Research Project Coordinator OR Senior Research Project Coordinator (Clinical Research Coordinator)

University of Maryland, Baltimore (UMB) is currently seeking a Research Project Coordinator (Clinical Research Coordinator) OR Senior Research Project Coordinator (Senior Clinical Research Coordinator) to join Department of Vascular Surgery. The position will be filled based on selected candidate's qualifications. Under supervision, the position will be responsible for oversight and coordination of multiple research protocols within the division of Vascular Surgery. Will serve as the direct point of contact for sponsors, research staff, study participants, and clinical support personnel. Will conduct and adhere to applicable regulations, good clinical practices, and ensure study protocols compliance.
**This is a FULL-TIME, CONTRACTUAL position**
BENEFITS:
UMB offers a generous benefits package that includes 10 vacation days, 11 personal and holidays, 5 sick days; comprehensive health insurance and supplemental retirement options; and limited tuition remission for employees enrolled at UMB.

ESSENTIAL FUNCTIONS:
For Research Project Coordinator:

• 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 Principle 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.

For Senior Research Project Coordinator:

• Independently manages operations of two or more research studies or clinical trial protocols. Serves as the primary liaison to other departments, outside organizations, government agencies, and product representatives to promote effective and efficient operation and use of resources. Provide guidance and direction to personnel engaged in research studies or clinical trials to ensure compliance with protocols and overall clinical objectives.
• Develops and tracks work flow policies and progress through the duration of the research study or clinical trial. Assists Principal Investigators and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing research studies or clinical trials.
• Oversees subject enrollment to ensure that informed consent is properly secured and documented. Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with research personnel.
• Monitors activities to ensure compliance with protocols and all relevant local, federal, and state regulatory and institutional policies. Continuously educates and trains personnel on compliance and protocol. Identifies protocol problems, informs investigators, and assists in problem resolution efforts.
• Manages complex study or trial data. Develops methods for collection, database storage, tracking, analysis, and interpretation of data.
• Develops and prepares study or research related documentation such as protocol worksheets, procedural manuals, adverse event reports, case report forms, and institutional review board documents. Responsible for developing and producing custom and routine reports.
• Reviews proposed study protocols to evaluate factors such as sample collection process, data management plans, and potential subject risks. Conducts quality assurance audits on data and regulatory documentation.
• Obtains tissue and blood samples as necessary and collects information through interviews, questionnaires, test results, and charts.
• Assists in budget development, expenditure adherence, grant applications, and maintenance of inventory on equipment and supplies.
• Provides training and guidance to less experienced personnel.
• Attends research study or clinical trial related meetings, conferences and teleconferences, as well as participating in any additional planning and development related activities.
• Performs other related duties as assigned.

Qualifications
For Research Project Coordinator:

• Education: Bachelor’s degree in nursing, emergency services, chemistry, biology, public health, psychology or another scientific discipline appropriate to position required.
• Experience: Clinical research experience with human subjects highly preferred.
• Supervisory Experience: NA
• Certification/Licensure: NA
• Other: May consider a combination of directly related experience and education.

For Senior Research Project Coordinator:

• Education: Bachelors in Sociology, Psychology, Nursing or field study related to the research of the clinic.
• Experience: Two (2) years of research coordination experience with at least one (1) year in research specialization. Clinical research experience with human subjects highly preferred.
• Supervisory Experience: NA
• Certification/Licensure: NA
• Other: May consider a combination of directly related experience and education.

Hiring Range: Commensurate with education and experience

If accommodations are needed for a disability, please contact Staffing & Career Services at 410-706-2606, Monday – Friday, 8:30am – 4:30pm EST. Maryland Relay can be accessed by dialing 711 (in-state) or 1-800-735-2258.

UMB is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law or policy.
Job: Reg or CII Exempt Staff - E3314D Employee Class Exempt Contingent II Full Time/Part Time: Full-Time Shift: Day Job Organization: School of Medicine - Surgery Job Posting: Jan 21, 2021 Unposting Date: Feb 18, 2021, 10:59:00 PM