Clinical Trial Site Manager

About Rare Disease Research:

As an independent clinical research site, we are 100% dedicated to conducting clinical research, accelerating the development of safe and effective treatments and providing rare disease patients with access to innovative investigational therapies. We are a passionate, caring, multi-disciplinary team conducting clinical research with expertise and compassion, and always to the highest ethical standards.

About This Opportunity:

We are looking for a Clinical Site Manager to join our team of researchers in our Hillsborough, NC location. The ideal candidate will have Senior Clinical Research Coordinator Experience and strong management skills, leading teams in all aspects such as hiring, training, PIPs if needed, developing SOPs, etc.

* Important Note: Applicants for employment in the United States must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States and with Rare Disease Research.

Responsibilities:

• Have in-depth knowledge of all active studies at Hillsborough RDR site.
• Serve as a resource for the clinical team to help navigate through the study protocol, problem-solve any issues that may arise, navigate new studies and anticipating problems before they arise
• Responsible for managing day to day functioning of the (CRC/RS/RA) research team
• Attend all relevant study meetings to help clinical staff project manage and prioritize projects and tasks
• If needed, serve as primary CRC for studies to provide direct oversight and mentorship for junior staff
• Assist the team by managing clinical evaluators and clinical vendors (such as anesthesia, PT, psych)
• Assist/clinical team in communications with medical monitors, CRA and other internal and external parties to ensure clinical trial activities and deliverables are completed on time and within budget.
• Works directly with the investigators on planning and coordination of clinical trials from Start-Up to study closure.
• Supports quality assurance on study documents to ensure that studies are being conducted effectively and with strong adherence to protocols and standardization.
• Directly manage Research Assistants and Research Specialists and their work to assist in their growth towards becoming a CRC.
• Directly manage CRCs and their work to assist in their growth towards becoming a CRC II.
• Responsible for onboarding via a hands-on mentorship approach to assess and train new RDR clinical staff, including contract and part-time staff
• Assist in creating and maintaining Standard Operating Procedures
• Report to the Head of Research
• Evaluates all CRCs, RSs, and RAs on a bi-annual and as needed basis addressing issues in real-time

REQUIREMENTS:

• Bachelor’s degree in clinical related field, post-secondary degree preferred
• 6 - 8 years experience in the clinical research field, including management of clinical research teams
• Previous experience as a CRC running clinical trials
• Detail-oriented, excellent verbal and written communication skills
• Certification from CRP from SOCRA or ACRP
• Please note that due to the immunocompromised nature of our patients COVID and flu vaccinations are REQUIRED

Notice To Third-Party Agencies:

Rare Disease Research does not accept unsolicited resumes from recruiters or agencies. Any staffing/employment agency, person or entity that submits an unsolicited resume to this site does so with the understanding that the applicant's resume will become the property of Rare Disease Research will have the right to hire that applicant at its discretion and without any fee owed to the submitting staffing/employment agency, person, or entity.

Work Remotely

• No, this position is full-time in-person

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Job Type: Full-time

Pay: $85,000.00 - $120,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday