The Project Associate, Clinical Operations (PA) supports the planning, execution, and management of clinical trials in accordance with regulatory guidelines, standard operating procedures (SOPs), and project timelines. The PA plays a key role in administrative coordination, documentation tracking, and ensuring effective communication among clinical team members, vendors and investigation sites.

Duties and Responsibilities (Responsibilities include but are not limited to):

• Assist in the coordination and oversight of clinical trials from initiation to closeout.
• Create and maintain study status trackers to monitor clinical study activities and milestones.
• Develop and maintain study dashboards to provide visibility of key clinical activities (e.g. sample shipments) for the clinical operations team.
• Facilitate the creation and execution of Confidentiality/Non-disclosure Agreements and clinical vendor contracts, and ensure the documents are maintained within the central repository system.
• Schedule and coordinate meetings, including preparing agendas and meeting minutes.
• Interface with clinical research sites to obtain recruitment updates, study status updates, and regulatory documents to facilitate communication and support site management activities.
• Assist with vendor management, such as central labs, CROs, and other third-party service providers.
• Participate in clinical financial tracking by assisting with invoice and budget reviews and updating and uploading clinical financial documents within the financial tracking system.
• Help maintain compliance with ICH-GCP, FDA, EMA, and other applicable regulatory requirements.
• Participate in quality control and audit preparation activities related to clinical trials.
• Support the preparation and distribution of clinical study documents such as protocols, informed consent forms, case report forms (CRFs), and study reports.
• Track and maintain study documentation, including essential regulatory documents, investigator site files (ISFs), trial master file (TMF), and study trackers.
• Update and maintain clinical systems (e.g., CTMS, eTMF) to ensure accuracy and completeness.
• Other duties and/or responsibilities as assigned.

Requirements:

Education/Experience/Skills:

• Bachelor’s degree in life sciences, health sciences, or a related field.
• 1–3 years of experience in clinical research or clinical operations; experience in a CRO or pharmaceutical company preferred.
• Understanding of clinical trial processes and GCP/ICH guidelines.
• Knowledge of FDA, EMA, and other relevant regulatory requirements.
• Prior experience supporting multiple clinical studies or therapeutic areas.
• Familiarity with budgeting and financial tracking in clinical trials.
• Excellent organizational skills and attention to detail and to consistently deliver work product accurately and within deadline.
• Strong written and verbal communication skills.
• Ability to multitask and work in a fast-paced team environment.
• Demonstrated proficiency using Microsoft Office applications (Word, Excel, PowerPoint, Smartsheet), etc.
• Experience working within clinical trial systems (e.g., CTMS, eTMF) is a plus.

Working Environment and Travel:
Generally accepted home office working conditions
Occasional travel is expected in this position.

Physical Requirements: 
While performing the duties of this job, the employee is regularly required to walk, stand and sit. The employee will be able to use a computer for extended periods at any given time. The employee must regularly lift and/or move up to 10 pounds.

ADA: 
The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.

SAB BIO is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. SAB BIO is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets