Clinical Research Project Coordinator OR Senior Clinical Research Project Coordinator
- Full-Time
- Baltimore, MD
- University Of Maryland, Baltimore
- Posted 2 years ago – Accepting applications
Job Description
The University of Maryland Division of Cardiac Surgery is actively team-minded individuals for their dynamic and progressive clinical operations team and is currently seeking a Clinical Research Project Coordinator or Senior Clinical Research Project Coordinator. The position will be filled as either a Clinical Research Project Coordinator OR Senior Clinical Research Project Coordinator, dependent on selected candidate's qualifications.The division is a highly effective multidisciplinary program within The Maryland Heart Center. We offer an extensive range of cardiac surgical services, from repairing congenital heart defects in infants and children to performing heart transplantations and other complex procedures for high-risk adult patients. The Cardiac Surgical faculty are engaged in over thirty translational and clinical research projects investigating the causes of heart disease and find new ways to treat it. Their research leads to therapies and treatments that dramatically transform patient care. 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. Our division recently completed the very first pig-to-human heart transplant! UMB was ranked one of America's Best Large Employers by Forbes Magazine (Feb 2021). BENEFITS:
UMB offers a generous benefits package, which includes 22 vacation days, 14 floating and holidays, 15 sick days; comprehensive health insurance and retirement options; and tuition remission for employees and their dependents at any of the University System of Maryland schools.
UMB requires all faculty, staff, and students to be vaccinated against COVID-19. Exemptions for medical or religious reasons will be processed through Human Resources.
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UMB offers a generous benefits package, which includes 22 vacation days, 14 floating and holidays, 15 sick days; comprehensive health insurance and retirement options; and tuition remission for employees and their dependents at any of the University System of Maryland schools.
UMB requires all faculty, staff, and students to be vaccinated against COVID-19. Exemptions for medical or religious reasons will be processed through Human Resources.
Coordinator Essential Functions:
- 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 peform 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.
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.
Coordinator Qualifications
Education: Bachelor’s degree in nursing, emergency services, chemistry, biology, public health, psychology or another scientific discipline appropriate to position required.
Experience: Prior experience in research preferred. May consider a combination of directly related experience and education.
Senior Coordinator Qualifications
- 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. 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.