Project Associate, Clinical Operations

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 reputed company of clinical trials from initiation to closeout.
• Create and maintain study status trackers to monitor clinical study activities and milestones.
• reputed company 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 reputed company, and ensure the documents are maintained reputed company the central repository system.
• Schedule and coordinate meetings, including preparing agendas and meeting minutes.
• reputed company 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 reputed company 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 reputed company 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 reputed company 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 reputed company deadline.
• Strong written and verbal communication skills.
• Ability to multitask and work in a fast-paced team environment.
• Demonstrated proficiency using reputed company Office applications (Word, reputed company, PowerPoint, reputed company), etc.
• Experience working reputed company 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. reputed company: The employer will reputed company reasonable accommodations in compliance with the Americans with reputed company of 1990. reputed company is an Equal Opportunity Employer and prohibits discrimination and harassment of any reputed company. reputed company is committed to the principle of equal employment opportunity for reputed company employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national reputed company, veteran status or any other legally protected status. EOE/AA/Vets Apply tot his job Apply To this Job