Job Overview 

Tufts Medical Center is seeking a highly motivated Clinical Research Coordinator III to join the Clinical and Translational Research Center (CTRC). The CTRC supports high-quality, innovative clinical research across Tufts CTSI partners and collaborators. Under the guidance of the Director of the CTRC, the center provides the infrastructure necessary to conduct cutting-edge clinical trials involving adult, and geriatric research participants. These trials focus on understanding the causes and progression of human diseases.
 
THE CRC will support a study focused on understanding mechanism for development of chronic Lyme Disease as well as other ongoing studies. 
The Lyme disease study will primarily recruit patients from the suburbs around Boston 
during the peak Lyme disease season (summer). The CRC II will enroll patients through 
video consenting. The CRC will also be responsible for collecting samples from study 
participants and delivering them to a lab in Boston.

 

Job Description 

Minimum Qualifications: 

1. Bachelor’s degree OR High School Diploma or equivalent AND Four (4) years of related experience. 

2. Basic Life Support (BLS) certification may be required based on specific role requirements. 

3. Two (2) years in clinical research related activities. 

 

Preferred Qualifications: 

1. Five (5) years in clinical research related activities. 

2. Experience with IRB submissions, compliance and clinical trial administration

3. IATA Hazardous Good Shipping certification. 

4. CITI Human Research Protection certification. 

 

Duties and Responsibilities: The duties and responsibilities listed below are intended to describe the general nature of work and are not intended to be an all-inclusive list.  Other duties and responsibilities may be assigned. 

 

1. Facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. 

2. Schedules study participant appointments and serves as the patient liaison to the PI and other participating physicians. 

3. Reviews and comprehends each assigned protocol including study proceedings and timelines, inclusion and exclusion criteria, confidentiality and privacy protections. 

4. Works closely with the PI, participates in an integral way in the informed consent process by communicating clearly and openly with potential study patients about protocols open to enrollment.  

5. Develops clinical study budgets based on proposed study protocols. 

6. Coordinates approval of new study agreements and contracts. 

7. Coordinates and attends sponsor prequalification visits, monitor visits, study termination visits. 

8. Completes case report forms.  

9. Responds to data clarification requests in a timely manner. 

10. May attend Investigator meetings requiring travel and report pertinent information back to research team members. 

11. Coordinates with PIs and department to help ensure that clinical research and related activities are performed in accordance with Federal regulations, Medical Center and sponsoring agency policies and procedures. 

12. Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan.  

14. Maintains a spreadsheet tracking updates to database of all subjects enrolled on clinical trials. 

15. Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by IRBs and sponsors. 

16. Collaborates with PI and institution to respond to any audit findings and implement-approved recommendations. 

17. Cooperates with sponsoring agency compliance and monitoring efforts related to human research participant protection and reports instances of noncompliance to the appropriate compliance office. 

18. Completes documentation on each study visit that is used to track all study related activities so that time, effort and materials can be accounted for on a monthly basis. 

19. Ensures that all materials for each clinical trial protocol are available for subject enrollment. 

20. Works collaboratively with the other members of the clinical research team and the clinical and administrative support teams to ensure all protocols are followed and that there is timely documentation and submission of study data. 

21. Performs specimen processing and shipment of biological specimen duties. 

22. Assists with study materials including but not limited to, the informed consent document, case report forms (CRFs), enrollment logs, and drug/device accountability logs. 

23. Establishes and organizes study files, including but not limited to, regulatory binders, study specific source documentation and other materials as required. 

24. Assists the Principal Investigator in submission of accurate and timely closeout documents to applicable Federal agencies, Tufts Medical Center, and the sponsoring agency in accordance with Federal regulations and institutional policies and procedures. 

25. Arranges secure storage of study documents that will be maintained according to institutional policy or for the contracted length of time, whichever is longer. 

26. Promotes the ethical conduct of research by reporting good faith suspicions of misconduct in research as defined within hospital policy and Code of Conduct. 

27. Extracts data from outpatient charts and hospital records in a timely manner. 

28. Maintains records and other documentation of training. 

13. Maintains subject screening logs and protocol deviation logs. 

 

Physical Requirements:  

1. Typical clinical and administrative office setting. 

2. May be required to travel to clinics,  subject homes, workplace or arranged locations to do study visits.

 

Skills & Abilities: 

1. High degree of organizational talents, data collection and analysis skills. 

2. Requires meticulous attention to detail. 

3. Excellent computer skills including word processing. 

4. Ability to prioritize quickly and appropriately. 

5. Excellent communication and interpersonal skills. 

6. Systematic record-keeping. 

7. Possesses a thorough knowledge of the informed consent process as well as a thorough understanding of the study protocol(s) in order to be able to answer all questions pertaining to the study posed during the informed consent process. 

Tufts Medicine is a leading integrated health system bringing together the best of academic and community healthcare to deliver exceptional, connected and accessible care experiences to consumers across Massachusetts. Comprised of Tufts Medical Center, Lowell General Hospital, MelroseWakefield Hospital, Lawrence Memorial Hospital of Medford, Care at Home - an expansive home care network, and large integrated physician network. We are an equal opportunity employer and value diversity and inclusion at Tufts Medicine. Tufts Medicine does not discriminate on the basis of race, color, religion, sex, sexual orientation, age, disability, genetic information, veteran status, national origin, gender identity and/or expression, marital status or any other characteristic protected by federal, state or local law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation by emailing us at careers@tuftsmedicine.org.