Clinical Research Program Manager- Covid-19 Testing Technologies

University Of Massachusetts Medical School Worcester , MA 01601

Posted 2 weeks ago



Under the general direction of the Principal Investigator or designee, the Research Project Manager is responsible for implementing multiple research and other projects from inception to completion and overseeing the daily operations.



  • Manage the performance and activities of research support staff

  • Responsible for operational procedures for one or more research teams

  • Represent studies/projects in internal and external settings

  • Coordinate the recruitment, hiring and training of staff

  • Participate in Steering Committee meetings and other study related activities

  • Manage all study events/tasks including offsite locations

  • Present study status reports

  • Design and implement research project tracking systems

  • Oversee all regulatory documentation, including local or central IRB. Oversee provision of data/support to study Investigators, sponsors and/or external monitors/auditors

  • Monitor strict adherence to all study protocols, including all regulatory requirements adhering to appropriate federal, local and institutional guidelines. Identify and resolve issues with protocol compliance. Keep principal investigator and manager aware of any issues regarding compliance

  • Comply with all safety and infection control standards appropriate to this position

  • Adhere to Good Clinical Practice (GCP) guidelines and all human subject protection practices

  • Collaborate with investigators in grant preparation, evaluation of protocol feasibility, conference presentations, manuscript writing and other project reports

  • Provide detailed written summaries from literature searches and related sources to serve as a resource for the study team and clinicians/PI's

  • Assist in the development of the design, development, and documentation of study related data and collection tools, (e.g. questionnaires, treatment data and/or therapeutic checklists) , IRB submissions and protocol implementation activities.

  • Document and collect data for research related procedures performed during participant study visits. Ensure clinicians and/or PI accurately document their study activities according to protocol.

  • Oversee the input of study related information in the data management system within the required timeframe

  • Conduct preliminary quality assurance reviews of study data.

  • Ensure consent of research participants is obtained in accordance with the IRB approved protocols and all applicable regulations including HIPAA are fulfilled.

  • Manage the recruitment, screening, and subject selection activities for a research study

  • Monitor adherence to protocol required study procedures and schedule

  • Perform other duties as required.



  • Bachelor's degree in a scientific or health related field, or equivalent experience

  • 5-7 years of relevant experience with a minimum of 1 year of supervisory experience

  • Demonstrated knowledge of quality management principles in a scientific or hospital setting

  • Ability to travel off site locations

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Research Nurse Coordinator II Covid19 Testing Technologies

University Of Massachusetts Medical School

Posted 1 week ago

VIEW JOBS 2/18/2021 12:00:00 AM 2021-05-19T00:00 Overview GENERAL SUMMARY OF POSITION: Under the direction of the Principal Investigator or designee, the Research Nurse Coordinator II is responsible to carry out all delegated tasks related to complex protocols testing investigational drugs, devices, or research interventions. The Research Nurse Coordinator II is a primary resource for study protocol conduct acting as a liaison between the University of Massachusetts Medical School (UMMS), clinical partners (ex. University of Massachusetts Memorial Health Care (UMMHC)), the Principal Investigator, Institutional Review Board (IRB), and sponsors to ensure good clinical practice standards (GCP) throughout the life cycle of the study. Responsibilities MAJOR RESPONSIBILITIES: * Assist the Principal Investigator in feasibility and budget assessments for research studies, recommend changes and adjustments as necessary * Responsible for the protocol specific training of the study team and clinical staff * Assist in the development of research protocols, case report forms, and case report form completion guidelines * Maintain and coordinate all aspects of complex study conduct, including data and source documentation, adverse event reporting, and communications with the IRB * In collaboration with the Principal Investigator, assist in collation, writing, and editing of research results * Provide feasibility assessment of research study protocol requirements and design a recruitment plan for assigned clinical studies * Participate in Quality Assurance internal audits * Take primary responsibility for creation and maintenance of all regulatory documents, including initial IRB submission, continuing review submissions, and FDA and sponsor required regulatory documents * Screen patients according to study criteria, randomize, enroll, and consent in accordance with GCP standards * Perform nursing assessments of study participants according to protocol and consult with clinician or Principal Investigator as necessary * Schedule, perform, and/or coordinate all study procedures according to protocol requirements and sponsor conventions * Review and abstract medical record information in a consistent manner, in accordance with study protocol, institutional, and HIPAA requirements * Organize and maintain appropriate regulatory documents in accordance with sponsor and institutional standards throughout the life of the study * In collaboration with the investigational pharmacy, ensure proper adherence to randomization schema, study drug dosing and administration per protocol * Responsible for all regulatory paperwork and to report findings to the Principal Investigator, sponsor, and IRB when necessary * Review clinical system billing charges for accuracy and appropriateness * Ensure that all required study event and protocol related data is accurately and efficiently entered into the clinical trial management system * Document and record, in writing or electronically, all study events and protocol related procedures * Maintain patient/subject confidentiality and strictly adhere to all federal, state, and institutional standards for GCP * Maintain business confidentiality as it relates to sponsor, protocol and related regulatory documents * Attend meetings, conferences, seminars, and applicable training as required * Ensure that all staff adhere to policies and procedures of any clinical site where study is being performed and adhere to all institutional health, safety, and infections control regulations and requirements. * Perform other duties as required. Qualifications REQUIRED QUALIFICATIONS: * RN with current registration to practice nursing in Massachusetts * 5-7 years of relevant nursing experience, 2 years of which must be research nurse coordinator experience * Proficiency in electronic medical records and relevant computer software * Strong oral and written communication skills, attention to detail is essential * Ability to work in a team environment to facilitate the integrity of the study and its timely completion * Maintain annual clinical partner nurse compliance standards * Ability to travel to off-site locations. Additional Information PREFERRED QUALIFICATIONS: * Bachelor's degree in Nursing * Experience with OnCore and Epic * Phlebotomy and EKG skills * BLS Certification University Of Massachusetts Medical School Worcester MA

Clinical Research Program Manager- Covid-19 Testing Technologies

University Of Massachusetts Medical School