ICON Clinical Research Clinical Research Associate (Senior) in Newark, Delaware
- Mapi is a leading global organization, offering evaluation and support of therapeutic strategies. With offices worldwide, Mapi provides high quality and efficient operations to help our clients secure product approvals and reimbursement, as well as addressing post-marketing requirements and late phase needs, meeting the needs of patients, physicians, regulatory authorities and health care technology purchasers.*
Mapi is adding a Late-Phase Clinical Research Associate (CRA) II / SR to our team! With your Bachelor's Degree and four (4) years of CRA experience, we would like to talk to you today! The desired location of this position is the western region of the USA, or remote USA with travel to the west coast. Relocation assistance is not available. * *
This position is responsible for performing project activities associated with site management and monitoring in accordance with protocol specifications, applicable guidelines, regulatory requirements and SOPs. Require minimum supervision for assigned responsibilities.
- Additional Responsibilities and Accountabilities will include:*
Responsible for performing on-site visits (including PSSV, SIV, IMV, COV) and/or remote site management activities for assigned investigative sites.
Responsible for managing clinical and regulatory aspects of assigned sites to ensure compliance with protocol specifications, SOPs, applicable regulations and guidelines.
Responsible for providing timely and accurate visit reports.
Responsible for assisting in the writing or the review of project plans and templates, as required.
Responsible for ensuring the integrity of the data collected when Source Data Verification is performed.
Responsible for maintaining knowledge of GCP, GEP, GPP and all applicable Regulations as required.
Responsible for participating in sponsor or regulatory site audits/inspections including preparation, attendance and follow-up of audit findings.
Responsible for providing ongoing support to investigative sites to facilitate the conduct of the study.
Responsible for local ethics and regulatory submissions activities including consulting, performing submissions, feasibility, translation, local adaptation of documents for the assigned country(ies).
Responsible for participating in investigator meetings and presenting as required.
Four (4) year or equivalent college degree from an appropriately accredited institution, preferable in science, nursing, or applicable industry-related experience.
Four (4) years relevant clinical research experience in a pharmaceutical, biotechnology company, CRO or clinical research setting.
Minimum of two (2) years field monitoring experience required.
- Certification/License**: *ACRP or SOCRA (certification or eligibility preferred) or equivalent.
Strong knowledge of ICH/GCP guidelines or other relevant guidelines (GEP, GPP...) and local requirements.
Proficiency with computer/software systems. Strong verbal and written communication skills.
Strong organizational, time management, interpersonal, listening, conflict management and negotiation skills.
Ability to prioritize and coordinate multiple tasks and producing quality results in a timely manner with minimal supervision.
Ability to work both independently and in a team environment.* *
- /For non-native English speakers/**: *possess good skills in written and spoken English (for international projects).