Clinical Research Coordinator Nurse (RN), (CMA), (LPN)

Part time or Full time positions for a Clinical Research Coordinator to coordinate clinical trials in outpatient settings.Also have part time/ semi full time availability for Administrative professional in our administrative office.

Immediate opening for an experienced RN/CMA/LPN who desires a career in the field of coordinating clinical trials. Prefer research experience but not required. If you can multi task, are detail oriented, and have strong assessment and communication skills you may qualify for this position!

The research coordinator is primarily responsible for coordinating research patient visits according to ICH-GCP guidelines, and according to the IRB-approved study protocol and/or manual of procedures. Day-to-day activities may include all or some of the essential functions listed below, depending upon individual experience / knowledge and the needs of the organization which are subject to change from time to time.
Essential Functions* 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 for submission to the sponsor (1572, CVs, etc.).* As delegated by the Principal Investigator, conducts and/or participates in the informed consent process with research participants per regulatory guidelines and practice SOP. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
* Conducts patient visits per the protocol procedures and tests, including but not limited to lab draws, sterile technique, quality of life assessments, EKG testing, and assisting investigators in conducting patient visits and treatments per protocol.
* Performs venipuncture to collect blood samples at the required study visits. Processes blood samples per the protocol and lab manual for each study.
* Collects adverse events and at each study visit, notifying the Sponsor and IRB of all SAEs within 24 hours.* Completes and maintains accurate case report forms (CRFs) for assigned research protocols.* Assures timely and accurate completion of electronic Case Report Forms for data entry.* Identifies study candidates internally using protocol specific inclusion and exclusion criteria, documenting each potential participant's eligibility or exclusion.
* Works with other members of the study team and practice staff to recruit eligible candidates to meet enrollment goals.* Must be attentive to data queries and resolve them within the required time frame.* Maintains adequate inventory of study supplies. If handling investigative drugs/devices, follows the sponsor protocol on Investigative Drug/Device Accountability.personnel * Documents training dates and collects signatures of trained on study training logs.* Ensures that the delegation of authority log is complete and all study personal are properly trained.* Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials.* Anticipates and assists with preparation of site monitoring visits. Assists the monitor during visits to resolve all queries promptly.* Maintains and updates the regulatory document file as requested by research manager.* Maintains correspondence from sponsor companies, certified research organizations and IRBs.* Attends teleconferences and Investigator Meetings as requested by research manager.
Hours are Monday thru Friday and can vary from day to day which requires a willingness to be flexible with work schedule.

Job Types: Full-time, Part-time

Pay: $25.00 - $35.00 per hour

Expected hours: 30 – 40 per week

Benefits:

• Dental insurance
• Flexible schedule
• Paid time off
• Retirement plan
• Vision insurance

Education:

• Associate (Preferred)

Work Location: In person