Clinical Research Coordinator - PRECiS Study

When you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives.

The Clinical Research Coordinator will support the administration and coordination of the PRECiSE study, a multicenter PCORI funded trial of pregnancy outcomes in Day 3 versus Day 5 embryo transfer in women undergoing in vitro fertilization. This role will assist the program manager and coordinating center staff in overseeing the operations of the Clinical Coordinating Center. Responsibilities include assisting in the development and maintenance of the trial protocol and study operations materials; assisting in oversight of study administration at the enrolling sites including maintenance of and compliance with the study protocol; study site and project committee communication, regulatory documentation for the study, and overall study management. This role will interact with project stakeholders - investigators, study site members, participant advisors, study sponsor, subcommittee members and other collaborators. Previous experience in clinical research and interest in Ob-Gyn research highly preferred.

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Primary Responsibilities:

1. Independently or in conjunction with other clinical research staff and/or research nurse, recruits and enrolls research subjects onto clinical research projects according to study protocols. May assess research subjects' eligibility for inclusion in a particular protocol based on contracts with physicians and nurses and knowledge of the protocol. (essential)

2. Checks all eligibility and ineligibility criteria with the research subjects' medical record. Verifies information with clinical research nurse and/or principal investigator. (essential)

3. Discusses informed consent with research subjects. Interacts with research subjects prior to entering the study and throughout the entire treatment. Assists with scheduling appointments and follow up tests. (essential)

4. Learns protocol and monitors strict adherence to protocols by physicians, nurses and research subjects. Reviews protocol requirements with physicians, nurses and fellows. Identifies any problems with protocol compliance and notifies principal investigator and/or research nurse. Begins to learn how to independently resolve problems with protocol. (essential)

5. Extracts data on protocol subjects from hospital records, outpatient charts and private physician office records in order to complete case report forms required by specific protocols. Enters data into computerized system. (essential)

6. Assists clinic staff in obtaining insurance approval for subject protocol participation and scheduling tests and arranging admissions or outpatient visits for subjects. (essential)

7. Assists investigator with correspondence with IRB. (essential)

8. As needed, may function in areas/clinics performing job duties related to clinical research studies.

Required Qualifications:

• Bachelor's degree required.
• 1-2 years of related work experience required.
• Medical terminology.
• Working knowledge of computer systems required, including web-based applications and some Microsoft Office applications, which may include Outlook, Word, Excel, PowerPoint or Access.

Competencies:

Decision Making: Ability to make decisions that are based on specific instructions, standard practices and established procedures which generally require little or no supervision.

Problem Solving: Ability to address problems that are routine, somewhat repetitive and generally solved by following clear directions and procedures and by identifying opportunities for process improvements.

Independence of Action: Ability to follow general instructions and procedures as provided. Work is monitored by supervisor/manager.

Written Communications: Ability to communicate clearly and effectively in written English with internal and external customers.

Oral Communications: Ability to comprehend and converse in English to communicate effectively with medical center staff, patients, families and external customers.

Knowledge: Ability to demonstrate full working knowledge of standard concepts, practices, procedures and policies with the ability to use them in varied situations.

Teamwork: Ability to work collaboratively in small teams to improve the operations of immediate work group by offering ideas, identifying issues, and respecting team members.

Customer Service: Ability to provide a high level of customer service to patients, visitors, staff and external customers in a professional, service-oriented, respectful manner using skills in active listening and problem solving. Ability to remain calm in stressful situations.

Physical Requirements:
Light work: Exerting up to 20 pounds of force frequently to move objects. Some elements of the job are sedentary, but the employee will be required to stand for periods of time or move throughout the hospital campus.

As a health care organization, we have a responsibility to do everything in our power to care for and protect our patients, our colleagues and our communities. Beth Israel Lahey Health requires that all staff be vaccinated against influenza (flu) and COVID-19 as a condition of employment. Learn more about this requirement.

More than 35,000 people working together. Nurses, doctors, technicians, therapists, researchers, teachers and more, making a difference in patients' lives. Your skill and compassion can make us even stronger.

Equal Opportunity Employer/Veterans/Disabled