PRAHS 2017-41530 in United States

Coordinate and participate in Phase I clinical research studies ensuring that studies are carried out according to protocol, standard operating procedures, and applicable guidelines and regulations. Provide safety monitoring for study participants. Carries out study-related activities under the supervision of local clinical management staff and in co-operation with Research Physician/(Associate) Medical Director. Reviews protocols for compliance with accepted research guidelines; collecting clinical data; performing phlebotomy and collecting other samples per research protocols; ensures appropriate laboratory, cardiopulmonary exercise tests and other diagnostic examinations are scheduled and completed per study protocols; reporting adverse events in a timely manner, recording and entering data. In addition, assist with the guidance and supervision of staff in this role. May be expected to participate in team quality improvement efforts.

Duties of this position include following, in accordance with established policies and nursing standards:

  • Clinical Quality, Data Integrity, and Safety

  • Maintaining nursing knowledge, skills and licensure.

  • Provide safety monitoring and supervision of study participants.

  • Administer investigational drugs and concomitant medications to subject according to study protocol.

  • Performs required study procedures.

  • Participate in mock emergency drills.

  • Ensure proper documentation to meet all reporting requirements.

  • Demonstrate strong ethical and safety practices.

  • Participate in peer support / evaluation, in services, education programs, and staff meetings, and Quality Improvement activities as assigned.

  • Reviews clinical records/charts and does quality controls (QC’s)

  • Coordinate and participate in clinical research studies to ensure that data collected on study volunteers adhere to study protocol; may assist in screening volunteers for inclusion in study based on pre-determined criteria.

  • Confer with volunteers to explain purpose of study and obtain informed consent forms; explain procedures and practical issues such as timelines for visits and restrictions on food and drink.

  • Record volunteer clinical data.

  • Collaborate closely with study investigator on adverse events (AE) according to procedures outlined in the protocol.

  • Collaborate and communicate with all internal groups and clinic management and their teams.

  • Participate in project meetings with sponsors and other members of the project team as needed.

  • Identify deficiencies and malfunction of equipment and supplies and assist in identifying proper replacements

  • Establish and maintain positive interactions with volunteers and other staff.

  • Promptly respond to volunteer needs.

  • Maintain a clean and organized work environment.

  • Supervise Medical Research Associates (MRAs) and subjects during studies, if applicable.

  • Provide shift report to MRAs and peers for the shift and to Clinical Research Nurse (CRN) or Floor Supervisor at shift change, if applicable.

  • Identify deficiencies in knowledge and performance of the MRAs and peers.

  • Mentor and coach clinical staff and peers in study tasks, procedures, and other areas of deficiencies in knowledge and performance relative to their roles.

  • Assist in inventory management.

  • Appropriate and proficient use of all equipment required for clinical procedures and assessments.

  • Other duties as assigned by clinic management.

Minimum Qualifications

  • Read, write and speak English. Fluency in host country required.

  • Minimum of 2 to 3 years clinical experience.

  • Effective written and verbal communication skills.

  • Excellent interpersonal and problem solving skills

  • Proficient in general computer use.

  • RN license in State of NJ

  • Provider Level BLS

  • ACLS

Flexibility to work day or night shift preferred.

PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

ID: 2017-41530

External Company Name: Pharmaceutical Research Associates, Inc

External Company URL: http://prahs.com/