Title: Family Planning Research Assistant 1 HSS</p> Location: Farnam Memorial Bldg New Haven, Connecticut Work Type: Hybrid, Full Time Job ID: 134854WD Job Description: Working at Yale means contributing to a better tomorrow. Whether you are a current resident of our New Haven-based community, eligible for opportunities through the New Haven Hiring Initiative, or a newcomer, interested in exploring all that Yale has to offer, your talents and contributions are welcome. Discover your opportunities at Yale! Overview The Research Assistant will be working in the Division of Family Planning in the Department of Obstetrics, Gynecology, and Reproductive Sciences supporting multiple clinical and translational research projects in reproductive health, including contraception and abortion. Applicants must be motivated, organized, and seeking to learn more about clinical trials. The assistant will work under the supervision of the Research Associate and the Principal Investigators but must be capable of performing self-directed tasks. Key responsibilities include research project recruitment, participant scheduling, data management, and research visit support. Study Recruitment: Conduct recruitment activities for clinical research projects, such as screening medical records and schedules to identify potentially eligible patients, contacting patients by phone to explain studies in detail, and consenting eligible participants. Data Collection: Schedule and communicate with participants regarding study activities, prepare research materials, administer surveys, and collect physical measurements. This role may also involve assisting with the handling and processing of human blood samples and accompanying study participants to study procedure locations. Data Management: Input, organize, and maintain research data in accordance with project protocols and ethical guidelines. Conduct data analyses with supervision. Compliance: Maintain current training in the protection of human research subjects and ensure that research activities comply with institutional, legal, and ethical requirements. Collaboration: Interact professionally and collaboratively with internal contacts, including the Principal Investigator (PI), research assistants, residents, and medical students, as well as with external contacts such as other research teams. Provide assistance with research projects for trainees, including medical students, residents, and fellows. Required Skills and Abilities 1. Active Good Clinical Practices Certification (GCP). 2. Demonstrated experience with patient recruitment obtaining informed consent. 3. Comfortable handling human biospecimens, such as blood tubes .Proficiency with word processing and data management software. 4. Produce high-quality work products with minimal supervision. 5. Positive attitude with strong work ethic and attention to details. Excellent oral and written communication skills. Reliable and punctual, with ability to make early (7:30am) or late (5:30pm) meetings as needed. Preferred Skills and Abilities 1. Familiarity with data entry in REDCap and OnCore. Phlebotomy training/experience with comfort performing blood draws independently. 2. Proven experience with data analysis using Stata, SAS, or SPSS. 3. Prior experience in engaging with the public through phone calls. 4. Proven experience working in a healthcare/clinical trials environment. 5. Possess knowledge of research methodologies and protocols. Principal Responsibilities 1. Researches and collects data through site or home visit intakes; library research; structured interviews; or through other means for designated research assignments. 2. Records and compiles information related to research data. Codes data accordingly to research specifications. Uses a computer terminal to input and retrieve data and to generate reports. 3. Processes and summarizes data using scientific or statistical techniques. Assists in data interpretation and analyses. Reports on status of research activities. 4. Recruits study participants and ensures that subject recruitment and follow-up are completed per protocol procedures. 5. Orders and maintains inventory of supplies. May assist in designing, developing, and modifying research experiments, procedures, or survey instruments. May assist research and support staff. 6. Performs additional functions incidental to research activities. Required Education and Experience Six years of related work experience, four of them in the same job family at the next lower level, and high school level education; or four years of related work experience and an Associate's degree; or little or no work experience and a Bachelor's degree in a related field; or an equivalent combination of experience and education. Job Category Technician Bargaining Unit L34 Compensation Grade Labor Grade C Compensation Grade Profile Hourly Range $28.43 Duration Type Staff Background Check Requirements All candidates for employment will be subject to pre-employment background screening for this position, which may include motor vehicle, DOT certification, drug testing and credit checks basedon the position description and job requirements. All offers are contingent upon the successful completion of the background check. For additional information on the background check requirements and process visit "Learn about background checks" under the Applicant Support Resources section of Careers on the It's Your Yale website. Health Requirements This role is a healthcare worker position. Healthcare workers (HCW) are defined as university employees working a healthcare setting who have the potential for direct or indirect exposure to patients, human research subjects or infectious materials including body substance, contaminated medical supplies, devices and equipment, surfaces, or air. HCW have specific health requirements that must be met prior to starting work, including MMR vaccine or immunity, varicella (chickenpox) vaccine or immunity, TB screening, COVID vaccine according to University policy, hepatitis B vaccine or immunity, and annual flu vaccination. Note Yale University is a tobacco-free campus.

• Considered as the primary point of contact for the investigative site. • High level of competency or experience in providing contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie’s positioning. • Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol and patient treatment principles for the trial ensuring a trusted partnership. • Conducts site evaluation, site training, routine, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects. • Advanced understanding of site engagement and ability to customize site engagement strategy for assigned study (ies). • Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategy. • Advanced level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. • Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey. • Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance. • Possesses experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development. • May participate in global/local task forces and initiatives. • Responsible for activities as assigned by manager. • Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues. • Advanced ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. • Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach. • Identifies, evaluates and recommends new/potential investigators/sites on an on going basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators. • Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel. • Ensures audit and regulatory inspection readiness at assigned clinical site at all times. • Manages investigator payments as per executed contract obligations, as applicable.

• Considered as the primary point of contact for the investigative site. • High level of competency or experience in providing contextual information on the clinical trials, connects stakeholder to the investigative sites and strengthens AbbVie’s positioning. • Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol and patient treatment principles for the trial ensuring a trusted partnership. • Conducts site evaluation, site training, routine, and site closure monitoring activities with compliance to the protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects. • Advanced understanding of site engagement and ability to customize site engagement strategy for assigned study (ies). • Gather local/site insights and utilize site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategy. • Advanced level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities. • Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey. • Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance. • Possesses experienced level of competency to mentor and train less experienced CRAs on various aspects of work and provides input into their development. • May participate in global/local task forces and initiatives. • Responsible for activities as assigned by manager. • Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues. • Advanced ability to think critically to resolve site risk signals while having robust understanding of site processes to drive study execution. • Ensures preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach. • Identifies, evaluates and recommends new/potential investigators/sites on an ongoing basis.

• Supervision of and continuous communication with investigational sites in the implementation of global clinical trials • Site management and monitoring activities such as on-site and remote site initiations • Monitoring and close-out visits for Phase I–IV clinical trials • Independent management of investigational sites; training study physicians and site staff prior to site activation • Preparation and updating of study-related documents • Support in site selection, collection of all relevant study documents, and preparation of submissions in CTIS • Ensuring compliance with all internal and external requirements as well as ICH-GCP guidelines • Documentation of visits and protocol deviations during the study