Sr. Clinical Trial Specialist Iii (Remote)

2-8 years

$46/hr - $56/hr

Remote, USA

10 Aug. 2, 2024

Job Description

Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position Title: Senior Clinical Trial Specialist (Remote)

About the Job:

Our client, a leading pharmaceutical company, is seeking a Senior Clinical Trial Specialist (CTS) to provide comprehensive logistical support for clinical trial programs. This role involves collaborating with cross-functional teams to ensure that site start-up through close-out activities adhere to Standard Operating Procedures (SOPs) and relevant regulations.

Job Type: Remote
Employment Type: W2 Only

Responsibilities:

Study Feasibility: Actively participate in feasibility assessments for studies.
Document Management: Develop and review study documents (e.g., site instructions, lab manuals, Pharmacy Binder, Study Management Plan) and clinical site documents (e.g., site-specific informed consent forms).
Regulatory Compliance: Manage the collection, review, and approval of regulatory documents from clinical sites.
Investigational Product: Coordinate investigational product release activities across clinical sites.
Trial Master File: Initiate, maintain, and reconcile the Trial Master File.
Meeting Preparation: Assist in preparing for Investigator and Study Coordinator Meetings.
Tracking Systems: Set up and maintain tracking systems (e.g., CTMS), tools, and report study metrics.
Payments Management: Manage and track study-specific payments.
Communication: Coordinate and communicate tracking information within the study team and to clinical sites.
SOP Development: Develop and review Standard Operating Procedures.
Subject Matter Expert: Serve as an expert on CTS initiatives and working groups.
Mentorship: Mentor Clinical Trial Associates and peer CTSs, including onboarding new hires.
Vendor Management: Manage ancillary vendors, such as specialty or central labs.
Training Assistance: Assist in training Clinical Research Associates.
Site Visits: Perform site initiation, routine monitoring, and close-out visits at select clinical sites, including co-monitoring with Clinical Research Associates.
Report Review: Review site visit reports under the direction of the Associate Director or designee.
Additional Duties: Other responsibilities as assigned.

Qualifications:

Education: Bachelor’s degree or equivalent (scientific or healthcare discipline preferred).
Experience: Fully proficient in clinical trial coordination with a thorough understanding of study phases and their application to clinical development.
Regulatory Knowledge: Working knowledge of ICH Good Clinical Practice guidelines.
Skills: Ability to handle multiple tasks and deadlines; self-motivated with strong problem-solving skills; effective verbal and written communication.
Relationships: Capability to build and maintain positive relationships with management and peers.
Technical Skills: Proficient in using computer applications, including spreadsheets, email, word-processing software, and web-based systems.
Travel: 10-30% travel may be required.

To apply, please submit your resume and cover letter outlining your qualifications and experience.

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Sr. Clinical Trial Specialist Iii (Remote)

Job Description

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