Clinical Research Coordinator Jobs in Florham Park, NJ

Research Coordinator Hybrid NYC with a top law firm! Key Responsibilities: Conduct high-level legal and business research, including analytics, legislative history, and regulatory monitoring. Support business development through litigation tracking, docket searches, and complaint pulls. Maintain alerts and monitor developments in cases, companies, and topics of interest, reporting timely updates to attorneys. Collaborate with library staff across offices to deliver firmwide research support. Assist with budgeting, ILL, acquisitions, invoice processing, and cataloging as needed. Utilize databases such as Lexis Advance, Courtlink, Intelligize, PACER, VitalLaw, Capital IQ, PLC, Manzama, DataTree, Accurint, and EOS. Requirements: MLS and 4+ years of law firm research experience. Strong written and verbal communication skills; comfortable presenting. Proficiency in Microsoft Office and legal research tools. Strong service mindset, detail-oriented, and collaborative. Ability to manage multiple priorities and deadlines independently. The Phoenix Group Advisors is an equal opportunity employer. We are committed to creating a diverse and inclusive workplace and prohibit discrimination and harassment of any kind based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. We strive to attract talented individuals from all backgrounds and provide equal employment opportunities to all employees and applicants for employment.

Job Details Job Location: Bronx, NY Position Type: Regular Full-Time Salary Range: $375,000.00 - $375,000.00 Salary Job Shift: 1 Job Category: Physician Description Physician Affiliate Group of New York (PAGNY) at Lincoln Medical Center, a leading community hospital in the South Bronx, is seeking a Board-Certified/Board-Eligible Hematologist-Oncologist to serve as the Director of Clinical Oncology Research. This role combines clinical excellence, leadership in oncology research, and teaching responsibilities in a dynamic academic environment. The Director will lead and expand clinical trials and translational research programs while also providing compassionate patient care. New/Recent graduates are welcome. Lincoln Medical Center is affiliated with Weill Medical College of Cornell University. The Mission of NYC Health + Hospitals is to extend equally to all New Yorkers, regardless of the ability to pay, comprehensive health services of the highest quality in an atmosphere of humane care, dignity, and respect. Their Values are built on a foundation of social and racial equity and has established the ICARE standards for all staff. NYC Health + Hospitals is the nation's largest municipal health care delivery system in the United States, dedicated to providing the highest quality health care services to all New Yorkers with compassion, dignity, and respect, and regardless of immigration status or ability to pay. The Hematology/Oncology division is part of the Department of Medicine. It provides adult inpatient consultations across the hospital and runs a busy hematology/oncology outpatient service and infusion center. Teaching & Mentorship: Work closely with Internal Medicine residents Oversee and mentor Hematology/Oncology fellows rotating from New York Medical College Position Highlights: Academic Appointment: Affiliation with Weill Cornell Medical College State-of-the-art facilities including a busy 11-chair infusion center Schedule & Call: Monday through Friday, 8-hour shifts On-call coverage is phone-based only Research & Clinical Balance: 0.3 FTE dedicated to cancer research 0.7 FTE dedicated to clinical Hematology/Oncology practice Participation in oncology clinical research required, with an opportunity to serve as the local Principal Investigator Qualifications: MD/DO degree from an accredited institution. Board Certified / Eligible in Hematology-Oncology. Eligible for medical licensure in New York. Experience in clinical trials, translational oncology research, or investigator-initiated studies. Strong commitment to academic medicine, mentorship, and patient-centered cancer care. Preferred (not required): Track record of peer-reviewed publications and research funding. Experience in early-phase trials, immunotherapy, or precision oncology. Leadership experience in an academic or clinical research setting is preferred but not required. This position offers an attractive compensation & benefits package; excellent work/life balance; clinical research and teaching opportunities; flexible starting date and schedule; reasonable call schedule. Wages and Benefits include: Annual Base Salary: $375,000* based on 40-hour work week. Additional compensation available for extra call or sessional/per diem hours. The annual total value of the compensation package is estimated at $450,000**, which includes the baseline salary, 401(k) contribution, and other factors as set forth below: Projected bonus of up to $40,000 (based on previous year's average), contingent upon meeting quality and productivity targets. 401(k) Company Contribution (subject to IRS contribution limits): Employees are immediately vested in a 3% company contribution of base earnings. No employee match is required. After one year of service, employees receive an additional 7% company contribution of base earnings. No employee match is required. Annual Continuing Medical Education (CME) Reimbursement. Generous Annual Paid Time Off (PTO): Vacation, Sick, Holiday, and CME days. Medical, Prescription, and Dental Coverage: Top-tier plans with employee contributions significantly below market rates. Life Insurance and Accidental Death and Dismemberment (AD&D) Coverage: Equal to 2x your salary (up to a maximum of $300,000) provided at no cost to you. Additional employee-paid Voluntary Life and AD&D coverage is available for you and your family. Loan Forgiveness: Position may be eligible for loan forgiveness through certain state or federal programs. Medical Malpractice Coverage (equivalent to occurrence-based): Provided at no cost to the employee. Healthcare and Dependent Care Flexible Spending Accounts (FSAs). Pre-tax employee-paid contributions for commuting expenses. Visa sponsorship will be considered for this position. Physician Affiliate Group of New York, P.C. (PAGNY) mission is to provide accountable, responsive, quality care with the highest degree of sensitivity to the needs of the diverse population that lives in our New York Community. PAGNY is one of the largest physician groups in the country and directly employs nearly 4,000 physicians and allied health professionals who provide services to NYC Health + Hospitals, the largest municipal health care system in the nation serving more than a million New Yorkers annually. Our providers are highly skilled professionals with outstanding credentials who deliver the highest level of quality healthcare to patients throughout New York City. Physician Affiliate Group of New York, P.C. (PAGNY) is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. We are committed to fostering an inclusive environment where everyone feels valued and respected. Our policies ensure equal opportunities for all. Learn more about our initiatives by visiting our Diversity, Equity, and Inclusion page. *Salary Disclosure Information: The annual base salary listed complies with the New York City law on Salary Transparency in Job Advertisements. The annual base salary listed is for full-time employment and does not include bonuses/incentive compensation or benefits. Actual total compensation depends on many factors, including experience, specialties, historical productivity, and historical collections. **The annual total value of the compensation package shown is provided as an illustration and is not guaranteed. #J-18808-Ljbffr

Title: Assistant Research Nurse Administrator - CCTO Org Unit: Nursing Work Days: Monday-Friday Weekly Hours: 35.00 Exemption Status: Exempt Salary Range: $132,700.00 - $147,500.00 *As required under NYC Human Rights Law Int 1208-2018 - Salary range for this role when Hired for NYC Offices Position Summary Under general guidance, reports to the Research Nurse Administrator. The Assistant Research Nurse Administrator assists with the day-to-day management of the Research Nurse Specialist and Medical Assistant. Job Responsibilities Serves as a resource to research nurse and medical assistant staff and guides team on clinically related questions within research programs. Troubleshoots potential issues and facilitates smooth clinical study operations. Provides training and education to Research Nurse Specialists, Medical Assistants, and Clinical Research Specialists on the clinical workflows across the MCC. Together with the Research Nurse Administrator, evaluates and identifies policies to streamline research nursing operations. Participate in institutional committees as MCC CCTO representative, in the absence of the Research Nurse Administrator. Serve as clinical trial operations expert in clinical research policies and workflows. Responsible for the Epic/Beacon build. Collaborate with the Epic/Beacon build team members to ensure that study treatment plans are built in according to the protocol for newly activated and amended therapeutic protocols. Provides direct patient care as needed to meet clinical research needs and precepts and mentors research personnel in related tasks. Responsible for various aspects of study treatment protocols, as deemed necessary; educates participants; reports adverse events; monitors participants on studies. Provides nursing coverage across all MCC research programs, as needed. Contributes to the implementation of research protocols and the clinical management of patients on protocol in compliance with federal regulations, GCP guidelines, and internal policies. Performs other related duties as assigned. Education Bachelor's of Science Degree in Nursing Experience 6+ years of related clinical research nurse experience Oncology clinical research experience preferred. Supervisory and management experience preferred. Knowledge, Skills and Abilities Strong knowledge in Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) regulations, and International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines. Excellent oral and written communication skills Ability to foster smooth communications and teamwork among clinical research faculty, fellows and staff as well as external organizations (sponsors and contract research organizations). Proficiency in MS Office, specifically word processing (Word), spreadsheets (Excel) and database applications. Demonstrated organizational skills and ability to pay close attention to detail. Demonstrated critical thinking and analytical skills. Demonstrated ability to multi-task and prioritize in a fast-paced environment. Demonstrated ability to remain focus despite frequent interruptions. Ability to treat confidential information with utmost discretion. Demonstrated ability to exercise standards of professionalism, including appearance, presentation, and demeanor. Demonstrated ability to work effectively in a collaborative manner with departmental faculty and staff, as well as other institutional representatives. Ability to work independently. Licenses and Certifications Current NY State Registered Nurse License & Registration. BLS certification, issued by the American Heart Association. Infection Control Certificate. Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP) certification preferred. Working Conditions/Physical Demands Standard office work. Weill Cornell Medicine is a comprehensive academic medical center that is committed to excellence in patient care, scientific discovery, and the education of future physicians and scientists in New York City and around the world. Our doctors and scientists - faculty from Weill Cornell Medical College, Weill Cornell Graduate School of Medical Sciences, and the Weill Cornell Physician Organization - are engaged in world-class clinical care and cutting-edge research that connect patients to the latest treatment innovations and prevention strategies. Located in the heart of the Upper East Side's scientific corridor, Weill Cornell Medicine's powerful network of collaborators extends to its parent university Cornell University; to Qatar, where an international campus offers a U.S. medical degree; and to programs in Tanzania, Haiti, Brazil, Austria and Turkey. Our medical practices serve communities throughout New York City, and our faculty provide comprehensive care at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, NewYork-Presbyterian/Lower Manhattan Hospital, NewYork-Presbyterian Hospital/Brooklyn Methodist Hospital, NewYork-Presbyterian Hospital/Westchester Behavioral Health Center, and NewYork-Presbyterian/Queens. At Weill Cornell Medicine, we work together to treat each individual, not just their conditions or illnesses, as we strive to deliver the finest possible care for our patients - the center of everything we do. Weill Cornell Medicine is an Equal Employment Opportunity Employer. Weill Cornell Medicine provides equal employment opportunities to all qualified applicants without regard to protected status, including race, sex, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, or genetic information.

Physician Affiliate Group of New York (PAGNY) at Lincoln Medical Center, a leading community hospital in the South Bronx, is seeking a Board-Certified/Board-Eligible Hematologist-Oncologist to serve as the Director of Clinical Oncology Research. This role combines clinical excellence, leadership in oncology research, and teaching responsibilities in a dynamic academic environment. The Director will lead and expand clinical trials and translational research programs while also providing compassionate patient care. New/Recent graduates are welcome. Lincoln Medical Center is affiliated with Weill Medical College of Cornell University. The Mission of NYC Health + Hospitals is to extend equally to all New Yorkers, regardless of the ability to pay, comprehensive health services of the highest quality in an atmosphere of humane care, dignity, and respect. Their Values are built on a foundation of social and racial equity and has established the ICARE standards for all staff. NYC Health + Hospitals is the nation's largest municipal health care delivery system in the United States. Dedicated to providing the highest quality health care services to all New Yorkers with compassion, dignity and respect, and regardless of immigration status or ability to pay. The Hematology/Oncology division is part of the Department of Medicine. It provides adult inpatient consultations across the hospital and runs a busy hematology/oncology outpatient service and infusion center. Teaching & Mentorship: Work closely with Internal Medicine residents Oversee and mentor Hematology/Oncology fellows rotating from New York Medical College Position Highlights: Academic Appointment: Affiliation with Weill Cornell Medical College State-of-the-art facilities including a busy 11-chair infusion center Schedule & Call: Monday through Friday, 8-hour shifts On-call coverage is phone-based only Research & Clinical Balance: 0.3 FTE dedicated to cancer research 0.7 FTE dedicated to clinical Hematology/Oncology practice Participation in oncology clinical research required, with an opportunity to serve as the local Principal Investigator Qualifications MD/DO degree from an accredited institution. Board Certified / Eligible in Hematology-Oncology. Eligible for medical licensure in New York. Experience in clinical trials, translational oncology research, or investigator-initiated studies. Strong commitment to academic medicine, mentorship, and patient-centered cancer care. Preferred (not required): Track record of peer-reviewed publications and research funding. Experience in early-phase trials, immunotherapy, or precision oncology. Leadership experience in an academic or clinical research setting is preferred but not required. This position offers an attractive compensation & benefits package; excellent work/life balance; clinical research and teaching opportunities; flexible starting date and schedule; reasonable call schedule. Wages and Benefits include: Annual Base Salary: $375,000* based on 40-hour work week. Additional compensation available for extra call or sessional/per diem hours. The annual total value of the compensation package is estimated at $450,000**, which includes the baseline salary, 401(k) contribution, and other factors as set forth below: Projected bonus of up to $40,000 (based on previous year's average), contingent upon meeting quality and productivity targets. 401(k) Company Contribution (subject to IRS contribution limits): Employees are immediately vested in a 3% company contribution of base earnings. No employee match is required. After one year of service, employees receive an additional 7% company contribution of base earnings. No employee match is required. Annual Continuing Medical Education (CME) Reimbursement. Generous Annual Paid Time Off (PTO): Vacation, Sick, Holiday, and CME days. Medical, Prescription, and Dental Coverage: Top-tier plans with employee contributions significantly below market rates. Life Insurance and Accidental Death and Dismemberment (AD&D) Coverage: Equal to 2x your salary (up to a maximum of $300,000) provided at no cost to you. Additional employee-paid Voluntary Life and AD&D coverage is available for you and your family. Loan Forgiveness: Position may be eligible for loan forgiveness through certain state or federal programs. Medical Malpractice Coverage (equivalent to occurrence-based): Provided at no cost to the employee. Healthcare and Dependent Care Flexible Spending Accounts (FSAs). Pre-tax employee-paid contributions for commuting expenses. Visa sponsorship will be considered for this position. Physician Affiliate Group of New York, P.C. (PAGNY) mission is to provide accountable, responsive, quality care with the highest degree of sensitivity to the needs of the diverse population that lives in our New York Community. PAGNY is one of the largest physician groups in the country and directly employs nearly 4,000 physicians and allied health professionals who provide services to NYC Health + Hospitals, the largest municipal health care system in the nation serving more than a million New Yorkers annually. Our providers are highly skilled professionals with outstanding credentials who deliver the highest level of quality healthcare to patients throughout New York City. Physician Affiliate Group of New York, P.C. (PAGNY) is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. We are committed to fostering an inclusive environment where everyone feels valued and respected. Our policies ensure equal opportunities for all. Learn more about our initiatives by visiting our Diversity, Equity, and Inclusion page. *Salary Disclosure Information: The annual base salary listed complies with the New York City law on Salary Transparency in Job Advertisements. The annual base salary listed is for full-time employment and does not include bonuses/incentive compensation or benefits. Actual total compensation depends on many factors, including experience, specialties, historical productivity, and historical collections. **The annual total value of the compensation package shown is provided as an illustration and is not guaranteed. Apply for this opportunity Click the button below to visit our job portal and fill out an application for this opportunity. #J-18808-Ljbffr

CareAbout Health is a managed services organization (MSO) that provides expert advice, resources, tools, and other support to its portfolio of medical groups and healthcare focused companies. CareAbout Health is helping align incentives to create a world where patients, providers, and payers work together in a seamless, coordinated manner toward common goals: higher quality, lower cost, better outcomes. Role Title: Clinical Associate FLSA Category: Non-exempt Role Location: Florham Park, New Jersey Reporting Relationships: This position reports to the Director of Care Coordination. Role Summary and Responsibilities: Care360 is a department of CareAbout Health which provides centralized support to our medical practices: care management, care access, care coordination, continuous quality improvement, HCC Coding, etc. We are a growing division with many patient-centered projects which provide continuity of care for patients between office visits to help improve clinical outcomes and patient satisfaction. Our Clinical Associates support the provision of excellent care for our patients between medical visits. They help schedule our patients for future appointments, monitor quality metrics, and help close important quality care gaps. Key Responsibilities / Essential Functions: Assist clinicians on various tasks including follow-up care, patient care notification, care gap closure, and patient scheduling. Responsible for high volume of outbound calls with the potential for future in-bound calling functionality, emailing online inquiries, and confirming appointments. Support patient care by generating patient letters, archiving reports in the EMR, printing lab results, and related tasks. Assist with various quality, care coordination, and population health projects. Non-Essential Functions: Other duties, as assigned. Qualifications: College Degree; preferably Pre-Health/Pre-Med track Ability to multi-task and use multiple systems, including our EMR to provide medical information and patient support/follow up after the clinical visit. Passionate about high-quality patient care and patient satisfaction. Courteous, empathic, and professional manner. Strong communication, interpersonal, and organizational skills. Flexible with a full-time work schedule including evening, weekends, rotating hours, and holidays, if needed. Some knowledge of medical terminology. Physical Requirements: Mainly sedentary. Sitting at the desk most of the day. Standing or walking less than two hours per day. Lifting no more than ten pounds on rare occasions. Must be able to work at a computer and answer phone calls on a regular basis. Featured Benefits: Health, dental, and vision insurance. 401K with automatic employer contribution. PTO and Paid Holidays. Company paid Life Insurance. Access to voluntary short and long-term disability insurance. Access to additional life insurance. Access to a variety of Wellness programs Salary within our ranges may also be determined by your education, experience, knowledge, skills, abilities, and location, as required by the role, as well as internal equity and alignment with market data. CareAbout Health is committed to providing an environment of mutual respect where equal opportunities are available to all applicants and employees without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances (referred to as “protected characteristics”). We are interested in every qualified candidate who is legally able to work in the United States without sponsorship. We cannot offer any visa sponsorship now at this time.

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 MD, PhD, or PharmD: 0 to 3 years with industry experience in clinical development and bioequivalence (BE) clinical trial management or similar experience in university, hospital or research organization • MS: 3 to 5 years of clinical development/clinical trial management • BS: 5 to 8 years with industrial or CRO clinical experience Experience in writing clinical portions of regulatory dossiers highly preferred • Knowledge of drug development (all clinical research process including protocol and case report form design, etc) • Knowledge of GCP/ICH guidelines and FDA regulations Additional Information $60/hr 12 MONTHS

Artech Information Systems is the #12 Largest IT Staffing Company in the U.S. and an employer of choice for over 7,000 consultants. We recruit world-class talent for IT, engineering, and other professional jobs at 70+ Fortune and Global 500 companies coast-to-coast across the U.S., India, and China. We are one of the fastest-growing companies in the US and we welcome you to search the thousands of jobs in our cutting-edge GEM system for employment opportunities that fit your qualifications. At the forefront of the staffing industry, Artech is a minority and women-owned business enterprise (MWBE) committed to maximizing global workforce solutions on behalf of its clients. Artech's deep heritage, proven expertise and insightful market intelligence has secured long-term partnerships with Fortune 500 and government clients seeking world-class professional resources. Job 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, Client, 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 BS/MS Additional Information For more information, Please contact Best Regards, Akriti Gupta ************** Morristown, NJ 07960

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!

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)

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

WHY VITALIEF? Vitalief is emerging as an innovative Healthcare consulting company, focused on empowering Research and transforming Clinical Trials. As a result, we are seeking a talented and enthusiastic Senior Clinical Research Coordinator to join our exceptional team (as full-time, fully benefited Vitalief employee) to support our mission and our clients' mission to impact and save lives. Reasons to work for Vitalief: You can actively contribute to our clients' mission of advancing scientific discoveries that have the potential to change patients' lives for the better. Our PEOPLE FIRST culture prioritizes personal and professional growth for all Vitalief employees. We give everyone a seat at the table - we encourage innovation. Life/work balance that includes 20 PTO (Paid Time Off) days plus 9 paid Holidays annually. Other benefits include Company paid life insurance and short / long term disability coverage; 401K retirement program; Robust healthcare plans to choose from. Salary Range: Market competitive - based on experience level. Work Location: Work is 5 days per week on-site in Newark, NJ. Possibility of working one day remote per week after acclimated. Responsibilities: Under supervision of clinical research leadership staff, the medical staff, and in collaboration with research nurse staff, performs protocol-specific tasks including patient screening, ordering tests, collecting specimens and study documentation of patient reported responses, relative to various Oncology trials. Serves as a liaison (Communicating effectively) between the organization, investigators, members of the research team (i.e., physicians, nurses, hospital, and laboratory staff), and the research sponsors - to ensure that services are coordinated and delivered to patients in a timely manner. Maintains research record (e.g., patient consent, eligibility, Case Report Forms (CRF), registration confirmation, corresponding source documents, etc.) for all patients enrolled in Oncology trials. Participates in site preparation for trials including protocol feasibility, preliminary study budget, startup meeting preparation, training staff, and preparation of IRB applications and preparation of regulatory documents, study documents and forms. Schedules and conducts trial visits by informing patients and coordinating procedures per protocol. Assesses and triages study patients appropriately for serious/unexpected adverse events (SAE), reports and records adverse events according to all applicable regulation and study protocol. Assists patients in understanding their diagnosis, treatment options, and the resources available including educating eligible patients about appropriate clinical research studies and technologies. Required Skills: Bachelor's Degree required. Minimum of 2 or more years of experience in clinical research as a Clinical Research Coordinator, with experience in patient recruiting/screening/consenting/retention; activation; regulatory compliance, data management, and ensuring Serious Adverse Events (SAEs) are completed and reported within reporting deadlines outlined in the protocol. Oncology clinical research experience is a huge plus. Strong working knowledge of current Code of Federal Regulation and Good Clinical Practice guidelines. Compassionate personality and ability to interact with patients in a clear and confident manner. Ability to work on several trials concurrently - can demonstrate versatility, “can do” attitude, and possess strong organizational, time management and prioritization skills. Ability to work collaboratively with all team members (i.e., physicians, nurses, hospital, and laboratory staff) to ensure that services are coordinated and delivered to patients in a timely manner. Needs to be communicative and responsive and know when to escalate and communicate issues to management. Capable of independent decision-making, and able to thrive in a fast-paced environment working on multiple clinical trials concurrently. Must have strong Microsoft Office skills. Any exposure to EPIC (Electronic Health Records system) and/or OnCore (Clinical Trials Management System) is a plus. PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs. IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis. #LI-DNP

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.

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

Artech Information Systems is the #12 Largest IT Staffing Company in the U.S. and an employer of choice for over 7,000 consultants. We recruit world-class talent for IT, engineering, and other professional jobs at 70+ Fortune and Global 500 companies coast-to-coast across the U.S., India, and China. We are one of the fastest-growing companies in the US and we welcome you to search the thousands of jobs in our cutting-edge GEM system for employment opportunities that fit your qualifications. At the forefront of the staffing industry, Artech is a minority and women-owned business enterprise (MWBE) committed to maximizing global workforce solutions on behalf of its clients. Artech's deep heritage, proven expertise and insightful market intelligence has secured long-term partnerships with Fortune 500 and government clients seeking world-class professional resources. Job 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, Client, 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 BS/MS Additional Information For more information, Please contact Best Regards, Akriti Gupta ************** Morristown, NJ 07960

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 CORE JOB RESPONSIBILITIES: Assist the Clinical Research team to interface with project team members including: Clinical Research Physician, Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management. Review and query of hematology/oncology data including: safety, primary efficacy variables, and laboratory data. Assist with protocol preparation (writing, reviewing, amending and cross-functional facilitation as appropriate). Assist with clinical study report preparation to include narrative writing Participate in adhoc meetings Qualifications KNOWLEDGE/SKILLS/ABILITIES (KSA's): Advanced Degree in Life Sciences (e.g., nursing, pharmacy or related medical field), minimum 5 years' experience in clinical research development or equivalent Oncology experience REQUIRED. Hematology experience is a plus. Protocol authoring is a plus. Data review and medical monitoring of data REQUIRED. Minimum 5 yrs experience in oncology clinical development Excellent written and verbal communication skills and interpersonal skills. Knowledge of clinical trial design, basic statistics, and data review tools Proficient at data interpretation Experience in protocol development, study report preparation, Investigator Brochure preparation, regulatory submissions Full understanding GCP and ICH Guidelines Detail-oriented, well-organized Ability to assimilate technical and scientific information quickly Proficient in Microsoft Office (Word, Excel, PowerPoint; Microsoft project a plus), JReview, EDC (Rave) Demonstrated ability to work as part of a team 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

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 3+ years of clinical research experience 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

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 • 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. • 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. Qualifications • Bachelors degree in relevant scientific discipline preferred. • 1-2 years experience in pharmaceutical industry. Additional Information Sneha Shrivastava Technical Recruiter (Clinical/Scientific) Artech Information Systems LLC 360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960 Office: ************ | Fax: ************ Connect with us on - LinkedIn | Facebook | Twitter

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!