Job: CLINICAL PROJECT COORDINATOR, TFF Pharmaceuticals Inc., Remote, NC
CLINICAL PROJECT COORDINATOR
Remote, NC 99999 United States
The Clinical Project Coordinator is responsible for assisting operational aspects of Clinical Development, including clinical study operations and regulatory operations, in accordance with departmental and project-specific guidelines, SOPs, and applicable regulations.
The individual works closely with the clinical study managers, scientific experts and regulatory to assist ongoing clinical study conduct and assembly of documents to support regulatory submissions. This person works closely with all team members to support clinical study execution.
Key Tasks & Responsibilities
• Responsible for professional, first line impression of the company through interaction via telephone and written correspondence with internal and external partners.
• Serves as project coordinator within company for assigned protocols and interacts with all cross functional departments.
• Supports clinical staff members by scheduling and coordinating meetings (e.g., webcasts, teleconferences) and preparing meeting materials and action item follow-up (e.g., agendas and minutes) as agreed upon with team.
• Participate in the implementation of key organizational process improvement initiatives as appropriate.
• Compose correspondence and memoranda, proofread communications, coordinate mass mailings, circulate, and file documents.
• Establish and maintain relationships with external vendors and team members to ensure professional, timely, and ongoing communication and documentation for each project
• Assist with reviewing, editing, or extracting data from study documentation such as vendor/CRO clinical trial documentation including monitoring visit reports, monitoring plans, communication plans, timelines.
• Track, review and prepare study-specific information utilizing databases, spreadsheets, and other tools and systems (IRT, EDC, etc.) for reporting status updates to the team and for ClinicalTrials.gov.
• Prepares Confidential Disclosure Agreements (CDAs) and Clinical Trial Agreement (CTA) templates with assistance from the clinical study manager.
• Liaise between Clinical and Legal to ensure documents reviewed, routed and prioritized efficiently. Responsible for tracking progress of legal documents until execution.
• Assist the Clinical Project Coordinator group with ongoing studies including contacting clinical sites for specific requests (enrollment updates, missing documentation, meeting arrangements, CTM returns, clinical study materials etc.)
• Work with the cross functional departments for CTM release authorization and site activation.
• Organize and support internal preparatory meeting in support of formal regulatory type B and type C meetings
• Responsible for managing the electronic files (eTMF) and coordinating/collaborating with the CRO to ensure eTMF is transferred to TFF in a timely and organized manner.
• Oversee or conduct internal file audits or QC of the final eTMF.
• Assists with the development and review of study specific tools, templates, and documents as well as study reference manual and regulatory binder creation. Work with external vendors to obtain pricing for study tools, documents, and ad hoc study services.
• Reviews and participates in the quality control of documents and ensures consistency across multiple programs/studies.
• Responsible for additional tasks supportive of all departments.
The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties and skills required of the job. All employees may have other duties assigned at any time.
Requires a high school degree (or GED) at minimum. Bachelor’s degree preferred.
Professional Skills & Experience:
• Two or more years work experience in CRO, biotechnology or pharmaceutical field at minimum.
• This position requires the ability to act independently and to take initiative with minimal supervision from manager.
• Basic knowledge of clinical development processes, including related functional areas outside of Clinical.
• Honest, flexible, dependable, self-motivated team player with a strong work ethic and exceptional interpersonal communication skills.
• Strong organizational skills and attention to details required. Ability to prioritize and plan workload is essential. Ability to multi-task and function effectively in an interrupt-driven and fast-paced work environment.
• Excellent keyboard skills, with experience using Microsoft Office (Word, Excel, Power Point) applications to prepare charts, tables, forms, reports, and presentations. Experience with e-mail and calendar programs. Experience with Microsoft Project, Smartsheet, IVRS and EDC systems a plus.
• Effective oral and written communication skills. Ability to act independently and to take initiative. Knowledge of FDA and/or EMEA regulations, GCP, ICH guidelines and/or familiarity with standard clinical operating procedures is a plus. Must be able to work both independently and as part of a team.
• The qualified applicant shall demonstrate a) sound reasoning; b) progressive learning agility; c) versatility or being capable of doing many things competently; and, d) resilience from a disappointment or setback.
• Ability to work on complex or multiple project assignments. Ability to understand and follow complex, detailed technical instructions, and deliver on time.
• Values achieving milestones, including team and company goals.
Personal Skills & Competencies
• Ethics: treats people with respect, inspires the trust of others, demonstrates integrity.
• Leadership by example, with empathy and influence.
• Communication: listens and gets clarification, responds well to questions, speaks clearly and persuasively in positive and challenging situations.
• Teamwork: balances team and individual responsibilities, gives and welcomes feedback, contributes to building positive team spirit, puts success of team above own interests, supports everyone’s efforts to succeed.
• Analytical, pragmatic approach to problem solving.
Physical Demand/Work Environment
• Typical office environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, use hands and fingers (i.e. typing) and occasional lifting up to 20 pounds.
• There will be an occasional requirement to work outside of normal business hours.
• Occasional travel may be required (5%).
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