JOB RESPONSIBILITIES:

The clinical research coordinator performs a wide range of professional, administrative, and evaluation responsibilities. The research coordinator will:

• Collaborate with the principal investigator and research/clinical teams to implement research studies.
• Develop high level of familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections, etc.
• Implement recruitment strategies in accordance with IRB requirements and approvals.
• Perform participant screening activities to ensure participant eligibility per inclusion/exclusion criteria and investigator oversight.
• Perform consent discussions with eligible participants as part of the consenting process.
• Obtain informed consent from participant or Legally Authorized Representative alone and/or with the investigator.
• Perform assessments as qualified by training and experience such as vital signs, vision screening, sample collection, ECGs, etc.
• Administer surveys and questionnaires and perform standardized assessments.  
• Perform source audits and meet with investigator regularly to resolve data queries and concerns.
• Transcribe data into the study data capture system. 
• Manage data capture and data transfer.
• Schedule study visits, and coordinate staff, resources and ancillary services, as required.
• Provide education to participants and caregivers.
• Prioritize participant safety by reporting outcomes and adverse events to the investigator/sponsor in a timely fashion.
• Regularly report participant statuses to the investigator throughout research engagement.
• Review participant medical records and charts, as required.
• Generate and distribute resource materials for participants, caregivers, and staff.
• Develop systems, forms, and documents to efficiently collect data and implement studies.
• Collaborate with pharmacists for the dispensing and storage of investigational products (IP).
• Ensure best practices are followed in the management of IP for drug, device, and biologic studies.
• Collect, record, and prepare data for transmission to sponsor and/or publication.
• Prepare for and attend investigator meetings, sponsor monitoring sessions, site audits, and inspections. Ensure follow up actions are resolved.   
• Communicate with Institutional Review Board(s) and manage submissions.
• Maintain regulatory documents for assigned studies.
• Develop working relationships with study sponsors, collaborating medical centers, and academic institutions.
• Maintain accurate time records for work performed on research studies.
• Order and track study supply inventories.
• Manage participant reimbursements and stipends.

Other requirements:

• Practices proper safety techniques in accordance with Shepherd Center and departmental policies and procedures. Responsible for the reporting of employee/patient/visitor injuries or accidents, or other safety issues to the supervisor and in the occurrence notification system.  
• Monitors and ensures compliance with all regulatory requirements, organizational standards, and policies and procedures related to area of responsibility. Identifies potential risk areas within area of responsibility and supports problem resolution process.

​

REQUIRED MINIMUM EDUCATION

• Level I: Bachelor of Science in related field.
• Level II: Advanced Degree such as master’s in public health (MPH)
• Level III: Advanced Degree

REQUIRED MINIMUM CERTIFICATION

• Basic Life Support Certification (BLS)

REQUIRED MINIMUM EXPERIENCE

• Level I: Minimum of two (2) years clinical research experience required.
• Level II: Three (3) years clinical research experience and advanced degree.
• Level III: Five (5) years, advanced degree, and specialty certification(s).

REQUIRED MINIMUM SKILLS

• Completes orientation and initial assessment of competency successfully by determined due date.
• Completes mandatory education and annual competency assessment requirements by determined due date.
• Computer Competency including proficiency in Microsoft Word, Excel, and PowerPoint.
• Familiarity with data storage and analysis systems helpful.
• Superior written communication skills.
• Flexibility to work shift per protocol demands.
• Basic testing competency (i.e. vital signs, collecting urine/blood specimens, specimen processing and shipping, ECG, etc.) per center policies with appropriate training and/or certifications.
• Human Subject Protection and Good Clinical Practices (GCP) Training
• Hazardous Material Shipping Training

PREFERRED QUALIFICATIONS:

• Certified Clinical Research Coordinator (CCRC) preferred.
• Certified Clinical Research Professional (CCRP) preferred.
• Research Certification (CCRC or CCRP) preferred

PHYSICAL DEMANDS:

• Physical ability to perform demands of job including bending, reaching, lifting, walking, and standing. Ability to lift 60 pounds on occasion, stand for up to 4 – 6 hours daily, able to read text from distance and see/discern colors.
• Occasional travel required.

WORKING CONDITIONS:

• Some potential for exposure to blood, body fluids, investigational drugs, and investigational devices.

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification.  They are not intended to be an exhaustive list of all job duties performed by the personnel so classified.