GENERAL SUMMARY/ OVERVIEW STATEMENT:



Working under the supervision of the Administrative Director of the CNCT and the Principal Investigator and following established policies and procedures, coordinates clinical research studies. May be responsible for the following activities: recruiting and evaluating patients for studies; collecting and organizing patient data; scheduling patients for study visits; performing clinical tests such as phlebotomy, EKGs, etc.; maintaining and updating data generated by the study, all IRB submissions such as applications, amendments, annual reviews, adverse events.



PRINICIPAL DUTIES AND RESPONSIBILITIES:



1. Provides assistance on clinical research studies as per study guidelines and protocols.


2. Recruits and evaluates potential study patients. Per protocol instruction, conducts telephone interviews or schedules patient for study visit and screening.


3. May be required to perform clinical tests such as questionnaires, phlebotomy, EKGs, etc. if certified and as needed. Will work in phlebotomy lab to set up lab testing, shipping, etc.


4. Interact with patients/subjects regarding study, including patient education, procedural instruction, follow-up. Answers any phone calls and inquiries regarding study protocol. Refers participants when appropriate to supervisor or clinical staff.


5. Will serve as a liaison between patient and physician. First point of contact for study communication. Advocate for patient to assure a good experience while in your trial and assure compliance.


6. Communicates with sponsor company, CRAs, central labs, and testing facilities both external and internal.


7. Responsible for all research meeting scheduling with monitors or sponsors.


8. Creates, distributes and files all study documents per protocol and updates as needed.


9. Responsible for collecting data and maintaining patient information database for study. May be required to input data. Maintains patients records as part of record keeping function.


10. Responsible for mailing various study information or packets; ie, schedules, directions, reimbursements to study participants.


11. Responsible for staff study trainings.


12. Prepares and submits all IRB documents; applications, amendments, annual reviews and serious adverse events.


13. Oversees study budgets and patient reimbursements.


14. Monitors and sets up any needed equipment.


15. Maintains inventory and orders supplies when necessary.


16. Maintains all study regulatory documents.


17. All research administrative tasks.


18. All other duties, as assigned.



Qualifications

QUALIFICATIONS:



BS or BA


New graduate with relevant course or project work



SKILLS/ ABILITIES/ COMPETENCIES REQUIRED:



1. Excellent interpersonal skills are required for working with the study participants.


2. Good oral and written communication skills.


3. Knowledge of clinical research protocols.


4. Knowledge of GCP and ICH guidelines.


5. Knowledge of computer programs, databases, etc.


6. Able to work independently.


7. Ability to problem solve quickly and accurately.


8. Excellent organizational skills and ability to prioritize and delegate a variety of tasks.


9. Careful attention to detail.


10. Ability to demonstrate professionalism and respect for subjects rights and individual needs.



Working conditions:



Work throughout the hospital areas such as clinic, labs, clinical trials center. Must be able to go independently to the investigational drug services pharmacy on L-2 to pick up investigational product, to clinic on ground and first floor. Daily operations conducted in open office cube space. May be required to lift boxes to ship to central lab or boxes of lab supplies.



HOSPITAL WIDE RESPONSIBILITIES: These are required of all staff, regardless of position. Do not remove these standards.


Works within legal, regulatory, accreditation and ethical practice standards relevant to the position and as established by BWH/Partners; follows safe practices required for the position; complies with appropriate BWH and Partners policies and procedures; fulfills any training required by BWH and/or Partners, as appropriate; brings potential matters of non-compliance to the attention of the supervisor or other appropriate hospital staff.



EEO Statement

BWH is an Affirmative Action Employer. By embracing diverse skills, perspectives and ideas, we choose to lead. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a 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.