Description
Job Title: Clinical Trials Project Management Administrator
Department: Study Management
Location: Hybrid, Rochester, NY
Hours Per Week: 40 hours
Schedule: Days, Monday – Friday
SUMMARY
As an integral part of the Clinical Trials Project Management team, the Project Management Administrator (PMA) plays a crucial role in supporting studies from start to finish. The PMA actively contributes to the success of the Project Management Team and therefore our clients by preparing study documents and executing study-specific functions as needed, ensuring smooth and efficient study operations.
RESPONSIBILITIES
- Support administrative study management activities, including New Awards, Database Locks, and Long-Term Storage studies in the clinical trials management system based on study needs.
- Assist Project Managers with key study start-up activities, such as, but not limited to, Investigator Meeting preparation, kick-off Meetings, and First Patient In Quality Check.
- Perform administrative tasks on assigned studies, including, but not limited to, timely processing of documents sent to clients, Lab Manual development and reviews, distributing mass memos and communications to clients, and providing documents and reports to internal team members.
- Collaborate with Project Managers on developing and maintaining study Notes to File, Lab Manuals, Site Memos, and training documents.
- Coordinate and complete internal closeout activities following study database lock.
- Communicate with ACM clients regarding escalated DIFs and medical alert site acknowledgment, and liaising with internal teams and clients to resolve investigator queries and maintain accounts and contact information.
- Assist with regulatory-required study documentation and compliance with standard operating procedures (SOP) for collecting, maintaining, and archiving materials. Perform duties with a general working knowledge of FDA, NYSDOH, GCP, ICH, and other pertinent
- rules concerning central laboratory functions.
- Provide exceptional customer service to clinical trial clients and maintain positive working relationships with internal stakeholders, such as the Project Management team, Study Set-Up team, and Study Support team.
- Perform other clinical trials administrative functions as needed to ensure study management success, such as, but not limited to, site initiation orders, expedited Site Contact lists, maintaining study binder materials, and handling all expedites and escalations within the study.
- Perform department, internal, and Investigator file reviews as assigned and documenting findings in appropriate systems.
- Ensure allocated tasks are performed on time and to a high-quality standard, and proactively communicate any risks to the project manager.
- Work directly with Lab(s) to collect and deliver associated documents from investigators and site personnel if necessary.
- Understand and follow company policies and procedures while maintaining patient and client confidentiality inside and outside the workplace
REQUIRED QUALIFICATIONS
- 1 year of experience working in Clinical Trials, Health Care or Administrative role
PREFERRED QUALIFICATIONS
- Excellent verbal and written communication skills
- Ability to multi-task and prioritize workload
Customer Service experience required
PHYSICAL REQUIREMENTS: Sedentary - Sedentary roles are primarily office-based and require prolonged sitting (67–100% of the workday) with minimal physical effort and lifting limited to under 10 lbs. Fine motor skills are necessary for computer work, writing, and telephone use, supported by clear visual and auditory ability. Cognitive and emotional demands are high due to extended concentration, frequent interruptions, independent decision-making, and information processing. Although physical exposure is low, administrative areas within healthcare environments may occasionally involve contact with infectious agents. Some roles may require flexible hours, TB screening, or a valid driver’s license.
PAY RANGE: $23.00 - $28.00
The listed base pay range is a good faith representation of current potential base pay for successful applicants. It may be modified in the future. Pay is determined by factors including experience, clinical licensure date, relevant qualifications, specialty, internal equity, location, and contracts.
