Mid-Atlantic HERC

**This is a FULL-TIME, CONTRACTUAL C2 position**

BENEFITS (Contractual/C2 Employee):

UMB offers a comprehensive benefits package that prioritizes wellness, work/life balance, and professional development. Contingent Category II staff receive a generous leave package that includes over 2 weeks of vacation each year, paid holidays, personal leave, 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

For Senior:
- 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.

For Lead:
- Independently manages and provide the most complex support to designated research studies or clinical trial protocols involving considerable responsibility, variety, and to manage and coordinate activities of a designated research project. 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 the highest level guidance and direction to personnel engaged in research studies or clinical trials to ensure compliance with protocols and meet clinical objectives.
- Plan, develop, administer, and coordinate new or revised project goals, objectives, work flows and policies through the duration of the research study or clinical trial. Implement approved study or trial policies and procedures.
- Assists Principal Investigators and regulatory staff in the preparation of new protocol submissions, protocol amendments, and renewals of ongoing research studies or clinical trials.
- Ensure that goals and objectives specified for the research project are accomplished in accordance within priorities, time and funding limitations, or other specifications.
- Evaluate project effectiveness in order to develop and implement new or improved methods. Devise and implement evaluation methodologies.
- Oversee 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.
- Coordinate research project activities through delegation of assignments to staff.
- Monitor 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. Identify protocol problems, informs investigators, and assist in problem resolution efforts.
- Manage complex study or trial data. Develop 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.
- Coordinate budget development, expenditure adherence, grant applications, and maintenance of inventory on equipment and supplies.
- Recommend additional equipment and resources for the program.
- Review 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.
- Provide training and guidance to less experienced personnel.
- Attend research study or clinical trial related meetings, conferences and teleconferences, as well as participating in any additional planning and development related activities.
- Perform other related duties as assigned.

For Both:
-Maintains detailed, accurate, and legible records to comply with the Guidelines of Good Laboratory Practice.
-Provides project management support on various commercially funded and government funded research projects, to reach goals and accomplish objectives in accordance with priorities, time and funding limitations ,or other specifications
-Works collaboratively with senior management to develop work plans and to manage timelines.
-Assists with the preparation and submission of project deliverables including, but not limited to, progress reports, communications plans, risk registers, and Gantt charts.
-Writes and presents information concisely and competently adapts writing style to fit the needs of the organization.
-Serves as a liaison between the institution and the study sponsor by preparing, maintaining, and disseminating meeting materials (e.g., agenda, presentation, minutes, action items) for technical study meetings, sponsor teleconferences, and onsite visits.
-Coordinates onsite Sponsor meetings and audits, including room reservation, preparation of sign-in sheets and distribution of meeting materials.
-Attends study related research meetings, conferences and teleconferences as well as participates in any additional planning and development related activities.
-Assists with archival of all study materials at the conclusion of each project.
-Assists Principal Investigator and Program Director in the preparation of new protocol submissions, protocol amendments and renewals of ongoing research studies
-Assists with study and department-specific procurements, including sourcing vendors and obtaining quotes.
-Assists with the maintenance of animal health records, requisitions, USDA receipts, and dispositions.
-Coordinates and executes shipping of study materials between collaborators, subcontractors, and/ or sponsors? which may include shipping hazardous materials or biological samples. Provides training on shipment of study materials.
-Handles, prepares (as applicable), and performs dispensation of test and control article as designated by the Study Director.
-Follows established quality control/management systems and associated processes and procedures to ensure compliance with the Guidelines for Good Laboratory Practices and/or other research requirements. Provides recommendations for improvement.
-Performs QC review of documentation, including electronic data, hand-written data, transcribed data, and equipment files. Communicates findings to staff and management.
-Collaborates with Study Directors to develop and maintain standardized data spreadsheets for analysis and reporting, ensuring the accuracy of transcribed entries against raw data collected.
-Assists with documentation of laboratory deviations and unanticipated events, identification of root cause, and solution implementation.
-Performs additional duties as assigned

MINIMUM QUALIFICATIONS

For Senior:
Bachelor's degree in nursing, emergency services, chemistry, biology, public health, psychology or another scientific discipline appropriate to position required.
Two (2) years of research coordination experience with at least one (1) year in research specialization.
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.

For Lead:
Bachelor's degree in nursing, emergency services, chemistry, biology, public health, psychology or another scientific discipline appropriate to position required.
Three (3) years of research coordination experience with at least two (2) years in research specialization.
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.

Preferred Qualifications:
Education: Bachelor's degree, preferably in animal sciences, biology, chemistry or other scientific discipline
Experience: Two (2) years research, animal care, project management, and/or quality control experience. Familiarity with Good Laboratory Practices is a plus.

KNOWLEDGE, SKILLS, ABILITIES
Knowledge of position requirements. Knowledge of all applicable requirements, regulations, and laws. Skill in effective use of applicable technology/systems. Ability to effectively communicate both verbal and written thoughts, ideas, and facts. Ability to work cooperatively with others and independently. Ability to demonstrate, understand, apply, and adhere to the UMB Core Values of Respect and Integrity, Well-being and Sustainability, Equity and Justice, and Innovation and Discovery.

HIRING RANGE: $57.000 - $64,000 per year for Senior / $60,000 - $67,000 per year for Lead / Commensurate with education and experience

UMB is committed to cultivating a diverse and inclusive workforce and is proud to be an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, ancestry or national origin, sex, pregnancy or related conditions, sexual orientation, gender identity or expression, genetic information, physical or mental disability, marital status, protected veteran's status, or any other legally protected classification.

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 leave_and_accom@umaryland.edu. Please note that only inquiries concerning an ADA request for reasonable accommodation will be responded to from this email address.

The University of Maryland, Baltimore prohibits sex discrimination in any education program or activity that it operates. Individuals may report concerns or questions to the Title IX Coordinator. Read the UMB Notice of Non-Discrimination for more information.