"Alerted.org

Job Profile** **Summary

•This role focuses on performing work related to research and development of new products, innovation, and improvement of products and processes. In addition, this role focuses on performing the following Research Programs and Projects duties: Supports the development of new products and innovation. Includes Clinical roles focused on research projects. Positions in this family perform basic, translational, and/or clinical research towards solving a specific problem for an entity or community. A professional individual contributor role that may direct the work of other lower level professionals or manage processes and programs. The majority of time is spent overseeing the design, implementation or delivery of processes, programs and policies using specialized knowledge and skills typically acquired through advanced education. An experienced level role that applies practical knowledge of job area typically obtained through advanced education and work experience. Works independently with general supervision, problems faced are difficult but typically not complex, and may influence others within the job area through explanation of facts, policies and practices.

Job Overview

This position will assist the Principal Investigator (PI) in planning and implementing clinical research studies as assigned. This individual will play a key role in expanding clinical research activities to a community hospital setting while being supported by a research infrastructure based at Tufts Medical Center. This position requires a highly motivated and independent professional who can navigate the challenges of implementing and conducting clinical studies with minimal on-site supervision. The CRC III will be responsible for participant recruitment, study visit coordination, engaging with participants and clinical staff, ensuring protocol adherence, regulatory compliance, data collection, and communication with the Institutional Review Board (IRB). Success in this role depends on strong problem-solving skills, adaptability, and proactive communication. The CRC III may need to identify operational challenges, propose solutions, and maintain clear, open lines of communication with a distanced supervisor and research team. This is an excellent opportunity for a candidate who thrives in an autonomous environment, takes initiative in addressing study-related challenges, and contributes to the growth of clinical research at a new site.

Job Description

Minimum Qualifications:

1. Bachelor’s degree OR High School Diploma or equivalent **AND** Four (4) years of related experience.

2. Basic Life Support (BLS) certification may be required based on specific role requirements.

3. Two (2) years in clinical research related activities.

Preferred Qualifications:

1. Master's degree or equivalent

2. (5) years clinical trial research experience, clinical or scientific related discipline.

3. CRA certification desired

4. BLS certification may be required based on specific role requirements

5. IATA Hazardous Good Shipping Certification

6. CITI Human Research Protection Certification

**Duties and Responsibilities:** The duties and responsibilities listed below are intended to describe the general nature of work and are not intended to be an all-inclusive list. Other duties and responsibilities may be assigned.

1. Responsible for assisting in the recruitment of study participants. Assesses potential patients and eligibility for inclusion in a particular protocol based on protocol requirements. Reviews all eligibility and ineligibility criteria in the patient’s record. Verifies information with the physician. Interviews patients to obtain information for eligibility assessment, explain the study, and obtains signature for the informed consent form.

2. Organizes strategies for recruiting study participants, and screening study participants for eligibility on the telephone, in the clinic and other settings as required.

3. Completes follow up with study participants in prescribed settings as required. Performs necessary tests as needed and as appropriate to level of training such as EKGs, Walk tests, etc.

4. Completes record abstraction of source documents, conducting required study measurements and completing study Case Report Forms in accordance with best practice methods. Conducting a QC check of completed CRFs prior to submission for data entry; coordinating resolution of all data queries. Completing data entry as warranted.

5. Performs basic laboratory activities as needed

6. Complies with all institutional policies and government regulations pertaining to human subjects protections.

7. Maintains regulatory binders, case report forms, source documents, and other study documents. Monitors the occurrence of clinical adverse events, reporting any to the (PI), the study sponsor and Institutional Review Board.

8. Reviews protocol with the clinical team and ensure clinical team is aware of their roles and responsibilities.

9. Maintains communication with IRB and study sponsor and takes lead in reporting adverse events, protocol deviations, safety reports, and other items as directed by regulatory guidelines.

10. Develops standard operating procedures in collaboration with site staff and sponsor to ensure compliance. Identifies and resolves problems with protocol compliance by notifying investigator and as necessary with the protocol sponsor.

11. May disburse drugs and provide patient teaching regarding administration.

12. Responsible for assisting with IRB requirements for each study including meeting institutional educational requirements, submitting documents for review, adverse event reporting and annual reviews.

13. Initiates, participates, and/or consults in interdisciplinary meetings to formulate, evaluate, and implement appropriate study plans. Monitors enrollment and provide enrollment updates for the clinical team and the sponsors. Collaborates with professional staff both within and outside the hospital.

14. Maintains patient confidentiality per HIPAA regulations and keeps study information in a safe and secure location. Adheres to FDA Good Clinical Practice Guidelines.

15. Organizes and participates in site visits with the study sponsor to review completeness and accuracy of study documentation.

16. May develop, in collaboration with the investigators and site staff, the site-specific protocol documents and informed consent document, with assistance from the sponsors.

17. May assist in budgeting clinical trials, grant preparation, and writing research reports and scientific papers.

18. May be responsible for junior staff supervision.

Physical Requirements:

1. Typical clinical and administrative office setting.

2. May be required to travel to clinics, subject homes, workplace or arranged locations to do study visits.

3. Must be able to perform all essential functions of this position with reasonable accommodation if disabled.

4. May access PHI/HIPAA identifiers as part of daily tasks.

Skills & Abilities:

1. High degree of organizational talents, data collection and analysis skills.

2. Requires meticulous attention to detail.

3. Excellent computer skills including word processing

4. Ability to prioritize quickly and appropriately

5. Excellent communication and interpersonal skills

6. Previous experience leading clinical trials

7. Strong leadership and communication skills.

8. Previous experience with IRB submissions.

9. Familiarity of ICH and GCP guidelines.

10. Supervisory experience desirable

_The above statements are intended to describe the general nature and level of work being performed. They are_ _not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so_ _classified. Tufts Medical Center reserves the right to modify position duties at any time, to reflect process_ _improvements and business necessity._

Tufts Medicine is a leading integrated health system bringing together the best of academic and community healthcare to deliver exceptional, connected and accessible care experiences to consumers across Massachusetts. Comprised of Tufts Medical Center, Lowell General Hospital, MelroseWakefield Hospital, Lawrence Memorial Hospital of Medford, Care at Home - an expansive home care network, and large integrated physician network. We are an equal opportunity employer and value diversity and inclusion at Tufts Medicine. Tufts Medicine does not discriminate on the basis of race, color, religion, sex, sexual orientation, age, disability, genetic information, veteran status, national origin, gender identity and/or expression, marital status or any other characteristic protected by federal, state or local law. We will ensure that individuals with disabilities are provided 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. Please contact us to request accommodation by emailing us at [email protected] .