Job Description
The Divisions of Vascular Surgery at the University of Maryland, Baltimore (UMB) are currently seeking dynamic team members to join their fast-paced, high reward, clinical research team.  Our leaders hold national and international prominence in their fields, and have translated their discoveries into clinical management guidelines.. We are one of only two transplant centers serving more than 5 million people in Maryland.The divisions are recruiting a Clinical Research Project Coordinator OR Senior Clinical Research Project Coordinator. The position will be filled based on the selected candidate's qualifications.  The position is responsible for coordinating the day-to-day operations of one or more research studies or clinical trial protocols. The position coordinates data collection and maintenance, project evaluation, meeting scheduling, and research subject interfacing. The Clinical Research Project Coordinator adheres to good clinical practices, study protocols, and applicable regulations; conducts complex work and contributes to measurable team objectives; and 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. The position will work in the Division of Transplant Surgery at the University of Maryland, Baltimore School of Medicine. The division of Transplant Surgery is located within the School of Medicine at the University of Maryland, Baltimore and maintains a large research portfolio involving the heart, lung, liver, kidney, and pancreas.    BENEFITS:UMB offers a comprehensive benefits package that prioritizes wellness, work/life balance, and professional development. This position participates in a retirement program that must be selected and is effective on your date of hire. Exempt regular staff receive a generous leave package that includes over 4 weeks of vacation accrued each year, paid holidays, personal leave, unlimited accrual of sick time, and comprehensive health insurance; professional learning and development programs; tuition remission for employees and their dependents at any University System of Maryland school; and flexible work schedules and teleworking options (if applicable per job). UMB employees are strongly encouraged to follow all CDC recommendations related to COVID-19 vaccinations and booster doses.  Employees whose job duties require them to work in clinical settings or at clinical or field sites continue to be subject to the vaccine requirements of those sites. For additional information on protocols and exemptions, please visit the COVID-19 website.   Coordinator Essential Functions:

Independently coordinates and communicates directly with the Principle Investigator, study participants, and sponsors to manage the operation and evaluation activities of the research studies or clinical trials. Serves as primary liaison for study participants, research personnel, support staff, and outside agencies such as the IRB. Responsible for ensuring optimum efficiency and monitors activities to ensure compliance with protocols and all relevant local, federal, and state regulatory and institutional policies. Identifies and resolves non-compliant issues by using evaluation techniques, originality, and ingenuity. Develop appropriate regulatory reports and associated documentation in accordance with SOPs and study or trial-specific processes. Recruits and screens patients to participate in research studies. Develops recruitment streams and advises participants of study objectives, requirements, risks, benefits and obtains their consent and enrollment. Lead the collection and management of study data by developing data collection tools, establishing and maintaining databases, and performing data quality checks. Develops and implements new processes to improve the 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. Develop and produce routine and non-routine reports of study data or study progress for study sponsors, Principle Investigator(s), and other research and clinical team members . Analyzes data and draw conclusions in order to make recommendations to improve study efficiency or effectiveness. Develop reports summarizing study deviations from protocol and communications with IRB. Contributes meaningful information to enhance publications or grant applications. 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.

Senior Coordinator Essential Functions:

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 the position required. Experience: Clinical research experience with human subjects is highly preferred. 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 is highly preferred. Other: May consider a combination of directly related experience and education.

Other: May require training related to occupational safety and health, environmental compliance, shipping of hazardous materials, and/or ionizing radiation.

KNOWLEDGE, SKILLS AND ABILITIES:

Possesses a knowledge of position requirements and able to perform the position in compliance with all requirements/regulations/laws. Knowledge in best practices of coordinating clinical research studies. Ability to understand and utilize scientific/medical terminology and research theory. Ability to gain knowledge and meet the reporting needs of UMB policies and practices for Institutional Review, Human Protections, Animal Protections, etc. Ability to maintain high standards with the work being performed and maintain awareness with trends and influences. Assumes personal responsibility for all outcomes; makes effective and timely decisions; and learns how to effectively use technology. Maintains productivity and uses knowledge strategies to increase knowledge base. Skill in continuously seeking to improve the quality of services and processes. Skill in meeting multiple priorities and studies in various stages of development. Able to strategically and analytically think with an ability to solve problems and make decisions. Skill in utilizing relevant PC and clinical applications. Ability to effectively communicate both verbal and written thoughts, ideas, and facts. Writes and presents information in a clear and concise way. Interprets and understands written information and is able to listen attentively to verbal and non-verbal cues that lead to a deeper understanding. Ability to work cooperatively with others and demonstrates professional, ethical, respectful, and courteous behavior when interacting with others. Capable of interacting pleasantly and positively with others to meet customer expectations, and provide follow-up with customers.

 Hiring Range: Commensurate with education and experience (Coordinator: $44-$48K/ Senior: $50-$58K) 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. For assistance related to employment, please contact the Staffing department at HRJobs@umaryland.edu.  If you anticipate needing a reasonable accommodation for a disability under the Americans With Disabilities Act (ADA), during any part of the employment process, please submit a UMB Job Applicant Accommodation Request. You may also contact HRDiversity@umaryland.edu. Please note that only inquiries concerning an ADA request for reasonable accommodation will be responded to from this email address.

Job: Reg or CII Exempt Staff
Shift: Day Job
Organization: School of Medicine - Surgery
Job Posting: Aug 4, 2022
Unposting Date: Aug 19, 2022, 10:59:00 PM