39 Clinical Research Coordinator II Jobs in Philadelphia, PA
DM Clinical Research is Hiring a Clinical Research Coordinator II Near Philadelphia, PA
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.
- High School Diploma or equivalent required
- Bachelor's degree a preferred
- Foreign Medical Graduates preferred
- At least 2 years of experience as a CRC, preferably with practice coordinating industry-sponsored vaccines in a private setting.
- ACRP or equivalent certification is preferred
- 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
Job Summary
Full Time
$64k-84k (estimate)
07/04/2024
07/21/2024
dmclinicalresearch.com
Bryan, TX
50 - 100
Related Companies
The job skills required for Clinical Research Coordinator II include Clinical Research, Clinical Trial, Data Entry, SOP, etc. Having related job skills and expertise will give you an advantage when applying to be a Clinical Research Coordinator II. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Clinical Research Coordinator II. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Clinical Research Coordinator II positions, which can be used as a reference in future career path planning. As a Clinical Research Coordinator II, it can be promoted into senior positions as a Clinical Research Manager that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Clinical Research Coordinator II. You can explore the career advancement for a Clinical Research Coordinator II below and select your interested title to get hiring information.
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