Clinical Research Coordinator II, Orthopaedic Surgery

Clinical Research Coordinator II - Orthopaedic Surgery Department

Job Summary 

Works under the direction of an Investigator(s) with limited supervision, to coordinate research projects. This position primarily performs patient/participant coordination, however, may conduct data management in smaller departments on as needed basis. Collects and ensures quality control of clinical or basic research data in support of multiple and/or complex research studies.    

Experience and Education

• Bachelor’s degree in medical or science related field and two years clinical research experience. 

• May consider additional years of experience or advanced degree in lieu of education or experience, respectively.   

• ACRP or SOCRA certification a plus. 

• A Heart Saver for non-licensure or BLS for Licensure may be required based on research study protocols or affiliate location requirements.   

Job Duties

May perform some or all the following:

• Directly interacts with clinical research participants, as required, for the research study (non-clinical and clinical procedures).

• Interacts via telephone, telehealth or in-person.

• Coordinates regulatory documentation for research studies that includes maintaining information to comply with industry standards, University policies, FDA requirements or other hospital policies.

• Coordinates and schedules procedures as per research study. 

• A non-licensed coordinator may pend study order sets with oversight by PI.

• Screens, recruits, enrolls and follows subjects according to research protocol guidelines (non-clinical and clinical procedures). 

• May also assist with the consent processes.

• Maintains and coordinates data collection information required for each study that may also include developing CRF's (case report form) or data collection tools.

• Assists in developing and implementing research studies, may include writing clinical research protocols.

• Conducts research procedures according to the protocol with proper training and check offs to maintain scope of service.

• May assist the PI on the fiscal management of the trial including budget preparation.

• Monitors patient safety by reviewing records and ensuring appropriate reporting per protocol and HRPP standards.

• May perform research billing activities, as needed, based on size of department (including linking patient calendars).

• Coordinates data management and collection for national (larger/more complex) research studies or multiple research studies at a given time.

• Serves as primary liaison/lead in preparing annual reports for federal, state, and or/or local agencies on assigned studies.

• Prepares protocols for Institutional Review Board (IRB) submission. 

• May also submit amendments and continuing review documents.

• Provides in-service training to all study team members and communicates to involved groups.

• Reviews research study protocols to ensure feasibility requirements of the study.

• Assists in developing website or other social media for marketing/recruiting based on assigned clinical research study.

• Enters data or assists in assembling data to enter in the assigned clinical trial management system, electronic medical record and/or other required data entry systems. 

• Maintains required subject documentation for each study protocol.

• Duties performed may include one or more of the following core functions:  a) Directly interacting with or caring for patients; b) Directly interacting with or caring for human-subjects research participants; c) Regularly maintaining, modifying, releasing or similarly affecting patient records (including patient financial records); or d) Regularly maintaining, modifying, releasing or similarly affecting human-subjects research records.

• Performs other duties as assigned.    

Knowledge, Skills & Abilities

• Work requires knowledge of basic and clinical research terminology, regulations, and procedures.

• Work requires strong computer skills (spreadsheets, databases, and interactive web-based software).

• Work requires ability to communicate effectively with various levels of internal and external contacts.

• Work requires ability to work with confidential information on daily basis

• Proactively works to maximize results of the team and organization

• Follows and understands the regulations for Protected Health Information (PHI)

• Work requires good communication skills.

• Work requires the ability to problem solve.