Responsibilities:

• Communicates information concerning subject health and safety to CRC and/or Principal Investigator in a timely and responsible manner.
• Observes regulations and ethical standards with regards to the rights and welfare of human subjects.
• Communicates concerns regarding ethical violations to Manager/ Principal Investigator.
• Functions as a team player with the department and works effectively with other coordinators in the department to foster an efficient and productive environment for Clinical Research.
• Implements and conducts multiple research projects in a timely and efficient manner.
• Maintains working knowledge of all departmental protocols, covers other departments if necessary on a temporary basis.
• Assists in preparation of IRB documents as requested.
• Secures/orders investigational devices or study supplies as necessary.
• Participates in meetings with research residents and research staff prior to implementation of protocol as necessary.
• Prepares/Creates/OA's source documents prior to study start and according to SOP's.
• Assembles source documents as necessary.
• Adheres to schedule and required procedures and follows research protocols.
• Collects data accurately and completes CRFs in a timely manner.
• Maintains neat, organized, accurate and detailed source documentation, records and forms.
• Communicates to all appropriate research staff/supervisor/PI, and IRB of any deviations/violations from protocols as necessary.
• Oversees/coordinates IRB renewal process as necessary and keeps abreast of due dates.
• Communicates closely with Regulatory Coordinator to ensure the timely completion of these documents.
• Ensures proper collection, processing and shipment of specimen.
• Prepares on-site monitor visits, including pre-study, initiation, and closeout visits.
• Assists as needed in preparing for FDA and internal audits.
• Prepares for study closures and ensures proper documentation and document storage to enable easy retrieval when necessary.
• Reports subject dropouts and exits them from study per procedure.
• Maintains and updates essential documents as required by the FDA, IRB, Sponsor/CRO or any other regulatory agencies or funding agencies as necessary.
• Prepares study advertisements and ensures sponsor and IRB approval are obtained as necessary.
• Tracks patient visits in the study management software program as necessary.
• May assist Regulatory Coordinator in the preparation of protocol documents for IRB submission as necessary.
• Ensures the preparation, submission and obtaining approval for any check request, purchase requisitions in accordance with study protocols and Cleveland Clinic Florida guidelines.
• Attends meetings at Cleveland Clinic Florida as expected and arrives in a timely manner.
• Oversees and assists with data clarification forms as necessary and in a timely fashion.
• Ensures appropriate coordination of the scheduling of external monitor/sponsor visits with PI, Research Coordinator and any other key personnel and ensures meeting space availability.
• Maintains data integrity where applicable.
• Ensures study supplies, office supplies and research equipment for research personnel/projects are maintained.
• Aids in the development of research tools, such as spreadsheets or questionnaires.
• Assists with grant applications, compiling literature reviews or the preparation of abstracts, entering information and/or maintaining databases for research department, ordering patient charts and placing reminder calls to patients as necessary.
• Develops, implements and continually evaluates patient recruitment strategies for effectiveness.
• Promotes patient recruitment by preparing patient mailers, postcards or mass communications and participating in presentations as necessary.
• Screens and assigns patients to appropriate research protocols.
• Provides general support functions, including copying, filing correspondence transcriptions, obtaining required signatures as required.
• Reviews study documents and oversees assembly and/or assembles source documents based on the protocol.
• Presents scientific statements or endorsements related to investigational devices/drugs with full disclosure.
• Provides information to research residents and staff regarding protocol requirements.
• Works with department supervisor/manager to assist and train new hires in the research department/across all specialties.
• Submits the IND to the FDA for investigator initiated studies and formulate/track regulatory documents necessary.
• Assists the staff physician and fellows, or independently writes, abstracts or manuscripts for submission to professional scientific meetings or journals.
• Performs study-related procedures and visits as required.
• Conducts follow-up visits of research subjects to evaluate progress and educate them regarding protocol, adverse events and compliance issues as requested.
• Reports and records adverse events/severe adverse events to Regulatory Coordinator, IRB Sponsor and PI and other agencies as required.
• Serves as primary contract for patient while enrolled in clinical trial.
• Reviews and documents lab and test results to ensure patient safety.
• Reports all abnormal values to the PI in a timely manner.
• Attends conferences and meetings related to research as required.
• Other duties as assigned.

Education:

• Bachelor's Degree or 3 years research experience. Familiar with medical terminology and procedures.
• Demonstrates proficiency in personal computers and various software and database applications.
• Excellent interpersonal, written and verbal communication skills and command the English language, both written and verbally.
• Excellent organizational and problem solving skills.
• Ability to work independently.
• Demonstrates clinic competency within 90 days of hire.

Languages:

• Language required
• Language preferred

Certifications:

• Certified Clinical Research Coordinator (CCRC) preferred.

Complexity of Work:

• All employees are expected to meet the standards of performance outlined in the Organizational-Wide Competencies listed below as applied to the position:
• World Class Service Orientation: Includes attitude, behavior, interpersonal skill, and problem solving that enable an employee to respond to internal and external customer needs and expectations in a positive manner.
• Adaptability: Includes teamwork and flexibility needed to fulfill job responsibilities including adapting to changes in work environment and accepting supervisory feedback.
• Efficiency and Effectiveness: Includes quantity and quality of desired work, as well as organization skills necessary to perform successfully.
• Essential Job Requirements: Includes adherence to all relevant policies, procedures, and guidelines affecting the work environment, including maintenance of required competencies and communication skills.
• Supervisory Responsibilities (if applicable): Includes overall accountability for assigned work group relative to operational goals, personnel requirements, and budgetary constraints.
• Note: The above stated duties are intended to outline those functions typically performed by individuals assigned to this classification. This description of duties is not intended to be all inclusive nor to limit the discretionary authority of supervisors to assign other tasks of similar nature or level of responsibility.
• Phlebotomy skills or the ability/willingness to learn required.
• Knowledge of all phases of the research process.

Work Experience:

• Clinical Research experience or other clinical training required.
•  Experience working with Federal Regulations and IRBs preferred.

Physical Requirements:

• Essential Duties: This position requires knowledge of all phases of the Clinical Research process as well as FDA and IRB regulations and procedures. Verbal and written communication skills to communicate with research staff, sponsors, physicians, patient/families, peers and administrative staff are required. Numerical ability to assist in budget planning. Color discrimination is required in the performance of medically related procedure. This position requires knowledge of medical terminology and procedures and Good Clinical Practice Guidelines. The ability to assume responsibility and exercise authority in implementing departmental policies and procedures is required. Very frequent interactive associations and authoritative tasks are inherent in this position. The ability to screen patients for research protocols, retrieve, communicate and present detailed data information verbally and in writing is essential. A professional demeanor is required. The ability to maintain detailed records and maintain confidentiality in the handling of sensitive information is critical.
• Physical Duties: This position requires physical work, lifting a maximum of 50 pounds with frequent lifting and/or carrying of objects weighting 25 pounds, frequent walking, sitting, bending, reaching and standing, etc. Visual acuity is required to screen patients for research protocols. Talking and/or hearing are required to give directions, instruction and explanations to staff and patients are necessary.
• Working Conditions: The employee in this position spends 100% of the time in air-conditioned office environment.

Personal Protective Equipment:

• There are high potential for frequent exposure to blood, blood-borne pathogens and bodily fluids.
• Use of personal protective equipment is required as per clinic/hospital policy.
• Video display screen protectors are available upon request.
• Follows Standard Precautions using personal protective equipment as required for procedures.