Clinical Research Coordinator jobs in North Bergen, NJ

Job title: Clinical Research Director, I and I, Pulmonology About the Job Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate Progress. The Clinical Research Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area is responsible for the creation of the clinical development plan in alignment with the project strategy, its endorsement by governance and its execution in close collaboration with clinical operations. The CRD is expected to advance scientific and clinical knowledge for immunology, and to incorporate new methodologies and pro-actively progress study execution. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities: Create the clinical development strategy for one or more assets and document it in the clinical development plan in collaboration with the global project team and internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing Advance the CDP through internal management review Leads a clinical subteam to design clinical studies and to create an abbreviated and full clinical study protocol Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations Review documents supporting clinical development such as Investigator's brochure, regulatory documents for IND/CTA, clinical sections of integrated development plans, and submission dossiers for regulatory approval Support drug registrations (contribution to submission dossiers label draft, regulatory response during the review process, Advisory Committee preparation) Contribute to data review, interpretation and publication of clinical study results Represent Clinical Development at Health Authorities and incorporating advise into development strategy Maintain or establish interaction with external scientific and clinical communities and to incorporate pertinent advice and learnings into the internal program Scientific and Technical Expertise: This position requires a strong scientific and clinical foundation in internal medicine. Pulmonology is a plus. Advanced leadership skills and the ability to effectively collaborate with external partners, regulators, and diverse internal stakeholders and collaborators are essential prerequisites. The candidate must Be experienced in advancing assets from discovery into clinical development Have experience in novel approaches in translational medicine Have and maintain deep scientific, technical and clinical knowledge in immune driven disease and clinical immunology. Demonstrated problem solving skills Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule of interest and the respective therapeutic area Be able to translate current understanding of disease pathogenesis into functional consequences and clinical outcome Have an understanding of novel biomarker and precision medicine approaches, novel clinical trial designs, endpoints and statistical methods About You Basic Qualifications: Medical Doctor. Should be board certified or equivalent in internal medicine / clinical immunology. Pulmonology is a plus. Must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME) or equivalent Experience in relevant clinical, scientific and/or industry experience within the field of immune driven diseases. Pulmonology is a plus. Strong scientific and academic background within clinical research, pharmaceutical experience or experimental medicine experience internal medicine, clinical immunology. Pulmonology is a plus. Knowledge of drug development preferred Strong interpersonal, communication, presentation, negotiation and networking skills in a cross-cultural global environment Performance oriented with ability to work along agreed timelines Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SA #LI-SA #LI-Onsite #vhd All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.

COMPANY Volastra Therapeutics, Inc. is a clinical-stage oncology biotech company based in New York City, pioneering novel approaches to treating cancer by targeting chromosomal instability (CIN), a unique vulnerability in cancer. Since its founding in 2019, Volastra has grown to support ongoing discovery efforts and a growing clinical organization. Our lead pipeline programs focus on two distinct inhibitors of KIF18A, a novel therapeutic target. VLS-1488, internally discovered, entered clinical trials in Q4 2023 for the treatment of advanced cancers. Sovilnesib, in-licensed from Amgen in 2023, re-entered the clinic in Q2 2024. Both assets have been granted Fast-Track Designation by the FDA. Volastra is backed by top US and European venture firms such as Arch, Polaris, Vida, Droia, Catalio, and B Capital, alongside strategic investment from Eli Lilly. In addition to venture funding, Volastra has established partnerships with oncology leaders. Our senior leadership team is highly experienced, supported by a world-class advisory board. We are headquartered in West Harlem, New York City, within easy reach of Columbia, Cornell, Memorial Sloan Kettering, and surrounding areas. Please visit ****************** for more information. JOB DESCRIPTION: The in-house Clinical Research Associate will report to the Senior Clinical Project Manager and will be responsible for supporting clinical team initiatives, including activities associated with clinical trial startup and maintenance. Volastra is a fast-paced biotech company of passionate employees, and there is ample opportunity for the ideal candidate to grow and develop with the organization. Individuals will from time to time have the opportunity to gain experience with projects outside their direct scope of work. Job is based in NYC with a flexible option for hybrid work RESPONSIBILITIES: Support all operational aspects of assigned clinical trial(s), including study start-up, enrollment, study conduct, and close-out Track metrics related to clinical trial milestones including, but not limited to investigational product release, site activation, site visit dates, subject visit milestones, etc. Review reports and maintain trackers related to investigational product accountability, study materials, subject sample management, etc. Assist with review and QC of essential clinical documents, including but not limited to study documents, training slides and subject-facing materials Assist with overseeing important vendor deliverables Coordinate distribution of study-specific communications to CROs, vendors and clinical sites Assist in planning and organizing external project-specific meetings including but not limited to vendor meetings, external CRA training, Investigator Meeting and PI meetings Assist in generating and distributing agendas and minutes for study team meetings Proactively identify and escalate issues to the Senior Clinical Project Manager Assist in organizing essential documents for the Trial Master File REQUIREMENTS Bachelor's degree in a relevant field At least 2 years of relevant clinical research experience Experience in oncology Experience working with CTMS, EDC and eTMF systems Knowledge of applicable ICH/GCP/FDA guidelines/regulations Highly detail oriented and organized Ability to multitask and handle multiple responsibilities simultaneously Demonstrated strong work ethic and curiosity to learn and contribute Strong interpersonal skills, including verbal and written communication, are essential Ability to work in a collegial and collaborative manner Ability to work in a fast-paced and informal startup environment SALARY RANGE: Base salary approximately $70,000 - $110,000 which may vary depending on qualifications, experience, and ultimate leveling.

Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job. Qualifications 3-5 years Strong Project Management Regulatory submission experience Oncology experience Participate on a cross functional team focused on US regulatory submissions (FDA). * Previous Pfizer experience is preferred; Pharmaceutical/biotech experience mandatory. Familiarity with U.S. NDA processes required Provides Financial Oversight Forecasts and manages high level clinical trial budget. Oversees the study risk planning process (e.g. IQMP) Works proactively with AP/CRO Supports Practical Clinical Trial Design o Partners with Clinician and other team members and supporting functional lines to provide operational expertise and insight to inform protocol design. o Initiates and ensures a Protocol Operational Feasibility and Budget assessment is performed by seeking input from other lines within Development Operations and at the Alliance Partner/Vendor as needed. o Facilitates early engagement of Alliance Partners/Vendors when needed. Additional Information $70/hr 6 months

COMPANY Volastra Therapeutics, Inc. is a clinical-stage oncology biotech company based in New York City, pioneering novel approaches to treating cancer by targeting chromosomal instability (CIN), a unique vulnerability in cancer. Since its founding in 2019, Volastra has grown to support ongoing discovery efforts and a growing clinical organization. Our lead pipeline programs focus on two distinct inhibitors of KIF18A, a novel therapeutic target. VLS-1488, internally discovered, entered clinical trials in Q4 2023 for the treatment of advanced cancers. Sovilnesib, in-licensed from Amgen in 2023, re-entered the clinic in Q2 2024. Both assets have been granted Fast-Track Designation by the FDA. Volastra is backed by top US and European venture firms such as Arch, Polaris, Vida, Droia, Catalio, and B Capital, alongside strategic investment from Eli Lilly. In addition to venture funding, Volastra has established partnerships with oncology leaders. Our senior leadership team is highly experienced, supported by a world-class advisory board. We are headquartered in West Harlem, New York City, within easy reach of Columbia, Cornell, Memorial Sloan Kettering, and surrounding areas. Please visit ****************** for more information. JOB DESCRIPTION The Clinical Scientist will report to the Senior Director, Clinical Science and will work collaboratively with the clinical team to contribute to the development, evaluation and execution of Volastra's oncology programs. The Clinical Scientist will be assigned to one or more clinical trials and be responsible for ensuring the scientific integrity of the trials. The ideal candidate is highly self-motivated, detail oriented and has relevant clinical experience. Volastra is a fast-paced biotech company of passionate employees, and there is ample opportunity for the ideal candidate to grow and develop with the organization. Individuals will from time to time have the opportunity to gain experience with projects outside their direct scope of work. Job is based in NYC with a flexible option for hybrid work. RESPONSIBILITIES * Collaborates closely with the Medical Monitor(s) to provide scientific input on planning, evaluation and analysis of clinical programs and trials * Supports clinical data review and interpretation including subject eligibility review and monthly listing review * Reviews emerging clinical data and supports identification of data trends and potential inconsistencies; raises appropriately to the clinical team. * Supports safety monitoring activities and procedures to ensure patient safety and compliance with reporting requirements, including review of SAE narratives. * Maintains data integrity and quality of clinical trial(s) in support of the development strategy for all assigned programs * Collaborates with cross functional study team as appropriate to execute clinical study deliverables * Assist with preparation/review of protocol and other study documents including medical monitoring plans, SAPs, informed consents, IBs, site training materials/presentations, and clinical components of the Clinical Study Reports and regulatory documents. * Answers site specific protocol questions as appropriate * Contributes to meetings with internal and/or external stakeholders where clinical data is presented/discussed * Ensures compliance with FDA, GCP and other applicable guidelines as well as SOPs * Maintains knowledge of therapeutic areas including standard practices, and stays abreast of competitive landscape QUALIFICATIONS * Master's Degree required, further advanced degree in related field preferred * Minimum of 5 years of highly relevant experience related to conduct of clinical trials * Experience in oncology required, experience in early phase trials preferred * Strong working knowledge of FDA, ICH, GCP guidelines and other relevant regulatory requirements * Experience working with EDC systems * Strong analytical skills and attention to detail with the ability to work with large data sets and ensure consistency across the clinical study databases. * Ability to navigate and succeed in a dynamic environment with collaboration and teamwork * Excellent communication, organizational, problem-solving and conflict resolution skills * Demonstrated scientific writing skills and communications skills in English * Ability to travel domestically ( SALARY RANGE Base salary of approximately $115,000- $170,000 which may vary depending on qualifications, experience, and ultimate leveling.

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description Medical Affairs - Global Oncology Assist in the management of the day to day operations of clinical trials including coordination and oversight of all CRO/clinical site/vendor activities, liaison between Clinical Operations Manager and CRO, manage scopes of work/budgets/invoice payments. Assist in the management of the Trial Master File (submit documents, reconciliation, QC, etc.). Participate in development of protocol, case report form, CRF guidelines and other study documents. Prepare and/or review regulatory documents (e.g. ICF), contracts, requests for proposal. Ensure the training of CROs/investigators on protocol, regulatory, Client SOPs and data issues. Reviews and approves monitoring reports and ensures tracking of ongoing site issues. Minimum of college degree in a relevant discipline. Bachelor's degree in relevant scientific discipline preferred. CANDIDATES MUST HAVE MIN 3-5 years in-house in pharma company. Not just 3-5 years in CRO or onsite monitoring. We want to see associate in-house large pharma. Also, want to see experience in phase 3 global study trials in multifunctional areas. MUST HAVE experience in reviewing patient data and patient profiles. **Oncology Experience Highly Preferred Qualifications BS Additional Information Best Regards, Akriti Gupta ************** Morristown, NJ 07960

Collabera is ranked amongst the top 10 Information Technology (IT) staffing firms in the U.S., with more than $525 million in sales revenue and a global presence that represents approximately 12,000+ professionals across North America (U.S., Canada), Asia Pacific (India, Philippines, Singapore, Malaysia), and Europe (Ireland, Netherlands, Poland, United Kingdom). We support our clients with a strong recruitment model and a sincere commitment to their success, which is why more than 75% of our clients rank us amongst their top three staffing suppliers. Not only are we committed to meeting and exceeding our customer's needs, but also are committed to our employees' satisfaction as well. We believe our employees are the cornerstone of our success and we make every effort to ensure their satisfaction throughout their tenure with Collabera. As a result of these efforts, we have been recognized by Staffing Industry Analysts (SIA) as the “Best Staffing Firm to Work For” for five consecutive years since 2012. Collabera has over 50 offices across the globe with a presence in ten countries and provides staff augmentation, managed services and direct placement services to global 2000 corporations. For consultants and employees, Collabera offers an enriching experience that promotes career growth and lifelong learning. Visit ***************** to learn more about our latest job openings. Awards and Recognitions --Staffing Industry Analysts: Best Staffing Firm to Work For (2016, 2015, 2014, 2013, 2012) --Staffing Industry Analysts: Largest U.S. Staffing Firms (2016, 2015, 2014, 2013) --Staffing Industry Analysts: Largest Minority Owned IT Staffing Firm in the US. Job Details: Job Title: Clinical Research Specialist Location: Manhattan, NYC Duration: 6 months (could go beyond) Job Description: · Job function includes, study coordination and implementation of a new clinical study. · The position arranges and oversees all clinical trial activities and plays a key role in assisting the Principal Investigator (PI) in recruiting patients for clinical studies. · The position works closely with the Principal Investigator, members of the department, study sponsors and monitors, and the institution, to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of clinical studies. It is a full time position, Monday-Friday. Positive candidate must possess the following: · Experience as a study coordinator 1-2 years in a hospital or outpatient setting, preferably with imaging trials, and EDC systems. · High organizational ability with strong attention to detail · Flexibility with a team player attitude · Professionalism · Proficient with MS Office, Outlook and Internet Explorer · Critical thinker and problem solver · Please include a cover letter with your resume. Qualifications Education Requirements : 4 yr Bachelor's Degree. Clinical research experience required. Additional Information To know more about this opportunity, please contact: Ujjwal Mane ************ ****************************

Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team. Essential Duties And Responsibilities Participate and assist in design and preparation of protocols and case report forms. Generate clinical SOPs, policies, charters, and plans according to US and international guidelines. Participate in the evaluation of potential clinical sites according to established criteria of acceptability. Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions. Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials. Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions. Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites. Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission. Assist with the maintenance of clinical archive and electronic files. Other tasks as assigned. Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. BA, BS, RN, BSN or equivalent Basic knowledge and adherence to GCPs 1-2 years of clinical research experience or equivalent experience or training Strong attention to detail Ability to multi-task Unquestionable integrity and highest ethical standards Excellent written and verbal communication skills Self-motivated, assertive, and driven BenefitsDental, Medical, Vision and 401K

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Job Description Title: Clinical Research Scientist Duration: 12 Months (Possibility of Extension) Location Woodcliff lake NJ Job Responsibilities: The incumbent is responsible for, but not limited to the following: Assist in the planning, implementation, managing, and reporting of Phase I-III clinical studies Prepare and review project and study documents including clinical trial protocols, clinical study reports, patient SAE narratives, clinical sections of registration dossier documents (ISS, ISE, Investigator Brochure, etc) Performs literature search and data analysis to address research questions In collaboration with other clinical staff and/or an external CRO, monitoring clinical trial conduct (enrollment, GCP practices, handling of safety issues, etc.) Assisting in database cleaning, review of study results, and interpretation of results Adhering to key performance indicators for clinical study development, conduct, and reporting Individual contributor with specialized knowledge Presents concepts, facts, and reports and advises on key trends and issues Troubleshooting routine site inquiries Work is completed under limited supervision Supports the planning, execution and reporting of clinical programs/trials May handle multiple protocols simultaneously Contributes to risk resolution by escalating and monitoring project risks Qualifications Qualifications Minimum of 2-5 years of experience in clinical research in the pharmaceutical industry A thorough understanding of clinical research methodology including study design, protocol writing, and CRF preparation is required, as is a knowledge of GCP and local regulatory requirements Working knowledge of the IND/NDA/CTD/MAA process acquired through direct industrial experience preferred Knowledge of medical, scientific and clinical research techniques in the oncology therapeutic area; Bachelor's Required. Doctoral (PharmD or PhD) or MD degree preferred . Additional Information Feel free to forward my email to your friends/colleagues who might be available. We do offer referral bonus Thank you for your time and consideration. I look forward to hearing from you! Kind Regards Ruchi Kumari Clinical Recruiter Integrated Resources , Inc. IT Life Sciences Allied Healthcare CRO Certified MBE | GSA - Schedule 66 I GSA - Schedule 621I (DIRECT BOARD) # 732-844-8716 (F) 732-549-5549 LinkedIn: https://www.linkedin.com/in/ruchi-kumari Gold Seal JCAHO Certified ™ for Health Care Staffing “INC 5 0 0 0 's FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)

Insight Global is looking for a Clinical Research Associate to support one of our Fortune-500 Medical Device clients. The purpose of this position is to provide study monitoring for clinical studies conducted by the Urology Critical Care (UCC) business unit. The studies range from simulated use studies to complex studies that may include devices or drug/device combinations. The Clinical Research Associate serves as a study monitor for moderate to complex studies in compliance with Good Clinical Practices. A key focus of this role is overseeing site operations and proactively resolving any issues that arise during the course of the study. The Clinical Research Associate role encompasses responsibilities across both data management and on-site study oversight. This remote role includes regular travelup to 50%for site visits, check-ins, and related responsibilities. When not traveling, the position will be performed from a home-based office. Responsibilities: Author study-specific Monitoring Plan aligned with clinical investigational plan Prepare, Contribute, Review and/or maintain study specific documentation and training materials Possess a working knowledge of the disease state and product(s) under investigation Effectively train and manage clinical study sites ensuring compliance with regulatory requirements and standards We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form (****************************************** Og4IQS1J6dRiMo) . The EEOC "Know Your Rights" Poster is available here (*********************************************************************************************** . To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: *************************************************** . Skills and Requirements 3-10 years of experience as a field-based Clinical Research Associate in the medical device/pharmaceutical industry Strong site management and data monitoring experience Technical proficiency in Veeva eTMF (Data Management System) Ability to work and operate independently Willingness and ability to travel up to 50% of the time for business-related site visits and responsibilities Bachelor's Degree in healthcare or science related field Previous experience or familiarity with the Urology and Critical Care therapeutic area null We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to ********************.

Clinical Research Associate Duration : 12 +months contract Start Time : 08:00 AM End Time : 05.00 PM Total Hours/week : 40.00 Qualifications: The Clinical Research Associate (CRA) is responsible for planning, negotiating, conducting, monitoring, and reporting on clinical trials. The CRA is responsible for protocol development, site selection and qualification, preparing Informed Consent materials, contracting, training, site monitoring, and study document management. The CRA collaborates with data management and statistics groups to ensure accuracy and integrity of study data. The CRA is responsible for preparing reports of study results for investigators and internal development teams, assisting in preparation of regulatory submissions, and supporting publication activities. The CRA will interface with appropriate internal individuals to manage trials in order to meet business objectives and timelines, provide clinical and technical support to product development activities, support product launches, and/or conduct post-market surveillance and evaluation activities. Responsibilities: Responsible for planning, budgeting, executing, and monitoring clinical evaluations of BD products to support product development. Clinical evaluations may also be for post-market surveillance studies, or claims extensions of existing products. Provide product development teams and other functions with technical and clinical expertise and support. Activities will be performed in accordance with international, federal and/or local regulations (FDA, ISO), Good Clinical Practices (GCPs), and compliance with corporate and local quality policies and procedures. Specific Responsibilities: Develop the study design and protocol(s) Screen, select, and qualify principal investigators and investigational sites Conduct negotiations of clinical site agreements and contracts Ensure the compliance to all human subject protection and privacy regulations, including developing Informed Consent materials Develop time schedules and budgets necessary to manage the clinical evaluations Coordinate and plan availability of supplies and shipment of materials Train clinical evaluation participants in study products and procedures. Monitor sites to assure that the Protocol is understood and followed Collect, review, analyze, and report data generated during clinical evaluations in a timely manner, through interactions with Clinical Database/Statistics Communicate results of data analysis to each clinical center, project teams and applicable functions within BD, and actively support the publication and presentation of results by investigators Support the reporting of performance data to regulatory authorities Assumes responsibility for occasional special departmental projects Anticipate 10% to 25% travel (primarily domestic; international travel a possibility

Real Staffing Group is a global staffing and recruitment specialist providing contract and permanent talent to a wide range of companies and industries. We take time to understand your career ambitions, working with you and for you at every stage of your job search. By applying our industry knowledge to your specific requirements we aim to supply you with the most effective route to your new career opportunity. To find out more about Real Staffing Group please visit http://www.RealStaffingGroup.com Job Description Responsibilities will include, but are not limited to, the following: 1. Assist the Clinical Research Physician to interface with project team members including: Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management. 2. Prepare or assist with preparation of key documents e.g. Investigator Brochures, regulatory submission documents, internal or external presentations, etc. 3. Protocol preparation (writing, reviewing, amending and cross-functional facilitation as appropriate). 4. Clinical study report preparation 5. Review literature and prepare summary documents for inclusion in IB, protocols regulatory submission documents, etc. 6. Participate in Development Planning for assigned compounds. 7. Oversee and challenges the adequacy of planning for study implementation 8. In collaboration with the project physician, directs the planning and implementation of clinical programs to meet corporate and clinical research goals 9. Assist Clinical Research Physician to make recommendations, take action and provide clinical research expertise related to projects 10. Work with department managers to prioritize project/study timelines to ensure adequate staffing (e.g. data management, drug supply, clinical operations, drug safety) 11. Collaborates and supports operational activities as need be. 12. Assist in establishing project budgets 13. Assist with review of ongoing summary data including: safety, primary efficacy variables, and laboratory data. 14. Participate and present at investigator meetings 15. Participate in adhoc meetings (e.g. marketing) 16. Assist in document template design and SOP writing 17. Participate on various corporate committees 18. Assist V.P./Executive Director/Director Clinical Research and Development on special projects as required 19. Lead team meetings as required Qualifications Qualifications Prerequisite : Degree in Life Sciences (e.g., BS in nursing, pharmacy or related medical field), Skills/Knowledge Required: • Minimum 2 yrs. experience in medical or technical writing • Clinical monitoring experience preferred • Excellent written and verbal communication skills and interpersonal skills. Must be able to relate effectively to people at all levels of the organization. • Extensive medical/scientific and clinical research knowledge • Knowledge of Medical Terminology • Knowledge of clinical trial design, basic statistics, pharmacodynamics and pharmacokinetics • Proficient at data interpretation • Experience in protocol development, study report preparation, Investigator Brochure preparation, regulatory submissions • Experience in all aspects of the drug development process • Knowledge of GCP and ICH Guidelines • Experience in presenting at Investigator Meetings • Detail-oriented, well-organized • Limited travel required • Ability to assimilate technical and scientific information quickly • Clinical project management skills • Proficient in Microsoft Word, Excel, PowerPoint; Microsoft project a plus • Demonstrated ability to work as part of a team • High level of interpersonal and communication skills (written and verbal) Additional Information All your information will be kept confidential according to EEO guidelines. IF THIS IS THE JOB OPPORTUNITY FOR YOU GIVE ME A CALL AT 646-357-1104 ASAP! I look forward to hearing from you!

Entrepreneurial Spirit, Rooted in Tradition . At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's oldest and most respected companies. Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy. Reporting to the Senior Director, Clinical Development, the Clinical Research Scientist will provide leadership in the direction, planning, execution, and interpretation of clinical protocols, research, data collection activities, and clinical operations. He/she will establish and approve scientific methods for design and implementation of clinical protocols and final reports. Incumbent will work with others to develop statistical plans and perform data analysis of completed clinical trials. The incumbent will support new and ongoing clinical research and clinical trials and ensure efficient and timely processing of Confidential Disclosure Agreements and Clinical Trial Agreements. Monitors adherence to protocols and determines study completion. The Clinical Research Scientist may interact with Investigational sites, clinical consultants, CRO's and other vendors. He/she will provide clinical research in therapeutic areas for purposes of Regulatory submissions and product selection and development. He/she will work directly with senior program leadership and with KOLs, investigators and CROs externally to design, execute, analyze and interpret the studies for which they are responsible. Job Description Prepare clinical-related documents with minimal supervision and routine documents independently as directed. Examples include, protocol synopses, protocols, CRFs, and supporting work for regulatory submissions such as INDs. Author abstracts and manuscripts for publication in peer-reviewed journals. Evaluate and select potential investigative sites in collaboration with Clinical Operations staff. Ability to prepare, present and defend complex aspects of protocol design and/or study data at investigator and internal meetings. Oversee and coordinate the collection of and/or collect pre-study documents Participate in data review and discrepancy resolution, team meetings/presentations with increasing levels of independence and support the Program Clinical Leader or Sr. Management as needed. Assist in managing regulatory safety reporting with the following: SAE queries and follow-up, annual reports, investigator brochures, ability to learn various databases. Critically review and synthesize complex information from reviews of the scientific and clinical literature. Qualifications Minimum 2-5 years of pharmaceutical industry clinical trial experience. Experience in immunology or endocrinology therapeutic areas is a plus. Primary experience with development of clinical trial protocols. Medical or scientific writing experience a must and familiarity with clinically applied science or pharmaceutical development. Good understanding of FDA regulatory, ICH, and GCP requirements. Excellent communication skills, written and verbal. Superior interpersonal communication and the ability to work across company disciplines and functional units. Proven ability to simultaneously manage activities associated with multiple clinical trials and programs with short timelines. Attention to detail and a commitment to high quality and on-time deliverables are key success factors. Willingness to travel up to 30% domestically and internationally. Additional Information Our Value Proposition: Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits: Medical/Dental Life Insurance | Supplemental Life Insurance/Dependent Life Insurance |Accidental Death & Dismemberment Insurance | Business Travel Accident Insurance | Short-Term Disability | Long-Term Disability | Flexible Spending Accounts | Employee's Savings Plan (401K Plan) | Competitive Paid Time Off

The Clinical Research Coordinator will play a pivotal role in coordinating the initiation and activation of new clinical trial protocols, ensuring all necessary study tools are prepared and utilized effectively. This position requires a robust background in data management and clinical research, with a strong focus on oncology trials. Responsibilities * Coordinate the initiation and activation of all new clinical trial protocols. * Prepare study tools including study binders, medication diaries, eligibility checklists, and flow sheets using Oncore, Excel, and Word. * Collaborate with the Research Nurse Clinician and/or physician to review patients' charts and medical history to confirm protocol eligibility and obtain necessary source documents. * Ensure IRB-approved informed consent forms are obtained, signed, and correctly filed in medical records, providing copies to patients. * Maintain comprehensive research records for all patients enrolled in studies, including consent, eligibility, Case Report Forms, and registration confirmations. * Assist with grading adverse events and complete Serious/Unexpected Adverse Event forms as required by study sponsors and institutional guidelines. * Provide regular reports to tumor study group members and Principal Investigators on assigned studies using Oncore. * Serve as a liaison with study sponsors, scheduling monitoring visits and conference calls, and respond accurately and timely to sponsors' queries. Essential Skills * Minimum of 4 years of clinical research experience. * At least 4 years of oncology experience. * Experience working in multiple EDC systems, specifically Medidata and Inform. * Strong background in data management, with 60% of the role focusing on data coordination. * Experience in recruiting, screening, and consenting patients for clinical trials. * Blood processing experience is required. Additional Skills & Qualifications * Bachelor's Degree is required. * Experience can come from clinical research, school, or nursing backgrounds, particularly in gynecology oncology groups. Work Environment This position requires onsite work in the Bronx four days a week. The work involves collaboration with tumor study group members, Principal Investigators, and study sponsors, utilizing multiple EDC systems in a clinical setting. Pay and Benefits The pay range for this position is $35.00 - $39.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: * Medical, dental & vision * Critical Illness, Accident, and Hospital * 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available * Life Insurance (Voluntary Life & AD&D for the employee and dependents) * Short and long-term disability * Health Spending Account (HSA) * Transportation benefits * Employee Assistance Program * Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in bronx,NY. Application Deadline This position is anticipated to close on Jul 11, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Seasonal BASE Field Studies Coordinator Department: Education Reports to: BASE Partnership Manager Term: August 2025-June 2026 Compensation: $32 per hour FLSA Status: Part-time Seasonal, Non-exempt Brooklyn Botanic Garden (BBG) seeks a seasonal coordinator for the BASE Field Studies program. This outdoor course was developed exclusively for ninth-grade students at Brooklyn Academy of Science and the Environment (BASE), a small public high school supported by a partnership with the Garden. Field Studies supplements the biology curriculum while making use of the environmental and scientific resources of the Garden and nearby Prospect Park; students investigate living organisms and the environmental qualities of aquatic, meadow, and forest ecosystems. Responsibilities: Plan and prepare ninth-grade Field Studies classes, including labs, outdoor investigations, field trips, and final projects. Lead the course with support from the BASE science teacher who will assist with lessons and activities. Teach two to three weekly, in-person Field Studies sessions outdoors at BBG and Prospect Park and in classrooms at BBG or BASE, September through June. Communicate with other staff at BBG to arrange student use of field resources and equipment and manage materials needed for each class session. Assist with BASE Garden Crew, an after-school club for BASE students in the Children's Garden in which students' plant, maintain, and harvest produce in the BASE Garden bed and participate in cooking and team-building activities. Support all BASE science department teachers in planning and assisting with science investigations at BBG and with field trips to other organizations throughout the city (e.g., American Museum of Natural History, DEP Wastewater Treatment Plant). Assist the BASE partnership manager with schoolwide events and partnership activities including the development of sustainability initiatives. Work Schedule: Fall Term: 35 hours per week, Monday-Friday, late August to January Spring Term: 35 hours per week, Monday-Friday, mid-January to end of May/early June This includes approximately one week of planning time in August/September before the course starts and a week of wrap-up in June; the position does not work on school holidays. Work Environment: Classes are held primarily outdoors, in all weather, on the grounds at BBG and at various locations in Prospect Park (Lullwater, Meadow, etc.). At times class locations may shift due to public use of these spaces. The coordinator prepares class materials to bring into the field and sets up learning spaces outdoors. Classrooms at BBG are also used to introduce lessons/activities, and in case of inclement weather. Classrooms at BASE may be used as well. Coordinator is assigned a desktop computer in the Education office at BBG for lesson preparation and planning. Qualifications: BS or BA in natural sciences, environmental studies, education, or a related field preferred Experience directly teaching adolescents Experience teaching in an outdoor setting Ability to obtain security clearance as per Department of Education regulations for working with students Benefits: BBG offers certain benefits to part-time employees including: Up to 56 hours of sick leave Short-term disability/New York Paid Family Leave As a 501(c)3, BBG is a Public Service Loan Forgiveness (PSLF) Eligible Employer Museum Pass, which provides employees the opportunity to enter many museums in New York City for free To be considered for this position, please submit an application by clicking Apply below. Applications submitted without a résumé and cover letter will not be considered. No telephone calls for position inquiries, please. Applicants with disabilities who need assistance with the online system, or who may require a reasonable accommodation during the application process, should contact Human Resources at **********. Brooklyn Botanic Garden is an Equal Opportunity/Affirmative Action employer.

Headquartered in Herndon, Virginia, LanceSoft is one of the fastest growing IT services Company. We are geographically spread to cover all the 50 states in the US and our global software development centers have the capability and capacity to cater to our global client's requirements in the most efficient manner. We have experienced exponential growth over the last few years and anticipate continuing to do so in the future as well. We have won numerous national, regional and state awards for being one of the fastest growing companies in the US. Our prestigious client base comprises of a number of Fortune 500 companies. LanceSoft dynamic work environment and culture constantly nurtures innovation, strategic thinking, and creativity and is complemented by strict process controls across our delivery centers globally. With attractive compensation packages, positive and productive work environments and challenging assignments to offer, LanceSoft is committed to being the employer of choice. We are committed not only to attracting and hiring top talent in the industry, but also developing and maintaining long-term relationships. LanceSoft recognizes true potential and provides people with the right opportunities. We offer a complete range of benefit packages to our employees which includes but is not limited to paid vacations, holidays, personal days, medical, dental and vision insurance, 401K savings plan, life insurance, disability insurance and many other attractive benefits. I look forward to work with you and encourage you to visit our website ***************** to learn more about LanceSoft as an organization. Job Description Description The incumbent is responsible for, but not limited to the following: • Assist in the planning, implementation, managing, and reporting of Phase I-III clinical studies • Prepare and review project and study documents including clinical trial protocols, clinical study reports, patient SAE narratives, clinical sections of registration dossier documents (ISS, ISE, Investigator Brochure, etc) • Performs literature search and data analysis to address research questions • In collaboration with other clinical staff and/or an external CRO, monitoring clinical trial conduct (enrollment, GCP practices, handling of safety issues, etc.) • Assisting in database cleaning, review of study results, and interpretation of results • Adhering to key performance indicators for clinical study development, conduct, and reporting • Individual contributor with specialized knowledge • Presents concepts, facts, and reports and advises on key trends and issues • Troubleshooting routine site inquiries • Work is completed under limited supervision • Supports the planning, execution and reporting of clinical programs/trials • May handle multiple protocols simultaneously • Contributes to risk resolution by escalating and monitoring project risks • Minimum of 5-7 years of experience in clinical research in the pharmaceutical industry • A thorough understanding of clinical research methodology including study design, protocol writing, and CRF preparation is required, as is a knowledge of GCP and local regulatory requirements • Working knowledge of the IND/NDA/ CTD/ MAA process acquired through direct industrial experience preferred • Knowledge of medical, scientific and clinical research techniques in the oncology therapeutic area; • Bachelor's Required. Doctoral (PharmD or PhD) degree preferred Qualifications Bachelor's Required. Doctoral (PharmD or PhD) degree preferred Minimum of 5-7 years of experience in clinical research in the pharmaceutical industry Additional Information All your information will be kept confidential according to EEO guidelines.

This role is subject to a flexible hybrid work arrangement requiring a minimum of 1-2 pre-determined days per week in our mid-town office. Under general supervision, the Clinical Research Associate - IVI is responsible for performing series of qualitative and quantitative analyses of patient intravascular image (IVI)s. ESSENTIAL DUTIES AND RESPONSIBILITIES Acts as a point person for assigned trials Responsible for setting up new trial documentation, Case Report Forms, Technician Worksheets; uses templates and revises for assigned client Becomes familiar with protocols and sub study for assigned client. Creates or revises, as needed, for review by Medical Director and Assistant Director, IVI Creates initial database/excel spreadsheet to track work Acquires images, logs work that is being completed Archives, digitizes, controls the quality, and performs measurements and image interpretation of intravascular ultrasound (IVUS), Virtual HistologyTM (VH)-IVUS, optical coherence tomography (OCT), near infrared spectroscopy (NIRS), and physiology recordings received in the core lab, related to ongoing contracted studies Follows training IVUS, VH-IVUS, OCT, NIRS, physiology and any other intravascular imaging modalities to maintain consistency of readings Responsible for analysis of assigned trials Receives and answers queries; contacts site coordinators or PIs and works with the sponsor to resolve issues May be responsible for data management activities Responsible for additional research, presentation, and academic activities as assigned Initially works in catheterization laboratory once a week or at department director's discretion to understand how to set up the ultrasound scanner, perform on-line measurements and understand basic coronary anatomy and principle of percutaneous interventions Additional duties as assigned QUALIFICATIONS B.A. or B.S. degree in Biomedical Engineering or Life Sciences 0 - 2 years working experience in a medical, academic or pharmaceutical environment Knowledge of medical terminology and morphology of the heart preferred Must be proficient in Microsoft Excel, Word, and Outlook Strong focus on flexibility, ability to multi-task, attention to detail, excellent organizational skills, good follow-up and judgment Ability to verbally communicate effectively with staff, physicians, nurses, managers, trial sponsors and colleagues. Ability to communicate effectively when reading and writing e-mail, letters, Manual of Operations, Case Report Forms and other reports or company documents Ability to analyze information and solve problems relating to intravascular images BENEFITS Choice of health plans include medical, Dental, and vision coverage Company-paid short-term and long-term disability and life insurance Health and dependent care flexible spending accounts Pre-tax travel expenses through TransitChek program 401(k) plan Generous paid time off (PTO) Ten paid holidays each year COMPENSATION The hiring range for this position is $52,000 - $58,000 per year. The annual salary that will ultimately be offered to the successful candidate will depend on job-related knowledge, education, skills, and experience. CONTACT INFORMATION To be considered for this opportunity, please submit your resume. Be sure and visit our web site to learn more about how we strive to enhance and save patient lives every day *********** CRF is an equal opportunity employer.

Research Coordinator Role:A Corbet's Research Coordinator is to provide ongoing support to the Corbet's investment staff. He/She will function as the integral, go-to person in helping our investment teams navigate the firm. The employee will be an extension of the corporate access team primarily focusing on assisting with Portfolio Manager-Analyst team support. They will work with Corbet's Broker Relations/ Corporate Access in helping investment staff liaise with our sell side counterparts. This role requires high attention to detail. He/She will work collaboratively and effectively with all levels of management, staff, clients, and external partners. In the role of Research Coordinator, the employee will be responsible for the following:· Execute on all Corporate Access & Sell Side Meeting Arrangements:· Schedule corporate access, sell side analyst meetings, and expert calls· Corporate Access Planning - develop a strategy with your investment teams and corporate access team to maximize access opportunities· Track and highlight all upcoming non-deal roadshows, conference meetings, events, analyst days, and earnings calls· Create and deliver regular corporate access reporting· Daily data entry and maintenance to keep internal database accurate· Schedule management calls for PM teams utilizing Corbet's systems to invite all relevant parties· Request conference meetings; confirm schedules with Broker Relations team· Work cross functionally across the firm to deliver best in class support to your investment teams· Provide day-to-day support for PM and analyst teams: manage calendar, travel, expenses, and any miscellaneous asks, including but not limited to:· Visa processing for work travel· Accurate and timely expense processing· Bespoke reporting and calendar updates for PM and Teams· Daily and weekly review of Teams' calendars to ensure they are abreast of meetings for the day ahead; address any conflicts or prioritization that is needed· Complete ad hoc requests for Broker Relations team, including broker subscriptions and resourcing· Work with Compliance to ensure adherence to policy, meeting clearance, and obtain approvals, vetting of industry expert meetings, any non-C-level management events, private company meetings In order to effectively represent the Company and communicate with clients, a Corbet's Research Coordinator should possess the following attributes:· Corporate Access knowledge· Collaborative Team Player· Analytical Thinker· Intellectually Curious· Strong written and verbal communication skills· Microsoft Office Suite, specifically Excel, Outlook, PowerPoint

A top NYC Hedge fund is seeking to hire a Junior Research Coordinator to work closely with the Research Coordinators providing administrative and operational support to the Investment Research team. The ideal candidate is an intrinsically motivated team player who sets high expectations for him/herself and has a positive mindset and passion for organization. RESPONSIBILITIES: Coordinate calendars and logistics for calls, meetings, and HQ visits with public company management teams Manage Outlook calendars for earnings call invites by monitoring and updating earnings call details across distribution lists Act as vendor relationship manager for all existing and new research subscriptions, contracts, and association memberships Schedule, transcribe and organize department wide internal meetings, not limited to taking detailed notes, compiling meeting materials/agendas, troubleshooting technical issues, and distributing daily reminders of upcoming calls, meetings, and investor events Coordinate strategy marketing binders quarterly and manage the deliverables spreadsheet for Investment Research, Trading, and Client Development teams Responsible for coding and monitoring entries to the department's central analyst calendar New Hire Onboarding: compile and distribute onboarding resources (welcome packets); maintain and update Research Handbook; add new hires to weekly calls/meetings and liaise with IT to add to email distribution lists Training Library: training and teach-in library support (schedule related events, distribute materials, and archive presentations in the research management platform; request legal and compliance approval and work with IT to record trainings for reference) Coordinate department wide engagement activities and/or off-site events, as needed Act as coverage support for administrative professionals across the department QUALIFICATIONS: Bachelor's degree A minimum of 1-2 years of related experience High level of accuracy, attention to detail and follow through Demonstrated organizing, planning, and problem-solving abilities Positive attitude and approach to assignments, regardless of how big or small Excellent interpersonal, writing, and communication skills Proficient in Microsoft Office Highest degree of integrity, professionalism, and confidentiality

Come join our team and make a difference as we blaze the way into the future of medical discovery through world-class clinical research. At Pinnacle Clinical Research, we are committed to driving innovation and advancing medical knowledge. Through our rigorous research studies, we strive to unlock breakthroughs that have the potential to transform patient care and improve lives. We pride ourselves on conducting high quality research as a complement to the medical care that our volunteers receive from their routine care center. Together, we will raise awareness about the importance of clinical research and its role in shaping the future of healthcare. Be a part of the discovery! Summary: PCR seeks a Clinical Research Coordinator who will be responsible for managing the day-to-day operations of assigned clinical trials, assisting in project planning, and ensuring that pre-established work scope, study protocol, and regulatory requirements are followed. They will attend meetings and events to promote studies, recruit, and screen study participants, as well as document and report on the daily operations of a study and participant status. This person must be able to understand clinical trial priorities and establish a workflow to complete all required activities in a timely manner. This position is responsible for a broad range of duties involving confidential information. The Clinical Research Coordinator I must be organized, excel at multi-tasking, detail-oriented, an excellent communicator, and be able to provide high quality patient care. This person will collaborate very closely with other members of the team, pharmaceutical sponsors, external vendors, and therefore must be highly collaborative, goal-oriented, flexible, and communicative. An ideal candidate will be responsive, thoughtful, empathetic, initiative-taking, a team-player, and manage multiple projects effectively and efficiently. This role reports directly to the Clinical Research Project Manager. Duties and Responsibilities: Clinical Trial Execution: Exercise judgement within the allowable limits defined within clinical trial protocols, standard operating procedures, and the direction from the study investigator, Project Manager, and Director of Clinical Research Operations Always maintain subject and document confidentiality, understand, and comply with the appropriate sponsor requirements and regulations which include the Food and Drug Administration, good clinical practices, International Conference on Harmonization, Health Insurance Portability and Accountability Act, institutional review boards, and institutional policies and procedures Complete study directed assessments with patients which include, but not limited to, informed consent, subject history, adverse events, Fibroscan, test article handling, appointment scheduling, records review, treatment coordination, collecting vital signs, and subject health assessment Create and complete study related documents and new study preparation Function as a liaison with pharmaceutical sponsors and external vendors Prepare for study monitor visits (onsite or remote), audit inspections, etc. Respond to internal and external requests for information in a timely manner Perform subject screening and recruitment Contribute to data management for research projects Identify opportunities to improve patient care and satisfaction Conduct patient-facing encounters with compassion, empathy, and thoroughness Must be able to review medical records against Inclusion/exclusion criteria to identify potential subjects Responsible for ensuring that subject qualifies for study prior to each dose and remains present for subject monitoring post-dose Obtains and documents adverse event data on appropriate forms Ensure source documents are transcribed to EDC platform per protocol on a timely manner Ensure EDC queries are answered within the required time set by the Project Manager or Data Management team Resolve other study-related queries within a reasonable time set by the Project Manager or Data Management team Interact with internal and external personnel such as physicians, nurses, administration staff, sponsor representatives, central laboratory and imaging personnel, and clinical trial patients Coordinate multiple projects with competing priorities and deadlines as needed based on clinical trial protocol directives and study volume Attends the investigator's meeting, pre-study site visit, study initiation visit, and all other study-related visits hosted by Monitors or Sponsor representatives as appropriate Administration: Ensure that electronic case report forms are completed Create memos, emails, and letters related to study activities Create and maintain reports and/or spreadsheets as requested Ensure that all patient data is entered into the clinical trial management system in a timely manner Maintain study documents and ensure electronic regulatory documents are saved and uploaded in the appropriate sections Responsible for reporting safety information to all regulatory agencies Understand the aspects of Regulatory and IRB requirements for studies Performs quality checks on source documents specific to the study Assist with the Corrective Action Preventive Action Plan (CAPA) process as needed Duties, responsibilities, and activities may change, or new ones may be assigned at any time. Education / Experience: Highschool diploma or general education degree (GED) required Bachelor's Degree in scientific area of study preferred or equivalent combination of education, training, and experience, or promotion internally from Research Assistant role Proficient in all Microsoft Office applications and Clinical Research IO (CRIO) or equivalent CTMS Must have strong knowledge of ICH/GCP guidelines Must complete CITI training before interacting with participants and must re-certify every 3 years Must be trained and certified in administration of Fibroscan, training provided during onboarding Must have basic life support (BLS) training, provided during onboarding Demonstrated organizational skills and outstanding time management, including keen attention to detail with the ability to track multiple projects at one time Strong written and oral communication skills Knowledge of basic medical terminology Possess impeccable integrity and personal and professional values that are consistent with PCR's high standards and mission Comply with the company policies, code of ethics, and guiding values always Proficient in Spanish and English preferred Certificates and Licenses: Valid driver's license and insurance Knowledge, Skills, and Other Abilities: Must be able to effectively communicate with all levels of internal and external contacts Ability to work independently and multi-task in a fast-paced team environment Strong people skills including ability to interact with individuals from diverse backgrounds and to oversee confidential matters and sensitive information with discretion and judgment Must possess a positive, friendly, and professional demeanor, particularly when interacting with patients Must be able to work independently and collaborate with a team Ability to interpret clinical research protocols Strong problem-solving and decision-making skills, particularly when under pressure Proactive at identifying, addressing, and solving issues in real time Energetic self-starter, results oriented, and the ability to work effectively in an entrepreneurial environment Work Environment and Physical demands: The work environment and physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Work is performed in an office/laboratory and/or a clinical environment. Exposure to biological fluids and/or bloodborne pathogens. Personal protective equipment required such as protective eyewear, garments, and gloves. Occasional travel may be required domestic and/or international. Ability to work in an upright and/or stationary position for 6-10 hours per day. Frequent mobility required. Occasionally squatting, kneeling, or bending. Light to moderate lifting and carrying (or otherwise moves) objects including medical equipment with a maximum lift of 20-50 lbs. Benefits of working at Pinnacle Clinical Research: 401k Medical, dental, vision, long term disability, short term disability, FSA, and life insurance 3 weeks of paid time off 14 paid company holidays Tranquility Room (specific positions apply) Pinnacle Gym (specific positions apply)