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Job ID: 180540

Clinical Research Manager
Tufts University


Date Posted Mar. 4, 2022
Title Clinical Research Manager
University Tufts University
Boston, MA, United States
Department The Trustees of Tufts College
Application Deadline Open until filled
Position Start Date Available immediately
 
 
  • Research Scientist/Associate
  • Nutrition and Dietetics
 
 

Overview

The mission of the Jean Mayer USDA human nutrition research center on aging at tufts university (HNRCA) is to promote healthy aging through nutrition science to empower people seeking to enjoy long, active, and independent lives. HNRCA investigators conduct the world's most advanced studies on nutrition and aging. The research focuses on determining the nutrient and physical activity requirements necessary to promote well-being for older adults. HNRCA scientists examine how nutrition and physical activity play a major role in the prevention of the major chronic degenerative conditions and diseases associated with aging.

 


What You'll Do

The clinical research project manager will be responsible for the planning and management of an HNRCA-based clinical center for the NIH common fund’s nutrition for precision health powered by the-all of us research program (NPH). Working closely with the study pi and co-is, the HNRCA human studies team, and HNRCA scientific cores, the project manager will be responsible for managing all aspects of the study’s operations, including oversight of the project timeline and project deliverables, clinical quality assessment, communications, reporting, and trial operations integrity. The project manager will oversee all aspects of study conduct; coordinate and organize protocol activities between all of us new England research collaborative teams; assist in data management; maintain records and documentation; maintain a working knowledge of the entire project’s protocols, policies, and procedures; conduct training for the staff; and implement best practices.  This position will also interact and communicate with multiple investigators and consortium teams (both onsite and at other NPH sites), scientific core staff, and study participants. 

Manages NPH study activities within the HNRCA, including but not limited to recruitment, adherence to project timeline, JRB documentation and regulatory monitoring, protocol integrity, data documentation, and reporting.  Provides expertise on establishing efficient workflows and helps identify and resolve issues.  Arranges or helps to organize clinical study meetings and leads team-wide communications, both at the HNRCA and with all of us new England collaborators.

 

In collaboration with the pi, acts as central communications liaison for all trial collaborators both within the-all of us new England research collaborative, as well as across all NPH collaborating sites. Identifies variances across participating sites’ standard operating procedures and develops processes to ensure compliance.  Assists with the development and execution of study materials, JRB materials, regulatory reports, monitoring plans, and data management plans.  Assists in preparation of routine and expedited reporting required to other governing groups (e.g., executive, or steering committee, JRB, NIH, DSMB, etc.) Helps ensure that research activities are performed within federal and university regulations and policies.

 

Supervises one or more clinical research coordinators and student employees.  Trains staff and prepares the site for all aspects of protocol readiness. Develops and maintains a thorough working knowledge of the entire project’s protocols, policies, and procedures training of staff as needed to assure adherence to the protocol, standard operating procedures, and best practices. Meets regularly with program and HNRCA leadership to discuss strategic planning, operations improvements, and personnel resource prioritization.

 

Serves as a resource for study participants as needed and contributes to participant engagement activities. As needed, helps coordinate study visits, covers general clinical duties during study visits, and interacts with study participants to make sure all study visit procedures are completed as necessary.

 

Works with the human studies team and biostatistics/data management core to help implement best practices for the collection, integrity, management, dissemination/shipping, and quality control of large amounts of data and biological samples. Identifies and resolves issues with data and/or samples. Plans for and executes proper study closeout.  Implements best practices and HNRCA policies for data sharing and data retention.

 


What We're Looking For

Minimum required experience, education, background, and certifications/licenses

·       Bachelor's degree nutrition or other health-sciences field and 8+ years’ progressively responsible experience in a clinical research setting (including direct management of multiple staff)

·       Exceptional project management, leadership, and organizational skills; capacity to prioritize multiple tasks in an environment of often-fluctuating demands; demonstrated excellence in oral, written, and interpersonal communication, as well as independent decision-making and real-time problem-solving

·       Strong data management skills, including the ability to handle and organize data from different sources; experience with data management software

·       Experience with redcap or other research data collection databases

·       Experience working within IRB guidance and policies and e-consenting

·       Experience with working with research participants

·       Familiarity with the code of federal regulation (CFR) and good clinical practice (ICH GCP); completion of human subject protection training program within two weeks of hire (required prior to interacting with human subjects)

·       Experience with and highly skilled at using multiple technological applications and platforms, data portals, and systems that capture, store and transact data and materials

Additional preferred experience, education, etc. 

·       Master’s degree in nutrition or a nutrition- or health sciences-related field and 10+ years’ progressively responsible experience in a clinical research setting (including direct management of staff); education, training, and/or experience in nursing, dietetics, dietary assessment, or data management desirable

·       Fluency in spoken and written English and Spanish

·       Project management or clinical research management certification

 

An employee in this position must complete all appropriate background checks at the time of hire, promotion, or transfer.

 

         Equal Opportunity Employer – minority/females/veterans/disability/sexual orientation/gender           identity.


 
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