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

EDUCATION:

LICENSES / CERTIFICATIONS: 

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.

For disease specific care programs refer to the program specific requirements of the department for further specifications on experience and educational expectations, including continuing education requirements.

Any physical requirements reported by a prospective employee and/or employee’s physician or delegate will be considered for accommodations.

PAY RANGE:

$23.00 - $28.00Rochester14624

The posted pay range is a good faith representation of potential base pay for this position. It may be modified in the future and eligible for additional pay components. Individual annual salaries/hourly rates could vary based on position details and FTE. Pay is determined by considering factors including, but not limited to, experience, relevant qualifications, specialty, internal equity, locations, and contracts.

Rochester Regional Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex (including pregnancy, childbirth, and related medical conditions), sexual orientation, gender identity or expression, national origin, age, disability, predisposing genetic characteristics, marital or familial status, military or veteran status, citizenship or immigration status, or any other characteristic protected by federal, state, or local law.