In-House Clinical Research Associate (Biotech - REMOTE)

Job Title: In-House Clinical Research Associate

Job Description

We are seeking a skilled Clinical Research Associate to join our dynamic Clinical Development team. This role will support and manage various aspects of clinical trials, ensuring that studies are conducted efficiently and in compliance with regulatory standards.

Responsibilities

• Support the Trial Manager in tracking regulatory submissions and approvals, recruitment, and enrollment for assigned studies.
• Assist in site start-up activities, including oversight of CRO start-up activities, essential document package review, and participation in initiation visits.
• Collaborate with the contracts team to review and negotiate site and vendor budgets/contracts.
• Contribute to the development and review of study, patient, and site-facing documents such as protocols and informed consent forms.
• Ensure meeting agendas are clear and distributed in advance; take comprehensive minutes for internal and external meetings.
• Participate in CRO monitoring activities and co-monitoring visits to ensure compliance with protocol and regulatory requirements.
• Identify potential operational challenges and collaborate with senior team members to provide solutions.
• Adhere to Clinical Operations processes and SOPs to maintain studies in an 'inspection ready' state.
• Support the oversight of vendors, review site invoicing, and manage financial aspects in accordance with clinical trial agreements.
• Engage in TMF activities, including review of TMF index and document provision.
• Support onboarding and mentoring of new department members.
• Comply with workplace health and safety policies and procedures.
• Perform other duties as assigned by the supervisor.

Essential Skills

• Experience in vendor management and clinical research.
• Proven monitoring oversight experience, including co-monitoring or remote monitoring.
• Experience with site contracts and budgets.
• Familiarity with TMF activities, such as review of TMF index and document provision.

Additional Skills & Qualifications

• At least 4+ years of relevant clinical operations experience.
• Bachelor's degree in Life Sciences with at least 2 years in a pharmaceutical sponsor environment.
• Excellent attention to detail and strong verbal, written, interpersonal, and presentation skills.
• Familiarity with routine medical/scientific terminology.
• Proficiency with MS Office.
• Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs is desirable.
• Ability to participate in strategic initiatives under general supervision.
• High energy, personal productivity, initiative, creativity, and commitment.
• Team-player attitude, eager to work in a fast-moving, dynamic start-up environment.

Work Environment

This role is primarily remote, requiring occasional travel (10-20%). The position is within a growing Clinical Development team based on the East Coast, with candidates ideally located in the Eastern Standard Time zone. The company offers an exciting opportunity to learn and take on additional responsibilities in a small but growing biotech environment. Job Type & Location This is a Permanent position based out of Gaithersburg, MD. Pay and Benefits The pay range for this position is $90000.00 - $115000.00/yr. Our Benefits: We are proud to offer health benefits, a discretionary bonus plan, stock option grants. a stock purchase plan, a 401(k) with match and paid time off to our team members as part of their compensation plan Workplace Type This is a fully remote position. Application Deadline This position is anticipated to close on Dec 31, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] for other accommodation options. Apply tot his job Apply To this Job