Hologic Clinical Research Associate 3 in Marlborough, Massachusetts
The Senior Clinical Research Associate takes a leading role in executing clinical studies and protocols in support of medical device R&D pipelines. Alongside key cross-functional collaborators, they will monitor subject recruitment, enrollment, data and study-related information related to clinical sites and study participation all with an eye to maintaining Good Clinical Practice and regulatory requirements. The Senior Clinical Research Associate will also participate in and contribute to clinical operations planning and activities, including protocol and documentation development responsive to product development and post-market research activities.
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
Leads the creation, development, and management of clinical study documents such as study protocol, study timeline, case report forms, informed consent forms, monitoring plans, clinical research agreements, enrollment tracking, device accountability, protocol deviations and adverse event reporting, study logs and forms, regulatory binders, interim and final reports, status updates and other study documents.
Develop and deliver on key metrics related to clinical study progress, including monitoring activities and finalization of monitoring reports.
Build internal cross-functional partnerships as well as establish and grow external relationships with key research partners and institutions.
Continuously evaluate tools and solutions for the efficient management of clinical monitoring tasks.
Responsible for providing guidance for issue resolution at site levels and generation of mitigation plans for potential risks during study execution.
Provide coaching and training to junior team members in the organization.
Performs independent clinical site visits including site qualification visits, site initiation visits, monitoring visits and site close-out visits.
Prepares accurate site visits reports and communicate with site staff to ensure completion of pending actions and resolution of study conduct issues.
Responsible for study enrollment tracking and reporting at individual study centers.
Oversees all aspects of the Trial Master File for completion and accuracy.
Assists in the execution of clinical studies to ensure study deliverables are completed on time and within budget, including assistance with subject recruitment as well as management of clinical study supplies and budgets.
Develops and maintains strong working relationships with site study staff and Principal Investigator(s).
Performs study and trial audits and review of all study documentation, as necessary.
Assists with writing the clinical data sections of regulatory submissions.
Contributes to departmental goal of standardization of Clinical Affairs research procedures and documents.
May participate in the training and management of external vendors and CRO teams, investigators and staff as needed Mentors junior clinical staff members on monitoring activities as needed.
Ability to travel at a minimum of 30-40%
Strong track record of clinical research experience, including site monitoring.
Excellent communication and writing skills.
Demonstrated ability to attain and maintain a working knowledge of ICH GCPs, applicable regulations and procedural documents.
Knowledge and expertise with FDA regulations related to clinical trials for medical devices a plus.
Experience performing literature searches and summarizing key findings for dissemination to a larger group.
Bachelor’s degree in relevant scientific discipline (life sciences, biomedical engineering, etc), or higher;
4+ years of experience working in clinical research, including monitoring experience
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.