Clinical Research Coordinator II

POSITION SUMMARY:

The Department of Pediatrics (Neonatal Medicine Research) is seeking a Clinical Research Coordinator (CRC) II for multiple projects that include clinical research and surveillance studies in the area of substance use disorders in pregnancy and substance exposed newborns. Under the supervision of the Principal Investigators and with some leadership by the Associate Director and Project Manager for assigned research studies, the Clinical Research Coordinator (CRC) will perform research activities using approved techniques.

The CRC procures, processes and ships research specimens and conducts patient recruitment, administers questionnaires and obtains informed consents, abstracts medical records, maintains patient databases, enters data into sponsor-specific electronic data capture forms, performs administrative tasks, and participates with the research team in preparation of data and other reports. Will also assist with audits and quality assurance reviews; and prepares and attends site visits. Assists with the preparation of IRB applications and document maintenance and collects and processes biological specimens for appropriate studies when needed (Ex: blood, saliva, urine, placenta, breastmilk).

Position: Clinical Research Coordinator II

Department: Pediatrics

Schedule: Full Time

ESSENTIAL RESPONSIBILITIES / DUTIES:

• Evaluating and tracking the eligibility of all patients seen in the clinic.

• Recruits subjects to participate in the assigned study by using approved methodologies, such as, reaching to healthcare providers for referrals, visiting clinics, using approved advertisements.

• Conducts the enrollment of study participants, including explaining research procedures, and obtaining informed consent of subject and registering patients to cohort studies and other protocols.

• Schedules appointments of study participants; conducts reminder phone calls and/or sends mail-outs.

• Performs biospecimen collection for study purposes, including but not limited to: blood (phlebotomy), saliva (cheek swabs), urine collection, breastmilk collection, and placental tissue.

• Performs office-related duties such as answering phones, picking up and delivering mail, storing and distributing office supplies, handling faxes, scanning, filing, photocopying, collating materials, maintaining the update of policy manuals, etc.

• Participates in staff meetings/initiatives including appropriate quality improvement and education activities, or if unable to attend non-mandatory activities, accepts responsibility to review meeting minutes and becomes knowledgeable of issues discussed.

• Reviews and abstracts the medical records for patients, including review of all records for inclusion/exclusion criteria.

• Accessing patient demographic and clinical information from the clinical systems.

• Entering information into the appropriate EMR and eCRF systems and departmental systems in an accurate manner.

• Supervises and trains student research assistants in EMR data abstraction and data entry.

• Reviewing data for quality and completeness for each enrollee for completion and quality (QA).

• Answers queries; performs data collection entry into database; maintains clear, concise, accurate and legible records.

• Assists with the coordination of the collection, processing, organization, and storage of biological specimens in the systems

• May assist in the preparation for IRB and regulatory submissions and maintenance of regulatory files

• Maintaining on-going communications with research managers and PIs for data collection needs.

JOB REQUIREMENTS

EDUCATION:

• Master degree OR

• Baccalaureate Degree plus2-5 years experience preferred

• Special Intermittent Project Responsibilities (2-5/year)

EXPERIENCE:

• CRC II: Experienced Level Position

KNOWLEDGE AND SKILLS:

• Bilingual in Spanish preferred

• Excellent organization and communications skills required.

• REDCap knowledge strongly preferred

• Strong interpersonal skills; ability to effectively interact with all levels of staff and externals contacts.

• Cultural sensitivity and comfort with a wide range of social, racial and ethnic populations

• Must be detail oriented and have the ability to follow-through.

• Ability to effectively manage time and prioritize workload. Must practice discretion and adhere to hospital confidentiality guidelines at all times.

• Must have computer skills including the use of Microsoft Office Suite

• Phlebotomy skills a plus

Equal Opportunity Employer/Disabled/Veterans