About Us:

Each of CenExel’s research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success.

Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.

Hourly Range:

$18.00 - $20.00/hour 

Schedule: 8am-4:30pm (Monday - Friday) - Weekends may be requested to work for additional staffing 

Be a part of a team or become aLEADER in helping discover tomorrow’s cures for today’s diseases with CenExel CNS

Why CenExel CNS? 

• Be part of one of the largest and fastest-growing clinical research companies in the United States with potential internal growth and advancement 
• Work alongside a successful and dynamic team conducting clinical trials for new medications and treatment in various therapeutic areas not limited to pain, sleep, internal medicine, psychiatric, general health, and neurological phase I-IV studies 
• Great benefits and perks

With continuous growth at CenExel CNS, we are looking to fill our vacant Regulatory Assistant. We would love to speak to you if you: 

EDUCATION/EXPERIENCE/SKILLS

• Must be able to effectively communicate verbally and in writing.
• Interest in and knowledge of specific study indications.
• Excellent computer skills and advanced knowledge of electronic equipment (i.e., e-mail, computer, fax machine, copier, etc.).
• Skilled in organization and record maintenance.
• Skilled in developing and maintaining effective working relationships with supervisors and co- workers.
• Strong personal initiative and attention to detail.
• Ability to react calmly and effectively in emergency situations.
• Ability to interpret, adapt and apply guidelines and procedures.
• Ability to clearly communicate both orally and verbally.

As a Research Assistant with CenExel CNS, you are responsible for assisting with preparing, submitting, and maintaining regulatory documents in clinical trials. 

Responsibilities and Duties: 

Provides direct support to Clinical Research Coordinators in the completion of protocol-specific study goals while observing strict adherence to ICH, GCP, protocol, and site guidelines and policies. 

• Creating and maintaining patient charts for all assigned studies. 
• Preparing participant visits based on CRCs schedule, ensuring all source documents, assessments, lab kits and other visit materials are available and accurate. 
• Maintaining inventory of study specific supplies including lab kits, assessments and participant facing materials. 
• Timely completion of data entry and query resolution for all CRFs, based on sponsor specific timelines and deadlines established in contract or other communication. 
• Assisting Coordinators in assessments, including but not limited to, blood pressure, urine collection. 
• Communicating with study participants, caregivers, third party vendors and laboratories as needed. 
• Assisting Coordinators with scheduling, copying, faxing, and other clerical tasks. 
• Aiding Coordinators in the facilitation of study monitoring visits. 
• Completion of daily responsibilities delegated by CRC as they pertain to the study and/or participants. 
• Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive. 

Working Conditions

1. Indoor, office environment.
2. Essential physical requirements include sitting, typing, standing, and walking.
3. Lightly active position, occasional lifting of up to 20 pounds.
4. Reporting to work, as scheduled, is essential.

We offer a competitive pay package which includes but not limited to: 

• PTO/Holiday 
• Medical/Dental/Vision 
• 401(k)/Dependent Care FSA/EAP
• Ancillary Benefits/Group Life Insurance/ AD&D 

CenExel CIT is an equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status regarding public assistance, veteran status, or any other characteristic protected by federal, state or local law.