We are looking for a Research Assistant II to join our team!
Are you well organized and adaptable to unexpected changes? Do you have good computer skills and a knack for details? If the answer is yes, keep reading!
In this position you will:
- Serve as a floating resource to perform a variety of activities in support of the execution and management of projects and programs.
- Based on business needs, provide assistance to the following functional areas:
- Research Operations
- Community Health
- Endpoint and Specialty Services
- Site Operations
- Data Management
- Quality Control
- Trial Master File
- Work closely with other team members to ensure timely completion of deliverables and resolution of issues.
- Perform a variety of general administrative tasks such as filing, copying, faxing and preparation of shipments for assigned projects.
- Participate in project, program, functional area and general CPC meetings as required.
- Adhere to CPC SOPs, Good Clinical Practice guidelines and applicable federal, state and local regulations.
Based on business needs, you may perform the following tasks:
- Assist in the preparation of Master Plans, Resource Materials, Source Documentation, Meeting Minutes, and submission of documents to the Trial Master File.
- Assist in the development, administration, and tracking of project-specific training.
- Assist with the printing, collation and distribution of study materials to project team members, sponsors and sites.
- Perform quality control reviews of project-specific documentation and support submission of documents to the Trial Master File.
- Perform quality control review of documents uploaded into eTMF system.
- Create Monitoring Report InfoCards, as requested.
- Upload essential documents into eTMF system.
- Manage email reconciliation and export at study close out.
- Collect and review investigational site documentation and process as directed.
- Correspond with investigational sites, CPC staff and sponsors to rectify data queries and collect outstanding documentation.
- Serve as one of the primary points of contact for investigational sites.
- Assist in sending project supplies to study sites and tracking receipt of those supplies.
- Assist in tracking receipt, entry, upload, reviews and feedback to investigational sites of endpoint testing.
- Assist with query management including report generation.
- Assist with report generation and work with appropriate team members to provide recommendations for centralized monitoring activities.
- Assist with User Acceptance Testing (UAT) and manage user access requests (including user reconciliation).
- Serve as a study coordinator for select projects as needed.
Here’s what you will need to bring to the table:
- GED or HS Diploma required. Nursing or bachelor’s degree preferred.
- Minimum of 2 years of experience working in a clinical research (or similar) setting. Higher degree may be considered in lieu of experience.
- Demonstrated ability to work on assigned tasks with minimal direction.
- Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical drug trials.
- Good understanding of the drug development process.
- Proficiency in MS Office, particularly spreadsheet databases and word-processing.
- Excellent communication and organizational skills.
- Great attention to detail.
- Ability to work with others in a manner that promotes group effort and achievement.
- Ability to shift priorities quickly while ensuring accuracy and timely completion of tasks.
- Ability to manage conflicts and resolve problems effectively.
- Ability to discern priorities and obtain direction to accomplish day-to-day tasks.
Note: Viable applicants will be required to pass a background and education verification check.
Targeted Compensation: $20.77/hr - $25.00/hr
Deadline to Apply: October 1, 2024
About CPC:
CPC is an academic research organization that offers full service clinical trial design, oversight, and management with rapid access to Key Opinion Leaders in a variety of therapeutic areas. With over 30 years of experience, CPC has provided services to over 150 clinical trials in a variety of indications, with an emphasis on cardiovascular, wound healing, diabetes and more.
CPC has expertise in managing clinical trials from a variety of funding sources including Industry, NIH, and Investigator Initiated trials.
CPC Community Health focuses on innovative programs that reach into communities to help people find effective ways to become active, empowered and healthy. http://www.cpccommunityhealth.org/
CPC offers:
- Comprehensive benefits package (medical, dental, vision, life, STD, LTD etc.)
- Matching 401(k) plan (dollar for dollar up to 4% of your eligible compensation, fully vested immediately)
- 11 paid holidays
- 15 - 25 vacation days based on years of service
- Paid sick time (2.67 hours accrued bi-weekly up to a maximum of 80 hours)
- In-suite exercise and relaxation room
- Monthly fun events (e.g. team building activities, games, charitable events, potlucks, picnics)
- Flexible and remote work schedules
An Equal Opportunity Employer
CPC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race (including traits historically associated with race, such as hair texture and length, protective hairstyles), sex, color, ancestry, sexual orientation, gender identity, gender expression, marital status, religion, creed, national origin, disability, military status, genetic information, age 40 and over or any other status protected by applicable federal, state or local law. It is our intention that all qualified applicants are given equal opportunity and that selection decisions be based on job-related factors.
Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act (ADA) and certain state or local laws. If you need assistance, please email our Human Resources team at careers@cpcmed.org.
Compensation$20.77/hr - $25.00/hr
