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Senior Clinical Research Associate

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Research & Development
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At Hologic, we’re an innovative medical technology company that enables healthier lives everywhere, every day. We are also a company that prospers and grows, which is why we’ve been able to expand our offerings to empower even more people and champion women’s health

 

What powers our growth across Breast & Skeletal Health, Diagnostics, GYN Surgical and Medical Aesthetics Solutions is also what differentiates us: the exceptional and clinically proven capacity of our products to detect, diagnose and treat illnesses and other health conditions earlier and better. This clinical superiority creates high expectations, which we fulfill by continually challenging ourselves to improve health through better technology, education and market access.

 

None of this would be possible without the talent and passion of our employees. Together, our expertise and dedication to developing and sharing more robust, science-based certainty drives our global presence and a promising pipeline that responds to the unmet health and wellness needs of women, families and communities.

 

While we focus on women’s health and well-being, we are committed to having an even broader benefit on the world. Together, we advocate for better health and wellness through solutions that provide ever greater certainty and peace of mind,


 

Summary of Duties and Responsibilities

 
  • Support protocol development
  • Responsible for the development of the study Monitoring Plan
  • Builds relationships with investigators and study site personnel.  Serve as primary liaison between sites and Hologic
  • Initiates, monitors and conducts study close-out visits at clinical centers independently
  • Schedules and conducts monitoring visits in accordance with the Monitoring Plan inclusive of training of study site personnel, oversight or protocol adherence, data verification of source documents and accountability of investigational study supplies.
  • Must be able to troubleshoot and resolve routine study conduct issues
  • Responsible for study enrollment tracking and reporting at individual study centers
  • Assists with writing the clinical data sections of regulatory submissions
  • Performs site audits and trial audits as necessary
  • Develops and maintains study timelines for assigned studies with some supervision
  • Oversees all aspects of the Trial Master File
  • Assists with development of clinical trial documents such as study newsletters, etc.
  • Assists with subject recruitment and retention programs
  • Responsible for the management of clinical study supplies
  • Assists with review of study reports including tables, listing and figures as needed
  • Contributes to departmental goal of standardization of Clinical Affairs research documents
  • May work closely with contracted research organizations to oversee projects and interactions with study site investigators
  • Work collaboratively with the study manager to execute investigator contracts in accordance with the departmental budget
  • Assures compliance of clinical studies with Good Clinical Practice (GCP). Federal regulatory requirements and Hologic Standard Operating Procedures (SOPs)
  • Prepares project status and study reports
  • Ensures prompt reporting and follow through of protocol deviations and adverse events
  • Collaborates with data management on data clarification processing, review, and verification of investigator clarification responses
  • Mentors more junior Clinical Operations staff and participates in the on boarding of new personnel
  • Responsible for additional projects, as required
  •  Ability to travel up to 30% domestically           


Qualifications:

 
  • Advanced knowledge of FDA regulations and ICH-GCP.
  • Strong communication and interpersonal skills.
  • Strong Attention to detail
  • Leadership skills, influence management and collaboration
  • Ability to work cross-functionally to problem solve
  • Ability to handle multiple tasks to meet deadlines in a dynamic environment
  • Ability to provide solid judgment in decision making
  • Strong project management skills
 

Education – Bachelor’s Degree

 

Experience – 3 years monitoring experience

 

Specialized Knowledge:

Microsoft office, familiar with electronic clinical database systems.


 

Agency and Third Party Recruiter Notice:

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter.  All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

 

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.


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