POSITION SUMMARY:

Under the guidance of the Principal Investigator (PI) or their appointed delegate, the role of Clinical Research Coordinator entails the independent execution of tasks and procedures associated with human subject research. This responsibility encompasses the coordination of regulatory components management and compilation of data pertaining to multifaceted research protocols. These protocols are deeply interwoven with treatment methodologies, ancillary services spanning across many disciplines, and preventive care approaches.

This position predominantly involves maintaining a balance of administrative responsibilities and direct subject interactions, and focuses on Duchenne/Beckers Muscular Dystrophy (DMD/BMD) as well as those who carry the DMD/BMD mutation. The range of these research projects are extensive and comprehensive, extending from biomarker/natural history studies to Investigator Initiated studies to Industry clinical trials (Phases 1-3).

Our overarching aim, through the integration of varied studies, is to elucidate the underlying causes of Duchenne Muscular Dystrophy diseases and to assess the efficacy of potential pioneering therapies, which could significantly ameliorate these conditions.

We are seeking an individual who has an investigative and enterprising nature, generally enthused about contributing to groundbreaking research endeavors and is eager to become a pivotal member of our esteemed team. The prospective candidate should desire fair outcomes and have a general concern for others. They should also exhibit methodical and reliable approach to work, proactive planning and organizational skills and enthusiasm for contributing to pioneering research endeavors.

This is an open-rank posting (there are 4 levels of Clinical Research Coordinator) - candidates will be hired into the level commensurate with their experience.

ESSENTIAL FUNCTIONS:

Clinical Research Coord I:

• Obtain consent of research participants in accordance with the IRB approved protocols and all applicable regulations including HIPAA
• Identify, schedule and/or conduct participant study visits, tests and/or interviews/telephone follow up calls
• Coordinate participant remuneration/compensation per protocol
• Maintain all regulatory documentation, including local or central IRB and study data. Provide data/support to study Investigators, sponsors and/or external monitors/auditors
• Identify issues with protocol compliance. Keep principal investigator and manager aware of any issues regarding compliance
• Document and collect data and/or samples for research related procedures performed during participant study visits.
• Ensure clinicians and/or PI accurately document their study activities according to protocol
• Track and maintain study enrollment and completion of milestones
• Assist with financial /operational aspects of grant and contracts. May be responsible for clinical research billing review within the required timeframe.
• Track and maintain study related information in the data management system within the required timeframe
• Responsible for monitoring the inventory of research related supplies
• Participate in grant preparation, manuscript writing, data presentations and Institutional Review Board (IRB) processes
• Provide detailed written summaries from literature searches and related sources to serve as a resource for the study team and clinicians/PIs
• Present study status reports related to assigned research projects
• Participate in the design, development, and documentation of study related data and collection tools, (e.g. questionnaires, treatment data and/or therapeutic checklists)
• Maintain strict adherence to all study protocols, including all regulatory requirements adhering to appropriate federal, local and institutional guidelines.
• Comply with all safety and infection control standards appropriate to this position
• Adhere with established policies, health and safety regulations and requirements, procedures, and department objectives
• Adhere to Good Clinical Practice (GCP) guidelines and all human subject protection practices
• Must practice discretion and adhere to school and hospital confidentiality at all times
• Perform other duties as required.

Clinical Research Coord II

Duties noted above plus:

• Conduct preliminary quality assurance reviews of study data
• Contribute to data presentations and Institutional Review Board (IRB) processes
• Track and maintain study related information in the data management system within the required timeframe
• Contribute to the design, development, and documentation of study related data and collection tools, (e.g. questionnaires, treatment data and/or therapeutic checklists)
• Document and collect data/ samples for research related procedures performed during participant study visits. Ensure clinicians and/or PI accurately document their study activities according to protocol.
• 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

Clinical Research Coord III

Duties noted above plus:

• Assist with recruiting, screening, selecting, maintaining and terminating study subjects for multiple protocols
• Ensure accuracy and completion of all regulatory documentation, including local or central IRB and study data. Provide data/support to study Investigators, sponsors and/or external monitors/auditors
• Direct the activities of research support staff. Assist with the training of staff
• Develop preliminary designs for study related documentation of data and collection tools, (e.g. questionnaires, treatment data and/or therapeutic checklists)
• Contribute to grant preparation, assessment of protocol feasibility, manuscript writing, data presentations and Institutional Review Board (IRB) processes

Sr Clinical Research Coord

Duties noted above plus:

• Responsible for internal review/monitoring of clinical data for quality assurance purposes. Reports findings
• Responsible for the smooth operation of all assigned studies on a day-to-day basis, interacting with investigators, staff members, clinicians, sponsors, etc. to ensure project timelines and goals are met
• Contribute independently to the development of preliminary designs for study related documentation of data and collection tools, (e.g. questionnaires, treatment data and/or therapeutic checklists)
• May Supervise the activities of research support staff. Assist with the selection, training, and supervision of staff
• Prepare ongoing summary reports from various data sources, and collaborate with investigators on data presentation, interpretation, and the writing of manuscripts for publication and grant proposals
• Identify and resolve issues with protocol compliance. Keep principal investigator and manager aware of any issues regarding compliance
• Accountable for quality assurance reviews of study data
• Assist with financial /operational aspects of grant and contracts. Responsible for clinical research billing review within the required timeframe.
• Contribute independently to grant preparation, assessment of protocol feasibility, manuscript writing, data presentations and Institutional Review Board (IRB) processes

REQUIRED QUALIFICATIONS:

Clinical Research Coord I:

• Bachelors degree in a scientific or health related field, or equivalent experience
• 0-1 year of related experience
• Ability to travel off site locations

Clinical Research Coord II:

• Requirements noted for CRC I plus:
• 1-3 years of related experience

Clinical Research Coord III:

• Requirements noted for CRC I plus:
• 3-5 years of related experience

Sr Clinical Research Coord:

• Requirements noted for CRC I plus:
• 5-7 years of related experience
• Demonstrated knowledge of quality management principles in a scientific or hospital setting