Work Shift:

Capital Health is the region's leader in providing progressive, quality patient care with significant investments in our exceptional physicians, nurses and staff, as well as advance technology. Capital Health is a five-time Magnet-Recognized health system for nursing excellence and is comprised of 2 hospitals. Capital Health Medical Group is made up of more than 250 physicians and other providers who offer primary and specialty care, as well as hospital-based services, to patients throughout the region.

Position Overview:

 Clinical Research Associate

JOB CODE:    20861
FLSA Exemption Status:    Exempt 

SUMMARY (Basic Purpose of the Job)
Coordinate and oversee clinical research studies in accordance with protocols and regulatory requirements. Develops, manages, and analyzes a clinical research database that acquires real world evidence obtained from clinical practice data. Manages databases and develop processes that integrate internal electronic medical records to generate outcome-based reports.

MINIMUM REQUIREMENTS
Education:    Bachelor Degree in Health Sciences (i.e. epidemiology, psychology) or related field.
Experience:    One year research experience and may include: lab rotations, internships in basic or clinical research, statistical data analysis. Experience in a hospital setting preferred.
Other Credentials:    
Knowledge and Skills:    Excellent people management skills. Demonstrated ability with interacting with physicians and various departments in a hospital setting. Excellent verbal and written communications skills along with strong attention to detail. Knowledge of medical terminology and clinical trial processes is essential
Special Training:    Proficient knowledge of MS Office Applications (Word, Excel, Powerpoint, Etc).
Mental, Behavioral and Emotional Abilities:    Ability to be effective in an ambiguous and ever-changing work environment. Ability to obtain results using a team-based approach, including working with associates across the hospital and staff who are not reporting to the Office of Clinical Research. 
Usual Work Day:    8 Hours  

                               Reporting Relationships
Does this position formally supervise employees? No

ESSENTIAL FUNCTIONS
Coordinate and oversee clinical research studies in accordance with protocols and regulatory requirements
Ensure compliance with study protocols, regulations, and institutional policies. Maintain regulatory documents and records as per FDA guidelines.
Collect, record, and maintain study data and source documents.
Perform or assist with clinical procedures, such as ,laboratory sample processing, phlebotomy and ECGs.
Responsible for the day-to-day management of data collection systems and processes as well their analysis under supervision. 
Communicates effectively with physicians (from different disciplines), medical support staff from different functional units (Emergency Department, ICU, Surgical Floor, Rehabilitation, Imaging, etc.), study sponsors and administrative functions (Information systems, quality management, etc.). 
Participates and shares data and reports with physicians and support staff at regularly-scheduled meetings, trainings and audits as required.    

PHYSICAL DEMANDS AND WORK ENVIRONMENT
Frequent physical demands include: Frequent movement around the clinical site to interact with participants, collect data, and coordinate with other staff members.

Occasional physical demands include: Handling and operating medical equipment, performing tasks such as drawing blood, taking vitals, and conducting ECGs

Continuous physical demands include: Alternating between standing for extended periods during participant interactions and sitting while entering data or reviewing study protocols

Lifting Floor to Waist 10 lbs. (Occasionally)
Lifting Waist Level and Above 5 lbs. (Occasionally)

Sensory Requirements include: Good vision and hearing are essential for monitoring participants, reading data, and communicating effectively
 

Offers are contingent upon successful completion of our onboarding process and pre-employment physical.  Capital Health will require all applicants (including contractors, travelers and consultants) to have an annual flu vaccine prior to start date, with the exception of individuals with medical and religious exemptions.

"Company will never ask candidates for social security numbers or date of birth during application phase. If you are asked for this information online, you may be a target for identity theft."