Members of the Clinical Development and Research teams help evaluate study protocol, target study population, recruit physicians and patients, and collect, clean, validate and report data. As a result, sponsors are able to submit findings to regulatory authorities or make a no-go decision in a timely and clear-cut manner. Additionally, our Safety and Risk Management teams develop, deliver, and report evidence to reinforce safe and appropriate product use.
Through our Patient Access services, we help patients begin therapy quickly and remain on therapy, building strong relationships with patients to ensure optimal care.
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