Clinical Research Nurse

Clinical Research Nurse – Job Description

The Clinical Research Nurse is responsible for overseeing the daily activities of clinical research studies, ensuring adherence to protocols, and working closely with clinical teams, investigators, and other stakeholders to ensure the smooth and effective conduct of clinical trials. This role involves a combination of patient care, data collection, and administrative responsibilities, making it essential for the Clinical Research Nurse to be detail-oriented, communicative, and highly organized. The ideal candidate will have a strong background in clinical research and patient care, with a commitment to ensuring the highest standards of research ethics and protocol adherence.

RESPONSIBILITIES

Study Understanding & Protocol Adherence:

• Thoroughly review all assigned study protocols, attend investigator meetings, and coordinate with the Principal Investigator to ensure full understanding of the study requirements.

• Strictly adhere to study protocols and obtain necessary exemptions when appropriate or required by the protocol.

Communication:

• Effectively communicate protocol issues, patient concerns, or any significant study-related issues to the Clinical Research Organization (CRO), Sponsor, Site Administrator, and Principal or Sub-Investigators.

• Document important information via email, letter, or meeting notes and communicate it to the appropriate parties in a timely manner.

Patient Interaction & Data Collection:

• Collect essential medical and psychiatric information from patients, including patient interviews and reviewing relevant medical records.

• Gather and accurately document all data as required for the study.

Communication Flow:

• Ensure clear communication between patients, study staff, referral sources, Sponsors, CROs, Monitors, Auditors, and any other groups involved in the study.

• Participate in regular telephone conferences and provide study updates to maintain effective communication flow.

Clinical Tasks & Procedures:

• Perform clinical tasks such as measuring vital signs, recording height and weight, conducting ECGs, performing phlebotomy, and packaging specimens.

• Ensure all clinical data is accurately recorded, maintained, and stored according to study protocols and regulatory requirements.

Documentation & Record Keeping:

• Maintain up-to-date and accurate source documentation, ensuring all sponsor-required information is completed on time and in compliance with study guidelines.

Medication Management:

• Dispense study medications and ensure they are stored, handled, and tracked according to study protocols.

• Maintain accurate records of medication distribution, usage, and inventory.

Patient Education:

• Provide patients and their families with detailed information about the study they are participating in, including treatment plans, potential risks, and benefits.

• Answer any questions patients or families may have about the study or the clinical trial process.

Monitor & Sponsor Queries:

• Address and complete any queries raised by study monitors or sponsors in a timely and accurate manner to ensure continuous study progress.

Referrals & Follow-Up:

• Provide appropriate community resource referrals to patients, caretakers, and family members at the conclusion of the patient's participation in the study.

• Ensure ongoing follow-up and support for patients as required by the study protocol.

ADDITIONAL RESPONSIBILITIES

Please note that, in addition to the specific duties listed above, you may be asked to take on other tasks and responsibilities as needed, but not limited to:

• Supporting additional clinical research activities or studies.

• Assisting with administrative duties related to study management.

• Collaborating in the development of new study protocols or other research initiatives.

• Participating in staff training sessions, meetings, or other company-related events.

• Providing assistance with audit preparation, regulatory submissions, and compliance tasks.

• Assisting with patient recruitment, retention, and engagement activities.

These responsibilities may evolve as the needs of the team and organization change, so flexibility and willingness to take on new challenges are essential to success in this role.

KNOWLEDGE, SKILLS, AND ABILITIES

• Strong verbal and written communication skills, with the ability to effectively communicate complex information.

• Ability to work in a dynamic, multi-office environment and manage multiple tasks effectively.

• Excellent interpersonal and customer service skills, with a patient-centered approach to care.

• Strong multitasking and organizational abilities, capable of managing time effectively and prioritizing tasks.

• Ability to handle sensitive information with confidentiality and professionalism.

• Proficient in the use of office equipment (phone, computer, fax, copier) and study-specific equipment (such as ECG machines, phlebotomy tools, etc.).

REQUIRED EXPERIENCE

·  Bachelor’s degree in nursing or a related field (required).

·  Active RN licensure (required).

·  Demonstrated competency in phlebotomy and specimen handling (required).

·  Prior experience as a Clinical Research Coordinator (CRC) or Research Assistant (preferred).

The Clinical Research Nurse is a pivotal role in the success of clinical trials, ensuring both patient safety and adherence to protocol. If you're passionate about clinical research and patient care and have a strong desire to make an impact, we'd love to meet you.