Candidates must have Oncology monitoring experience to be considered.
The Senior Clinical Research Associate is responsible for performing monitoring and tracking study progress, thereby contributing to the overall management of clinical trials in accordance with the standards ICH-GCP and applicable local regulations and Standard Operating Procedures (SOPs). The job may include clinical lead activities as well as the mentoring and training of less senior CRAs. S/he is responsible for clinical study start-up, maintenance and closure activities, including maintenance of study documents. This role may be located remote (any location in the US).
- Interfaces with sponsor representatives and Synteract study team to ensure timely initiation and completion of clinical trials.
- Responsible for the identification, evaluation and qualification of investigators and sites.
- Prepares initial regulatory document packages necessary for clinical site initiation. Collects and reviews regulatory documents received from clinical sites to ensure all required documents are obtained, complete and in compliance with ICH-GCP and local regulations.
- May assist with the preparation, review and submission of all relevant regulatory documents to the appropriate Regulatory Authorities and IRB/IECs.
- Maintains Trial Master File (TMF) and/or Investigator site files for the duration of the study, ensuring essential documents are filed appropriately, and assisting in the file review and reconciliation process in preparation for audits and archival.
- Maintains and updates project-related data in an existing database, i.e. CTMS, EDMS, etc.
- Develops or contributes to the development of clinical documents (e.g. study manuals, plans and monitoring tools).
- Reviews Patient Information Sheet/Informed Consent Forms (PIS/ICFs) and/or data protection authorizations as required.
- Assists with the translation process of study documents.
- Assists with investigator/site contract preparation and negotiation.
- Coordinates and assists with feasibility studies.
- Performs on-site monitoring of clinical studies through review of Case Report Forms (CRFs) and study records in order to report trends in safety, ensure timely reporting of Adverse Events and compliance with protocols, local regulations, ICH-GCP and SOPs.
- Documents monitoring activities in monitoring reports and follow-up letters. Responsible for communicating issues in a timely manner.
- Responsible for site management. Duties include, but are not limited to, communicating directly with investigative sites to provide study direction, answer questions, assess study recruitment rates and respond to sponsor requests.
- Monitors and reports study progress/status on a site level.
- Assists with processing of clinical investigator payments, study expense reports and other financial items.
- Prepares or contributes to study related correspondence, including but not limited to, meeting minutes, tracking spreadsheets and the preparation of presentations.
- May attend and participate in bid defense meetings.
- Assists in the planning, organizing and executing of project-specific meetings including but not limited to, client meetings, CRA training meetings, and Investigator Meetings.
- May represent Synteract and Clinical Operations at study team meetings. May present at CRA Training Meetings and Investigator Meetings and may also assist with the organization of such meetings.
- Prepares sites for audit by sponsor or inspections by FDA or other Competent Authorities; participates in internal audit preparation; assists with audit responses.
- May manage and direct the clinical study activities and oversight of study clinical team; main point of contact for the sponsor and study team with regard to clinical information.
- Performs training and mentoring of Clinical Research Associates and site personnel.
Academic & Professional Qualifications:
- Bachelor’s degree in a life science or related field of study or equivalent combination of studies, nursing qualifications, and/or work experience.
- Minimum of 5 years relevant experience, to include substantial monitoring experience and the development of study-related documents. Must have oncology monitoring experience.
Skills & Experience:
- In-depth knowledge of ICH-GCP and state and local regulations, as applicable.
- Keeps abreast of regulatory requirements and scientific knowledge and maintains technical expertise by reading relevant publications, attending courses and through membership in relevant professional associations.
This position requires the ability to travel 50-75%.
What We Have to Offer
Our team-oriented organization is collaborative and diverse; our work is interesting and challenging; and every individual has an opportunity to thrive, grow, and achieve success in his or her position. We are proud of our reputation in the industry for quality services and specialized teams dedicated to meeting or exceeding client expectations
Who We Are
Synteract is a full-service contract research organization with a successful two-decade track record supporting biotechnology, medical device and pharmaceutical companies in all phases of clinical development. With our “Shared Work – Shared Vision” philosophy we provide customized Phase I through IV services collaboratively and cost effectively ensuring on-time delivery of quality data so clients get to decision points faster. Operating in 15 countries, we deliver trials internationally, offering expertise across multiple therapeutic areas including notable depth in oncology, CNS, infectious disease, endocrinology, cardiovascular and respiratory, among other indications.
Our mission is to support the innovation and development of better therapies in healthcare. Our focus on patients’ safety and comfort helps us to establish ethical standards for everything we do.
Synteract’s policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Applicants for positions with Synteract must be legally authorized to work in the country which they are applying and verification of employment eligibility will be required as a condition of hire.