• Understands and adheres to Good Clinical Practice (GCP), U.S. Food and Drug Administration (FDA), and Institutional Review Boards (IRB) guidelines

• Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures

• Assist with periodic review of study files for completeness

• Assist CRCs with preparation, handling, and distribution of Clinical Trials Supplies and maintenance of tracking information

• Assist with the tracking and management of Case Report Forms (CRFs), queries, and clinical data flow

• Act as a central contact for the clinical team for designated project communications, correspondence, and associated documentation

• May accompany CRCs to assist with clinical monitoring duties upon completion of required training

• Maintains security and confidentiality of patients and study-specific information per protocols and applicable federal regulations

• Performs other required duties as requested by the Clinical Research Lead, Director, or Principal Investigator

Education/Experience/Certifications

• High School Graduate or equivalent required

• College Graduate preferred

• Current Good Clinical Practice certification required (must be obtained in the first 14 days after hire)

Technical Skills:

• Intermediate computer skills: Microsoft Word, Outlook and Excel preferred

• Intermediate clerical skills: typing, data entry, filing, and record keeping

Other Skills/Requirements:

• Excellent interpersonal and communication skills (both verbal and written) required

• Ability to adapt to multiple and rapidly changing priorities and deadlines

• Work well under pressure and maintain a sense of urgency

• Excellent organizational skills

• Confident and capable communication with patientsand coworkers

• Handle Company business with the utmost professionalism, discretion, and tact

• Friendly, helpful team player with a positive, customer-serviceattitude

• Good collaboration and problem-solving skills 

• The ability to work independently and productively with little or no supervision

• Dependable and reliable

• Exercise good judgment and take initiative to properly address and resolve issues

• Keep supervisor and coworkers informed of the status of issues and projects

Physical Requirements:

The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions to the extent the Company may do so without undue burden.

While performing the duties of this job, the employee will regularly be required to:

• Sit for prolonged periods at a desk while working on a computer

• Stand

• Walk

• Use hands to touch, handle, or feel

• Reach with hands and arms

• Speak and hear

While performing the duties of this job, the employee will occasionally be required to:

• Stoop, kneel, crouch, and/or crawl

• Lift and/or move up to 25 pounds

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 

• Climate controlled, temperate indoor working environment

• The noise level in the work environment is usually moderate