Management of Studies and Site Workload:

• Oversee all site staff’s work to ensure data is entered in a timely manner, all queries answered, training is complete, and accesses are obtained timely 
• Collaborate with Investigator(s) to evaluate and determine feasibility of upcoming opportunities/protocols 
• Partner with the Region Manager to coordinate Investigator and Sub-Investigator coverage  
• Work with Region Manager to identify outside vendors needed for studies
• Assess and adjust distribution of studies to coordinators to best meet site, coordinator, study, sponsor needs 
• Build relationships with local providers to ensure Trial Access Partners are in place to support study recruitment
• Ensure study required training has been completed by all site staff (including PI) in a timely manner as to not delay study start up 
• Attend all study audits and play an active role in their management and execution of follow up items 
• Ensure recruitment activities are optimized, and all studies are meeting their study enrollment goals 
• Participate in all Root Cause Analysis for the site; contribute to CAPAs and ensure compliance
• Assume CTMS superuser status and assist others to ensure accuracy, compliance, and quality input

Personnel:

• Through partnership with the Region Manager review and approve PTO requests, ensuring there is adequate coverage at the site
• Participate in annual performance appraisals and have goal setting and milestone meetings regularly throughout the year
• Participate in the interview process for site staff
• Work with Region Manager to develop a positive team environment, striving for high staff morale
• Work in conjunction with Region Manager to manage personnel challenges
• Conduct weekly one on ones with staff and ensure staff complete all required training
• Work with Region Manager to identify staffing needs for the site

Financial:

• Work with Region Manager and PI to ensure timely responses to feasibility questionnaires and scheduling of site evaluation visits
• Keep Region Manager apprised of any study changes and all study-related issues that affect the performance of the site and the revenue generation

Site Maintenance: 

• Keep Region Manager apprised of any site maintenance issues
  • Coordinate building and equipment maintenance
• Ensure staff are following guidelines and SOP’s as pertain to the sites
  • Ensure that site has the equipment necessary to safely perform job responsibilities and is kept clean and organized
  • Work with the Region Manager to review and address injury reports if necessary
• Ensure the lab follows IATA guidelines and applicable staff are properly certified

 Other Responsibilities:

• Create and implement processes that will enhance and improve workflow, minimize deviations, minimize no-shows, to benefit overall functionality  
• Collaborate and communicate with other departments regarding inter-site issues 

• Strong organizational and planning skills to maintain a busy and diverse work schedule
• Proactive approach with the ability to work autonomously
• Excellent problem-solving skills
• The ability to multi-task and work well within a high-paced pressurized environment
• The ability to use your initiative to deliver a great customer experience
• Excellent communication skills paired with the ability to develop and nurture relationships
• Intermediate/Advanced IT skills including experience of using Word, Excel, Outlook and PowerPoint
• Excellent working knowledge of medical and research terminology
• Excellent working knowledge of federal regulations, good clinical practices (GCP)
• Ability to communicate and work effectively with a diverse team of professionals
• Excellent computer skills with demonstrated abilities using CTMS, eREG, IWRS systems, electronic data capture, MS word, and excel
• Critical thinker and problem solver
• Excellent interpersonal skills, detail-oriented and meticulous
• Friendly, outgoing personality with the ability to maintain a positive attitude under pressure
• High level of self-motivation and energy
• Excellent professional writing and communication skills
• Ability to work independently in a fast-paced environment with minimal supervision and as a team player working together towards common goals

Certifications/Licenses, Education, and Experience

• Minimum Education:
  • Bachelor’s Degree or equivalent professional experience 
  • Research Professional Certification 
• Minimum Experience:
  • A minimum of 3 years of clinical research experience
  • A minimum of 2 years prior Clinical Research Coordinator experience preferred
  • Previous Research Site Management experience preferred

 

Mandatory Employer Disclosures

Notice to Illinois applicants: Applicants are not obligated to disclose expunged juvenile records or adjudication, arrest, or conviction.
Notice to Connecticut applicants: Care Access may require applicants to submit to a urinalysis drug test in connection with an application for employment.
Notice to Arizona, Georgia, Indiana, and North Dakota applicants: Care Access complies with applicable laws prohibiting smoking in and around places of employment.
Notice to Massachusetts applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Notice to Rhode Island applicants: Care Access complies with Rhode Island law prohibiting smoking in enclosed areas within places of employment. Care Access is also subject to is subject to Chapters 29–38 of Title 28 of the Rhode Island General Laws.
Notice to Maryland applicants: UNDER MARYLAND LAW, AN EMPLOYER MAY NOT REQUIRE OR DEMAND, AS A CONDITION OF EMPLOYMENT, PROSPECTIVE EMPLOYMENT, OR CONTINUED EMPLOYMENT, THAT AN INDIVIDUAL SUBMIT TO OR TAKE A LIE DETECTOR OR SIMILAR TEST. AN EMPLOYER WHO VIOLATES THIS LAW IS GUILTY OF A MISDEMEANOR AND SUBJECT TO A FINE NOT EXCEEDING $100.