Summary:

Job Responsibilities:

1) Works under limited supervision. Supervisor available to handle most unusual situations and review progress of work

2) Conducts study tasks which are moderately complex to complex in accordance with established protocols or guidelines. Follows established guidelines in the review and collection of clinical data. May conduct screening of patients for inclusion in study based on predetermined criteria.

3) Assists with/conducts informed consent process with PI/Sub-I available for questions. Assists with/conducts patient education regarding protocol and requirements. Assists with/conducts protocol evaluation and implementation planning.

4) Develops, prepares, submits and maintains regulatory documents. Creates and maintains study and patient files in a highly accurate and organized manner. May develop study specific source and site documentation.

5) Performs actual study tasks as appropriate to level of knowledge & training. Responsible for source documents and case report forms. Prepares submissions to sponsor. Notifies investigators and sponsors of problems or issues, checks on progress and well-being of research subjects and overall direction of the research study.

6) May have responsibility for study budget development in conjunction with SPA. May have responsibility for planning related to protocol analysis and implantation. May perform preliminary data analysis.

Required Work Experience:

1) 4-6 years of research experience

Preferred Work Experience:

1) IRBnet and reporting of Serious Adverse Events (SAEs)

Skills and Competencies:

1) Solid knowledge of physiologic disease states and medical terminology

2) Solid knowledge of clinical research data collection and clinical data report preparation

3) Proven ability to work in a data management setting in the accurate capture of patient data

4) Holds specialty certification in clinical research through an approved accrediting organization or college/graduate program

Within one year of eligibility must obtain Certified Clinical Research Professional - Association of Clinical Research Professionals

You Belong At Baystate

At Baystate Health we know that treating one another with dignity and equity is what elevates respect for our patients and staff. It makes us not just an organization, but also a community where you belong. It is how we advance the care and enhance the lives of all people.

DIVERSE TEAMS. DIVERSE PATIENTS. DIVERSE LOCATIONS.

Education:

Bachelor of Science, GED or HiSET (Required)

Certifications:

Certified Clinical Research Professional - Association of Clinical Research Professionals, Within one year of elgiblity must obtain Certified Clinical Research Professional - Association of Clinical Research Professionals - other

Equal Employment Opportunity Employer

Baystate Health is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, marital status, national origin, ancestry, age, genetic information, disability, or protected veteran status.

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Ab out Baystate Health

Baystate Health (BH) is one of New England’s leading and largest integrated health care organizations, serving a population of nearly one million people throughout western New England. With roots dating back to the founding of Springfield City Hospital in 1873, Baystate Health has been providing high-quality and compassionate health care in western Massachusetts for more than 145 years. With more than 12,000 employees, a medical staff of nearly 3,100 physicians, and a net patient service revenue of more than $1.4 billion, the ever-growing health system includes five Massachusetts hospitals and the Baystate Mary Lane Outpatient Center in Ware:

• Baystate Medical Center in Springfield

• Baystate Children’s Hospital (located at Baystate Medical Center)

• Baystate Franklin Medical Center in Greenfield

• Baystate Wing Hospital in Palmer

• Baystate Noble Hospital in Westfield