Clinical Research Coordinator 1

Department
 

BSD MED - Hospital Medicine

About the Department
 

Our section prides itself on its strong and integrated programs in clinical care, research, and education. The strength of our clinical programs is essential not only to our ability to provide excellent patient care, but to our ability to perform research that advances the frontiers of clinical practice and to train future generations of physicians in hospital medicine. Our research programs allow us to advance the scientific basis and clinical practice of hospital medicine and to train hospital medicine researchers who can carry this scientific mission into the future, often finding inspiration in the desire to solve clinical dilemmas we encounter in our own practices. Likewise, our training programs allow us to bring talented young persons into the relatively new field of hospital medicine, preparing them for productive and sustainable careers as clinicians, researchers, and educators.

Job Summary
 

The Clinical Research Coordinator 1 (CRC1) is a specialized researcher working with the clinical Principal Investigator (PI) and under the direction of a departmental research manager. While the PI is primarily responsible for the overall design, conduct, and management of the conducted studies and trials, the CRC1 plays a critical role by supporting, facilitating and coordinating the daily study and trial activities. This includes but is not limited to being responsible for providing technical and administrative support and managing: screening, enrollment, subject follow-up, completion of case report forms, adverse event reports, and data cleaning. The CRC1 also works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the conducted studies and trials.

Responsibilities

• Coordinate the conduct of the study from startup through closeout including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence.

• Organizes and attends site visits from sponsors and other relevant study meetings.

• Protect patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols.

• Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications.

• Maintains accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), drug dispensing logs, and study related communication.

• Understand the IRB submission and review process and when and how to apply for IRB review, including facilitation of study initiation through meticulous and timely preparation of IRB submissions.

• Understand the federal research regulations and identify the federal research organizations’ role in regulating human research participation.

• Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.

• Analyzes study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.

• Performs other related work as needed.

Minimum Qualifications
 

Education:

Minimum requirements include a college or university degree in related field.

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Work Experience:

Minimum requirements include knowledge and skills developed through < 2 years of work experience in a related job discipline.

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Certifications:

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Preferred Qualifications

Education:

• Bachelors degree.

Experience:

• Knowledge of medical terminology/environment.

Preferred Competencies

• Ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others.

• Ability to communicate with tact and diplomacy.

• Strong organizational skills.

• Strong communication skills (verbal and written).

• Excellent interpersonal skills.

• Strong data management skills and attention to detail.

• Knowledge of Microsoft Word, Excel and Adobe Acrobat.

• Read and understand complex documents (e.g., clinical trials).

• Handle competing demands with diplomacy and enthusiasm.

• Absorb large amounts of information quickly.

• Adapta