Clinical Research - Assistant Site Director

Princeton Consumer Research Corp:

Our core team here at Princeton Consumer Research Corp have been extensively-published experts in this field of clinical testing since the early 1990′s and continue to provide their expertise in clinical trials focusing on the cosmetic, beauty, toiletry, personal care and baby care industries.

We are industry experts in claims substantiation studies and pride ourselves on our ability to provide the relevant procedures necessary to substantiate each specific claim in-keeping with the most current regulations. We continue to conduct our studies for the leading retailers and supermarkets, the high-end luxury skin care industry, independent start-up brands and the major cosmetic manufacturers around the world. Whatever your testing needs, Princeton Consumer Research can help you from the initial concept of product development to seeing tangible goods on the shelves by delivering up-to-date, efficient and approved processes for you throughout our business relationship.

We are seeking an Assistant Site Director to work at our site in Cincinnati, Ohio.

Assistant Site Director is responsible for the overall site conduct under the direction of the Site Director/Vice President. The Assistant Site Director is responsible for ensuring delivery of enrolment goals while maintaining adherence to any regulations, ICH guidelines, and PCR SOPs in all aspects of conducting clinical trials. The Assistant Site Director is able to function and still partakes in all levels of a Study Supervisor.

Duties include but are not limited to:

Site Support Responsibilities:

• Supports Key Sponsors and Managers during site visits
• Manages some of the sites most challenging therapeutic areas and study designs
• Able to monitor and mentor all levels of the team to ensure complete understanding of PCR processes, SOPs, and values, ensuring that they are successful during their transition to more demanding opportunities and responsibilities
• Assist Site Director and Quality Assurance Director with all PCR Quality and Client audits
• Assist other managers during their sponsor and study audits
• Develops and maintains CAPAs, when needed, with approvals from the Regional Manager
• Assist Regional Manager in performing Quality Control (QC) check of all study source documents for completeness and quality when needed, or assign others to assist.
• Assign workloads to your team.

Personnel:

• Assisting Site Director to ensure HR policies are implemented and maintained at the site
• Work with site staff in annual training and documentation
• Encourage a positive team-oriented environment at all times
• It is your job to work with Site Director to ensure high staff morale and low turnover rates at the site
• Report to Site Director all personnel issues at assigned sites as it happens
• Routine monitor office operations at assigned site to ensure compliance with current policies and procedures and report any issues to Site Director
• Lead by example and display a high level of integrity and professionalism.
• Do not get involved in any office drama. It is your job to calm things down as they happen and report to your manager without delay

Financial:

• Assist Site Director to ensure timely responses to feasibility questionnaires and scheduling of site evaluation visits at assigned sites
• Keep Site Director appraised of any study changes and all study-related issues that affect the performance of the site and the revenue generation of the assigned site
• Assist Site Director to identify and communicate staff needs as appropriate at assigned site Report site needs to the Site Director without delay and aim to save money and cut spending at all times.

Study Preparation:

• Ability to understand and follow company SOPs
• Review and assess protocol (including amendments) for clarity, logistical feasibility, safety, inconsistencies, etc when requested too.
• Assist PI and the Study Supervisor (and also act as a Study Supervisor) to ensure that all training and study requirements are met prior to trial conduct
• Discuss study test products, required procedures, eligibility criteria, and impact on office flow with Investigator and site staff
• Assist with planning and creation of appropriate recruitment materials
• Assist in the development of recruitment plan and obtain a listing of potential candidates to contact from the subject database
• Actively work with the recruitment team in calling and recruiting subjects for your studies and other site studies
• Attend Investigator meetings.
• Coordinate and attend pre-study site visits, site initiation visits and monitor visits with clinical staff and Sponsor/CRO representatives and report summary to the Site Director if they are not in attendance
• Assist in the creation or review of sponsor-provided protocol specific source documents
• Determine facility, equipment and outsource vendor requirements and availability
• Ensure adequate supplies have arrived on site for protocol initiation
• Ensure education of Assistant CTAs and other site staff, and/or sub-investigators is completed for required tasks. Ensure all training records for team members is up to date.

Study Management:

• Assist Site Director with the delegation of tasks as necessary, and prioritize activities with specific regard to protocol timelines
• Maintain organized files for blank source documents, patient charts, CRFs, and supplies
• Help other team members create source documents when needed and establish a template folder for ease of access the next time a similar study runs.
• Investigational Product Accountability: receive, inventory, dispense, monitor patient compliance, and reorder as necessary. Document accountability log and patient records. Temperature monitoring and compliance of IP storage conditions.
• Collect and evaluate concomitant medication
• Integrate monitoring visits and study teleconferences into existing work schedule to allow for adequate preparation and time for interaction during meetings
• Ensure trial activities are continuously discussed with covering personnel in preparation for vacation or sick leave
• Maintain adherence to company regulations and ICH guidelines in all aspects of conducting clinical trials
• Communicate sponsor updates, patient-specific concerns/progress, unforeseen issues, and overall trial management with appropriate members of the PCR team in an ongoing fashion
• Maintain effective relationships with study participants and other PCR personnel o Interact in a positive, professional manner with patients, sponsor representatives, investigators, and PCR personnel and management
• Communicate clearly verbally and in writing
• Accept accountability for actions and function independently

Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all inclusive.

Knowledge, skills, and abilities:

• Excellent working knowledge of medical and research terminology
• Excellent working knowledge of federal regulations, good clinical practices (GCP) Understanding of issues affecting clinical research in the identified therapeutic area of expertise
• Ability and willingness to mentor and guide less experienced CRC as they develop and gain experience in all therapeutic areas
• Ability to communicate and work effectively with a diverse team of professionals Excellent organizational, prioritization, and leadership skills and capabilities with strong attention to detail o Excellent computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word, and excel
• Critical thinker and problem solver

Job Type: Full-time

Benefits:

• 401(k)
• Health insurance

Schedule:

• Monday to Friday

Ability to Relocate:

• Cincinnati, OH: Relocate before starting work (Required)

Work Location: In person