Clinical Research Associate Jobs in Moorestown-Lenola, NJ

The Clinical Research Associate is primarily responsible for carrying out the responsibilities involved in the execution of clinical trials. This includes site initiation, monitoring and close out of clinical trial sites. Clinical trials may be carried out at various phases in the life cycle of the product. Responsibilities * Monitor activities conducted by clinical investigative sites as they relate to sponsor clinical studies to ensure successful execution of the protocol. * Ensure adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Standard Operating Procedures (SOPs), Protocol/Amendment(s), Monitoring Plans, and to quality standards in conducting clinical research. * Ensure subject safety and verify diligence in protecting the confidentiality and well-being of study subjects * Conduct site qualification, site initiation, interim monitoring and close out visits for Phase 1-4 studies * Verify completeness, accuracy, consistency, and compliance/quality of trial data collected at study sites; identify deficiencies and discrepancies and provides remedial training and/or corrective action as required; generate and resolve queries in between monitoring visits * Complete monitoring reports and follow-up letters, which includes providing summaries of significant findings, deviations, deficiencies, and recommended action to secure compliance * Responsible for timely identification of problems or issues that could affect the results or timely completion of the trial, or any protocol deviations, and for suggesting mechanisms for solving the problem * The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job. * Skills:* CRA, Monitoring, Medical Device, CRO, ICH, GCP, FDA, Clinical Research, Clinical Trials * Top Skills Details:* CRA,Monitoring,Medical Device * Additional Skills & Qualifications:* Bachelor of Science Degree 4-5 Years + experience with a Sponsor or CRO Site Monitoring Experience Work experience at more than 1 company Experience with set-up monitoring plan, conducted site monitoring, and conducted site close-out. Medical Device preferred, Pharma OK, CRO OK * Experience Level:* - Entry Level

As a Clinical Research Associate you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. **What will you be doing?** + Works on multiple trials within Oncology + Quality of life focus wtih Regional Travel + Demonstrated leadership, through involvement in specific initiatives when needed, and/or SME to systems and/or processes - Mentors/coaches junior flex team + Acts as Lead SM-training other SMs on study + Develops site start up documents for studies including SIV agenda + Provides SM "voice" when reviewing study documents (e.g. Monitoring Guidelines) + Represents LTMs or SMs on SMTs/meetings + Takes over LTM role reports review (SQV, SMV, SCV) for sites assigned to other SMs from the same trial + Supports country budget development and/or contract negotiation in liaison with CCS colleagues + Assists with ASV + Metrics/KPIs: Metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP) document. Interfaces - Primary/Other: + Primary interfaces: Provider Functional Manager, Clinical Trial Assistant, Local Trial Manager and Central Study Team for assigned clinical trials. + Other Interfaces: Study Responsible Physician, Regional Quality and Compliance. Manager/Specialist, Local Drug Safety Officer (where required) and Site Manager team; Investigators and their delegates at site (trial personnel including study coordinators, pharmacists, etc.) **You Are:** + B.S., R.N., or equivalent degree, preferably in Biological Sciences + Located in Chicago near a major airport + Have a minimum of 2 -3 years' experience in monitoring pharmaceutical industry clinical trials + Have a minimum of 1-3 years' experience monitoring Oncology trials + Knowledge of several therapeutic areas + Analytical/risk-based monitoring experience is an asset + Ability to actively drive patient recruitment strategies at assigned sites + Ability to partner closely with investigator and site staff to meet all of our study timelines + Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting). + Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently. + Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements. + Need to travel up to 50% + To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status. **What ICON can offer you:** Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: + Various annual leave entitlements + A range of health insurance offerings to suit you and your family's needs + Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead + Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being + Life assurance + Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON: ************************************ At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

About Us: Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. Job Summary: Independently responsible for coordinating all aspects of multiple and/or complex clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies. Essential Responsibilities and Duties: Coordinates all aspects of patient involvement for complex and/or multiple studies from study initiation until study completion. Organizes research information for clinical trials. Observes subjects and assists with data analysis and reporting. Oversees study protocol scheduling and collection of data. Identifies, reviews, and reports adverse events, protocol deviations, and other unanticipated problems appropriately. Manages, monitors, and reports research data to maintain quality and compliance. Performs administrative and regulatory duties related to the study as appropriate. Participates in other protocol development activities. Works collaboratively with internal departments, sponsors and investigators to ensure protocols are understood and assists in training staff members. Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.) Educates potential participants and caregivers on protocol specific details and expectations. Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned). Assists senior management with site qualification visits by knowledge of staff credentials, equipment, calibrations, and enrollment capabilities. Assesses and delegates daily tasks to research staff, ensuring goals of accuracy and timeliness. Trains, mentors, and/or manages Research Assistants and lower level Clinical Research Coordinators. Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive. Education/Experience/Skills: Must have proper experience and demonstrate mastery of Clinical Research Coordinator II position. Bachelor's degree, preferred. CCRC certification preferred. 5 years of experience in the medical field or Masters Degree, preferred. Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials. Strong leadership and mentorship skills. Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level. Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations. Works independently as well as functioning as part of a team. Must be able to effectively communicate verbally and in writing. Working Conditions Indoor, Office environment. Shift work, depending on location. Essential physical requirements include sitting, typing, standing, and walking. Lightly active position, occasional lifting of up to 20 pounds. Reporting to work, as scheduled, is essential. Overnight travel may be required for training and/or investigative meetings. CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.

Mindlance is a national recruiting company which partners with many of the leading employers in the Life Sciences, IT, and Financial Services sectors, feel free to check us out at ************************* Job Description • This role is to provide comprehensive project coordination support for reducing the risk of phishing by supporting Info Protect Culture Change Behavioral Research Project • Clinical experience is helpful but not mandatory • Provide operational support and project administration for the Info Protect Culture Change Behavioral Research Project. The role entails coordinating clinical project development and implementation, project monitoring and control, risk management, and project governance. Efforts must adhere to principles of transparency across the programs and enable comparability with other efforts. Incumbent will serve as an operational 'single point of contact'; Collaborate with internal and external partners and vendors; Develop and implement project activities as assigned by the project manager; Track study budget spend and report monthly; Review and reconcile invoices for payment approval; and create and maintain project documentation including project plans, meeting minutes and agenda, project risk and decision logs, and other documents needed for project execution. Qualifications • Experience running clinical trials or University studies not required but recommended. • Project Admin/Coordinator - Level of knowledge/expertise: Extensive capability and expert understanding Job Profile: project admin/coordinator Provide administrative project planning support to Programme/Project Manager as required and provide plans converted into various formats Convert the output of the PM meeting into a monthly report and maintain the ISAC and FPAC project tracking tools Provide support to the PMO as requested. • The Information Protection programme at multi-year global programme to protect information. Within the programme, there is an Information Protection Culture work stream with the goal to fundamentally drive worldwide employee culture change for protecting information through education and awareness.

Responsible for the overall operation of one or more research studies, coordinates research through project recruitment, scheduling and retention of study subjects and exercising appropriate communication skills in order to ensure retention of subjects in the study. This is a fully grant-funded position. Essential Functions Assist in identifying and recruiting eligible participants for research study. Ensure coordination of subjects and study personnel as required by protocol. Act as liaison between study personnel and study participants. Encourage and motivate participants to maintain compliance and attendance throughout the duration of the study and coordinate all aspects of retention. Maintain study records and related documentation as required by protocol and regulatory bodies (internal and external). Work with external study sites and coordinating centers as required. Participate in study meetings (in-person and by phone) as required. Perform study related testing and/or procedures as certified/trained. Maintain the highest level of confidentiality regarding patient and study records. Assist in the training of study support staff and student interns as assigned. Support and complete all study related paperwork including requirements of the Internal Review Board. Conduct screenings of preschool children as necessary to maintain recruitment goals (after training). Other related duties as assigned. Required Qualifications Minimum of Bachelor's Degree in or the equivalent combination of education and work experience. Please review the Equivalency Chart for additional information. Minimum of Experience working in a research environment desirable Proficiency in computer based operations including word processing, spreadsheets, REDCap and data base software. Excellent time management and organizational skills Excellent record keeping skills Ability to work independently Excellent interpersonal skills Comfortable working with children Familiarity with standard concepts, practices and procedures within study related field and study specific skills. Physical Demands Typically sitting at a desk/table Location The Eye Institute - Oak Lane Additional Information This position is classified as Exempt, grade J Compensation for this grade ranges from [$ 47,490 to $71,230 per year] [. Please note that the offered rate for this position typically aligns with the minimum to midrange of this grade, but it can vary based on the successful candidate's qualifications and experience, department budget, and an internal equity review. Applicants are encouraged to explore the Professional Staff salary structure and Compensation Guidelines & Policies for more details on Drexel's compensation framework. For information about benefits, please review Drexel's Benefits Brochure. Special Instructions to the Applicant Please make sure you upload your CV/resume and cover letter when submitting your application. Additional Required Documents A review of applicants will begin once a suitable candidate pool is identified.

Clinical Research Coordinator (Recruitment Only) - (16001534) Description The Clinical Research Coordinator, in collaboration with the Clinical Investigators at the Lewis Katz School of Medicine, will be responsible for the planning, implementation, and execution of Clinical Trials in the assigned department. Primary responsibilities include the coordination of study enrollment; oversight of study protocols; and submission of research activities per IRB regulations. The incumbent will establish and maintain databases of subjects; process informed consent paperwork; and ensure study payment is processed and received in a timely fashion. Additional responsibilities include working independently to drive day-to-day research activities; supporting multiple active protocols simultaneously; and working with multiple investigators while adhering with FDA, IRB, Pennsylvania, and related regulations. Performs other duties as assigned. Required Education and Experience:Bachelor's degree in life science, health professions or related field and at least three years of directly related clinical research coordinator experience. An equivalent combination of education and experience may be considered. Required Skills and Abilities:*Demonstrated computer and data entry skills, and proficiency with MS Office Suite software programs.*Demonstrated knowledge of IRB protocols and processes.*Strong written and verbal communication skills.*Strong interpersonal skills, along with the ability to interact with a diverse population of students, faculty, staff, and program participants.*Ability to work independently or as part of a team.*Demonstrated strong attention to detail and ability to adhere to project deadlines.*Ability to travel to off-site locations that may not be accessible via public transportation.*Ability to work evenings/weekends hours as needed. Preferred:*Prior Surgical Department experience. *Experience with eDC database. Temple University values diversity and is committed to equal opportunity for all persons regardless of age, color, disability, ethnicity, marital status, national origin, race, religion, sex, sexual orientation, veteran status or any other status protected by law.Compliance Statement: In the performance of their functions as detailed in the position description employees have an obligation to avoid ethical, legal, financial and other conflicts of interest to ensure that their actions and outside activities do not conflict with their primary employment responsibilities at the institution. Employees are also expected to understand and be in compliance with applicable laws, University and. employment policies and regulations, including NCAA regulations for areas and departments which their essential functions cause them to interact. To obtain additional information about Temple University please visit our website at *************** Temple University's Annual Security and Fire Safety Report contains statistics, policies, and procedures related to campus safety and can be found at: ********************************** You may request a copy of the report by calling Temple University's Campus Safety Services at ************. Primary Location: Pennsylvania-Philadelphia-Health Sciences Campus (HSC)-Student Faculty CenterJob: StaffSchedule: Full-time Shift: Day JobEmployee Status: Regular

We are seeking a dedicated Clinical Research Coordinator to join our team. The ideal candidate will be responsible for recruiting, screening, and enrolling subjects into clinical trials, explaining the informed consent process, and documenting adverse events. You will also be responsible for collecting study documents, protocols, regulatory documents, informed consents, case report forms, and source documents, as well as preparing Institutional Review Board (IRB) applications. Responsibilities * Recruit, screen, and enroll subjects into clinical trials * Explain the informed consent process to patients * Document adverse events * Collect study documents, protocols, regulatory documents, informed consents, case report forms, and source documents * Prepare Institutional Review Board (IRB) applications Essential Skills * Experience in patient recruitment and consenting * Experience with adverse event reporting * Effective communication and writing skills * Knowledge of IRB and human research protection regulations * 1-3 years of clinical research experience Additional Skills & Qualifications * BA/BS preferred * Experience with in-hospital clinical research Work Environment This role involves a combination of office and hospital/outpatient surgery settings. The work environment is very fast-paced with a high volume of industry and investigator studies. You will be working in one of the most prestigious academic research institutes in the world, utilizing state-of-the-art equipment, and working on high-profile studies with well-known sponsors. Please send your resume and 2-3 professional references to hjaquez @actalentservices.com for more information. Pay and Benefits The pay range for this position is $25.00 - $31.25/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 Philadelphia,PA. Application Deadline This position is anticipated to close on Apr 28, 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. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: * Hiring diverse talent * Maintaining an inclusive environment through persistent self-reflection * Building a culture of care, engagement, and recognition with clear outcomes * Ensuring growth opportunities for our people 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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Job Details Entry Center City 833 Chestnut - Philadelphia, PA Full Time Bachelors Degree Day ShiftDescription Rothman Orthopaedics is looking to hire a full time Clinical Research Coordinator based in our Center City Philadelphia, PA office! Schedule: Monday through Friday 8 AM to 430 PM Job Summary: The Clinical Research Coordinator collects, prepares and distributes information necessary for protocol development and study initiation at the Rothman Institute Orthopaedics. He or she maintains integrity & quality of research data, patient enrollment process, data analysis for various medical publications & reports, protocol implementing, research data base management, & IRB submission. Determines the feasibility of protocols to be performed at the Rothman Institute. Conducts clinical trails: Obtains consent and enrolls eligible patients, collects follow up data, acts as patient liaison. Assists the Director (Manager) of the Research Department with his research strategy. Attends out-patient clinics to evaluate patients and complete data sheets. Travels, participates in advisory board meetings for the industry and has direct contact with the pharmaceutical industry. Prepares IRB (Institution Review Board) applications for approved protocols. Coordinates with physicians and other departments on all relevant information for upcoming and ongoing studies in a timely manner. Prepares for and attends protocol meetings as required. Coordinates patient visits with scheduling department according to study requirements. Monitors data and enters information on CRFs (Case Report Forms) Compiles all relevant documents and results according to sponsor's requirements. Exemplifies the desired culture and philosophies of the organization. Minimum Requirements: Bachelors degree Clinical experience and knowledge of Orthopaedics Computer skills including, but not limited to, MS Office Preferred Qualifications: Two (2) to four (4) years related experience preferred Our Commitment to Employees: Come work at Rothman Orthopaedics! Our employees are our single greatest asset, as such, we strive to provide a professional, nurturing environment where every member of our team can make a meaningful difference in the lives of others. This commitment to our employees has earned us the distinction as a Top Workplace in Philadelphia by the Philadelphia Inquirer year after year. Our employees enjoy competitive pay, comprehensive health and dental benefits, tuition reimbursement, paid time off, and retirement savings plans. Rothman Orthopaedics is an Equal Opportunity employer committed to providing opportunities to all qualified applicants without regards to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. We value developing an inclusive and equitable environment that strengthens our organization and allows us to better attract and retain a diverse workforce that is representative of our patients and our community. We model our values by creating and enacting practices that encourage participation from all backgrounds, perspectives, and experiences. As a condition of employment at Rothman Orthopaedics, it is required you receive the COVID-19 vaccination. Rothman Orthopaedics is an Equal Opportunity Employer and requests for reasonable accommodations will be considered.

Clinic Research Coordinator I The Clinical Research Coordinator I, will ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. The CRC I will also ensure study enrollment meets or exceeds Sponsors' expectations. To ensure company goals are achieved on a timely basis. Duties & Responsibilities: Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis. Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to: a. Sponsor-provided and IRB-approved Protocol Training b. All relevant Protocol Amendments Training c. Any study-specific Manuals Training, as applicable d. Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training. Conducting study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner. Adherence to ALCOA-C Standards with all the relevant clinical trial documentation. Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations. Demonstration of appropriate and timely follow-up on the action items, at their respective sites. Demonstrated understanding and implementation of Laboratory Manuals and protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration and laboratory kit inventory, under the direction of the Site/Study Management Team, for assigned protocols. Liaising with Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives, under the direction of the Site/Study Management Team, for assigned protocols. Submitting required administrative paperwork per company timelines. Participating in subject recruitment and retention efforts. Engaging with Research Participants and understanding their concerns. Any other matters, as assigned by management. Knowledge & Experience: Education: High School Diploma or equivalent required Bachelor's degree a plus Foreign Medical Graduates preferred Experience: At least one years of experience as a CRC, preferably with practice coordinating industry-sponsored vaccines in a private setting. At least two years of experience as a research assistant, data coordinator, laboratory personnel, or equivalent experience in a clinical research setting Credentials: ACRP or equivalent certification is preferred Registered Medical Assistant certification or equivalent is preferred Knowledge and Skills: Be an energetic, go-getter who is detail-oriented and can multi-task. Be goals-driven while continuously maintaining quality. Bilingual in Spanish is preferred

Job Title Clinical Research Coordinator II Reporting to Regional Research Manager Permanent Full Time (1099) Contractor Position Provides study information and obtains relevant information as required by the protocol, from patients who are participating in, or interested in clinical studies. Assists in the recruitment and screening of volunteers, schedules patient visits in EMR, provides information to potential subjects and those participating in clinical trials and obtains relevant medical history by telephone and in person. Collects relevant medical records when needed. The CRC is responsible for meeting recruitment goals for each study. The methodology of recruitment will include, but is not limited to daily chart review, advertising when funds are available, referrals from rheumatologists and other staff and may include attending health fairs and community outreach. Reviews and administers the informed consent form to subjects; allowing them time to read and ask questions. Provides progress notes in EMR and source documents to describe procedures at each visit. Plans, prepares and performs tasks required by protocol, which may include, but not limited to the following: Obtaining patient medical history and medication lists Phlebotomy and basic laboratory tests Patient education and training ECG Administer Questionnaires Vital signs Assist with Joint counts and other assessments Data Entry Study drug administration, including injections Triages adverse events and communicates with the research physician regarding the occurrence of adverse and serious adverse events. Follow-up with the subject and collateral informants as needed. Provides educational information to subjects. Serves as a resource and support person for subjects and families by being a consistent person they can contact within the clinical research program. Ensures uniform implementation of protocols by completing required documentation in a consistent, accurate and timely manner. Assists in preparing appropriate Institutional Review Board (IRB) forms, informed consents, correspondence with sponsor, etc., in an accurate and timely manner. May participate in the annual IRB approval and update process. Serves as a liaison to all physicians and AARA employees. Ensures that primary referring physicians receive timely progress notes on the patient's diagnosis and treatment. May assume primary responsibility in the implementation and management of new clinical trials in a knowledgeable and collaborative manner. Performs all functions according to established policies (SOPS), procedures, regulatory and accreditation requirements, as well as applicable professional standards. Provides all AARR research subjects with an excellent service experience by consistently demonstrating professional decorum Assignment and Review of Work All new AARA employees will agree initial objectives to be assessed on completion of their 90-day initial review period. Thereafter, all employees will enter the annual appraisal cycle under the AARA Talent, Performance and Career Management Policy where annual appraisals will be conducted by their Line Manager and CRO. Further information on the appraisal cycle calendar is available from the HR Manager and from the Talent, Performance and Career Management Policy on the AARA Intranet. Communication and Relationships The postholder must have strong interpersonal and relational talents. Success in this role involves building and maintaining relationships with internal and external stakeholders Demands of the Job Role requires frequent light physical effort. The role requires a combination of sitting, standing and walking. Role requires frequent, moderate mental effort. The role requires a consistent high level of concentration, attention to detail and organization. Role requires frequent, light emotional exposure to distressing diagnoses. Occasional direct moderate emotional exposure to patients or relatives who may be ill, upset, distressed or angry. Role requires frequent exposure to hazardous materials and contact with contained bodily fluids. Requirements 11. Knowledge, Skill, Training and Experience to do the Job Essential Bachelors Degree in science related field Good Clinical Practice Certification (GCP) Clinical Research Coordinator Certification, (CRCC) preferred Experience in Phlebotomy & Clinical Assessments (Vitals, ECG, etc) Experience in biospecimen handling and processing

Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives! We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. We are actively hiring Bilingual Clinical Research Coordinators at our Keystone Clinical Studies site in Plymouth Meeting, PA! The Clinical Research Coordinator assists the Investigators in executing Phase I, II, III, and IV clinical research trials in accordance with Standard Operating Procedures (SOPs), FDA and GCP guidelines, and study protocols while providing an impeccable patient experience in every, single interaction. Shift: Monday-Friday, 8:30 AM - 5 PM (occasional weekends) Compensation: Hourly Rate based on experience + comprehensive benefits, PTO, and 401k match *paid overtime for weekend work, evening work, or early morning work as needed RESPONSIBILITIES The Clinical Research Coordinator (CRC) obtains study participant informed consent. Executes study protocol procedures in a detailed, organized, and professional manner. Performs human specimen lab draws and processing, and packages specimen shipments. Creates and completes study source documents and adverse event reporting on an e-source system. Maintains study-specific files and supplies. Communicate with the Study Sponsor/CRO regarding study-specific questions. Participates in site visits from Sponsors/CROs, including site initiation and monitoring visits. QUALIFICATIONS Bachelor's degree preferred, but not required Experience working neurology studies is a plus, but not required - this site primarily conducts Alzheimer's clinical studies Phlebotomy experience is required, EKG or other patient labs/processes preferred Preferably 2+ years of experience as a Clinical Research Coordinator Familiar with e-source reporting via an electronic platform A clear understanding of ICH, FDA, and GCP regulations Impeccable organizational skills and attention to detail Excellent communication and interpersonal skills to effectively interact with the Principal Investigator, research team, Study Sponsor/CROs, potential subjects, and referral sources An ethical compass that compels the candidate to be honest, detail-oriented, and self-driven High-level critical thinking skills Working knowledge of medical terminology and lab collection/processing/storage procedures Proficiency with computers and Microsoft Office Suite Flourish Research offers an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. Apply today to learn more about how you can join us in our mission to save and improve the lives of others! Flourish Research is where clinical trials thrive. Flourish Research represents one of the industry's most progressive and diversified clinical trial companies with robust capabilities in the therapeutic areas of cardiology/metabolic disorders/renal, CNS, pulmonology, and vaccines. At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality. Flourish Research is driven by a diverse and inclusive community of passionate people who are committed to improving the quality of life of communities around the world. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect. Flourish Research strives to build an organization that attracts and leverages diversity in our staff, which reflects the diversity of our local communities. We promote education, acceptance, and inclusion because there is beauty in diversity. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU! It is the policy of Flourish Research not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status.

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

About Us: Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. Job Summary: Responsible for assisting with coordinating clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies. Essential Responsibilities and Duties: Assists with coordinating all aspects of patient involvement from study initiation until study completion. Organizes research information for clinical trials. Observes subjects and assists with data analysis and reporting. Schedules the collection of data. Documents adverse events, protocol deviations, and other unanticipated problems appropriately. Reports research data to maintain quality and compliance. Performs administrative and regulatory duties related to the study as appropriate. Participates in other protocol development activities. Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.) Educates potential participants and caregivers on protocol specific details and expectations. Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned). Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive. Education/Experience/Skills: High school graduate or equivalent; Bachelors Degree, preferred. 0-3 years of experience in the medical field. Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials. Strong leadership and mentorship skills. Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level. Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations. Works independently as well as functioning as part of a team. Must be able to effectively communicate verbally and in writing. Working Conditions Indoor, Office environment. Shift work, depending on location. Essential physical requirements include sitting, typing, standing, and walking. Lightly active position, occasional lifting of up to 20 pounds. Rarely lift over 20 pounds. Reporting to work, as scheduled, is essential. Overnight travel may be required for training and/or investigative meetings. CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.

Clinical Research Coordinator- Pool24003069Description Grade: T25 The link below will give you information about the University's “T” salary structure. Learn more about the “T” salary structure. A variety of important factors are reviewed by HR when considering salary, including job duties, the applicant's education and experience, all relevant internal equity considerations, department budget, and funding source. Summary: The Clinical Research Coordinator, under the direction of the Director, CRORA and Clinical Investigators, will be responsible for the planning, implementation, and execution of Clinical Research studies in one or more departments in the Lewis Katz School of Medicine at Temple University. Incumbent will work independently to drive day to day research activities from study start-up to closeout. Founded in 1901 as Pennsylvania's first co-educational medical school, the Lewis Katz School of Medicine has attained a national reputation for training humanistic clinicians and biomedical scientists. The school attracts students and faculty committed to making a difference in patient care, research, education and public service - at home and across the globe. The Lewis Katz School of Medicine at Temple University has experienced dramatic growth in the breadth and scope of its research enterprise over the past decade. As part of its strategic plan, our researchers and scientists have been responsible for ground-breaking advancements in areas across the scientific spectrum, including: Cancer Biology, Cardiovascular and Thrombosis, Cell and Developmental Biology, Clinical Lung Research, HIV, Immunology and Autoimmunity, Metabolic Syndrome and Diabetes, Neuroscience, Substance Abuse, Translational Medicine and more. Essential Functions: · Coordinate recruitment and enrollment of research participants; · establish and maintain databases of subjects; · schedule and conduct study visits; · collect and enter data; register subjects and study visits in OnCore; · perform Epic research billing review; · maintain an up to date regulatory binder; · schedule and attend sponsor visits; and prepare and submit IRB paperwork to ensure compliance with IRB regulations. · Incumbent may assist with grant or manuscript preparation and · maintenance of investigator-initiated studies registered on clinicaltrials.gov; · support multiple active protocols simultaneously; · work with multiple investigators while adhering with FDA, IRB, Pennsylvania, and related regulations. Benefits of working at Temple University include: Great Benefit package Generous time off Parental Leave Tuition Remission Dynamic Workforce Click here to learn more about the benefits of working at Temple University. Required Education & Experience: Bachelor's degree in life science or health professions field and at least three years of directly related clinical research coordinator experience. An equivalent combination of education and experience may be considered. Required Skills & Abilities: **Must have strong written and verbal communication skills with the ability to interact with a diverse population of students, faculty, staff, sponsors, and research participants. *Ability to operate all standard office equipment/software including MS office. *Ability to work independently or as a team with excellent attention to detail and adherence to project deadlines. *Knowledge of FDA, IRB, Pennsylvania and related regulations. Preferred **Prior experience with IRB submissions both local and central. *Prior experience processing and shipping biological samples a plus *Prior phlebotomy certification or willing to learn a plus *Prior experience with RedCap, OnCore CTMS, Epic Research and Florence eBinders *Prior Electronic Data Capture (eDC) data entry skills. *Prior research experience in a healthcare setting *Prior research experience with NIH sponsored research studies, industry clinical trials, and investigator-initiated research studies. There may be an opportunity for a hybrid work schedule depending on the department and study-specific needs. This position requires a background check. This position requires Child Abuse Certifications prior to the commencement of service. This is a grant funded position. Temple University is committed to a policy of equal opportunity for all in every aspect of its operations, including employment, service, and educational programs. The University has pledged not to discriminate on the basis of age, color, disability, marital status, national origin or ethnic origin, race, religion, sex (including pregnancy), sexual orientation, gender identity, genetic information or veteran status. In accordance with the City of Philadelphia's COVID-19 mandate, all Temple University students, faculty, staff, and contractors working in a healthcare setting must be fully vaccinated before receiving authorization to work unless they have a medical or religious exemption approved by the University. An individual is considered fully vaccinated two (2) weeks following the second dose of the Pfizer or Moderna vaccine or two (2) weeks following a single dose of the Johnson & Johnson vaccine. Individuals who do not meet the University's vaccination or exemption requirement will be prohibited from working until proof of full vaccination or an exemption is requested and approved. For more information, visit the University's Vaccines web page at ******************************************** Compliance Statement: In the performance of their functions as detailed in the position description employees have an obligation to avoid ethical, legal, financial and other conflicts of interest to ensure that their actions and outside activities do not conflict with their primary employment responsibilities at the institution. Employees are also expected to understand and be in compliance with applicable laws, University and employment policies and regulations, including NCAA regulations for areas and departments which their essential functions cause them to interact. To obtain additional information about Temple University please visit our website at *************** Temple University's Annual Security and Fire Safety Report contains statistics, policies, and procedures related to campus safety. Click here. You may request a copy of the report by calling Temple University's Campus Safety Services at ************. Primary Location: Pennsylvania-Philadelphia-Health Sciences Campus (HSC)-Kresge Science HallWork Locations: Kresge Science Hall Schedule: Full-time Job Posting: Oct 3, 2024, 8:39:40 PM

Clinical Research Coordinator-Obstetrics - (25000641) Description Grade: T25 The link below will give you information about the University's “T” salary structure. Learn more about the “T” salary structure. A variety of important factors are reviewed by HR when considering salary, including job duties, the applicant's education and experience, all relevant internal equity considerations, department budget, and funding source. Summary: The Lewis Katz School of Medicine has an exciting opportunity for a clinical research Coordinator (CRC) to work on a translational grant funded by the National Institutes of Health that seeks to identify biomarkers and examine factors that are likely to influence the consequences of fetal alcohol exposure during pregnancy. The CRC will work under the Director, CRORA and will work closely with the research team of clinical and basic scientists to carry out all clinical aspects of this project. The CRC will recruit study participants, obtain informed consent, administer questionnaires, collect urine and blood samples, and assist with specimen processing and perform data management. The CRC will be involved with all day-to-day study activities and will be an integral member of the study team. Essential Functions: • Submissions to IRB for review and approval; • Maintenance of regulatory and study-related documents; • Patient recruitment and tracking participants throughout the study; • Obtaining informed consent; • Administration of the alcohol exposure questionnaire; • Storage of all clinical samples; • Oversee collection of blood samples from 300 subjects during their first visit with the OB/GYN team (first trimester), then during their follow-up visits during their second and third trimesters; • Processing, aliquoting and storing blood samples and urine in a freezer; • Perform all the biochemical and molecular assays, maintain inventories, order supplies, and generally will participate in the organization of the laboratory; • Data management and data entry; • Responsible for preparation of exosomal RNA and protein samples from serum, from EtOH-used subjects and controls; • Organizing matching groups for Controls and alcohol consumed cases for further biomarkers assays. Benefits of working at Temple University include: 403(B) Retirement Plan Great Benefit package Generous time off Parental Leave Tuition Remission Dynamic Workforce Click here to learn more about the benefits of working at Temple University. Required Education & Experience: Bachelor's degree in life science or Health Professions field and at least three years of directly related experience. An equivalent combination of education and experience may be considered. Required Skills: *Must have strong written and verbal communication skills with the ability to interact with a diverse population of students, faculty, staff, and program participants. *Ability to operate all standard office equipment/software including MS office. *Ability to work independently or as a team with attention to detail and adherence to project deadlines. *Ability to work evenings and weekends if needed. Preferred: *Prior experience with IRB submissions both local and central. *Prior experience with OnCore clinical trial management system, Florence electronic regulatory system *Prior experience using Epic EHR. *Prior experience using electronic data capture (eDC). This position requires a background check. This is a grant-funded position. Temple University is committed to a policy of equal opportunity for all in every aspect of its operations, including employment, service, and educational programs. The University has pledged not to discriminate on the basis of age, color, disability, marital status, national origin or ethnic origin, race, religion, sex (including pregnancy), sexual orientation, gender identity, genetic information or veteran status. Compliance Statement: In the performance of their functions as detailed in the position description employees have an obligation to avoid ethical, legal, financial and other conflicts of interest to ensure that their actions and outside activities do not conflict with their primary employment responsibilities at the institution. Employees are also expected to understand and be in compliance with applicable laws, University and employment policies and regulations, including NCAA regulations for areas and departments which their essential functions cause them to interact. To obtain additional information about Temple University please visit our website at *************** Temple University's Annual Security and Fire Safety Report contains statistics, policies, and procedures related to campus safety. Click here. You may request a copy of the report by calling Temple University's Campus Safety Services at ************. Primary Location: Pennsylvania-Philadelphia-Health Sciences Campus (HSC) Job: StaffSchedule: Full-time Shift: Day JobEmployee Status: Regular

The Clinical Research Coordinator III will ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. To ensure study enrollment meets or exceeds Sponsors' expectations. To ensure company goals are achieved on a timely basis. DUTIES & RESPONSIBILITIES Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis. Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to: Sponsor-provided and IRB-approved Protocol Training All relevant Protocol Amendments Training Any study-specific Manuals Training, as applicable Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training. Conducting and overseeing study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner. Adherence to ALCOA-C Standards with all the relevant clinical trial documentation. Completing and overseeing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations. Demonstration of appropriate and timely follow-up on the action items, at their respective sites. Demonstrated understanding, implementation and supervision of protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration, and laboratory kit inventory for assigned protocols. Liaising with the Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives for assigned protocols. Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s) Maintaining a working knowledge of the recruitment and retention process for their assigned protocol(s) at their respective site(s). Ability to train and mentor site staff, as needed Supervise visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) Demonstration of appropriate and timely follow-up on the action items, at their respective sites. Maintaining a working knowledge of the most recent versions of the Study Protocols, Informed consents, Study Manuals, and all the other relevant study-related documents that are utilized and implemented for the assigned protocols at their respective site(s). Maintaining a working knowledge of Study Participants' Scheduling, Visit Tracking, Stipends and Transportation by liaising with the Administrative team. Maintaining a working knowledge of the Essential Clinical Trial Documents and maintenance of the Investigator Site Binders for their assigned protocol(s) at their respective site(s) Oversee reporting of all Adverse and Serious Adverse Events and any other relevant Safety Information to the appropriate authorities per internal company guidelines, Sponsor, IRB, and ICH-GCP Guidelines. Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s). Being prepared for and available at all required company meetings. Submitting required administrative paperwork per company timelines. Occasionally attending out-of-town Investigator Meetings Any other matters as assigned by management KNOWLEDGE & EXPERIENCE Education: High School Diploma or equivalent required Bachelor's degree preferred Foreign Medical Graduates preferred Experience: Minimum of 5 years experience in Clinical Research Supervisory experience preferred Wide therapeutic range of clinical trials experience preferred Regulatory research experience is a plus Credentials: ACRP or equivalent certification is preferred Knowledge and Skills: Goals-driven while continuously maintaining quality. Must be detailed-oriented, proactive, and able to take initiative. Must have strong written and communication skills. Must have excellent customer service skills. Bilingual in Spanish is a plus

Clinical Research Coordinator-Obstetrics25000641Description Grade: T25 The link below will give you information about the University's “T” salary structure. Learn more about the “T” salary structure. A variety of important factors are reviewed by HR when considering salary, including job duties, the applicant's education and experience, all relevant internal equity considerations, department budget, and funding source. Summary: The Lewis Katz School of Medicine has an exciting opportunity for a clinical research Coordinator (CRC) to work on a translational grant funded by the National Institutes of Health that seeks to identify biomarkers and examine factors that are likely to influence the consequences of fetal alcohol exposure during pregnancy. The CRC will work under the Director, CRORA and will work closely with the research team of clinical and basic scientists to carry out all clinical aspects of this project. The CRC will recruit study participants, obtain informed consent, administer questionnaires, collect urine and blood samples, and assist with specimen processing and perform data management. The CRC will be involved with all day-to-day study activities and will be an integral member of the study team. Essential Functions: • Submissions to IRB for review and approval; • Maintenance of regulatory and study-related documents; • Patient recruitment and tracking participants throughout the study; • Obtaining informed consent; • Administration of the alcohol exposure questionnaire; • Storage of all clinical samples; • Oversee collection of blood samples from 300 subjects during their first visit with the OB/GYN team (first trimester), then during their follow-up visits during their second and third trimesters; • Processing, aliquoting and storing blood samples and urine in a freezer; • Perform all the biochemical and molecular assays, maintain inventories, order supplies, and generally will participate in the organization of the laboratory; • Data management and data entry; • Responsible for preparation of exosomal RNA and protein samples from serum, from EtOH-used subjects and controls; • Organizing matching groups for Controls and alcohol consumed cases for further biomarkers assays. Benefits of working at Temple University include: 403(B) Retirement Plan Great Benefit package Generous time off Parental Leave Tuition Remission Dynamic Workforce Click here to learn more about the benefits of working at Temple University. Required Education & Experience: Bachelor's degree in life science or Health Professions field and at least three years of directly related experience. An equivalent combination of education and experience may be considered. Required Skills: *Must have strong written and verbal communication skills with the ability to interact with a diverse population of students, faculty, staff, and program participants. *Ability to operate all standard office equipment/software including MS office. *Ability to work independently or as a team with attention to detail and adherence to project deadlines. *Ability to work evenings and weekends if needed. Preferred: *Prior experience with IRB submissions both local and central. *Prior experience with OnCore clinical trial management system, Florence electronic regulatory system *Prior experience using Epic EHR. *Prior experience using electronic data capture (eDC). This position requires a background check. This is a grant-funded position. Temple University is committed to a policy of equal opportunity for all in every aspect of its operations, including employment, service, and educational programs. The University has pledged not to discriminate on the basis of age, color, disability, marital status, national origin or ethnic origin, race, religion, sex (including pregnancy), sexual orientation, gender identity, genetic information or veteran status. Compliance Statement: In the performance of their functions as detailed in the position description employees have an obligation to avoid ethical, legal, financial and other conflicts of interest to ensure that their actions and outside activities do not conflict with their primary employment responsibilities at the institution. Employees are also expected to understand and be in compliance with applicable laws, University and employment policies and regulations, including NCAA regulations for areas and departments which their essential functions cause them to interact. To obtain additional information about Temple University please visit our website at *************** Temple University's Annual Security and Fire Safety Report contains statistics, policies, and procedures related to campus safety. Click here. You may request a copy of the report by calling Temple University's Campus Safety Services at ************. Primary Location: Pennsylvania-Philadelphia-Health Sciences Campus (HSC) Schedule: Full-time Job Posting: Mar 25, 2025, 7:00:03 PM

Clinical Research Coordinator (Recruitment Only) - (16001534) Description The Clinical Research Coordinator, in collaboration with the Clinical Investigators at the Lewis Katz School of Medicine, will be responsible for the planning, implementation, and execution of Clinical Trials in the assigned department. Primary responsibilities include the coordination of study enrollment; oversight of study protocols; and submission of research activities per IRB regulations. The incumbent will establish and maintain databases of subjects; process informed consent paperwork; and ensure study payment is processed and received in a timely fashion. Additional responsibilities include working independently to drive day-to-day research activities; supporting multiple active protocols simultaneously; and working with multiple investigators while adhering with FDA, IRB, Pennsylvania, and related regulations. Performs other duties as assigned. Required Education and Experience:Bachelor's degree in life science, health professions or related field and at least three years of directly related clinical research coordinator experience. An equivalent combination of education and experience may be considered. Required Skills and Abilities:*Demonstrated computer and data entry skills, and proficiency with MS Office Suite software programs.*Demonstrated knowledge of IRB protocols and processes.*Strong written and verbal communication skills.*Strong interpersonal skills, along with the ability to interact with a diverse population of students, faculty, staff, and program participants.*Ability to work independently or as part of a team.*Demonstrated strong attention to detail and ability to adhere to project deadlines.*Ability to travel to off-site locations that may not be accessible via public transportation.*Ability to work evenings/weekends hours as needed. Preferred:*Prior Surgical Department experience. *Experience with eDC database. Temple University values diversity and is committed to equal opportunity for all persons regardless of age, color, disability, ethnicity, marital status, national origin, race, religion, sex, sexual orientation, veteran status or any other status protected by law.Compliance Statement: In the performance of their functions as detailed in the position description employees have an obligation to avoid ethical, legal, financial and other conflicts of interest to ensure that their actions and outside activities do not conflict with their primary employment responsibilities at the institution. Employees are also expected to understand and be in compliance with applicable laws, University and. employment policies and regulations, including NCAA regulations for areas and departments which their essential functions cause them to interact. To obtain additional information about Temple University please visit our website at *************** Temple University's Annual Security and Fire Safety Report contains statistics, policies, and procedures related to campus safety and can be found at: ********************************** You may request a copy of the report by calling Temple University's Campus Safety Services at ************. Primary Location: Pennsylvania-Philadelphia-Health Sciences Campus (HSC)-Student Faculty CenterJob: StaffSchedule: Full-time Shift: Day JobEmployee Status: Regular

Clinical Research Coordinator II The Clinical Research Coordinator II, will ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. The CRC II will also ensure study enrollment meets or exceeds Sponsors' expectations. To ensure company goals are achieved on a timely basis. Duties & Responsibilities: Completing all the DMCR-required training, including but not limited to ICH-GCP Certification and IATA Certification on a timely basis. Completing all the relevant training prior to study-start and on a continued basis in a timely manner. This will include but is not limited to: Sponsor-provided and IRB-approved Protocol Training All relevant Protocol Amendments Training Any study-specific Manuals Training, as applicable Sponsor-specified EDC and/or IVRS and any other relevant Electronic Systems training. Conducting study subject visits, and all other relevant protocol-required procedures and documenting these in a timely manner. Adherence to ALCOA-C Standards with all the relevant clinical trial documentation. Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations. Demonstration of appropriate and timely follow-up on the action items, at their respective sites. Demonstrated understanding and implementation of Laboratory Manuals and protocol-specified laboratory procedures, storage, temperature monitoring, equipment calibration, and laboratory kit inventory, under the direction of the Site/Study Management Team, for assigned protocols. Liaising with the Laboratory team, Data team, Administrative staff, Clinical Investigators, Research Participants and Sponsor/CRO representatives, under the direction of the Site/Study Management Team, for assigned protocols. Demonstrating adherence and compliance to the assigned protocols at their respective site(s). Maintaining a working knowledge of current FDA regulations, ICH-GCP guidelines, all the organizational SOPs, all the guidance documents, and assigned study protocol(s) Maintaining a working knowledge of the recruitment and retention process for their assigned protocol(s) at their respective site(s). Demonstrating visit preparedness for all the relevant sponsor and CRO visits for their assigned protocol(s) Demonstration of appropriate and timely follow-up on the action items, at their respective sites. Maintaining a working knowledge of the most recent versions of the Study Protocols, Informed consents, Study Manuals, and all the other relevant study-related documents that are utilized and implemented for the assigned protocols at their respective site(s). Oversee reporting of all Adverse and Serious Adverse Events and any other relevant Safety Information to the appropriate authorities per internal company guidelines, Sponsor, IRB, and ICH-GCP Guidelines. Completing data entry and query resolution in a timely manner as per internal company guidelines and as per sponsor expectations. Striving to meet Sponsor subject enrollment goals for their assigned protocols at their respective site(s). Being prepared for and available at all required company meetings. Submitting required administrative paperwork per company timelines. Occasionally attending out-of-town Investigator Meetings Any other matters as assigned by management. Knowledge & Experience: Education: High School Diploma or equivalent required Bachelor's degree a preferred Foreign Medical Graduates preferred Experience: At least 2 years of experience as a CRC, preferably with practice coordinating industry-sponsored vaccines in a private setting. Credentials: ACRP or equivalent certification is preferred Knowledge and Skills: Be an energetic, go-getter who is detail-oriented and can multi-task. Be goals-driven while continuously maintaining quality. Bilingual in Spanish is a plus