Location: all cities,MD, USA
The University of Maryland Cardiac Surgery Research Unit (CRU) is currently seeking a dynamic Senior Clinical Research Coordinator to join their fast-paced, high-reward clinical research team.
The University of Maryland Cardiac Surgery Division houses the highly effective multidisciplinaryprogram within The Maryland Heart Center. The CRU is a fully integrated organization created specifically to facilitate the advancement of clinical research, discoveries, and innovations. The CRU manages a broad domain of surgical studies, including surgical coronary revascularization, mitral valve disease, aortic valve disease, thoracic aortic disease, pediatric cardiac disease, LVAD, ECMO, and heart and lung transplant.
The position is responsible for assisting with 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 Assistant adheres to good clinical practices, study protocols, and applicable regulations, conducts complex work, contributes to measurable team objectives, and uses discretion to solve issues. The position will work in the Division of Cardiac Surgery at the University of Maryland, Baltimore School of Medicine.
BENEFITS (Exempt Regular):
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. This position participates in a retirement program (pension or optional retirement plan/ORP) that must be selected and is effective on your date of hire. Exempt regular staff receive a generous PAID leave package that includes over 4 weeks of vacation accrued each year, 15 paid holidays, 3 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 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
* 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.
MINIMUM QUALIFICATIONS
Education: Bachelor's degree in nursing, emergency services, chemistry, biology, public health, psychology or another scientific discipline appropriate to position required.
Experience: Two (2) years of research coordination experience with at least one (1) year in research specialization.
Supervisory Experience: N/A.
Certification/Licensure: N/A.
Other: May consider a combination of directly related experience and education.
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: $55,000 - $60,000 per year (Commensurate with education and experience)
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 ...@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 ...@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. For more information, follow this link UMB Notice of Non-Discrimination.