Lead Clinical Research Specialist - (170000FR)
The University of Maryland, Baltimore (UMB), Institute for Global Health (IGH) - Center for Vaccine Development (CVD) is currently seeking a Lead Clinical Research Specialist. Under general supervision of the principal investigator and clinical research manager, the Lead Clinical Research Specialist plans and carries out key elements of a clinical research project from protocol development to project close-out. Responsible for timely completion of deliverables to meet the needs of the project, study sponsor, principal investigator and department administration. This position may be required to work weekends and/or evening/night shifts during inpatient studies.
UMB offers a generous benefits package that 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.
- Determine recruitment strategy, project timeline and work plan to accomplish project (or program), deliverables. Consult with principal investigator, clinical research manager and study monitor to clarify techniques and negotiate deliverables. Apprise investigator(s) of project status.
- Oversee all aspects of a clinical trial from protocol development through closure, including key elements listed, such as interactions with study participants, ensuring informed consent and compliance with protocol; monitoring subject symptoms, and overseeing quality control and data entry.
- Compile, analyze, and interpret clinical research, including data collection, data entry, data verification, data analysis, compliance and clinical relevance of data. Present research findings.
- Perform phlebotomy related tasks as required.
- Create protocol-specific procedure manuals and data collection tools.
- Perform other related duties as required.
Education: Bachelor's degree in nursing, social work, or other field related to the research of the clinic.
Experience: Five (5) years experience in clinical research including three (3) years in the relevant research specialization.
Consideration may be given for a unique combination of education and experience.*
May require training related to occupational safety and health, environmental compliance, shipping of hazardous materials and/or ionizing radiation.
* Bachelor's degree in an unrelated field with at least 18 credits in a field related to the research of the clinic, or Bachelor's degree in unrelated field with at least one year of experience in a field directly related to the research of the clinic. 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 college credits being equivalent to one year of experience.
Knowledge, Skills, and Abilities
- Working knowledge of key practices in the field of clinical research as well as all relevant federal, state, local laws, regulations, and policies.
- Ability to understand and utilize scientific/medical terminology and research theory in both oral and written communications.
- Ability to take a lead role in performing and directing various advanced, routine, and maintenance procedures.
- Skill in ethically communicating project risks and benefits.
- Skill in meeting multiple priorities for studies in various stages of development.
- Ability to manage resources as diverse as budget, availability of examination rooms, and use of staff.
- Must be "team player" who is able to work with investigators and the research team.
- Must be a good communicator, both orally and in written word.
- Willing to have flexible hours dependent on research project requirements.
Hiring Range: Commensurate with education and experience
If accommodations are needed for a disability, please contact Staffing & Career Services at 410-706-2606, Monday – Friday, 8:30am – 4:30pm EST. Maryland Relay can be accessed by dialing 711 (in-state) or 1-800-735-2258.
Equal Opportunity/Affirmative Action Employer. Minorities, women, protected veterans, and individuals with disabilities are encouraged to apply.
: Exempt Staff - E3324F
Employee Class : Exempt Regular
Full Time/Part Time: Full-Time
: Day Job
: Mar 7, 2017
: Mar 26, 2017, 11:59:00 PM