Sr. Clinical Research Associate at TELA Bio – Malvern, Pennsylvania

Education and Experience:

• Bachelor’s degree in Life Sciences or related field
• Advanced degree or clinical research certification preferred

Required Knowledge, Skills and Abilities:

• Minimum of 4 years of experience in clinical research with at least 2 of those years with demonstrated on-site monitoring experience.
• Experience in Medical Devices is preferred, with prior experience in US IDE clinical studies is highly desired.
• Solid understanding of clinical regulations/guidelines and procedures (e.g., ICH/GCP, ISO 14155, CFR 820, EU MDR, UKCA); ability to work within the constraints of a regulated industry while achieving objectives.
• Excellent interpersonal relationship skills including collaborating, negotiating, and influencing to drive achievement of objectives.
• Strong communication (oral and written) skills including publications, regulatory documents, and presentations; ability to communicate in small and large settings and with all organizational levels, regulatory agencies, and physicians.
• High attention to detail and ability to manage multiple priorities.
• Ability to thrive in a fast paced, dynamic, and constantly changing work environment with competing priorities.
• “Hands-on”, “roll-up-the-sleeves” leader who understands the need for involvement in a small company environment while recognizing when to delegate and seek results from the team.
• Proficient with MS Office Suite and clinical systems such as CTMS (Clinical Trial Management System), eTMF (electronic Trial Master file), and EDC (electronic data capture).

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.

Must be able to:

• Ability to carry and lift product inventory of up to 10 lbs.
• Must have demonstrated ability to multitask in high pressure, changing conditions.

Working Conditions

This position works in a home office, hospital, HCP office, home office or clinical environment. The noise level in the work environment is quiet to moderate.

Primary Location and Travel:

• Ability to travel up to 50%

We anticipate that on an ongoing basis this role will be a office-based position although the incumbent will need to participate in face to face Corporate meetings as needed.

Disclaimers:

This is a representative description of the job and is not intended to be all-inclusive. Employee 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.

For more information, please check out our website: www.telabio.com