Clinical Research Associate Job

CLINICAL RESEARCH ASSOCIATE needed for a contract opportunity with Yoh's client located in Philadelphia, PA.

What You'll Be Doing:
- Responsible for organizing, administering and overseeing clinical trials and performing clinical monitoring activities for more than 20 Faculty Sponsored IND Phase I/II clinical research studies to verify that the rights and well-being of human subjects are protected and that the reported trial data are accurate, complete, and verifiable from source documents.
- Responsible for the overall day to day management of assigned clinical trials including contributing to the preparation of clinical trial related documentation (case report forms, enrollment eligibility documentation, providing site staff training at SIV and throughout the study).
- Work closely with the assigned Project Manager during study start-up meetings, study site initiation meetings, and throughout the study in obtaining all required regulatory documents, Sponsor required documents, assuring they are complete and filed in accordance with GCP/ICH requirements.
- Communicate site study issues, concerns, and progress to Project Manager accordingly and follow-up to resolution.
- Maintain complete investigational product accountability records and perform 100% review during initial and ongoing monitoring visits.
- Conduct initial and interim monitoring visits according to the data safety monitoring plan (DSMP) and mandated regulatory requirements for all the assigned clinical trials following the Sponsor's SOPs and in accordance with GCP/ICH guidelines.
- Plan monitoring visits with clinical trial staff and provide updated calendars regarding monitoring site visits and follow-up visits.
- Complete 100% source data review of enrollment criteria and patient source data at clinical trial site, ensuring data entered into the CRF is verified, accurate, and complete.
- Work to help develop and implement corrective actions, CAPAs, resolution of audit findings when appropriate. Write and submit for management review, initial and interim monitoring visit reports, follow-up letters, and resolve all outstanding observations documented in an Observation Report according to Sponsor timeline requirements and DSPMs.
- Tracking the requirements for clinical trial material, reviewing ongoing clinical trial material accountability at site level, setting up and monitoring the systems in place for the investigator's documentation on maintaining procedures to account for the CT material, is applicable, checking the expiration of CT, and monitoring drug accountability logs.
- Be the point of first contact when investigators/site personnel enquire about patient inclusion/exclusion criteria for ongoing clinical trials.
- Participate in conference calls and meetings to review progress of ongoing clinical trials.
- Tracking completed CRFs and setting up systems whereby completed CRFs are rapidly entered into the database.
- Ensure that queries generated during cleaning are responded to in a timely fashion.

What You Need to Bring to the Table:
- Bachelor's degree in a Science or Healthcare related field; Bachelors of Science in Nursing preferred.
- FIVE (5) YEARS OF RELATED CLINICAL MONITORING EXPERIENCE AND/OR TRAINING, INCLUDING THREE (3+) YEARS AS A CRA
- EXPERIENCE IN THE PHARMACEUTICAL ENVIRONMENT IS A MUST.
- Requires extensive knowledge of ICH GCP, and Code of Federal Regulations (CFR) and clinical monitoring practices.
- Ability to organize, multi-task and manage a team with a strong attention to detail.
- Ability to work independently and exercise good judgment in planning and accomplishing goals.
- Ability to proactively identify issues and address with solutions-oriented approach.
- Excellent interpersonal, communication (verbal and written), organizational and staff management skills
- Ability to work well in a cross-functional environment that is team-oriented and collaborative.
- Ability to travel domestically up to 25% of the time.

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Krista Leach

Yoh, a DayJ2W: SCIENTIFIC

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