OPEN RANK: Senior OR Lead Research Project Coordinator - (240001FP) University of Maryland Baltimore (UMB), Department of Otorhinolaryngology is currently seeking a Senior OR Lead Research Project Coordinator. This position will be filled either as a Senior or Lead dependent upon the chosen candidate's qualifications. The Project Coordinator is responsible for coordinating the day-to-day operations of two or more complex research studies 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 guidance and direction to personnel engaged in research studies or clinical trials to ensure compliance with protocols and overall clinical objectives. The position is responsible for data maintenance, grant expenditure adherence, project evaluation, meeting scheduling, and research subject interfacing. Adheres to good clinical practices, study protocols, and applicable regulations. The 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.
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. ESSENTIAL FUNCTIONS - Senior Research Project Coordinator:
- Coordinates the preparation of Institutional Review Board (IRB) and Health Insurance Portability and Accountability Act (HIPPA) protocol development and ensure compliance of research operations with protocols. Coordinates developing and recommending policies and procedures and/or design methods for clinical research activities.
- Serves as liaison to other departments such as IRB or CCT, outside organizations, government agencies, and product representatives to promote effective and efficient operation and use of resources.
- 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.
- 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.
- 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.
- 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. 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.
- 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.
- Perform other duties as assigned.
ESSENTIAL FUNCTIONS - Lead Research Project Coordinator: - 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.
MINIMUM QUALIFICATIONS - 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 with at least one (1) year in research specialization. Other: May consider a combination of directly related experience and education. MINIMUM QUALIFICATIONS - Lead Research Project Coordinator:
Education: Bachelors in Sociology, Psychology, Nursing or field study related to the research of the clinic. Experience: Three (3) years of research coordination experience of research coordination experience with two (2) years in research specialization. Other: May consider a combination of directly related experience and education. HIRING RANGE: $55,000 per year for Senior/ $65,000 - $78,000 per year for Lead (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 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. 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. : Reg or CII Exempt Staff - E3314E Employee Class : Exempt Regular Full Time/Part Time: Full-Time : Day Job Financial Disclosure: No : School of Medicine - Otorhinolaryngology - Head and Neck Surgery : Sep 27, 2024 : Oct 28, 2024, 3:59:00 AM | | |