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Clinical Research Coordinator

3 months ago

Rockville, United States Sunstone Therapies Full time
Job DescriptionJob Description

Scope: We are seeking a highly skilled and motivated Clinical Research Coordinator who is also a certified Registered Nurse (RN) to join our team in Rockville, MD. The successful candidate will be responsible for coordinating and overseeing clinical research studies while ensuring compliance with regulatory requirements and maintaining the highest standards of patient care.

Job activities include but are not limited to:

Clinical Research Coordination

  1. Collaborate with principal investigators and other research staff to develop, implement, and monitor clinical research protocols.

  2. Coordinate all aspects of clinical research studies, including participant recruitment, screening, enrollment, and follow-up visits.

  3. Obtain informed consent from study participants and ensure understanding of study procedures and potential risks.

  4. Works collaboratively and functions as an effective member of the research team.Assist with scheduling study visits, procedures, and assessments according to protocol requirements and participant availability.

  5. Collect, record, and manage research data accurately and efficiently using electronic data capture systems.

  6. Maintain study documentation, including regulatory documents, case report forms, and study logs, in compliance with institutional and regulatory guidelines as per FDA and GCP guidelines.

  7. Serve as the primary point of contact for study participants, addressing their questions, concerns, and adverse events throughout the study duration.

  8. Coordinate study-related activities with external stakeholders, including sponsor representatives, contract research organizations (CROs), and regulatory authorities.

  9. Ensure compliance with Good Clinical Practice (GCP) guidelines, federal regulations, and institutional policies throughout the conduct of clinical trials.

  10. Participate in study monitoring visits, audits, and inspections by regulatory agencies, ensuring timely resolution of findings.

Registered Nurse Responsibilities

  1. Provide occasional clinical support and assistance to study participants, including conducting vital signs assessments, administering study-related medications or interventions, and addressing any medical concerns within the scope of nursing practice.

  2. Collaborate with healthcare providers and other members of the research team to ensure seamless integration of clinical research activities with patient care activities.

  3. Maintain knowledge of current nursing practices and standards of care to support evidence-based clinical research activities.

The successful candidate must demonstrate the following skills, experience and competencies:

  • Bachelor's degree in nursing (BSN) from an accredited institution.

  • Current unrestricted RN license in the state of Maryland.

  • Minimum of 3 years of clinical research experience, preferably in a clinical research coordinator role.

  • Strong understanding of clinical research methodology, regulatory requirements, and ethical principles governing human subjects research.

  • Excellent interpersonal, communication, and organizational skills.

  • Ability to work independently and collaboratively in a fast-paced research environment.

  • Proficiency in using electronic health record systems and data management software.

  • Commitment to maintaining patient confidentiality and privacy.

  • Flexibility to adapt to changing priorities and project timelines.

  • Proficient in phlebotomy and IV therapy.

Compensation and Benefits

Sunstone Therapies offers a competitive salary package commensurate with skills and experience plus benefits that include medical, dental, and vision coverage, and a retirement savings 401(k) plan.