Overview

*Please note: this position is internally listed as SEEV Specialist I on our website*

 

We are looking for a SEEV Specialist I to join our team!

 

Do you have clinical research background? Do you enjoy traveling and adapt to change easily? Can you quickly connect and build strong relationships with others? Can you proactively identify a problem and develop solutions? If you have answered yes, then keep reading!

 

In this position you will:

 

Review and provide feedback on EQuIP® study-specific documents (e.g., Study Manual, CRFs, Source Document, SEEV Plan, SEEV Report Templates).
Contact study site and schedule Site Endpoint Evaluation Visits (SEEV) as assigned. Provide sites with confirmation documentation regarding the SEEV.
Conduct SEEVs domestically and internationally including hands-on training with site staff on endpoint data collection, source document/reference tools review for endpoint data and equipment assessment according to the CPC SOP.
Understand and comply with all CPC Polices, SOPs and WIs related to assigned activities.
Provide detailed, accurate and comprehensive written reports of the SEEVs within the allowable timeframe.
Report any study site concerns to the study Project Manager within a timely manner.
Conduct online CRA/Sponsor endpoint trainings.
Process Core Lab submissions; including tracking, distribution of materials to appropriate CPC staff members, filing and uploading documents to the TMF.
Distribute feedback to sites on quality issues, as required by project. Follow up with appropriate individuals (site staff or site CRA) to ensure complete and documented resolution of issues.
Contact appropriate individuals (site staff or site CRA) regarding incomplete, inaccurate or missing submissions and other documents as required by project.
Maintain study recruitment logs, reconcile against Core Lab submissions and follow up with site staff on any missing submissions.
Participate as a member of designated project teams to support Core Lab staff. Establish and maintain central project and regulatory files, both electronic and paper.
Assist in scheduling and writing meeting minutes for project team meetings.
Help assess project issues and propose resolutions to the PM.
Communicate with sites as necessary.
Help ensure the overall quality of project services and deliverables.
Assist in scheduling SEEVs for other team members, as requested.
Perform additional activities as assigned.
Here’s what you will need to bring to the table:

Nursing or bachelor’s degree preferred but not required.
A minimum of 2 years of experience in a clinical research setting or 1 year of experience at CPC as Research Assistant is required.
Thorough knowledge of the Good Clinical Practice guidelines and the applicable FDA and ICH regulations for conducting clinical trials.
Proficiency in Microsoft Office, particularly Outlook, Word and Excel.
Excellent interpersonal communication skills, organizational and problem-solving skills.
Great attention to detail.
Ability to work as a member of a team and to interact with multiple individuals with varied skill sets in a positive, collaborative and educational manner.
Ability to manage conflicts.
Willingness to travel up to 80%.
Note: Viable applicants will be required to pass a background and education verification check.

 

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)
10 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, color, religion, national origin, sex, gender identity, veteran status, marital status, sexual orientation, age forty and over, disability, genetic information 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.

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