Entry-Clinical Research Assistant/Onsite/Ich/Gcp/Bio

Clinical Research Assistant – A

33966 25-28.00 an hour w2 contract ONSITE long term 02/19/2024-  02/21/2025

 Entry-level position responsible for assisting the Clinical Research Associate in conducting Phase I - IV clinical studies according to ICH guidelines. The major role is to begin learning CRA work including verifying the content of critical regulatory documents, writing basic protocols, monitoring clinical sites, and reviewing case report forms (CRF's).1-3 Years Experience Level.

Clinical Trial Assistant (CTA) for the 65 Gannett Drive Portland location.

This role is 100 percent onsite-long term position. Not Remote or Hybrid Candidates. Cands with clinical experience are a plus, but recent grads with some biological specimen experience and direct or indirect experience with finance/accounting (overall organized!) with a willingness to learn are a good fit as well.

Will be providing general administrative support to the Medical, Clinical, Scientific Organization and assistance to department Manager(s) and Director(s). Candidate will support the Clinical Operations teams with ongoing conduct of studies.

Needs to be familiar with ICH GCP, Good Documentation Practices, appropriate regulations, relevant SOP’s and internal tracking systems.

Research or health care related academic or work experience preferable High Attention to Detail and good computer skills Looking to start selected candidate ASAP after screenings clear.

 Clinical Trial Assistant (CTA)

·        To provide general administrative support to the Medical, Clinical, Scientific Organization and assistance to department Manager(s) and Director(s).

·        To assist the Clinical Operations teams in completion of all required tasks to meet departmental and project goals.

·        To support the Clinical Operations teams with ongoing conduct of studies.

·        To be familiar with ICH GCP, Good Documentation Practices, appropriate regulations, relevant SOP’s and internal tracking systems.

·        To assist in tracking of clinical studies and site related purchase orders, invoice receipt, and facilitate creation of new vendors in the purchasing system.

·        To assist with reconciliation of payments and resolve discrepancies, if applicable.

·        To attend project team and department meetings and generate meeting minutes.

·        To assist in the production of slides, overheads, etc., as needed for project, departmental, and/or site training presentations.

·        To monitor and order study supply inventory.

·        To create kits for collection of samples for clinical studies.

·        Receive, log and store biological specimens.

·        Create shipments and complete customs paperwork for packages to external collaborators.

·        Enter data, run reports and perform QC of biological specimen database.

·        Other duties as assigned

QUALIFICATIONS/EXPERIENCE REQUIRED:

·        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.

·        Either relevant work experience or HS Diploma/Associate’s degree; Bachelor’s degree preferred(or equivalent).

·        Research or health care related academic or work experience preferable.

·        Good organizational skills, ability to manage multiple tasks and meticulous attention to detail.

·        Good written and verbal communication skills.

·        Good written and spoken English.

·        Computer literacy: e.g. Microsoft Word, Excel, PowerPoint, Outlook.

·        Willingness to travel for job related activities if required (expected travel for this position is < 10%).