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 seasoned Clinical Research Coordinator who has at least 3 years of experience with the conduction of clinical research to join our wonderful team of motivated research professionals in our home health division.
* 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:
- Assists the home health team in protection of the rights and welfare of all human research participants involved in research in accordance with federal regulations and university and sponsoring agency policies and procedures.
- Assists the home health team in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training.
- Collaborates with PI and institution to respond to any audit findings and implement approved recommendations.
- Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
- Collects documents needed to initiate the study and submit to the sponsor (e.g., Form FDA 1572, CVs, etc.).
- Performs safety and efficacy assessments per study protocol.
- Collect or coordinate collection of clinical procedures such as vital signs, ECGs, blood draws, IP infusions.
- Ensure completeness of study documentation by home health RNs
- Updates source documents per study protocol amendment.
- Coordinate operations with other departments to facilitate completion of procedures during participant visits, includes communications with nurse practitioners, medical assistants, pharmacy, regulatory, and/or physical therapy.
- Assists with training and mentoring home health RNs
- Ability to exercise independent judgment and discretion
The above statements are intended only to describe the general nature of the job, and should not be construed as an all-inclusive list of position responsibilities.
Requirements:
- Secondary degree in social science, health science or related field
- Alternative educational backgrounds may be accepted (i.e., LPN, Medical Assistant, etc) in combination with previous CRC experience
- Phlebotomy certification/skills preferred
- CCRP from SOCRA preferred
- Must have GCP, IATA, ALCOAC training
- BLS/CPR training upon hire date
- 3 years of experience in progressively growing CRC roles in clinical trial settings
- Experience training/mentoring RAs and other research team members
- Some travel for home health visits may be required
- Fully vaccinated against COVID-19 and willing to receive annual flu vaccination
Job Type: Full-time
Salary: $65,000.00 - $75,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
- Day shift
- Monday to Friday
Ability to commute/relocate:
- Atlanta, GA 30329: Reliably commute or planning to relocate before starting work (Required)
Work Location: One location, on site and in person
Rare Disease Research is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected Veteran status, or any other characteristic protected by federal, state or local laws.
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.
Job Type: Full-time
Pay: $65,000.00 - $75,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Schedule:
Education:
Experience:
- Clinical Research Coordinator: 3 years (Required)
- Clinical trials: 3 years (Required)
Work Location: In person