National Clinical Research Coordinator

Position Summary
Functions as a traveling research coordinator to clinical centers across the United States working with local research teams or independently to develop, implement and coordinate clinical research. This position will perform diverse administrative duties requiring analysis, sound judgement and a high level of study specific protocol. Travel to other clinical centers across the United States throughout the calendar year will be required.

Essential Duties

1. Daily logging and reporting of activities.
2. Organizational skills related to travel, including but not limited to: booking/securing travel arrangements, saving all travel related receipts, and submitting receipts for reimbursement.
3. Well versed in Good Clinical Practices, Food and Drug Administration Rules and Regulations, NIH guidelines, HIPAA regulations and ICH guidelines in relation to clinical trials.
4. Become familiar with institution Policy and Procedures for National Jewish Health and each institution that he/she travels to.
5. Is fully knowledgeable with the purpose and the details of study protocol in which he/she will be involved through review of the consent, protocol and IRB submission documents, avoiding deviations from the protocol.
6. Works well as a member of the clinical research team with positive and timely written and verbal communication, including sharing information up, down and laterally.
7. Exhibits positive behaviors interacting with colleagues and study subjects, sets a tone for effective communication at each new site.
8. Recruits and interviews prospective subjects for the clinical study, consistently meeting or exceeding goals.
9. Familiarizes potential subjects with the details of the study through phone contacts and personal interviews. Schedules subject participation in research, coordinating availability of necessary space, laboratory and physician support.
10. Properly dispenses study medication under the direction of the Principal Investigator and/or Sub-investigators.
11. Assures compliance with protocol, completion of necessary records, and scheduling of monitoring and subject visits.
12. Is familiar with all records required for each study, reviews records after each visit for completeness and accuracy.
13. Transfers source documentation into Case Report Form (CRF) within 24 hours of subject visit.
14. Maintains patient NJH and clinical research files, including updating medical history, allergies and concomitant medications on an ongoing basis.
15. Shows initiative to identify and implement ways to improve their job and surroundings.
16. Seeks supervision appropriately. Plans work in a manner that allows adequate completion of all tasks. Follows through on assignments in a timely manner.
17. May be called upon to perform the following specific tests and procedures, including others not listed: a) spirometry and other pulmonary function tests, b) electrocardiogram, c) blood pressure, pulse, height, weight, and temperature measurements d) phlebotomy and specimen processing, e) data collection and formatting into Excel, as necessary.
18. Demonstrates accuracy in all details, is able to record and report properly in patient records all pertinent information.
19. Performs subject competencies (including age-specific competencies) as identified through the departmental competency program. Maintains compliance for training for specific tests and procedures, as needed per NJH policy and study protocol.
20. Implements care and services that recognize age-specific needs and issues for customers served. Performs as a back-up to staff absences and vacancies, as necessary.
21. Demonstrates adherence to the policies and procedures established by both NJH and their specific Unit. This includes but is not limited to, time and attendance policies.

Other Duties
None

Competencies

1. Accountability: Accepts full responsibility for self and contribution as a team member; displays honesty and truthfulness; confronts problems quickly; displays a strong commitment to organizational success and inspires others to commit to goals; demonstrates a commitment to National Jewish Health.
2. Business Acumen: Using economic, financial, market, and industry data to understand and improve business results; using ones understanding of major business functions, industry trends, and own organizations position to contribute to effective business strategies and tactics.
3. Collaboration/Teamwork: Cooperates with others to accomplish common goals; works with employees within and across his/her department to achieve shared goals; treats others with dignity and respect and maintains a friendly demeanor; values the contributions of others.
4. Customer Focus: Ensuring that the customer perspective is a driving force behind business decisions and activities; crafting and implementing service practices that meet customers and own organizations needs.
5. Peer Relationships: Interacts with others in a constructive, positive, and respectful manner, regardless of individual differences. Assists team members or co-workers in achieving personal goals and completing assignments.

Supervisory or Managerial Responsibility
None

Travel
None

Core Values

1. Be available to work as scheduled and report to work on time.
2. Be willing to accept supervision and work well with others.
3. Be well groomed, appropriately for your role and wear ID Badge visibly.
4. Be in compliance with all departmental and institutional policies, the Employee Handbook, Code of Conduct and completes NetLearning by due date annually.
5. Fosters an inclusive workplace where diversity and individual differences are valued and leveraged to achieve the vision and mission of the institution.
6. Adheres to safe working practices and at all times follows all institutional and departmental safety policies and procedures.
7. Wears appropriate PPE as outlined by the infection control policies and procedures.
8. Demonstrates compliance with all state, federal and all other regulatory agency requirements.

Minimum Qualifications

1. Education: Bachelors degree required.
2. Work Experience: Minimum three (3) years of work experience with minimum of two (2) years of experience functioning as a clinical research coordinator or clinical research monitor preferred.
3. Special Training, Certification or Licensure: Must have a valid drivers license. Local IRB certification will be required prior to or within 1 week of arriving at any clinical center. This includes HIPAA and GCP training, as well as any institutional training required at each local center. CPR/BLS certification may be required at each clinical center prior to independent patient contact. Current ACRP or SOCRA Clinical Research Coordinator Certification (CCRC or CCRP), or Clinical Research Associate (CCRA), preferred.