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Position: Clinical Research Coordinator II
Location: Boston, Mass (2-5 Days on site)
Duration: 6 month contract to hire
Job Description:
The Clinical Research Network Clinical Research Coordinator II (CRC II) position provides clinical research support for studies managed by our clients Clinical Research Network (CRN), under the direction of the CRN Program Manager, CRN Director and Principal Investigators. The CRC II will coordinate CRN supported research protocols in the clinic setting. The CRC II will coordinate assigned administrative aspects of each study and interact with study subjects, CRN Regulatory Specialist, CRN Program Manager, study investigators, ancillary departments, and other research and clinical staff.
Minimum Qualifications:
- BA or BS Degree, Masters degree preferred.
- 2-5 years of directly related experience.
- Bi-lingual in Spanish, Haitian Creole or Cape Verdean is preferred.
- Demonstrated proficiency in clinical research operations, quality assurance and reporting.
- Knowledge of MS Word, Power Point, and Excel is essential.
- Knowledge of federal research regulations.
- Experience applying Good Clinical Practice Guidelines, HIPAA, The Protection of Human Research Subjects, CHR regulations for recruitment/consent of research subjects
Responsibilities:
- Conduct the enrollment of study participants, including explaining research procedures, and obtaining informed consent of subjects and/or their families. Complete the administrative aspects of the research study
- Assist in data collection and analysis provides feedback on study's progress. Review the data collection forms for each enrollee for completion and quality; checks work of junior staff performing data entry to ensure timely and accurate entry.
- Train and onboard newly hired CRN coordinator staff. Provide training and mentorship to junior research coordinators.
- Participate in staff meetings/initiatives including appropriate quality improvement and education activities, or if unable to attend non-mandatory activities, accepts responsibility to review meeting minutes and becomes knowledgeable of issues discussed.
Study Start Up
- Maintain GCP certification and complete all study required protocol training
- Design and document study workflows and perform walk-throughs with impacted units.
- Assist with the collection of all regulatory documentation from study team and ancillary departments. Prepare study documents (source documents, packets, etc.)
- Assist with the development of subject recruitment materials
Study Management & Closeout
- Subject prescreening and recruitment. Schedule and complete participant visits and perform/assist with procedures
- Timely data collection, CRF/eCRF completion and query resolution
- Maintain training requirements/Coordinate specimen drawing and processing
- Regular monitoring and documentation of Adverse Event and Serious Adverse Events
What's In It For You
Our Client works together for one goal — to provide exceptional and equitable care to improve the health of the people of Boston. Their bold vision to transform health care is powered by their respect for their patients and their commitment to ensure everyone who comes through their doors has a positive experience.
As one of the top places to work in health care, they know that providing exceptional care for patients begins with caring for their staff. That’s why you’ll find a supportive work environment with rich opportunities throughout your career for training, development, and growth and where you’ll have the tools you need to take charge of your own practice environment.
Medasource provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, national origin, age, sex, citizenship, disability, genetic information, gender, sexual orientation, gender identity, marital status, amnesty or status as a covered veteran in accordance with applicable federal, state, and local laws.
JO-2311-141315