Senior Clinical Trial Technology Imaging Manager
Clinical Research Coordinator Job In King of Prussia, PA
Sr. Manager Imaging [Clinical Trial Technology]
Salary: ($140,000-$200,000)
San Francisco, CA or Philadelphia, PA (on-site 5 days per week)
This publicly traded biotech is at the forefront of drug development within oncology. They are revenue generating, as this biotech already has a blockbuster oncology drug approved on the market. They are seeking a Senior Manager Clinical Trial Technology specifically for imaging.
Responsibilities:
Spearhead the creation and documentation of business and system requirements at the study level in collaboration with internal stakeholders and technology vendors
Lead the governance and oversight of IxRS, Imaging, ECG, eCOA, and other Clinical Technology suppliers.
Work cross functionally with Clin Ops, Data Management, Biometrics, Clinical Supply, etc.)
The ideal candidate for this role will have:
BA/BS in a life science related field
8+ years experience within imaging
Ability to answer site clinical technical questions
Ability to examine and understand the image
The company offers a competitive compensation package:
Annual bonus
Equity package
401(k) match program
Insurance (health/vision/dental)
If you're interested in this role, please apply now!
Director Clinical Research Hematology
Clinical Research Coordinator Job In King of Prussia, PA
CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.
With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions.
Could you be our next Director Clinical Research? This is a hybrid role located in our King of Prussia PA or Marburg Germany office. You will report to the Physician Lead.
Responsibilities:
You will have global responsibility for medical oversight of selected pipeline and products within the assigned therapeutic area(s).
Ensure medical standards and processes are with expectations of manufacturers by partners including regulators, governmental agencies, payors, physicians, patients and the general public.
May coordinate the activities of other staff and manage the talent development.
Be a senior medical representative on the therapeutic area, development teams or post-marketing product teams.
Set technical medical strategies for global projects and therapeutic areas, consistent with functional expectations.
Identify potential challenges, risks and roadblocks associated with the global medical strategy and work as a leader in developing solutions to address these, working and inter-functionally with other departments.
Identify tools necessary to facilitate risks and to implement necessary risk management programs.
Work with main high-level partners, contribute to, and approve regulatory reports / submissions / queries.
Qualifications:
MD (Medical Doctor degree) or international equivalent plus accredited residency.
2+ years minimum experience as a physician in patient care.
3+ years pharmaceutical / biotechnology industry experience, with 1 including accountability for medical oversight/evaluation or clinical development.
Industry experience in designated therapeutic area(s).
Experience and success in addressing and managing complex medical issues in the pre-approval and post-approval environment.
BENEFITS
Medical, Dental Vision
401K
Paid time Off
#LI-Hybrid
Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what's available to you as a CSL employee.
About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
We want CSL to reflect the world around us
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Behring!
Research Nurse Coordinator (RN) - Cancer Research
Clinical Research Coordinator Job In Newark, DE
Research Nurse Coordinator (RN)
Day Shift (Hours: 8-4:30pm/hours can vary) No nights or weekends.
Newark, DE
Christiana Care Health System is currently seeking a Research Nurse Coordinator with two years of Hematology/Oncology Clinical experience for our Cancer Research Department at the Helen F. Graham Center & Research Institute in Newark, DE.
In this role the Research Nurse Coordinator screens, enrolls, plans, implements, and evaluates protocol-related care of participants and data for assigned research projects. Follows study-specific protocol guidelines, communicates, and interacts with investigators, hospital staff, department manager, sponsoring agencies, and others to effectively perform clinical research activities.
Frequent contact with physicians, nurses, laboratories, pharmacy, medical records, social services, and ancillary hospital staff; contact with sponsors and government agencies related to research and grant activities (e.g., National Institutes of Health); frequent contact with Principal Investigators and study chairs of individual protocols to address questions relating to specific participants registered to protocols. Contact with participants, family members and significant others.
Correctly interprets and implements complex hematology/oncology/screening protocols for multiple patients on multiple protocols.
Coordinates all aspects of protocol treatment and monitoring and ensures everything is completed and documented.
Meticulously creates and maintains patient research charts containing source documents supporting all reported data.
Creates methods and systems to ensure patient compliance with protocol procedures, uses a problem-solving process when non-compliance occurs.
Serves as a preceptor and mentor for new or less experienced research nurse coordinators, clinical research associates, and support staff.
Serves as an active member of assigned Multidisciplinary Clinics and Tumor conferences, pre-screens all MDC patients for participation in clinical trials, and educates other professionals regarding specific clinical trials.
Collects, documents, and reports medical data required by study protocols from numerous resources, using multiple data reporting systems.
Using multiple resources, interprets complex laboratory, pathology, and molecular testing results and uses them to determine study eligibility and outcomes.
Interprets radiology and other test results and reports data using RECIST or other criteria.
Develops new data collection forms as needed.
In collaboration with the Principal Investigator, determines patient eligibility for specific trials and performs ongoing informed consent (using Teach back Technique).
Identifies local and NCI system issues that serve as barriers to care. Participates in development and Implementation of strategies to remove barriers by using a problem-solving process.
ChristianaCare Offers:
Full Medical, Dental, Vision, Life Insurance, etc.
Two retirement planning offerings, including 403(b) with company contributions.
Generous paid time off with annual roll-over and opportunities to cash out.
12 week paid parental leave.
Tuition assistance
Incredible Work/Life benefits including annual membership to care.com, access to backup care services for dependents through Care@Work, retirement planning services, financial mentor, fitness and wellness reimbursement, and great discounts through several vendors for hotels, rental cars, theme parks, shows, sporting events, movie tickets and much more!
Helen F. Graham Cancer Center & Research Institute
The 240,000 square-foot Graham Cancer Center is amultidisciplinary cancer center, or MDC, which means an entire team of our highly skilled specialists work together to create and implement a treatment plan as unique for the patient. At each of our 12 multidisciplinary disease site centers, patients have a fully dedicated team that include oncologists, surgeons, navigators, and social workers, as well as a clinical research nurse at each MDC to explore avenues for potential cutting-edge treatments in the latest clinical trials. With our personalized and compassionate approach to care means convenient and efficient care. Patient can see three disciplines of surgical, medical and radiation oncology, including subspecialists and support service teams, in a singlevisit.
****************************************************************************************************************
Education & Requirements:
DE RN License or Compact Nursing License
BSN required or commitment to obtain BSN within three years of the hire date.
BLS Required.
All candidates must have a minimum of two years hematology/oncology experience required.
Certification in oncology nursing preferred.
RequiredPreferredJob Industries
Other
Senior Clinical Trial Technology Imaging Manager
Clinical Research Coordinator Job In King of Prussia, PA
SUMMARY/JOB PURPOSE:
SUMMARY/JOB PURPOSE:
** This position is a Data Managment role overseeing oncology Imaging Vendors. This is an onsite role to be located in Alameda, CA or King of Prussia PA.
The Senior Clinical Trial Technology Manager works independently and cross-functionally with internal stakeholders (Clinical Operations, Data Management, Biometrics, Clinical Supply, QA, Strategic Sourcing and Procurement, Clinical Programming, Clinical Development, and Clinical Science) to support the implementation and maintenance of IxRS systems and other Clinical Technology suppliers to support Exelixis clinical trials. This role provides program-level oversight to Clinical Technology suppliers. This role will conduct training on standards, processes, and metrics for the consistent conduct of Exelixis trials.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
* Lead development and documentation of study-level business and system requirements with internal stakeholders and technology suppliers.
* Lead the governance and oversight of IxRS, Imaging, ECG, eCOA, and other Clinical Technology suppliers.
* Provide study-level technical oversight and support towards designing, implementing, and maintaining the IxRS to support Exelixis trials.
* Provide study parameters and requirements for RFPs and Scope of Work for evaluation, selection, and startup of technology suppliers
* Represent Clinical Trial Technologies group in study team meetings, data working groups, and project workstreams.
* Act as Lead Clinical Trial Technologies stakeholder when implementing, maintaining, and closing out various clinical systems.
* Manage clinical technology suppliers to develop user requirements that satisfied business requirements.
* Manage supplier and internal teams for timelines and associated activities
* Identify and track study-related technical and escalated issues to resolution.
* Manage communications and expectations between the study team, internal stakeholders, and clinical technology suppliers.
* Provide input to IxRS design and specifications and reviewer of IxRS supplier's documents (e.g., user requirements).
* Create test plans for user acceptance test (UAT) and conduct UAT for IxRS and eCOA
* Work to identify metrics and solutions for trend analysis of potential and current issues.
* Collect, track, and analyze supplier performance metrics. Ensure Clinical Technology suppliers provide service and support as outlined in contract terms and based on agreed-upon performance goals.
* Provide imaging protocol deviation surveillance oversight as well as SOP change management and deviation surveillance.
* Perform periodic clinical data systems user audits.
* Support records retention management.
SUPERVISORY RESPONSIBILITIES:
No direct reports.
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
* BS/BA degree in related discipline and a minimum of nine years of related experience; or,
* MS/MA degree in related discipline and a minimum of seven years of related experience; or,
* PhD in related discipline and a minimum of two years of related experience; or,
* Equivalent combination of education and experience.
* May require certification in assigned area.
Experience/The Ideal for Successful Entry into Job:
* Experience in biotech/pharmaceutical industry is preferred.
* Previous experience working in a fast-paced, entrepreneurial environment is preferred.
* Experience in clinical operations, supplier management, and cross-functional team leadership is preferred.
* Experience with Microsoft Office applications (Outlook, Word, Excel, Visio, PowerPoint).
* Experience in imaging or clinical supply or CRO experience is preferred.
* Experience in radiographic imaging in a clinical environment preferred.
* Experience in RECIST 1.1 preferred.
Knowledge/Skills:
* Has extensive experience in relevant industry/profession.
* Well-versed and Knowledgeable in Good Clinical Practice and FDA regulations.
* Well-versed and Knowledgeable of the drug development/clinical trials process/basic clinical research and/or experience working in a pharmaceutical environment preferred.
* Use broad expertise or unique knowledge and skills to contribute to the development of company objectives and principles and to achieve goals in creative and effective ways.
* Experienced in Interactive Response Technologies, including design, testing, deployment, user management, and report generation.
* Experienced in Clinical Trial Databases (e.g., EDC, CTMS).
* Previous experience implementing a clinical system.
* Develop technical and/or business solutions to complex problems.
* Identify and implement methods, techniques, procedures, and evaluation criteria to achieve results.
* Perform a variety of complicated tasks with a wide degree of creativity and latitude.
* Possess a complete understanding and wide application of technical principles, theories, concepts, and techniques.
* Possess a good general knowledge of other related disciplines.
* Apply strong analytical and business communication skills.
JOB COMPLEXITY:
* Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.
* Exercises independent judgment in methods, techniques, and evaluation of criteria for obtaining results.
* Creates formal networks involving coordination among groups.
#LI-CW1
If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $141,500 - $201,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
RequiredPreferredJob Industries
Other
Distinguished Scientist, Clinical Research, Thoracic Oncology
Clinical Research Coordinator Job In North Wales, PA
Our Clinical Development teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs and new indications for existing products. We ensure we conduct high quality clinical trials by integrating state-of-the-art technology and applying rigorous scientific and ethical standards.
The Distinguished Scientist (Executive Director) and Product Development Team (PDT) Lead, Oncology Global Clinical Development, has primary responsibility for the planning and directing clinical research activities involving new or marketed drugs in the Oncology Clinical Research group and in the field of Thoracic Oncology.
The Executive Director, PDT Lead will manage the entire cycle of clinical development, including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, publication, and presentation at national and international meeting. They will provide internal scientific leadership for cross-functional areas supporting clinical trials and will interact externally with key opinion leaders.
Specifically, the Executive Director, PDT Lead may be responsible for:
+ Evaluating pre-clinical and translational work for the purpose of generating early clinical development plan and Investigational New Drug applications.
+ Developing clinical development strategies for investigational or marketed agents that incorporate the latest scientific developments, regulatory requirements, the competitive landscape, and commercial considerations.
+ Planning clinical trials (design, operational plans, settings) based on these clinical development strategies
+ Monitoring and managing the conduct of ongoing or new clinical trials for investigational or marketed agents
+ Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publications
+ Participation in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds and support of business development assessments of external opportunities.
+ Provide support for other therapeutic areas regarding clinical issues related to oncology compounds.
The Executive Director, PDT Lead may:
+ Manage Directors and/or Senior Directors responsible for Oncology Global Clinical Development projects.
+ Supervise the activities of entire Clinical Teams in the execution of clinical studies.
+ Will report to and work collaboratively with the Section Head to promote the development strategy of the company on the indication of interest.
+ Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, medical affairs and manufacturing to manage clinical development projects; and assist the Section Head in ensuring that appropriate Corporate personnel is informed of the progress of studies of our company and competitors' drugs and internal and external expert opinion on scientific questions relevant to their areas of responsibility.
The Executive Director is responsible for maintaining a strong scientific fund of knowledge by:
+ Maintaining awareness of scientific developments within their area of expertise, in terms of new scientific findings, research methodologies
+ Identification of scientifically and operationally strong investigators who can assist in the development of our company's investigational and marketed drugs
+ Establishing communications with prominent clinical investigators in their field of interest, particularly those who will be willing and able to assist in the evaluation of our company's drugs
+ Attending appropriate scientific meetings to maintain their competency and to maintain awareness of research activities in their area of responsibility.
To accomplish these goals, the Executive Director, PDT Lead may:
+ Author detailed development documents, presentations, budgets, and position papers for internal and external audiences
+ Facilitating collaborations with external researchers around the world
+ Travel on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects.
**Education:**
M.D or M.D./Ph.D.
**Required Experience and Skills:**
+ Must have experience in industry in the field of Thoracic Oncology
+ Minimum of 3 years of clinical medicine experience
+ Minimum of 5 years of industry experience in drug development
+ Demonstrated record of scientific scholarship and achievement
+ A proven track record in clinical medicine and background in biomedical research is essential
+ Strong interpersonal skills, as well as the ability to function in a team environment, are essential.
**Preferred Experience and Skills:**
+ Board Certified or Eligible in Oncology (and/or Hematology)
+ Prior specific experience in clinical research and prior publication
Current Employees apply HERE (*****************************************************
Current Contingent Workers apply HERE (*****************************************************
**US and Puerto Rico Residents Only:**
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights (******************************************************************************************
EEOC GINA Supplement
Pay Transparency Nondiscrimination (***********************************************************************************************
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts (**********************************************
**U.S. Hybrid Work Model**
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected US salary range:
$304,800.00 - $479,800.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here (********************************* .
**San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
**Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
**Search Firm Representatives Please Read Carefully**
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
**Employee Status:**
Regular
**Relocation:**
**VISA Sponsorship:**
**Travel Requirements:**
**Flexible Work Arrangements:**
Hybrid
**Shift:**
**Valid Driving License:**
**Hazardous Material(s):**
**Job Posting End Date:**
02/21/2025
***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.**
**Requisition ID:** R334862
Clinical Research Associate 1
Clinical Research Coordinator Job In Philadelphia, PA
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, PTO and 401K
Study Setup & Specimen Coordinator
Clinical Research Coordinator Job In Exton, PA
Study Setup and Specimen CoordinatorJob Title: Study Setup and Specimen Coordinator Reports To: Project Manager, Team Lead Full-time
Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China, and growing over 30% YOY. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
POSITION OVERVIEW:
Key responsibilities of the position:
When a new specimen is received, the Study Setup and Specimen Coordinator needs to
Process e-Manifest
Update Specimen Trackers
Provide update to the clients regarding specimen status
Work with Specimen Processing (BioA and Central Lab) closely on Sample Management including specimen status, problem reconciliation, as well as generation of related SOPs
Work with BioA closely on analysis status for studies
Assist laboratory management and QA specialist with CAPA, Change Control, and other processes
Trouble Shooting
Other responsibilities as needed
Requirements:
Has a High School Diploma or higher
Experience working with laboratory specimens
Has excellent communication skills
ESSENTIAL SKILLS include the following:
The skills listed below are representative of those that are required to perform this job successfully. Interview questions should be designed to verify/validate that the candidate possesses the specified below.
High level of accountability with self and others
Hands-on approach with a desire to teach others
Track record of challenging the status quo
Team and action-oriented
Problem-solving
Priority setting
Salary and Benefits:
Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
Clinical Research Coordinator
Clinical Research Coordinator Job In Philadelphia, PA
This position is eligible for Mid Atlantic Retina's $1,000 Hiring Incentive! The hired candidate will receive $500 after successful completion of 90 days of employment and $500 after successful completion of 1 year of employment! Available to new hires only- not available to agency hires, internal transfers, or re-hires.
Job Type: Full Time
Sign on bonus Eligible: Yes
Training: Full Orientation in addition to ongoing department training and study training.
Qualifications
* College degree in related health science or 2 years Clinical Research work experience.
* Desire to work with patients
Full Job Description
Mid Atlantic Retina is one of the largest retina practices in the area, offering bonuses, top pay and growth opportunities for employees to not just work a job, but build a career. As a Research Coordinator, you will be responsible for coordinating all aspects of Mid Atlantic Retina's phase 1 through phase 4 clinical research trials.
Benefits
* 401(k) & Profit Sharing
* Health Insurance
* Dental Insurance
* Vision Insurance
* Life Insurance
* Short & Long Term Disability
* Paid Time Off
* Bonuses
Essential Functions
* Maintains a solid understanding of objective (primary and secondary endpoint) and rational of study.
* Obtains written informed consent and ensures all documentation of processes.
* Maintains awareness of regulatory need for study and ensures completion of action items.
* Reviews 1572 and delegation logs prior to start of study.
* Provides guidance to ancillary staff (Photographer, OCT Tech, BCVA, Receptionist, unmasked personnel) to make sure protocol is properly completed and any action items are completed. Communicates with them proactively throughout the study.
* Understands inclusion and exclusion criteria as they relate to study objectives, patient safety and retention of patients for valuable data.
* Informs subjects of any study changes including risks and signs amended informed consents.
* Collaborates with Screening Department in order to initiate a screening packet within the time frame for enrollment.
* Determines required visits and protocol agendas.
* Enrolls and retains patients in all assigned clinical trials.
* Manages clients within protocol parameters to ensure patient safety and the collection of valuable data and keeping protocol violations to a minimum.
* Completes clear, concise documentation of source documents following sample source SOPs to compliment data in CRFs in a timely manner.
* Records all communication in source or regulatory file.
* Communicates proactively with sponsors and CROs and assures all action items are completed in a timely manner.
* Boosts enrollment by informing doctors of study details, competing chart reviews and utilizing supplemental material.
* Responds to referrals within 24 hours.
* Completes all DCFs and ECRFs in a timely manner (within 7 days of visit).
* Works with CRAs, Medical Monitors and/or other personnel who are instrumental in answering questions, as well as building a professional rapport that can help in the successful undertaking and completion of study.
* Transports clinical specimens to lab or arranges for specimen pick up.
* Follows all FDA/GCP regulations.
* Responsible for all regulations for assigned clinical trials.
* Cross-covers for other Coordinators as needed.
* Telephone screening of patients.
* Regular and predictable attendance required.
* Works overtime as needed.
* Travels as needed.
* Performs other duties as assigned.
Physical & Cognitive Demands
* This position is very active and requires standing and walking all day in order to get patients and bring them to rooms, assist physicians and rotate assignments with other staff.
* While performing the duties of this job, the employee is regularly required to talk, communicate verbally in front of groups, one to one and over the telephone and in email.
* Occasional bending, kneeling, stooping, and crouching.
* Lift or move objects weighing over 15 pounds as needed.
* Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus with or without corrective lenses. Working environment in exam rooms is often in moderate light.
* Using hands to operate equipment, show manual or finger dexterity, handle things with precision or speed, use muscular coordination and physical stamina.
* Ability to raise dominant arm above shoulder height to administer drops.
* Use senses to observe and examine patients, paying attention to detail.
* Works with data and numbers, calculating and manipulating numbers, processing data on a computer, attending to details, classifying and recording, storing and retrieving information.
* Sustain physical contact with another person in order to guide them due to their diminished vision.
Clinical Research Coordinator I
Clinical Research Coordinator Job In Marlton, NJ
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
Clinical Research Coordinator Job In Philadelphia, PA
We are seeking a dedicated and experienced 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, documenting adverse events, and collecting study documents. This role requires preparing Institutional Review Board (IRB) applications and ensuring compliance with all regulatory requirements.
Responsibilities
* Recruit, screen, and enroll subjects into clinical trials.
* Explain the informed consent process to participants.
* Document adverse events accurately.
* Collect and manage study documents, protocols, regulatory documents, informed consents, case report forms, and source documents.
* Prepare and submit Institutional Review Board (IRB) applications.
Essential Skills
* Experience with patient recruitment and consenting.
* Knowledge of informed consent processes.
* Proficiency in documenting adverse events.
* Ability to collect and manage study and regulatory documents.
* Experience with IRB applications.
* 2+ years of clinical research experience.
* Experience in in-hospital clinical research.
* Effective communication and writing skills.
* Knowledge of IRB and human research protection regulations.
* BA/BS degree preferred.
* Experience with chart review, data entry, and regulatory compliance.
* Familiarity with oncology and pre-screening patients.
* Proficiency in GCP (Good Clinical Practice) and EDC (Electronic Data Capture).
Work Environment
This position involves a combination of office and hospital/outpatient surgery settings. The work environment is 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, equipped with state-of-the-art facilities and collaborating on high-profile studies with well-known sponsors.
Pay and Benefits
The pay range for this position is $25.00 - $31.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
* Medical, dental & vision
* Critical Illness, Accident, and Hospital
* 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
* Life Insurance (Voluntary Life & AD&D for the employee and dependents)
* Short and long-term disability
* Health Spending Account (HSA)
* Transportation benefits
* Employee Assistance Program
* Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a hybrid position in Philadelphia,PA.
Application Deadline
This position is anticipated to close on Feb 14, 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.
Clinical Research Coordinator
Clinical Research Coordinator Job In Wilmington, DE
Clinical Research Coordinator in Oncology supporting the Moseley Institute/NCCBD (Nemours Center for Cancer & Blood Disorders) - coordinates, implements and completes clinical research studies and/or clinical trials by assisting in screening oncology patients, obtaining parental permission/assent/consent forms, educating parents/participants, scheduling and conducting study procedures, collecting and recording study data, maintaining detailed study records, interfacing with study sponsors, participation in sponsor study monitoring visits, prepare for and participate in internal and external research audits, maintain various research databases, process and shipment of research samples, participation in continuous process improvement initiatives in the Delaware Valley.
Essential Functions:
1. Follows all aspects of Standard Operating Procedures and Good Clinical Practices in the conduct of clinical research; collects and prepares documents as required by sponsoring agencies; attends Investigator Meetings, as assigned
2. Understands and can conduct clinical research studies that require but not limited to Emergent Access/Compassionate use, Multi-site clinical trials, conduct Investigator Initiated studies, Research Team training manuals
3. Participates in the conduct of parental permission/assent process for assigned studies; schedules study visits with study participants in accordance with study protocols; develops strategies to assure compliance of study participants with protocol requirements.
4. Supports NCCBD's NCORP: NCI Community Oncology Research Program across the Nemours enterprise.
5. Performs clinical data gathering, measurements and monitoring of data integrity, including data completeness, accuracy and quality. Maintains multiple study databases. Ability to be submit data proactively and address queries in a timely manner.
6. Participates in training nursing and ancillary study staff for study purposes; builds relationships with various departments to ensure protocol compliance.
7. Assists in identifying, reporting and following-up on Serious Adverse Events and/or Unanticipated problems
8. Assists in the maintenance of study medication accountability records; works closely with research pharmacist to coordinate study drug administration and documentation
9. Prepares clinical specimens for shipment to central laboratories. Ensures manual of procedures is followed and applicable documentation is sent with samples
10. Coordinates monitoring activities with Sponsor's representative(s). Completes Case Report Forms; responds to sponsor queries, prepares for audits by sponsor, IRB and/or the FDA/DHHS.
11. Attendance at and participation in relevant clinical divisional/departmental activities to assure routine administrative procedures are followed. Further attendance at Sponsor Coordinator meetings as needed for study related training.
12. Prepares for internal and external audits. Prepares corrective action plans as indicated
QUALIFICATIONS:
* Bachelor's degree in medical or science related field required;
* Clinical Research Coordinator certification or eligible to sit for exam after 2 years clinical research coordination experience
* Basic Life Support Certificate (may obtain upon hire)
* Effectively uses Microsoft computer software;
* Maintains the highest possible standards for work quality; accepts feedback; gives accurate information
* Builds and fosters professional relationships with staff, families, and patients
* Makes decisions when appropriate; manages resources prudently; schedules time efficiently; works independently
* Demonstrates ability to coordinate and establish priorities among diverse tasks;
* Effectively communicates verbally and in writing with patients, families, associates, and providers;
Clinical Research Coordinator
Clinical Research Coordinator Job In Wilmington, DE
The Clinical Research Coordinator coordinates, implements and completes clinical research studies and/or clinical trials involving Cerebral Palsy by assisting in regulatory document preparation and collection, in-servicing research teams, recruiting study participants, obtaining parental permission/assent/consent forms, educating parents/participants, scheduling and conducting study procedures, collecting and recording study data, maintaining detailed study records, interfacing with study sponsors, participation in sponsor study monitoring visits, prepare for and participate in internal and external research audits, maintain various research databases.
Requirements:
Bachelor's degree in medical or science related field required
1-3 years Clinical Research Coordination experience required
Effectively uses Microsoft computer software
Demonstrates ability to coordinate and establish priorities among diverse tasks
Effectively communicates verbally and in writing
Essential Functions:
Follows all aspects of Standard Operating Procedures and Good Clinical Practices in the conduct of clinical research; collects and prepares documents as required by sponsoring agencies; attends Investigator Meetings, as assigned
Understands and can conduct clinical research studies that require but not limited to Emergent Access/Compassionate use, Multi-site clinical trials, conduct Investigator Initiated studies, Research Team training manuals
Participates in the conduct of parental permission/assent process for assigned studies; schedules study visits with study participants in accordance with study protocols; develops strategies to assure compliance of study participants with protocol requirements.
Performs clinical data gathering, measurements and monitoring of data integrity, including data completeness, accuracy and quality. Maintains multiple study databases. Ability to be submit data proactively and address queries in a timely manner.
Participates in training nursing and ancillary study staff for study purposes; builds relationships with various departments to ensure protocol compliance.
Assists in identifying, reporting and following-up on Serious Adverse Events and/or Unanticipated problems
Assists in the maintenance of study medication accountability records; works closely with research pharmacist to coordinate study drug administration and documentation
Prepares clinical specimens for shipment to central laboratories. Ensures manual of procedures is followed and applicable documentation is sent with samples
Coordinates monitoring activities with Sponsor's representative(s). Completes Case Report Forms; responds to sponsor queries, prepares for audits by sponsor, IRB and/or the FDA/DHHS.
Participates in continuous process improvement initiatives and implementation of outcomes
Prepares for internal and external audits. Prepares corrective action plans as indicated.
Clinical Research Coordinator
Clinical Research Coordinator Job In Wilmington, DE
The Clinical Research Coordinator coordinates, implements and completes clinical research studies and/or clinical trials involving Cerebral Palsy by assisting in regulatory document preparation and collection, in-servicing research teams, recruiting study participants, obtaining parental permission/assent/consent forms, educating parents/participants, scheduling and conducting study procedures, collecting and recording study data, maintaining detailed study records, interfacing with study sponsors, participation in sponsor study monitoring visits, prepare for and participate in internal and external research audits, maintain various research databases.
Requirements:
Bachelor's degree in medical or science related field required
1-3 years Clinical Research Coordination experience required
Effectively uses Microsoft computer software
Demonstrates ability to coordinate and establish priorities among diverse tasks
Effectively communicates verbally and in writing
Essential Functions:
Follows all aspects of Standard Operating Procedures and Good Clinical Practices in the conduct of clinical research; collects and prepares documents as required by sponsoring agencies; attends Investigator Meetings, as assigned
Understands and can conduct clinical research studies that require but not limited to Emergent Access/Compassionate use, Multi-site clinical trials, conduct Investigator Initiated studies, Research Team training manuals
Participates in the conduct of parental permission/assent process for assigned studies; schedules study visits with study participants in accordance with study protocols; develops strategies to assure compliance of study participants with protocol requirements.
Performs clinical data gathering, measurements and monitoring of data integrity, including data completeness, accuracy and quality. Maintains multiple study databases. Ability to be submit data proactively and address queries in a timely manner.
Participates in training nursing and ancillary study staff for study purposes; builds relationships with various departments to ensure protocol compliance.
Assists in identifying, reporting and following-up on Serious Adverse Events and/or Unanticipated problems
Assists in the maintenance of study medication accountability records; works closely with research pharmacist to coordinate study drug administration and documentation
Prepares clinical specimens for shipment to central laboratories. Ensures manual of procedures is followed and applicable documentation is sent with samples
Coordinates monitoring activities with Sponsor's representative(s). Completes Case Report Forms; responds to sponsor queries, prepares for audits by sponsor, IRB and/or the FDA/DHHS.
Participates in continuous process improvement initiatives and implementation of outcomes
Prepares for internal and external audits. Prepares corrective action plans as indicated.
Unblinded Clinical Research Coordinator
Clinical Research Coordinator Job In Philadelphia, PA
Unblinded Clinical Research Coordinator DM Clinical Research, the largest privately-owned clinical research organization in the Houston area and one of the top fifty in the country, is looking for an Unblinded Clinical Research Coordinator to join our team. This individual will be responsible for dispensing Investigational Products (IP) as part of clinical research trials.
Duties & Responsibilities:
Compound and dispense prescribed IP.
Supervise and maintain records of all medications
Ensure compliance with study-specific blinding plans.
Provide consultative support regarding the preparation and dosing of drugs.
Maintain documentation of IP accountability: receipt, dispensing, return to sponsor/destruction.
Interpret clinic schedule and protocol into a resource that can be used to identify the date/time to compound/prepare and dispense IP for clinical trials.
Understand and apply all applicable site procedures.
Ensure receipt and proper storage of IP and bioretention samples.
Manage inventory, ensuring that expired items are removed from the inventory prior to expiration, and purchasing, and delivery processes for the pharmacy.
Review protocols and provide input on clinical and pharmacy supply needs.
Meet with sponsors, monitors, auditors, and regulatory authorities to review drug accountability and other study-specific information.
Temperature reporting.
Any other duties/ tasks assigned by the manager, computer proficiency, especially Word, Excel, Outlook, and Google Docs.
Knowledge & Experience:
Education:
High School Diploma or equivalent required
Foreign Medical Graduate is a plus
Pharmacy Technician Certification a plus
Experience:
Clinical Experience
Credentials:
LPN (Licensed Professional Nurse) or CMA (Certified Medical Assistant)
Knowledge and Skills:
Computer proficiency, especially Word, Excel, Outlook, and Google Docs.
Excellent communication and customer service skills.
Outgoing personality Well-organized with attention to detail.
Must be able to multitask.
Bilingual (Spanish) preferred but not required
Clinical Research Coordinator II
Clinical Research Coordinator Job In Philadelphia, PA
Clinical Research Coordinator II - (230606) Description Coordinates and facilitates the conduct of clinical research protocols which may be supported by NCI, industry, cooperative groups, or grant funded and investigator-initiated. Provides leadership in the management and operation of clinical research protocols to ensure research participant recruitment and accrual, protocol compliance, research participant safety and data quality.
The position will work closely with the members of the clinical research team to develop effective tools for close monitoring and reporting of trials accrual, and coordinate the timely study activation and submission of protocol amendments.
In addition, this position is expected to interact with the institutional investigators, other members of the healthcare team, service line members and research participants/families in a manner, which supports the conduct of clinical trials.
Flexibility in work schedule when possible must be maintained to ensure coverage of study responsibilities.
EducationBachelors Degree (Required) Masters Degree (Preferred) Experience2 Years experience in clinical research (Required)2 Years experience with oncology clinical trials.
(Required) General experience and knowledge of chemotherapy and/or radiation therapy administration (Required) License/CertificationsCCRC - Cert Clin Research Coordinator (Preferred) CCRP - Cert Clin Research Prof (Preferred) CCRA - Cert Clin Research Associate (Preferred)_ Your Tomorrow is Here!Temple Health is a dynamic network of outstanding hospitals, specialty centers, and physician practices that is advancing the fight against disease, pushing the boundaries of medical science, and educating future healthcare professionals.
Temple Health consists of Temple University Hospital (TUH), Fox Chase Cancer Center, TUH-Jeanes Campus, TUH-Episcopal Campus, TUH-Northeastern Campus, Temple Physicians, Inc.
, and Temple Transport Team.
Temple Health is proudly affiliated with the Lewis Katz School of Medicine at Temple University.
To support this mission, Temple University Health System is continuously recruiting top talent to join its diverse, 10,000 strong workforce that fosters a healthy, safe and productive environment for its patients, visitors, students and colleagues alike.
At Temple Health, your tomorrow is here!Equal Opportunity Employer/Veterans/DisabledAn Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Your Tomorrow is Here! As one of the first cancer hospitals in the country, Fox Chase Cancer Center has been a national leader in cancer treatment, research, and prevention for more than 100 years.
Fox Chase Cancer Center, part of the Temple University Health System, is committed to providing the best treatment options for our patients, and delivering that care with compassion.
At Fox Chase, we consider defeating cancer to be our calling.
Our unique culture allows employees to work collaboratively with a single, shared focus, regardless of which department they're in.
It's essential for us to recruit not only the best talent in hospital care, but hire well-qualified prospective employees who are committed to serving our patients with the passion and excellence for which Fox Chase is known.
Apply today to be part of the future of prevailing over cancer.
Primary Location: Pennsylvania-PhiladelphiaJob: Research & ScienceSchedule: Full-time Shift: Day JobEmployee Status: Regular
Clinical Research Associate II
Clinical Research Coordinator Job In Philadelphia, PA
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
Clinical Research Coordinator II
Clinical Research Coordinator Job In Philadelphia, PA
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
Clinical Research Lab Coordinator
Clinical Research Coordinator Job In Philadelphia, PA
Participate in the day-to-day research sample collection, processing, storage, and shipment across CRO clinical trials throughout each protocol's lifecycle (start-up, maintenance, and closeout). Responsibilities * Collaborate with MDG Coordinator and/or Project Manager/Clinical Research Coordinator to review, initiate, and manage protocols requiring the collection and handling of research specimens.
* Assist with maintaining inventory of study-specific materials and supplies.
* Prepare lab kits.
* Assist with responding to queries and communication with study sponsors.
Essential Skills
* Experience with lab and specimen processing.
* 1 year of clinical research experience.
Additional Skills & Qualifications
* Clinical Research Coordinator experience.
* Oncology experience.
* Sample management skills.
* Specimen processing knowledge.
* Clinical research and trial experience.
* Data management skills.
* Patient recruitment experience.
* Experience with patient records.
* EDC (Electronic Data Capture) experience.
* Specimen collection experience.
Work Environment
This position operates in a fast-paced environment on a large campus. You will work five days a week, Monday through Friday from 11:00am to 7:00pm with the occasional requirement to stay later. Collaborating with a prestigious academic research institute. The role offers tuition reimbursement once permanent, great health benefits, and opportunities for growth and upward mobility. You will work on high-profile studies with well-known sponsors, providing great exposure to oncology research.
Pay and Benefits
The pay range for this position is $22.00 - $27.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
* Medical, dental & vision
* Critical Illness, Accident, and Hospital
* 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available
* Life Insurance (Voluntary Life & AD&D for the employee and dependents)
* Short and long-term disability
* Health Spending Account (HSA)
* Transportation benefits
* Employee Assistance Program
* Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Philadelphia,PA.
Application Deadline
This position is anticipated to close on Feb 18, 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.
Clinical Research Coordinator
Clinical Research Coordinator Job In Philadelphia, PA
Clinical Research Coordinator - (244584) Description Coordinates and facilitates the conduct of clinical research protocols which may be supported by NCI, industry, cooperative groups, or grant funded and investigator-initiated. Provides leadership in the management and operation of clinical research protocols to ensure research participant recruitment and accrual, protocol compliance, research participant safety and data quality.
The position will work closely with the members of the clinical research team to develop effective tools for close monitoring and reporting of trials accrual, and coordinate the timely study activation and submission of protocol amendments.
This position supports the Fox Chase Cancer Center Office of Clinical Research at Temple University Hospital, Main Campus or East Norriton and Buckingham Campuses.
In addition, this position is expected to interact with the institutional investigators, other members of the healthcare team, service line members and research participants/families in a manner, which supports the conduct of clinical trials.
Flexibility in work schedule, when possible, must be maintained to ensure coverage of study responsibilities.
EducationBachelors Degree (Required) Graduate Level Classes or Degree in a relevant program (Preferred) Combination of relevant education and experience may be considered in lieu of degree.
Experience2 Years direct experience in a healthcare setting preferably oncology or clinical trials or a minimum of 3 Years related experience (Required) General experience and knowledge of chemotherapy and/or radiation therapy administration (Preferred) Previous experience performing phlebotomy and specimen processing (Preferred) License/CertificationsCCRC - Cert Clin Research Coordinator (Preferred) or CCRP - Cert Clin Research Prof (Preferred) or ACRP-CP - Assn Clin Res Prof - Cert Prof (Preferred)_ Your Tomorrow is Here!Temple Health is a dynamic network of outstanding hospitals, specialty centers, and physician practices that is advancing the fight against disease, pushing the boundaries of medical science, and educating future healthcare professionals.
Temple Health consists of Temple University Hospital (TUH), Fox Chase Cancer Center, TUH-Jeanes Campus, TUH-Episcopal Campus, TUH-Northeastern Campus, Temple Physicians, Inc.
, and Temple Transport Team.
Temple Health is proudly affiliated with the Lewis Katz School of Medicine at Temple University.
To support this mission, Temple Health is continuously recruiting top talent to join its diverse, 10,000 strong workforce that fosters a healthy, safe and productive environment for its patients, visitors, students and colleagues alike.
At Temple Health, your tomorrow is here!Equal Opportunity Employer/Veterans/DisabledAn Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Your Tomorrow is Here! As one of the first cancer hospitals in the country, Fox Chase Cancer Center has been a national leader in cancer treatment, research, and prevention for more than 100 years.
Fox Chase Cancer Center, part of the Temple University Health System, is committed to providing the best treatment options for our patients, and delivering that care with compassion.
At Fox Chase, we consider defeating cancer to be our calling.
Our unique culture allows employees to work collaboratively with a single, shared focus, regardless of which department they're in.
It's essential for us to recruit not only the best talent in hospital care, but hire well-qualified prospective employees who are committed to serving our patients with the passion and excellence for which Fox Chase is known.
Apply today to be part of the future of prevailing over cancer.
Primary Location: Pennsylvania-PhiladelphiaJob: Research & ScienceSchedule: Full-time Shift: Day JobEmployee Status: Regular
Clinical Research Coordinator
Clinical Research Coordinator Job In Philadelphia, PA
Clinical Research Coordinator - (235932) Description Coordinates and facilitates the conduct of clinical research protocols which may be supported by NCI, industry, cooperative groups, or grant funded and investigator-initiated. Provides leadership in the management and operation of clinical research protocols to ensure research participant recruitment and accrual, protocol compliance, research participant safety and data quality.
The position will work closely with the members of the clinical research team to develop effective tools for close monitoring and reporting of trials accrual, and coordinate the timely study activation and submission of protocol amendments.
In addition, this position is expected to interact with the institutional investigators, other members of the healthcare team, service line members and research participants/families in a manner, which supports the conduct of clinical trials.
Flexibility in work schedule when possible must be maintained to ensure coverage of study responsibilities.
EducationBachelors Degree (Required) Graduate Level Classes or Degree in a relevant program (Preferred) Combination of relevant education and experience may be considered in lieu of degree Experience2 Years experience in a healthcare setting preferably oncology or clinical trials (Required)2 Years experience with oncology clinical trials.
(Preferred) General experience and knowledge of chemotherapy and/or radiation therapy administration (Preferred) License/CertificationsCCRC - Cert Clin Research Coordinator (Preferred) CCRP - Cert Clin Research Prof (Preferred) CCRA - Cert Clin Research Associate (Preferred)_ Your Tomorrow is Here!Temple Health is a dynamic network of outstanding hospitals, specialty centers, and physician practices that is advancing the fight against disease, pushing the boundaries of medical science, and educating future healthcare professionals.
Temple Health consists of Temple University Hospital (TUH), Fox Chase Cancer Center, TUH-Jeanes Campus, TUH-Episcopal Campus, TUH-Northeastern Campus, Temple Physicians, Inc.
, and Temple Transport Team.
Temple Health is proudly affiliated with the Lewis Katz School of Medicine at Temple University.
To support this mission, Temple Health is continuously recruiting top talent to join its diverse, 10,000 strong workforce that fosters a healthy, safe and productive environment for its patients, visitors, students and colleagues alike.
At Temple Health, your tomorrow is here!Equal Opportunity Employer/Veterans/DisabledAn Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Your Tomorrow is Here! As one of the first cancer hospitals in the country, Fox Chase Cancer Center has been a national leader in cancer treatment, research, and prevention for more than 100 years.
Fox Chase Cancer Center, part of the Temple University Health System, is committed to providing the best treatment options for our patients, and delivering that care with compassion.
At Fox Chase, we consider defeating cancer to be our calling.
Our unique culture allows employees to work collaboratively with a single, shared focus, regardless of which department they're in.
It's essential for us to recruit not only the best talent in hospital care, but hire well-qualified prospective employees who are committed to serving our patients with the passion and excellence for which Fox Chase is known.
Apply today to be part of the future of prevailing over cancer.
Primary Location: Pennsylvania-PhiladelphiaJob: Research & ScienceSchedule: Full-time Shift: Day JobEmployee Status: Regular