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Senior Clinical Research Associate Hematology and OncologyJob ID 148326 Date posted 05/17/2018
Position Summary: Coordinates multiple research studies by implementing study protocols in accordance regulatory and institutional requirements. Sets up administrative systems to manage the progress of each study while screening, recruiting and educating patients and collecting and reporting study data. Maintains interdisciplinary relationship with participating physicians and clinical departments. Provides daily supervision, mentoring and training to Clinical Research Associates, and Study Coordinators.
Essential Duties & Responsibilities including but not limited to:
1) Knowledge and experience in the implementation of all aspects of clinical trials research
2) Leads the clinical trial research team in all aspects of the implementation of clinical trials
3) Contacts and coordinates develops the multidisciplinary trial team
4) Develops support staff roles, alters roles as deemed necessary
5) Responsible for oversight of support staff
6) Implements training program for support staff
7) Assigns responsibility of new protocols to staff members
8) Develops sponsor contacts / relationships
9) Oversight of protocol preparation for IRB submission
10) Knowledge of FDA, OHRP and GCP regulations, assures adherence to regulations, educates study staff
11) Active participation in trial budget preparation
12) Works collaboratively with investigators to identify cost saving measures in relation to system/operational efficiencies
13) Site initiation activities coordination
14) Management of subjects via recruitment, protocol specific assessment of data collection
15) Education of study subjects / family members about requirements of the clinical trial
16) Maintain study drug Rx dispensing / device inventory logs
17) Coordination with study staff for preparation / participation in site monitoring visits / collaborative group audits
18) Assistance with investigator protocol development (when requested)
19) Responsible for regulatory submissions to IRB in a timely manner
20) Assurance that applicable adverse events are properly reported to the sponsor and IRB
21) Ensures quality of data reported
22) Incorporates Lahey Clinic Guiding Principles , Mission Statement and Goals into daily activities.
23) Complies with all Lahey Clinic Policies.
24) Complies with behavioral expectations of the department and Lahey Clinic.
25) Maintains courteous and effective interactions with colleagues and patients.
26) Demonstrates an understanding of the job description, performance expectations, and competency assessment.
27) Demonstrates a commitment toward meeting and exceeding the needs of our customers and consistently adheres to Customer Service standards.
28) Participates in departmental and/or interdepartmental quality improvement activities.
29) Participates in and successfully completes Mandatory Education.
30) Performs all other duties as needed or directed to meet the needs of the department.
Education: Associates degree or equivalent work experience.
Licensure, Certification, Registration: N/A
Skills, Knowledge & Abilities: Strong organizational and communication skills. Proven ability to provide clear supervision and training, to function independently and to interact with professional personnel at all levels of an organization. Working knowledge of medical terminology and medical practice protocols. Working knowledge knowledge of computer databases and word processing systems.
Experience: Minimum of 2 years experience working in an inpatient or outpatient clinical setting. Minimum of 6 months experience as a Clinical Research Associate or equivalent responsibilities.
About Lahey Health
At Lahey Hospital & Medical Center, as one of the world's premier health care organizations, we provide superior health care leading to the best possible outcome for every patient. We exceed our patients' high expectations for service each day. We also help advance medicine through research and the education of tomorrow's health care leaders
We care for our patients with compassion and openness, unsurpassed expertise, a drive for continuous learning improvement, and with respect, caring, teamwork, excellence and commitment to doing our personal best.
Join our team and our mission of excellence by applying today!
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