Project Management Administrator
About The Position
The Project Management Administrator (PMA) is an integral member of the Clinical Trials Project Management team, supporting studies from start to finish. The role contributes to the success of the Project Management Team and its clients by preparing study documents and carrying out study-specific functions to help ensure smooth and efficient study operations. The PMA supports administrative study management, study start-up, ongoing study tasks, closeout, documentation, and client communication. The role works with Project Managers, internal teams, laboratories, clients, investigators, and site personnel, while following company policies, standard operating procedures, and applicable requirements concerning central laboratory functions. The position is hybrid in Rochester, New York, with a 40-hour Monday–Friday daytime schedule.
Requirements
- At least 1 year of experience working in clinical trials, health care, or an administrative role.
Nice To Haves
- Excellent verbal and written communication skills.
- Ability to multitask and prioritize workload.
- Customer service experience is required.
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 study start-up activities, including Investigator Meeting preparation, kick-off meetings, and First Patient In Quality Checks.
- Perform administrative tasks on assigned studies, including processing documents sent to clients, developing and reviewing Lab Manuals, distributing mass memos and client communications, and providing documents and reports to internal team members.
- Collaborate with Project Managers to develop and maintain 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; liaise with internal teams and clients to resolve investigator queries and maintain accounts and contact information.
- Assist with regulatory-required study documentation and follow SOPs for collecting, maintaining, and archiving materials.
- Provide customer service to clinical trial clients and maintain positive working relationships with internal stakeholders, including the Project Management, Study Set-Up, and Study Support teams.
- Perform other clinical trials administrative functions as needed, including site initiation orders, expedited Site Contact lists, maintaining study binder materials, and handling study expedites and escalations.
- Perform assigned department, internal, and Investigator file reviews and document findings in appropriate systems.
- Complete allocated tasks on time and to a high-quality standard, and proactively communicate risks to the Project Manager.
- Work directly with laboratories to collect and deliver associated documents from investigators and site personnel when necessary.
- Follow company policies and procedures and maintain patient and client confidentiality inside and outside the workplace.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
No Education Listed
