Job Description

PeaceHealth is seeking a Clinical Research Assistant for a Full Time, Day position.  Hourly compensation starts at $21.30, more depending on experience.

JOB SUMMARY

Provides research and related administrative. Provides regulatory support for submission and continuous reporting to relevant regulatory agencies (e.g., Institutional Review Board (IRB), Study Sponsors, Cancer Consortium partner institutions).Maintains databases including participant visits, financial revenue, invoicing for research services, and regulatory documents (e.g. CVs, licenses, lab certifications, training certifications).

ESSENTIAL FUNCTIONS

Assists with coordination of the regulatory submission in the study start-up phase and throughout the study to meet sponsor and institutional timelines. Maintains and updates regulatory documents (e.g. FDA Form 1572, Protocol Signature page, Financial Disclosure Forms, CV’s, licenses, lab certifications, lab reference ranges, other related forms per sponsor or federal requirements).
Communicates with research caregivers, IRB and sponsors regarding necessary documents and timelines. Participate in assessing feasibility of proposed clinical trials. Assists with management of Investigational Product and study-related equipment handing, storage and documentation. Prepares, submits and files documentation for closing out studies, maintain document inventory, storage and retrieval.
Maintains participant-related research expense databases and research reimbursements, including invoicing for research services.
May assist with patient recruitment and scheduling. May meet with patients to complete follow up visits, quality of life or other questionnaires, if authorized per training. May collect study required biological specimens, if authorized per training. Participates in protocol-specific training as required. Documents in the electronic medical record, if appropriate.
May manage data registries.
Assists with scheduling sponsor visits, monitors and obtaining appropriate security access to EMR, when required.
Performs other duties as assigned.

QUALIFICATIONS

EDUCATION:

Associates degree in a health care or science related field is required.
Bachelor’s degree in related discipline is preferred.

EXPERIENCE/TRAINING:

Minimum one year experience in healthcare setting required.
Experience in clinical trials research, tumor registry or outpatient clinical environment preferred
Prior experience in clinical regulatory compliance and IRB submission procedures preferred.
Experience using electronic data submission software is preferred.

LICENSE/CERTIFICATION:

Basic Life Support (BLS) for Healthcare Providers required upon hire.
If applicable proper certification or licensing – i.e. Medical Assistant Certification & certified or registered (CMA/RMA) or Licensed Practical Nurse (LPN).

OTHER SKILLS:

Good oral, written and interpersonal communication skills.
Ability to review data and report appropriately.
Good analytical/critical thinking skills.
Highly detail oriented and organized.
Good understanding of research concepts and standards.
Strong extracting and reporting data from electronic medical records.
Excellent Microsoft Office skills (office, word, excel).
Medical terminology.

SYSTEM PHYSICAL/COGNITIVE REQUIREMENTS

Work requires fairly light physical exertion from up to 65% of the time.
Ability to lift objects weighing 30 lbs. or less.
Work requires frequent exposure to minor cold, heat, poor ventilation or sharp instruments. Reasonably anticipated exposure to blood and body fluids daily.
Job duties frequently require intense concentration and attention to detail (up to 65% of work time).