Site Manager

Job Description

Job Description

Description:

SITE MANAGER

Position Summary:

The Site Manager is responsible for assuring the study team is accountable for performing assigned responsibilities in compliance with project plans, federal regulations, GCP and good medical practice. This position collaborates with internal teams and external stakeholders to ensure all sites and studies are adequately and appropriately resourced and delivered efficiently to timeline, budget and quality expectations. The Site Manager will provide study management expertise and mentor Coordinators and other research clinic staff. This position reports directly to the Site Director.

Key Responsibilities:

• Ensures study compliance against protocol, SOPs, regulations and ICH/GCP guidelines
• Acts as a primary liaison with CRO/sponsors; establishes quality guidelines to ensure clinical study vendors are adhering to the agreed upon timelines
• Build and maintain strong relationships with investigators, referring physicians, and community partners
• Ensures timely responses to clinical site staff and all regulatory agencies
• Develop strong, collaborative working relationships with CROs, sponsors, investigators, and other essential staff members
• Assembles and coordinates clinical trial study teams of study coordinators and other personnel needed to support the execution of the clinical study
• Oversees overall study progress, data collection, and cleaning activities for all study trials
• Interacts and coordinates with sponsor on study specifics
• Prepares study reports and provides ongoing updates for leadership team/meetings
• Develops and contributes to best practices and SOPs
• Provides clinical leadership to CROs and sponsors
• Oversees leadership of the Study Management team while ensuring site training/communications are occurring
• Interviews and onboards new hires for the Study Management team
• Conducts continuing performance management and annual reviews of the Study Management team
• Participates in all study related meetings
• Ensure adherence to Good Clinical Practice (GCP), FDA regulations, and IRB requirements
• Communicates out of scope activities to ensure billing compliance and communicates all study invoiceables timely
• Ensures staff work is “inspection ready” at all times
• Represent the site at industry meetings and conferences

Education and Experience:

• Minimum 5 years of experience in clinical research
• Strong knowledge of relevant regulations ICH/GCP and FDA guidelines
• Effective site management and organizational skills/ability to meet key study milestones
• BS/BA in Life Science or related discipline or equivalent work experience Basic understanding of regulations governing clinical research (CFR, GCP, HIPAA)
• Previous nursing, medical assistant experience in a clinical setting a plus
• CCRC certification a plus
• Demonstrated relationship building, with strong verbal and written skills.
• Ability to successfully coordinate protocols with overlapping timelines
• Ability to travel as needed: to support other sites, attend audits, attend meetings (Investigator Meetings, conferences, etc.)
• Ability to explain importance of GCP guidelines and their application
• Ability to train others on coordinating responsibilities and protocol adherence
• Able to clearly explain and enforce clinical research participant safety requirements including ICF process, role of the IRB and adverse event reporting
• Strong interpersonal skills with attention to detail a must
• Proven ethical and professional codes of conduct
• Demonstrated proficiency with word processing, spreadsheet, database, and presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, SharePoint) and with regulatory filing systems.

Skills and Competencies:

• Demonstrated relationship building skills through professional communication, interpersonal, analytical and problem-solving skills
• Demonstrated ability to Coordinate complex protocols with overlapping timelines
• Microsoft Office Suite proficiency, technologically skilled in various systems
• Strong study documentation skills in compliance with ALCOA+ preferred
• Close attention to detail and strong organizational skills to deliver high-quality work within project timelines
• Demonstrates strong analytical, problem-solving skill
• Must be results oriented, multi-tasking and a quick learner
• Familiarity with electronic case report form systems such as Medidata Rave, Inform, TrialKit, etc. preferred
• Demonstrated risk identification and mitigation
• Ability to effectively lead a team
• Ability to prioritize and manage multiple projects simultaneously
• Previous experience training and mentoring others
• Time management skills

Physical Requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

• Ability to sit, stand, walk, reach with hands and arms, and use hands along with fingers, to handle or feel.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands and wrists
• Ability to lift and/or move up to 25 pounds.

The above is not an exhaustive list of duties, and you will be expected to perform different tasks as necessitated by your changing role within the organization and the overall business objectives of the organization.

Why JCCT?

JCCT has provided exceptional customer service to clients, volunteers, and vendors for the last 20 years. This team effort has resulted in our company getting recognized as one of the best clinical research sites in the United States.

We are actively growing through acquisition and organic growth and need high performing individuals to help support our continued success. Our clients come from all over the world to place a study at our research sites. We are proud of what we have accomplished and invite you to explore career opportunities with us. JCCT makes a promise to support, accept and respect you as an individual, in our family focused environment.

Our vision is to make a difference in our world to help improve the health and wellbeing of others through pharmaceutical research and the processes of drug development. Our impact is driven by genuine care, support and customer service provided to our employees, volunteers, and sponsors.

If you are looking for a positive work environment and the opportunity for personal growth and satisfaction, we encourage you to apply at JCCT. Qualified candidates will be contacted for interviews. Unleash your potential and apply today!

EEO

JCCT provides equal employment opportunities (EEO) to all employees and applicants. We value diversity at our company, and it is our policy to recruit, hire, and promote qualified individuals without regard to race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.