Clinical Research Coordinator

Clinical Research Coordinator

The Clinical Research Coordinator is responsible for overseeing the administrative responsibilities and project management of TELA Bio's clinical operations activities including supporting the execution of company sponsored studies, investigator-initiated activities, and day-to day clinical operation tasks.

Essential Duties and Responsibilities

Clinical Trial Support:

• Support the set-up and have operational responsibility for the maintenance of the local electronic Trial Master File (eTMF) including document tracking in accordance with ICH-GCP and local requirements.
• Collaborate with Clinical Project Managers (CPM) or designees during the document collection process to support effective delivery of a study and its documents.
• Builds and/or imports clinical-regulatory documents into the eTMF ensuring compliance with local and international regulations and guidance.
• Maintains study documents, ensuring template and version compliance.
• Ensures important documents under their responsibility are of quality and uploaded in a timely manner to maintain eTMF Inspection Readiness.
• Assists with the management and/or distribution of study team internal and external communications.
• Sets-up, populates and accurately maintains information in tracking and communication tools and supports others in the usage of these systems.
• Reviews study documents ensuring accuracy of content.
• Ensure that all study documents are ready for final archiving and completion of the local part of the eTMF.

Clinical Contracts and Payments:

• Oversees the administrative activities of the clinical trial contracting process including study agreements, NDAs, etc.
• Maintain proactive communication with institutions, CROs, vendors and finance to process invoices, make payments, and track receipts.
• Liaison/collaborate with Clinical Project Manager, Investigational Sites, Legal and Compliance to expedite and finalize contracts and amendments.

General:

• Create, prepare, and deliver reports to various departments.
• Receive and forward communications to different staff and departments.
• Organize meetings and meeting schedules.
• Perform clerical duties, such as filing, faxing, answering phone calls, and responding to emails.
• Other duties as assigned include organizing and managing document control and general invoice tracking.
• Collaborate cross-functionally with regulatory, legal, compliance and other departments as required.

Education and Experience

Bachelor's Degree in relevant discipline or associate degree including a minimum of 2 years of relevant experience.

Required Knowledge, Skills and Abilities

• Minimum 2+ years of related industry experience is required
• Previous document management experience in a regulated industry, preferably in the medical/ life science field.
• Previous experience in program or project coordination or equivalent experience.
• Extensive knowledge of Microsoft Office and Adobe suite applications.
• Detail-oriented, results-driven collaborator with advanced multi-tasking experience.
• Strong communication (written and oral) and interpersonal skills.

Preferred

• Familiarity with CFR Part 11 Compliant systems (i.e., DocuSign) and clinical trial systems (eTMF, CTMS, EDC).
• Further training in administration and/or in the life science field are desirable.
• Solid understanding of the Clinical Study Process and working procedures relating to it, together with the knowledge of the ICH-GCP guidelines.
• Ability to develop digital literacy to increase efficiency daily.
• The ability to train others to study administration procedures.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Ability to carry and lift up to 10 lbs.
• Must have demonstrated ability to multi-task in high pressure, changing conditions.

Working Conditions

This position works in an office or home office. The noise level in the work environment is quiet to moderate.

Primary Location and Travel

We anticipate that this role will be in a corporate office or a remote home office position.

Disclaimers

This is a representative description of the job and is not intended to be all-inclusive. Employees may perform other related duties as required to meet the ongoing needs of the organization. Duties, responsibilities, and activities may change at any time with or without notice.

TELA Bio, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, national origin, age, marital status, protected veteran status, disability status, or any other status protected by federal, state, or local law.