Research Project Coordinator

Research Project Coordinator

The University of Maryland School of Medicine, Division of Rheumatology, is currently recruiting a contractual Research Project Coordinator.

Benefits: Contingent Category II

UMB offers a comprehensive benefits package that prioritizes wellness, work/life balance, and professional development, along with additional exciting perks that employees can take advantage of. Contingent Category II staff receive a generous leave package that includes over 2 weeks of vacation each year, paid holidays, sick time, and time for community service; subsidized comprehensive health insurance and supplemental retirement options; professional learning and development programs; limited tuition remission for employees enrolled at UMB; life insurance and long-term disability; and flexible work schedules and teleworking options (if applicable per job).

UMB is a public university and constituent institution of the University System of Maryland. All employees are expected to work primarily physically within the State of Maryland.

Primary Duties:

• Responsible for coordinating the day-to-day operations of research studies in the department. The position coordinates data maintenance, grant expenditure adherence, project evaluation, meeting scheduling, and research subject interfacing. Serves as a point of contact for study participants, research personnel, and support staff. Adheres to good clinical practices, study protocols, and applicable regulations. The Research Project Coordinator conducts complex work and contributes to measurable team objectives. Uses discretion to provide solutions to issues. Performs work that is varied and that does not follow prescribed procedures or processes and is responsible for effective operations and use of resources, rather than clinical outcomes.
• Independently coordinates and communicates directly with the Principal Investigator, study participants, and sponsors to manage the operation and evaluation activities of the research studies. Responsible for ensuring optimum efficiency and compliance with appropriate policies, procedures, and specifications. Uses evaluation techniques, originality, and ingenuity to resolve non routine issues.
• Recruits and screens volunteers to participate in research studies. Develops recruitment streams and advises participants of study objective, requirements, risks, benefits and obtains their consent and enrollment.
• Lead the collection and management of study data by developing data collection instruments, establishing, and maintaining databases, and performing data quality checks. Develops and implements new processes to improve effectiveness and efficiency of data collection and evaluation. Track, report, and audit study data and regulatory study documentation. May supervise those who perform data entry and perform non-routine data analysis.
• Develop and produce reports of study data for project staff and stakeholders. Analyzes data and draws conclusions in order to make recommendations. Develop reports summarizing study deviations from protocol and communications with IRB. Contributes meaningful information to enhance publications or grant applications.
• Monitor activities to ensure compliance with protocols and all relevant local, federal, and state regulatory and institutional policies. Assists in budget development, expenditure adherence, and maintenance of inventory on equipment and supplies.
• Obtains, processes, and transports specimens to appropriate laboratory according to established aseptic technique. Performs venipunctures and finger sticks to obtain blood specimens.
• Performs other related duties as assigned.

Clinical Research Coordinator will work closely with and will directly report to Dr. Ashira Blazer the Rheumatologist (Principal Investigator).

Responsible for all aspects of clinical research studies including but not limited to:

• Data management activities associated with clinical research
• Assisting with protocol development
• Submitting new and continuing review IRBs
• Data entry
• Coordinating with biostatistics team for analysis as appropriate

• Maintaining compliance with all regulatory, institutional, and departmental requirements
• Participate in all aspects of research management and quality assurance of data for the Principal Investigator
• Oversees and conducts the informed consent process on studies as appropriate (requires appropriate training and certification of human research subjects training)
• Manages data collection specific to research studies including but not limited to:
  • Performance of measurements for applicable studies
  • Collection of clinical data from study participants
  • Managing the performance of all other duties as put forth in the protocol.
• Maintaining proficiency in disease-relevant standardized scoring systems as per research protocols
• Updating de-identified data capture during longitudinal clinical visits
• Collaboration with multidisciplinary teams involved in the initiation and conduct of clinical research studies (clinical research administration, legal, finance, compliance, etc.)
• Managing timelines for participant enrollment targets
• Keeping inventory of scheduled clinical visits for both enrolled and potential research participants, and ensuring that research is conducted on schedule during designated follow-up visits per protocol.
• Making contact with study participants either by phone, email, or mail per compliance and with physician office staff and ancillary departments
• Managing and executing IRB submissions for initial approvals, re-approvals, amendments, etc.
• Providing timely reports to Institutional Review Board, Principal Investigator, Research Director, National Institutes of Health, and/or sponsor for each research project.
• Participating in the development of new protocols, prospective databases, and new initiatives
  • This may include the independent design of databases and tools to facilitate data collection as required for specific projects (calendars, schedules, tracking logs)
• Assisting in collecting, transporting, processing, and storing biospecimens obtained from research patients to the laboratory.
• Maintaining good clinical practice for the handling of biospecimen.

Primarily Administrative

• Managing timelines for progress reports to funding agencies and Institutional Review Board.
• Facilitating dissemination of relevant findings by organizing the Principal Investigators academic calendar including, but not limited to conference appearances, grand rounds appearances, and invited talks.
• Meeting weekly with the Principal Investigator to coordinate scheduling and avoid conflicts.

Qualifications

Education: Bachelor's degree in nursing, emergency services, chemistry, biology, public health, psychology, or another scientific discipline appropriate to position required.

Experience: Prior experience in clinical research preferred.

Supervisory Experience: N/A

Certification/Licensure: N/A

Other: Except for qualifications established by law, additional related experience and formal education in which one has gained the knowledge, skills, and abilities required for full performance of the work of the job class may be substituted for the education or experience requirement on a year-for-year basis with 30 undergraduate college credits being equivalent to one year of related experience. In instances where specific education and/or experience is required only directly related education and/or experience may be substituted.

• Knowledge of regulations regarding Human Subjects research and assure HIPAA compliance.
• Ability to multitask and prioritize research projects.
• Ability to communicate in an effective manner with management, clinical staff, external sponsors, and patients.
• Strong organizational and problem-solving skills, attention to detail, excellent written and communication skills.
• Proficient use of computers and REDCap software; Familiar with electronic data capture platforms such as REDCap and EMRs platforms.

Hiring Range: $48,000 - $53,000, Commensurate with education and experience