Regulatory Assistant

JOB TITLE

Regulatory Assistant

Job Summary:

CenExel Clinical Research and its fully owned and operated Centers of Excellence (research sites) provide unparalleled medical and scientific support in the design and execution of clinical trials. Each of our 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.

Responsibilities:

• Assisting with the completion of signature logs, training logs, and all regulatory documents
• Assembling regulatory binders and preparing files in the eRegulatory software
• Assisting with administrative Regulatory duties assigned
• Scanning/filing/uploading of regulatory documents
• Assisting with the maintaining of spreadsheets, trackers, etc.
• Assisting with the maintaining of the Medical Records area-to include organization of files, assigning location of files, checking files in and out, notifying teams of when a study can be broken down, assisting with the breaking down of studies, and other miscellaneous duties in Medical Records
• Serves as a back up to the Quality Department Assistant by maintaining the Monitor area:
• Opening and closing the monitoring area
• Ensuring monitoring rooms and area and Conference Room are ready for monitors/sponsor representatives
• Ensuring supplies in the monitoring area and Conference Room are stocked
• Assisting as Monitor liaison by copying, contacting staff, providing directions, etc.

• Responsible for allowing monitors/sponsor representatives access in and out of monitor parking area and monitor area

• Serves as a back up to the Quality Department assistant by maintaining the master Monitor & Trip Calendar
• Assists Investigators with their day to day calendar, emails, etc.
• Helping with special assignments as needed
• Filing regulatory documents appropriately in medical records
• Other duties as assigned

Education/Experience/Skills: 

This position requires the following minimal requirements:

• Knowledge of clinical trials
• Skill in maintaining records
• Skill in developing and maintaining effective working relationships with patients, staff, and the public
• Ability to work independently as well as within a team
• Ability to effectively present study information
• Ability to present a positive image of the clinic
• Ability to maintain client confidentiality
• Ability to communicate effectively with peers, physicians and management
• Ability to communicate clearly both orally and written

EDUCATION – Bachelor’s degree preferred

EXPERIENCE – At least one (1) year of Regulatory experience and/or knowledge in a Clinical Trial setting preferred

CERTIFICATE/LICENSE – CPR training provided

Service Excellence: We believe all relationships with co-workers, sponsors, and subjects are partnerships. We demonstrate service excellence through a personal commitment to producing high quality, high value work, and delivering on time and on target results for every partner.

Safety: We believe that physical and psychological safety are foundational for a healthy organization.  We proactively identify and mitigate safety risks as part of our daily work and value those who speak up for safety.

Resilience: We believe resilience is critical for doing our best work. We demonstrate resilience by remaining flexible, adapting to sudden change, and bouncing back from difficult situations with grace and confidence.

Team Orientation: We believe that having a team orientation leads to individual and organizational success. We demonstrate team orientation by working collaboratively and leveraging collective knowledge, ideas, and strengths to achieve a common goal.

Ethical Behavior: We believe the pillars of ethical behavior are integrity, honesty, respect, courtesy, and caring. We demonstrate ethical behavior by modeling professional standards of conduct.

Mutual Respect: We believe that mutual respect cultivates a supportive workplace. We demonstrate mutual respect by embracing diverse perspectives, sharing ideas, and trusting in each other’s abilities.

Open Communication: We believe that open communication results in a rich and rewarding dialogue that allows for the flow of energy and creativity. We demonstrate open communication by listening for understanding, speaking up without fear, freely sharing experiences, and soliciting ideas and opinions from others.

Working Conditions
Standard operating hours are Monday through Friday, 8:00a.m. to 4:30pm. May be required to complete job-related tasks outside of that time frame, in excess of a standard 40-hour work week (if approved by Manager).  Requires prolonged walking, standing, some bending, stooping and stretching.  Requires hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator and other office equipment.  Requires normal range of hearing and eyesight to record, prepare and communicate appropriate reports.  Requires occasional lifting of boxes up to 50 pounds.  Work is performed in a medical office environment and includes exposure to blood-born pathogens and bio-hazardous materials.  This role requires the ability to work with a broad range of personalities, situations and psychiatric disorders; therefore, candidates must possess the ability to resolve conflicts immediately and diffuse potentially escalating events before they occur.

COVID-19 vaccination is strongly recommended at CenExel Clinical Research and all its research sites.  As permitted by applicable law, COVID-19 vaccination may be required for employees that work directly with patients.

CenExel Clinical Research is an Equal Opportunity Employer.  All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.