Job Description

COME JOIN OUR TEAM AND MAKE A DIFFERENCE AS WE BLAZE THE WAY INTO THE FUTURE OF LIVER MEDICINE. PINNACLE CLINICAL RESEARCH IS DEDICATED TO CONDUCTING CUTTING-EDGE RESEARCH WITH A SPECIAL FOCUS ON FATTY LIVER DISEASE (NON-ALCOHOLIC). WE PRIDE OURSELVES ON CONDUCTING HIGH QUALITY RESEARCH AS A COMPLEMENT TO THE MEDICAL CARE THAT OUR VOLUNTEERS RECEIVE FROM THEIR ROUTINE CARE CENTER. BE A PART OF THE DISCOVERY!

Summary: Due to our rapid growth, Pinnacle Clinical Research is looking to add a Source Control Specialist to support the Document Control Specialist in providing support and coordination of E-source creations and aspects surrounding electronic web-based source creation and functionality.  This position will be vital to the development, implementation, and success for all E-source creation.

Duties and Responsibilities:

• Responsible for creating records for document capture within CRIO (Electronic Source). 
• Creates study related documents and new study preparation. 
• Maintains the integrity of the working documents and updates version control when revised. 
•  Maintain systems for document version control. 
•  Responsible for document accuracy and security and for removing obsolete documents. 
•  Ensures applicable staff approve documents prior to publishing for use. 
•  Always maintains subject and document confidentiality, understands, and complies with the appropriate sponsor requirements and regulations which includes the Food and Drug Administration, good clinical practices, International Conference on Harmonization, Health Insurance Portability and Accountability Act, institutional review boards, and institutional policies and procedures.

Education/Experience:

• High school diploma or general education degree (GED).
• Two to four years related experience and/or training; or equivalent combination of education and experience.
• Clinical Research Coordinator with minimum 1+ years’ experience (preferred)
• Familiarity of clinical trial operations, ICH, GCP Guidelines and other applicable Regulatory requirements.

Knowledge, Skills, and Other Abilities: 

• Good working experience in a team environment across multi-functional areas.
• Highly organized, self-motivated, detail-oriented, proactive, and accurate.
• Ability to work with urgency and thrive in a high-energy, fast-paced environment.
• Demonstrate excellent communication, verbal and written, and interpersonal skills.
• Demonstrate advanced proficiency in MS Office Suite: Word, PowerPoint, Excel, Project and Published
• Experience working with e-Source creation systems preferred (CRIO etc.

Work Environment and Physical demands:

The work environment and physical demands 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.

• Work is performed in an office/laboratory and/or a clinical environment.
• Exposure to biological fluids and/or bloodborne pathogens. 
• Personal protective equipment required such as protective eyewear, garments, and gloves.
• Occasional travel may be required domestic and/or international.
• Ability to work in an upright and/or stationary position for 6-10 hours per day.
• Frequent mobility required.
• Occasional squatting, kneeling, or bending.
• Light to moderate lifting and carrying (or otherwise moves) objects including medical equipment with a maximum lift of 20-50 lbs.

Perks of working at Pinnacle Clinical Research:

• 401k
• Medical, dental, vision, long term disability, short term disability, FSA, and life insurance
• 3 weeks of paid time off
• 10 paid company holidays
• $200 scrub voucher (specific positions apply)
• And more!

Pinnacle Clinical Research is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, disability, gender, national origin, age, genetic information, military or veteran status, sexual orientation, gender identity, marital status or any other protected Federal, State/Province or Local status unrelated to the performance of the work involved.