Senior (Start-Up) Clinical Research Coordinator

Position Title:

Clinical Research Coordinator Employment Status:

Full -Time (40 hours/week) Position Summary The Senior Clinical Research Coordinator plays a critical role in the overall operational management of multiple clinical research study / trial activities with a focus on early stage start-up support. We are seeking a technical leader responsible for ensuring the study protocol and procedures have been completed accurately, safely, and in a timely manner. The ideal candidate is an experienced professional or leader who has direct responsibility for the implementation of research activities for one or more studies which may include multicenter clinical trials (NIH and industry-sponsored), local investigator-initiated clinical trials, and/or programmatic clinical research activities. The incumbent will perform diverse duties across multiple therapeutic areas and research programs, requiring analysis, sound judgment, attention to detail, and a high level of knowledge of study-specific documents. The Senior Clinical Research Coordinator will recognize and perform necessary early-stage start-up project management tasks, while closely working with PIs, departments, sponsors, and other internal / external partners as needed to support study goals and compliance, as well as the financial, personnel and related aspects of studies. Work will be assigned by VA Research and/or FAVER senior leadership, and assignments may be changed on an as-needed basis in order to ensure that studies and patient care needs are handled appropriately and in a timely manner. Travel to local clinics may be required. This role is responsible for, but not limited to, the following: Recruiting / screening study participants, patient and family education, performing patient evaluations, administering medications and/or research instruments, collecting / shipping specimens, collecting / documenting data, compiling reports. Coordinating, implementing and evaluating clinical research trials, studies and/or projects to improve and advance clinical research within the organization. Serving as the central regulatory resource for the study / trial. Preparing, reviewing, and submitting regulatory documents for initial IRB submission, amendments, continuing reviews, and protocol deviations. Providing audit and monitoring activities support. Training new clinical research staff, providing updated information on internal processes and resources and external benchmarks. Ensuring compliance with research and health care regulatory requirements and guidelines. Performing related responsibilities as required. Working well with other members of the research team, appreciating a diverse workplace, and seeking and providing input when appropriate. Job Functions Function 1 (40%): Support Principal Investigators by facilitating study start-up activities and maintain documentation of and administer regulatory compliance throughout the duration for research studies involving human participants. Function 2 (40%): Overall coordination and execution of clinical research activities, such as participant recruitment, screening, consenting, study visits, etc. Function 3 (20%): Collaborating with the principal investigators, study coordinators, and other study personnel regarding study planning, implementation, budgeting and evaluation efforts.

Minimum Requirements Education:

High school or GED is required. Bachelor's or Master's degree in science, public health, business is preferred.

Experience:

5+ years of research experience with a H.S. diploma or GED. 2+ years of research experience with a Bachelor's degree. 1+ year of research experience with Master's degree. Advance knowledge of the clinical research regulatory framework and institutional requirements. Must have advanced knowledge of Good Clinical Practice (GCP) for clinical research.

Specific Skills:

Ability to work flexibly to accommodate deadlines, maintain concentration in a work environment with distracting stimuli, manage multiple projects, and meet competing deadlines. Capability to handle work assigned by multiple individuals while also demonstrating the ability to work independently. Demonstrated strong analytical skills. Excellent interpersonal communication skills to effectively and diplomatically interact with others. Excellent written and verbal communication skills, with the ability to compose professional correspondence. Proficiency in creating and managing organizational systems (binders, electronic records, etc.). Advanced typing and computer skills, including the use of spreadsheets, email, and accurate data entry. Ability to handle confidential material with judgement and discretion. Skill in managing diverse, complex tasks and facilitating information exchange among multiple stakeholders. High level of use and comfort with MS Office products and other technological platforms, specifically REDCap and MS Access for data entry and management. Friendly and people-oriented to ensure that the veteran population is engaged in a positive experience. Ability to achieve / exceed time-bound goals in both an independent and team environment. Special Knowledge, Licenses, etc.: Certified Research Associate (CRA) or Clinical Research Coordinator (CRC) preferred. Relocation and Visa sponsorship are not available for this position. Salary commensurate with qualifications and experience. We are committed to an inclusive and diverse workplace. All individuals, regardless of personal characteristics, are encouraged to apply! FAVER is an Equal Employment Opportunity Employer. FAVER provides equal employment opportunities to all qualified applicants without regard to race, sex, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, or genetic information. This job description is intended to convey information essential to understanding the scope of the job and general nature and level of work performed by job holders within this job. It is not intended to be an exhaustive list of qualifications, skills, duties and responsibilities or working conditions associated with the job, and is not an employment contract.